STEQEYMA

Package leaflet: Information for the user

Steqeyma 130 mg concentrate for solution for infusion

ustekinumab
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This leaflet has been written for people who take this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Steqeyma is and what it is used for
2. What you need to know before using Steqeyma
3. How to use Steqeyma
4. Possible side effects
5. How to store Steqeyma
6. Contents of the pack and other information

1. What Steqeyma is and what it is used for

What Steqeyma is
Steqeyma contains the active substance "ustekinumab", a monoclonal antibody. Monoclonal
antibodies are proteins that recognise and bind to specific proteins in the body.
Steqeyma belongs to a group of medicines called "immunosuppressants". These medicines
partially reduce the activity of the immune system.
What Steqeyma is used for
Steqeyma is used to treat the following inflammatory diseases:

• moderate to severe Crohn’s disease – in adults and children weighing at least 40 kg;

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be
treated with other medicines. If you do not respond adequately or are intolerant to these
medicines, Steqeyma may be given to you to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below)
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using Steqeyma.
Warnings and precautions
Talk to your doctor or pharmacist before using Steqeyma. Your doctor will check your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. In addition, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Steqeyma. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.

Be aware of serious side effects
Steqeyma can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Steqeyma. See “Serious side effects” in section 4 for a complete list of these side effects.

Before using Steqeyma, contact your doctor

• If you have ever had an allergic reaction to ustekinumab – ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Steqeyma partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or have recently had an infection or have abnormal openings in the skin (fistulas).
• If you have ever had any new or changing lesions within the area of psoriasis or on normal skin.
• If you are currently taking any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been studied. However, it may increase the possibility of conditions related to a weakened immune system.
• If you are using or have ever used injections for the treatment of allergies – it is not known whether ustekinumab may affect these.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with Steqeyma.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.

Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents
Steqeyma is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease, nor in children and adolescents, as it has not been studied in this age group.

Other medicines, vaccines, and Steqeyma
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Steqeyma.
• if you received Steqeyma during pregnancy, inform your child’s paediatrician about the Steqeyma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Steqeyma during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an adequate method of contraception during treatment with Steqeyma and for at least 15 weeks after stopping treatment with Steqeyma.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Steqeyma during pregnancy, your child may have an increased risk of developing infections.
• If you received Steqeyma during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Steqeyma during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Steqeyma. You cannot do both.

Driving and using machines
Steqeyma has no or negligible effect on the ability to drive vehicles or use machines.

Steqeyma contains sodium
Steqeyma contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free". However, before Steqeyma is administered, it is mixed with a solution containing sodium. Talk to your doctor if you are on a low-salt diet.

Steqeyma contains polysorbate 80
Steqeyma contains 10.37 mg of polysorbate 80 (E433) per dose, equivalent to 0.40 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

Steqeyma is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease.
Your doctor will administer Steqeyma 130 mg concentrate for solution for infusion through a drip into a vein in your arm (intravenous infusion) for at least one hour. Discuss with your doctor when you should have your injections and follow-up visits.

How much Steqeyma is administered

Your doctor will decide how much Steqeyma you need and for how long.

Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose based on body weight.

Body weight Dose
≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg Steqeyma as an injection under the skin (subcutaneous injection), followed by subsequent doses every 12 weeks.

Children with Crohn's disease weighing at least 40 kg

• Your doctor will calculate the recommended intravenous infusion dose based on body weight.

Body weight Dose
≥ 40 to ≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg Steqeyma as an injection under the skin (subcutaneous injection), followed by subsequent doses every 12 weeks.

How Steqeyma is administered

• The first dose of Steqeyma for the treatment of Crohn's disease is administered by your doctor via an intravenous drip into your arm (intravenous infusion). Inform your doctor if you have any questions about the use of Steqeyma.

If you forget to use Steqeyma

If you forget or miss your scheduled dose, contact your doctor to arrange a new appointment.

If you stop using Steqeyma

It is not dangerous to stop using Steqeyma. However, if you discontinue treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab
  (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing
  o low blood pressure, which may cause dizziness or a feeling of lightheadedness
  o swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Infusion-related reactions – If you are being treated for Crohn’s disease, your first dose of Steqeyma is administered via an intravenous infusion. Some patients have experienced severe allergic reactions during the infusion.
Rarely, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Steqeyma again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Steqeyma may reduce your body’s ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that typically occur in people with weakened immune systems (opportunistic infections). In patients treated with ustekinumab, opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported.

You should be alert for signs of infection while using Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbances or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which may lead to serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Steqeyma until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.

Other side effects

Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Blocked or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell’s palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Blistering skin rash, possibly with redness, itching, and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain)

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Steqeyma

• Steqeyma 130 mg concentrate for solution for infusion is administered in a hospital or clinic setting, and patients do not need to handle or store it.

• Keep this medicine out of the sight and reach of children.

• Store in a refrigerator (2 °C – 8 °C). Do not freeze.

• Keep the vial in the outer packaging to protect the medicine from light.

• If necessary, individual vials of Steqeyma may also be stored at room temperature up to 30 °C for a single period of up to 31 days, while remaining in the outer packaging to protect from light.
  Record the date when the vial is first removed from the refrigerator and the date when it should be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging.
  Once a vial has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Discard the vial if not used within 31 days at room temperature or by the original expiry date, whichever comes first.

• Do not shake the Steqeyma vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton following EXP or “Scad.”. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Steqeyma and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.
• If the seal is broken.

Steqeyma is for single use only. Any unused diluted solution for infusion remaining in the vial and syringe must be disposed of in accordance with local regulations.

6. Package contents and other information

What Steqeyma contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: disodium EDTA dihydrate (E385), L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Steqeyma and contents of the pack
Steqeyma is a concentrate for solution for infusion, from clear to slightly opalescent, from colourless to pale yellow. It is supplied in a cardboard pack containing one single dose in a 30 mL glass vial. Each vial contains 130 mg of ustekinumab in 26 mL of concentrate for solution for infusion.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1528 7418 Tel: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Teл.: + 36 1 231 0493 Tél/Tel: + 32 1528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: + 36 1 231 0493 Tel.: + 36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: + 31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
Kern Pharma, S.L. Astro-Pharma GmbH
Tel: +34 93 700 2525 Tel: +43 1 97 99 860

Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 Tel.: + 36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL
Tél.: +33 (0)1 71 25 27 00 LDA
Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: + 36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals.

Traceability
In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly documented.

Instructions for dilution
Steqeyma concentrate for solution for infusion must be diluted, prepared, and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of Steqeyma vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL vial of Steqeyma contains 130 mg of ustekinumab.
2. Withdraw and discard a volume of 9 mg/mL (0.9%) sodium chloride solution from the 250 mL infusion bag equal to the volume of Steqeyma to be added (discard 26 mL of sodium chloride for each required Steqeyma vial; for 2 vials, discard 52 mL; for 3 vials, discard 78 mL; for 4 vials, discard 104 mL).
3. Withdraw 26 mL of Steqeyma from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Mix gently.
4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration, or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within 48 hours of dilution in the infusion bag.
6. Use a single infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometres).
7. Each vial is for single use only, and any unused medicinal product must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution may be stored at room temperature up to 30 °C. The infusion must be completed within 48 hours of dilution in the infusion bag. Do not freeze.

Package leaflet: information for the user

Steqeyma 45 mg solution for injection

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are a parent or caregiver of a child who is to be given Steqeyma, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Steqeyma is and what it is used for
2. What you need to know before using Steqeyma
3. How to use Steqeyma
4. Possible side effects
5. How to store Steqeyma
6. Contents of the pack and other information

1. What Steqeyma is and what it is used for

What Steqeyma is
Steqeyma contains the active substance "ustekinumab", a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
Steqeyma belongs to a group of medicines called "immunosuppressants". These medicines reduce the activity of the immune system to some extent.

What Steqeyma is used for
Steqeyma is used to treat the following inflammatory diseases:

• plaque psoriasis – in adults and children from 6 years of age
• psoriatic arthritis – in adults
• moderately to severely active Crohn’s disease – in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails. Steqeyma will reduce inflammation and other signs of the disease.
Steqeyma is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or in whom these treatments are ineffective.
Steqeyma is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Steqeyma to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before using Steqeyma.
Warnings and precautions
Talk to your doctor or pharmacist before using Steqeyma. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Additionally, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Steqeyma. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Steqeyma can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Steqeyma. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Steqeyma, contact your doctor

• If you have ever had an allergic reaction to ustekinumab – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – This is because immunosuppressants like Steqeyma partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – The risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changed lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce immune system activity. The concurrent use of these therapies with ustekinumab has not been studied. However, it may increase the likelihood of conditions related to

weakening of the immune system.

• If you are using or have ever used injections for allergy treatment – It is not known whether ustekinumab may affect these treatments.
• If you are aged 65 years or older – You may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or
pharmacist before starting treatment with Steqeyma.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Steqeyma is not recommended for the treatment of children under 6 years of age with psoriasis, children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines, and Steqeyma
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Steqeyma.
• if you received Steqeyma during pregnancy, inform the child’s paediatrician about the Steqeyma treatment before the child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Steqeyma during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in utero, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Steqeyma and for at least 15 weeks after stopping treatment with Steqeyma.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Steqeyma during pregnancy, your child may have an increased risk of developing an infection.
• If you received Steqeyma during pregnancy, it is important to inform the child’s paediatrician and other healthcare providers before the child receives any vaccine. If you received Steqeyma during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether

you should breastfeed or use Steqeyma. You cannot do both.
Driving and using machines
Steqeyma has no or negligible influence on the ability to drive vehicles or operate machinery.
Steqeyma contains polysorbate 80
Steqeyma contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

Steqeyma is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Steqeyma is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive injections and subsequent follow-up
appointments.
How much Steqeyma is administered
Your doctor will decide how much Steqeyma you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Steqeyma. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor via an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by every 12 weeks via subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Steqeyma to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time of each dose administration.
• If body weight is below 60 kg, the recommended dose is 0.75 mg of Steqeyma per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Steqeyma.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Steqeyma.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor via an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by every 12 weeks via subcutaneous injection (subcutaneous route).

• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Steqeyma is administered

• Steqeyma is administered via subcutaneous injection (“subcutaneous route”). At the beginning of treatment, medical or nursing staff may administer Steqeyma to you.
• However, you and your doctor may decide whether you can self-inject Steqeyma. In this case, you will be trained on how to self-inject Steqeyma.
• For instructions on how to inject Steqeyma, see “Instructions for administration” at the end of this patient information leaflet.

Inform your doctor if you have any questions about self-injection.
If you use more Steqeyma than you should
If you have used or received too much Steqeyma, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.
If you forget to use Steqeyma
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.
If you stop using Steqeyma
Stopping treatment with Steqeyma is not dangerous. However, if you discontinue treatment, symptoms may return.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Some patients may experience serious side effects that may require urgent treatment.
Allergic reactions – these may require urgent treatment; therefore, contact your doctor or seek urgent medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, low blood pressure (which may cause dizziness or a feeling of lightheadedness), or swelling of the face, lips, mouth, or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.
If you experience a severe allergic reaction, your doctor may decide that you should no longer use Steqeyma.
Infections – these may require urgent treatment; therefore, contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Steqeyma may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that primarily occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be aware of signs of infection while using Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbances or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Steqeyma until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.
Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes accompanied by joint pain).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Steqeyma

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2 °C - 8 °C). Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• If necessary, individual vials of Steqeyma may be stored at room temperature up to 30 °C for a single period of up to 15 days, while remaining in the outer packaging to protect from light. Record the date when the vial is first removed from the refrigerator and the date when it should be discarded in the spaces provided on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a vial has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Discard the vial if not used within 15 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the Steqeyma vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Steqeyma and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been vigorously shaken.
• If the seal is broken.

Steqeyma is for single use only. Any unused product remaining in the vial and syringe must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Steqeyma contains

• The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Steqeyma and contents of the pack
Steqeyma is an injectable solution ranging from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. It is supplied in a cardboard pack containing 1 single dose in a 3 mL glass vial. Each vial contains a single dose of ustekinumab 45 mg in 0.5 mL of injectable solution.
Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary
Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: +32 1528 7418 Tel: +36 1 231 0493
[email protected]
България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Teл.: +36 1 231 0493 Tél/Tel: +32 1528 7418
[email protected]
Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493
Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]
Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: +31 20 888 7300
[email protected] [email protected]
Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]
España Österreich
Kern Pharma, S.L. Astro-Pharma GmbH
Tel: +34 93 700 2525 Tel: +43 1 97 99 860
Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 Tel.: +36 1 231 0493
France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL LDA
Tél.: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542
[email protected]
Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493
Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]
Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]
Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]
Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]
Latvija
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .
Instructions for administration
These instructions for administration contain information on how to inject Steqeyma from a vial.
Read these administration instructions before using Steqeyma. Do not perform
self-injection or administer to someone else before being shown how to inject
Steqeyma from a vial. The healthcare professional may demonstrate to you or to the person assisting you how to prepare, measure the dose, and correctly administer the Steqeyma injection before you do it yourself for the first time. Keep these administration instructions. If you have any doubts, contact your healthcare professional.
Steqeyma is used in adults and children from 6 years of age.
This Steqeyma vial is for single use only. It contains 45 mg of Steqeyma for subcutaneous injection (subcutaneous injection).
Important information

• Read all instructions carefully before using Steqeyma.
• Ask your healthcare professional how often you should inject the medicine.
• Before starting, check the package to ensure the dose is correct. If the dose is less than or equal to 45 mg, you will receive one 45 mg vial. If the dose is 90 mg, you will receive two 45 mg vials and you will need to administer two injections, one after the other.
• In children and adolescents (from 6 to 17 years of age), it is recommended that Steqeyma be administered by an adult or under adult supervision.
• Children with paediatric psoriasis weighing less than 60 kg require a dose lower than 45 mg.
• Always use the syringe provided by the pharmacist to ensure the correct amount of Steqeyma is measured.
• Check the expiry date printed on the vial and on the package. Do not use the medicine if the expiry date has passed. If the expiry date has passed, seek help from your doctor or pharmacist.
• Inspect the vial for particles or changes in colour. The vial should appear from clear to slightly opalescent and colourless to pale yellow, possibly with some white particles.
• Do not use Steqeyma if it has been frozen, if it has changed colour, is cloudy, or contains large particles. Obtain a new vial.
• To avoid needlestick injuries, do not reinsert the cap onto the needles.
• Immediately dispose of the used syringe and needle(s) after use.
• Do not use a Steqeyma vial more than once, even if some medicine remains inside. Once the rubber stopper has been pierced, Steqeyma may become contaminated with harmful bacteria, which could cause infection if reused. Therefore, discard any unused medicine after administering the Steqeyma injection.
• Dispose of (discard) used Steqeyma vials safely after use.
• Steqeyma is for subcutaneous use only. Do not inject Steqeyma into a vein.
• Do not mix Steqeyma with other injectable liquids.

Storage of Steqeyma

• Store unused Steqeyma vials in a refrigerator between 2 °C and 8 °C. If necessary, individual vials may be stored at room temperature up to 30 °C for a single period of up to 15 days in the original carton to protect from light. Discard the vial if not used within 15 days when stored at room temperature.
• Store Steqeyma in the original carton to protect it from light.
• Do not remove the Steqeyma vial from the original carton during storage.
• Do not shake the Steqeyma vial under any circumstances.
• Shaking the vial may damage the medicine. Do not use the vial if it has been shaken. Obtain a new vial.
• Do not heat the Steqeyma vial.
• Do not freeze the Steqeyma vial.
• Do not expose the Steqeyma vial to direct sunlight.
• Keep the Steqeyma vial and all medicines out of the sight and reach of children. It contains small parts.

Explanation of terms (see Figure A)

Vial
Syringe with needle
Figure A
Preparation for Steqeyma injection

1. Gather the materials for the injection.

a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
b. Remove from the refrigerator the carton containing the Steqeyma vial required for the prescribed dose.
c. Make sure you have the following items available (see Figure B):
­ Carton containing the Steqeyma vial
Not included in the package:
­ Syringe with needle
­ 2 alcohol swabs
­ Cotton ball or gauze pad
­ Adhesive bandage
­ Sharps disposal container
Note: A prescription from a healthcare provider may be required to purchase syringes with needles at a pharmacy.

Figure B

2. Check the expiry date shown on the carton (see Figure C).

Do not use the medicine if the expiry date has been exceeded. If the expiry date has
been exceeded, return the entire package to the pharmacy.

Figure C

3. Wait for 30 minutes.

a. Remove the box containing the Steqeyma vial from the refrigerator.
b. Leave the box at room temperature (20 °C–25 °C) for 30 minutes to allow it to warm up (see Figure D).
Do not warm the vial using heat sources such as hot water or a microwave.
If the vial does not reach room temperature, the injection may be uncomfortable and difficult to administer.

30 minutes
Figure D

4. Inspect the Steqeyma vial.

a. Check the vial and make sure you have the correct medicine (Steqeyma) and dosage.
b. Examine the vial and make sure it is not broken or damaged.
Do not use Steqeyma if the vial has fallen or is damaged.
c. Check the expiry date shown on the vial label (see Figure E).
Do not use Steqeyma if the expiry date has passed.

Figure E

5. Inspect the medicine.

a. Observe the medicine in the vial to ensure that the liquid is clear to slightly opalescent and colorless to pale yellow (see Figure F).
Do not use Steqeyma if the liquid has a changed color or is cloudy, or if it contains visible flakes or particles.

Figure F

6. Choose an appropriate injection site (see Figure G).

a. The injection may be administered:
­- in the upper thigh;
­- in the lower abdomen, except for the area within 5 cm of the navel;
­- in the outer area of the upper arm, if the injection is administered by a caregiver.

• Do not inject into moles, scars, bruised areas, or regions where the skin is painful, red, hard, or damaged. If possible, avoid skin areas affected by psoriasis.
• Do not administer the injection through clothing.

b. Select a different injection site each time, at least 2.5 cm away from the site used for the previous injection.

Figure G

7. Wash your hands.

a. Wash your hands with water and soap and dry them thoroughly (see Figure H).

Figure H

8. Clean the injection site.

a. Clean the area where the injection is to be given with an alcohol swab
using circular motions (see Figure I).
Allow the skin to dry before administering the injection. Do not touch the injection
site or blow on it before administering the injection.

Figure I

9. Remove the protective cap from the vial.

a. Remove the protective cap from the Steqeyma vial (see Figure J).
Do not remove the rubber stopper.

Figure J

10. Clean the rubber stopper.

a. Wipe the vial's rubber stopper with an alcohol swab and allow it
to dry.

• Do not touch the rubber stopper after cleaning it.
  b. Place the vial on a flat surface.

11. Remove the needle cap from the syringe.

a. Holding the syringe by the middle of the barrel with the needle pointing outward, pull
off the needle cap from the syringe.
b. Immediately dispose of the needle cap in a sharps disposal container (see Step 19. Disposal of Steqeyma).

• Do not reinsert the cap onto the syringe.
• Do not touch the needle and do not let the needle touch anything to avoid accidental needlestick.
• Do not use the syringe if it has been dropped without the needle cap in place. If this occurs, contact your doctor, nurse, or healthcare provider for further instructions.

12. Withdraw the correct dose.

a. Insert the needle through the rubber stopper of the vial.
b. While keeping the needle in the vial, turn the syringe and vial upside down (vial on top).
c. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is immersed in the liquid.

• It is important that the tip of the needle remains immersed in the liquid at all times to prevent air bubbles from entering the syringe.
  d. With the other hand, pull back the plunger to fill the syringe with the amount of liquid prescribed by the doctor (see Figure K).
• Fill the syringe until the black tip of the plunger aligns with the mark corresponding to the prescribed dose.

Figure K

13. Check for air bubbles.

• Do not remove the needle from the vial.
  a. With the syringe held upright and the needle pointing upward, check whether there are any air bubbles inside the syringe.
  b. If air bubbles are present, gently tap the side of the syringe to move them to the top of the syringe (see Figure L).
  c. Push the plunger to expel all air bubbles (but not the liquid).

• Do not place the syringe down and do not allow the needle to touch anything.

Figure L
Administration of Steqeyma injection

14. Insert the needle into the injection site.

a. Hold the syringe barrel with one hand between the thumb and index finger (see Figure M).
With the other hand, gently pinch the clean skin between the thumb and index finger. Do not squeeze
too tightly. Note: This step is important to ensure that the injection is administered under the skin (into the fatty tissue) and not deeper (into the muscle).
b. With a quick and firm motion, insert the needle completely into the skin fold at a 45-degree angle (see Figure M).

• Do not pull back the plunger under any circumstances.

Figure M

15. Perform the injection.

a. After inserting the needle, slowly and steadily push the plunger all the way down with your thumb. Gently pinch the skin.

• Make sure you have injected all the Steqeyma liquid (see Figure N).

Figure N

16. Remove the syringe from the injection site.

a. When the syringe is empty, release the skin fold and slowly remove the needle from the injection site (see Figure O).

• Do not reinsert the cap onto the used needle to avoid accidental needlestick injury.
• Do not reuse the syringe.
• Do not rub the injection site.

Figure O
After injection

17. Care of the injection site.

• Gently press an alcohol-soaked swab against the injection site for a few seconds after the injection. There may be a small amount of blood or fluid at the injection site. This is normal. If bleeding occurs, you may press a cotton ball or gauze pad against the injection site for 10 seconds. If needed, the injection site may be covered with a small adhesive bandage.

18. If the dose requires 2 injections, administer the second injection IMMEDIATELY.

• If the dose is 90 mg, you will receive two vials of 45 mg. The second injection must be administered immediately after the first.
  a. Repeat Steps 5–17 for the second injection using a new vial.
• Choose a different injection site for the second injection.

19. Disposal of Steqeyma.

a. Place the syringe into a sharps disposal container immediately after use (see Figure P).

• Do not dispose of the syringe in household waste. If you do not have a sharps disposal container, you may use a closeable, puncture-resistant household container.
• For your safety and the safety of others, needles and syringes must never be reused. Unused medicine and waste material from this medicine must be disposed of in accordance with local regulations.
• Do not throw any medicine into wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Figure P

Package leaflet: Information for the user

Steqeyma 45 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before using this medicine because it contains important
information for you.
This leaflet has been written for people who take this medicine. If you are the parent or caregiver of a child who is to be given Steqeyma, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if their symptoms seem identical to yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Steqeyma is and what it is used for
2. What you need to know before using Steqeyma
3. How to use Steqeyma
4. Possible adverse reactions
5. How to store Steqeyma
6. Contents of the pack and other information

1. What Steqeyma is and what it is used for

What Steqeyma is
Steqeyma contains the active substance "ustekinumab", a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
Steqeyma belongs to a group of medicines called "immunosuppressants". These medicines partially reduce the activity of the immune system.

What Steqeyma is used for
Steqeyma is used to treat the following inflammatory diseases:

• plaque psoriasis – in adults and children from 6 years of age
• psoriatic arthritis – in adults
• moderate to severe Crohn’s disease – in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails. Steqeyma will reduce inflammation and other signs of the disease.
Steqeyma is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate or phototherapy, or in whom these treatments have not worked.
Steqeyma is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Steqeyma to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you should know before using Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Steqeyma.

Warnings and precautions

Talk to your doctor or pharmacist before using Steqeyma. Your doctor will check your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. Also, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Steqeyma. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.

Be aware of serious side effects

Steqeyma may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Steqeyma. See “Serious side effects” in section 4 for a complete list of these side effects.

Before using Steqeyma, contact your doctor

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.

• If you have ever had any type of cancer – because immunosuppressants like Steqeyma partially weaken the immune system. This may increase the risk of cancer.

• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.

• If you have or have recently had an infection.

• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.

• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been studied. However, it could increase the likelihood of conditions related to immune system weakening.

• If you are using or have ever used allergy shots (injections for allergy treatment) – it is not known whether ustekinumab may affect them.

• If you are 65 years of age or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with Steqeyma.

During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on sun-exposed areas of skin, or if you experience joint pain.

Heart attack and stroke

In a study of patients with psoriasis treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensations on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents

Steqeyma is not recommended for the treatment of children under 6 years of age with psoriasis, for children with Crohn’s disease weighing less than 40 kg, or for children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.

Other medicines, vaccines, and Steqeyma

Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines,
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Steqeyma.
• if you received Steqeyma during pregnancy, inform your child’s paediatrician about the Steqeyma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Steqeyma during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Steqeyma and for at least 15 weeks after stopping treatment with Steqeyma.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Steqeyma during pregnancy, your baby may have an increased risk of developing an infection.
• If you received Steqeyma during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Steqeyma during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Steqeyma. You cannot do both.

Driving and using machines

Steqeyma has no effect or negligible effect on the ability to drive vehicles or operate machinery.

Steqeyma contains polysorbate 80

Steqeyma contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

Steqeyma is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Steqeyma is indicated.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive injections and subsequent follow-up
appointments.
How much Steqeyma is administered
Your doctor will decide how much Steqeyma you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Steqeyma. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor via intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by subcutaneous injections (subcutaneous route) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Steqeyma to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time each dose is given.
• A 45 mg vial is available for children requiring a dose lower than 45 mg.
• If body weight is below 60 kg, the recommended dose is 0.75 mg of Steqeyma per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Steqeyma.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Steqeyma.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn's disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor via intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by subcutaneous injections (subcutaneous route) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Steqeyma is administered

• Steqeyma is administered via subcutaneous injection ("subcutaneous route"). At the beginning of treatment, medical or nursing staff may administer Steqeyma to you.
• However, you and your doctor may decide whether you can self-inject Steqeyma. In this case, you will be trained on how to self-administer Steqeyma.
• For instructions on how to inject Steqeyma, see "Instructions for administration" at the end of this leaflet.

Inform your doctor if you have any questions regarding self-injection.
If you use more Steqeyma than you should
If you have used or received too much Steqeyma, inform your doctor or pharmacist immediately. Always
bring the outer packaging of the medicine with you, even if it is empty.
If you forget to use Steqeyma
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the
missed dose.
If you stop treatment with Steqeyma
Stopping treatment with Steqeyma is not dangerous. However, if you discontinue treatment, symptoms
may return.
If you have further questions about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs:

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
  • Difficulty breathing or swallowing
  • Low blood pressure, which may cause dizziness or a feeling of lightheadedness
  • Swelling of the face, lips, mouth, or throat
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Contact your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.

If you experience a severe allergic reaction, your doctor may decide that you should not use Steqeyma again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs:

• Nasal and throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue under the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Steqeyma may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.

You should be aware of the signs of infection while using Steqeyma. These include:

• Fever, flu-like symptoms, night sweats, weight loss
• Feeling tired or short of breath, persistent cough
• Warm, red, and painful skin, or a painful blistering rash
• Burning sensation when urinating
• Diarrhoea
• Vision problems or loss of vision
• Headache, neck stiffness, sensitivity to light, nausea, or confusion

Contact your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Steqeyma until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, contact your doctor immediately.

Other side effects

Common side effects (may affect up to 1 in 10 people)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (may affect up to 1 in 100 people)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (may affect up to 1 in 1,000 people)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (may affect up to 1 in 10,000 people)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on areas of skin exposed to sunlight, sometimes with joint pain)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Steqeyma

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, in the original packaging to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator in the space provided on the outer packaging. At any time before the end of this 31-day storage period at room temperature, the medicine may be returned to the refrigerator once, where it can be stored until the original expiration date. Discard the syringe if not used within 31 days at room temperature or by the original expiration date, whichever comes first.
• Do not shake the pre-filled syringes of Steqeyma. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and on the carton after EXP or Exp. The expiry date refers to the last day of the month.
• If the solution has changed colour, is cloudy, or if you see foreign particles floating in it

(see section 6 “Description of the appearance of Steqeyma and contents of the pack”).

• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

Steqeyma is for single use only. Any unused product remaining in the syringe must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Steqeyma contains

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Steqeyma and contents of the pack
Steqeyma is an injectable solution ranging from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains one dose of ustekinumab 45 mg in 0.5 mL of injectable solution.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: +32 1528 7418 Tel: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Tel.: +36 1 231 0493 Tél/Tel: +32 1528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: +31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
Kern Pharma, S.L. Astro-Pharma GmbH
Tel: +34 93 700 2525 Tel: +43 1 97 99 860

Ελλάδα Polska
VIANEX S.A. Celltrion Healthcare Hungary Kft.
Tel: +30 210 8009111 Tel.: +36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL LDA
Tél.: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Tel: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for administration
At the beginning of treatment, a healthcare professional will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Steqeyma. If so, you will be taught how to administer the injection yourself. Inform your doctor if you have any questions about self-injection.

Important information

• Do not open the sealed box until you are ready to use the pre-filled syringe.
• Do not remove the cap until it is time to administer the injection.
• Do not mix Steqeyma with other injectable liquids.
• The pre-filled syringe must not be reused. Immediately dispose of the used pre-filled syringe in a sharps disposal container (see Step 14. Disposal of Steqeyma).
• The shape of the syringe cap may vary depending on the supplied materials and may be flexible or rigid.

Storage of Steqeyma

• Keep the pre-filled syringe out of the sight and reach of children. It contains small parts.
• Store the pre-filled syringe in the refrigerator at 2 °C to 8 °C. Do not freeze.
• Keep this medicine in its original packaging, tightly closed, to protect it from light.
• If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, in the outer packaging to protect from light.
• Record the date when the pre-filled syringe is first removed from the refrigerator in the designated space on the outer packaging.
• At any time before the end of the room temperature storage period, the medicine may be returned to the refrigerator once only, where it can be stored until the original expiry date.
• Do not shake the pre-filled syringes of Steqeyma. Vigorous shaking may damage the medicine.
• Do not use the medicine if it has been shaken vigorously.
• Do not use the pre-filled syringe if it has been dropped.

Parts of the pre-filled syringe (see Figure A)
Before use After use

Plunger
Grip
View
window
Needle
Medicine
Needle
shield
Needle

Cap
Figure A
Preparing for injection

30
minutes

Administering the injection

After the injection

Package leaflet: Information for the user

Steqeyma 90 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.
This leaflet is intended for people taking this medicine. If you are a parent or caregiver administering Steqeyma to a child, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Steqeyma is and what it is used for
2. What you need to know before using Steqeyma
3. How to use Steqeyma
4. Possible side effects
5. How to store Steqeyma
6. Contents of the pack and other information

1. What Steqeyma is and what it is used for

What Steqeyma is
Steqeyma contains the active substance "ustekinumab", a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins in the body.
Steqeyma belongs to a group of medicines called "immunosuppressants". These medicines reduce the activity of the immune system to some extent.

What Steqeyma is used for
Steqeyma is used to treat the following inflammatory diseases:

• plaque psoriasis – in adults and children from 6 years of age
• psoriatic arthritis – in adults
• moderate to severe Crohn’s disease – in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Steqeyma will reduce inflammation and other signs of the disease.
Steqeyma is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments are ineffective.
Steqeyma is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who cannot tolerate phototherapy or other systemic therapies, or when these treatments have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis.
If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Steqeyma to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease.
If you have Crohn’s disease, you will first be treated with other medications. If you do not respond sufficiently or are intolerant to these medicines, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Steqeyma.
Warnings and precautions
Talk to your doctor or pharmacist before using Steqeyma. Your doctor will check your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. Additionally, inform your doctor if you have recently been in contact with someone who may have had tuberculosis. Your doctor will examine you and carry out tests for tuberculosis before administering Steqeyma. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Steqeyma can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Steqeyma. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Steqeyma, contact your doctor

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Steqeyma partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or have recently had an infection.
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments may also partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been

studied. However, it could increase the likelihood of conditions related to a weakened immune system.

• If you are currently using or have ever used injections for allergy treatment – it is not known whether ustekinumab may affect these.
• If you are aged 65 years or older – you may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Steqeyma.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Steqeyma is not recommended for the treatment of children under 6 years of age with psoriasis, children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines, and Steqeyma
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Steqeyma.
• if you received Steqeyma during pregnancy, inform your child’s paediatrician about the Steqeyma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Steqeyma during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• No increased risk of congenital malformations has been observed in newborns exposed to ustekinumab in utero. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.
• If you are of childbearing age, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Steqeyma and for at least 15 weeks after stopping treatment with Steqeyma.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Steqeyma during pregnancy, your child may have an increased risk of developing infections.
• If you received Steqeyma during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Steqeyma during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether to breastfeed or use Steqeyma. You cannot do both.

Driving and using machines
Steqeyma has no or negligible influence on the ability to drive or use machines.
Steqeyma contains polysorbate 80
Steqeyma contains 0.04 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

Steqeyma is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Steqeyma is indicated.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive your injections and follow-up
appointments.
Dose of Steqeyma administered
Your doctor will determine the appropriate dose of Steqeyma and the duration of treatment.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Steqeyma. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor via an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Steqeyma to be injected to ensure the correct dose is administered. The correct dose depends on the child’s body weight at the time each dose is given.
• A 45 mg vial is available for children requiring a dose lower than 45 mg.
• If body weight is below 60 kg, the recommended dose is 0.75 mg of Steqeyma per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Steqeyma.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Steqeyma.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor via an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Steqeyma is administered
Steqeyma is administered by subcutaneous injection (“subcutaneously”). At the beginning of
treatment, medical or nursing staff may administer Steqeyma to you.

• However, you and your doctor may decide whether you can self-inject Steqeyma. In this case, you will be trained on how to self-administer Steqeyma.
• For instructions on how to inject Steqeyma, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

If you use more Steqeyma than you should
If you have used or received too much Steqeyma, inform your doctor or pharmacist immediately. Always
bring the outer packaging of the medicine with you, even if it is empty.
If you forget to use Steqeyma
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a
missed dose.
If you stop using Steqeyma
Stopping treatment with Steqeyma is not dangerous. However, if you discontinue treatment, symptoms
may return.
If you have further questions about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek emergency medical help if you notice any of the following signs:

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness, or swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.

If you experience a severe allergic reaction, your doctor may decide that you should no longer use Steqeyma.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs:

• Nasal, throat infections, and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Steqeyma may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that primarily occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.

You should be alert for signs of infection while using Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• visual disturbances or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which can have serious complications. Contact your doctor if you have any type of infection that persists or keeps recurring. Your doctor may decide to stop Steqeyma until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.

Other side effects

Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on areas of skin exposed to sunlight, sometimes accompanied by joint pain)

Reporting of side effects

If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Steqeyma

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, in the original packaging to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator in the space provided on the outer packaging. At any time before the end of this 31-day storage period at room temperature, the medicine may be returned to the refrigerator once and stored there until the original expiry date. Discard the syringe if not used within 31 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Steqeyma. Vigorous and prolonged shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and on the carton after EXP or "Scad". The expiry date refers to the last day of the month.
• If the solution has changed colour, is cloudy, or if you see foreign particles floating in it (see section 6 “Description of the appearance of Steqeyma and contents of the container”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously. Steqeyma is for single use only. Any unused product remaining in the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Steqeyma contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Steqeyma and contents of the pack
Steqeyma is an injectable solution ranging from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains one dose of ustekinumab 90 mg in 1 mL of injectable solution.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: +32 1528 7418 Tel: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Tel.: +36 1 231 0493 Tél/Tel: +32 1528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: +31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
Kern Pharma, S.L. Astro-Pharma GmbH
Tel: +34 93 700 2525 Tel: +43 1 97 99 860

Polska
Ελλάδα Celltrion Healthcare Hungary Kft.
ΒΙΑΝΕΞ Α.Ε. Tel.: +36 1 231 0493
Τηλ: +30 210 8009111

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL
Tél: +33 (0)1 71 25 27 00 LDA
Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

Instructions for administration
At the beginning of treatment, a healthcare professional will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Steqeyma. If so, you will be taught how to administer the injection yourself. Inform your doctor if you have any questions about self-injecting.

Important information

• Do not open the sealed box until you are ready to use the pre-filled syringe.
• Do not remove the cap until it is time to administer the injection.
• Do not mix Steqeyma with other injectable liquids.
• The pre-filled syringe must not be reused. Immediately dispose of the used pre-filled syringe in a sharps disposal container (see Step 14. Disposal of Steqeyma).
• The shape of the syringe cap may vary depending on supplied materials and may be flexible or rigid.

Storage of Steqeyma

• Keep the pre-filled syringe out of the sight and reach of children. It contains small parts.
• Store the pre-filled syringe in a refrigerator at 2 °C to 8 °C. Do not freeze.
• Keep this medicine in its original closed packaging to protect it from light.
• If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, in the outer packaging to protect from light.
• Record the date when the pre-filled syringe is first removed from the refrigerator in the space provided on the outer packaging.
• At any time before the end of the room temperature storage period, the medicine may be returned to the refrigerator once only, where it can be stored until the original expiry date.
• Do not shake the pre-filled syringes of Steqeyma. Vigorous shaking may damage the medicine.
• Do not use the medicine if it has been vigorously shaken.
• Do not use the pre-filled syringe if it has been dropped.

Parts of the pre-filled syringe (see Figure A)
Before use After use

Plunger
Grip
View
Medicine window Needle
Needle
Cover

Needle

Cap
Figure A
Preparing for injection

Figure B

30
minutes

Administering the injection

After injection

Package leaflet: Information for the user

Steqeyma 45 mg solution for injection in pre-filled pen

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicinal product as it contains important information for you.
This leaflet has been written for people who are taking this medicinal product.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Steqeyma is and what it is used for
2. What you need to know before using Steqeyma
3. How to use Steqeyma
4. Possible side effects
5. How to store Steqeyma
6. Contents of the pack and other information

1. What Steqeyma is and what it is used for

What Steqeyma is
Steqeyma contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal
antibodies are proteins that recognise and bind to specific proteins in the body.
Steqeyma belongs to a group of medicines called “immunosuppressants”. These medicines partially reduce the activity of the immune system.

What Steqeyma is used for
Steqeyma administered via a pre-filled pen is used to treat the following inflammatory conditions:

• plaque psoriasis – in adults
• psoriatic arthritis – in adults
• moderate to severe Crohn’s disease – in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails. Steqeyma will reduce inflammation and other signs of the disease.
Steqeyma administered via a pre-filled pen is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or in whom these treatments are ineffective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Steqeyma to:

• reduce the signs and symptoms of the disease,
• improve physical function,
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond adequately or are intolerant to these medicines, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Steqeyma.
Warnings and precautions
Talk to your doctor or pharmacist before using Steqeyma. Your doctor will assess your health status before each treatment. Make sure to inform your doctor, before each treatment, about any medical conditions you have. In addition, inform your doctor if you have recently been in contact with people who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Steqeyma. If your doctor believes you are at risk for tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Steqeyma may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Steqeyma. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Steqeyma, contact your doctor

• If you have ever had an allergic reaction to ustekinumab – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – This is because immunosuppressants like Steqeyma partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – The risk of cancer may be higher.
• If you have or have recently had an infection.
• If you have ever had any new or changing skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce immune system activity. The concomitant use of these therapies with ustekinumab has not been studied. However, it may increase the possibility of conditions related to a weakened immune system.
• If you are using or have ever used allergy shots (injections for allergy treatment) – It is not known whether ustekinumab may affect these treatments.
• If you are 65 years of age or older – You may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Steqeyma.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
The Steqeyma pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children aged 6 years and older (and adolescents) with psoriasis, the pre-filled syringe or vial should be used instead. For children with Crohn’s disease weighing at least 40 kg, the infusion solution, vial, or pre-filled syringe should be used instead.
Steqeyma is not recommended for the treatment of children and adolescents under 18 years of age with psoriatic arthritis, or for children with Crohn’s disease weighing less than 40 kg, as it has not been studied in these populations.
Other medicines, vaccines, and Steqeyma
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) must not be administered while you are using Steqeyma.
• if you received Steqeyma during pregnancy, inform your child’s paediatrician about the Steqeyma treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Steqeyma during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise advised by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant. You should use an effective method of contraception during treatment with Steqeyma and for at least 15 weeks after stopping treatment with Steqeyma.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Steqeyma during pregnancy, your baby may have an increased risk of developing infections.
• If you received Steqeyma during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccines. If you received Steqeyma during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise advised by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Steqeyma. You cannot do both.

Driving and using machines
Steqeyma has no or negligible effect on the ability to drive vehicles or operate machinery.
Steqeyma contains polysorbate 80
Steqeyma contains 0.02 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

Steqeyma is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Steqeyma is indicated.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive your injections and follow-up visits.
How much Steqeyma is administered
Your doctor will decide how much Steqeyma you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Steqeyma. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor through an intravenous infusion into the arm (intravenous infusion). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by subcutaneous injections (subcutaneous route) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Steqeyma is administered

• Steqeyma is administered by subcutaneous injection (“subcutaneous route”). At the beginning of treatment, medical or nursing staff may administer Steqeyma to you.
• However, you and your doctor may decide whether you can self-inject Steqeyma. In this case, you will be taught how to self-administer Steqeyma.
• For instructions on how to inject Steqeyma, see “Instructions for administration” at the end of this leaflet.

Inform your doctor if you have any questions regarding self-injection.
If you use more Steqeyma than you should
If you have used or received too much Steqeyma, inform your doctor or pharmacist immediately. Always
bring the outer packaging of the medicine with you, even if it is empty.
If you forget to use Steqeyma
If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the
missed dose.
If you stop using Steqeyma
Stopping treatment with Steqeyma is not dangerous. However, if you discontinue treatment, symptoms
may return.
If you have further questions about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include: difficulty breathing or swallowing, low blood pressure (which may cause dizziness or lightheadedness), or swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Allergic lung reactions and lung inflammation have been reported rarely in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.

If you have a severe allergic reaction, your doctor may decide that you should no longer use Steqeyma.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue under the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Steqeyma may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.

You should be aware of signs of infection while using Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Steqeyma until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.

Other side effects

Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Blocked or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Blistering skin rash, possibly with redness, itching and pain (bullous pemphigoid)

• Cutaneous lupus or lupus-like syndrome (red, raised, scaly rash on sun-exposed areas of skin, sometimes associated with joint pain)

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Steqeyma

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Keep the pre-filled pen in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled pens of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, while remaining in the outer packaging to protect them from light. Record the date when the pre-filled pen is first removed from the refrigerator in the space provided on the outer packaging. At any time before the end of this 31-day room temperature storage period, the medicine may be returned to the refrigerator once, where it can be stored until the original expiry date. Dispose of the pre-filled pen if not used within 31 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the Steqeyma pre-filled pens. Vigorous and prolonged shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and box after EXP or Exp. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Steqeyma and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been vigorously shaken.

Steqeyma is for single use only. Any unused product remaining in the pre-filled pen must be discarded.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Steqeyma contains

• The active substance is ustekinumab. Each pre-filled pen contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Steqeyma and contents of the pack
Steqeyma is an injectable solution ranging from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain small translucent or white protein particles. It is supplied in a cardboard package containing one single dose in a 1 mL glass pre-filled pen. Each pre-filled pen contains one dose of ustekinumab 45 mg in 0.5 mL of injectable solution.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1528 7418 Tel: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Tel.: + 36 1 231 0493 Tél/Tel: + 32 1528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: + 36 1 231 0493 Tel.: + 36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: + 31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
Kern Pharma, S.L. Astro-Pharma GmbH
Tel: +34 93 700 2525 Tel: +43 1 97 99 860

Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 Tel.: + 36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL
Tél.: +33 (0)1 71 25 27 00 LDA
Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: + 36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for administration
At the beginning of treatment, your healthcare provider will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Steqeyma. In this case, you will be taught how to inject Steqeyma yourself. Inform your doctor if you have any questions about self-injection.

Important information

• Use the pre-filled pen only if your healthcare provider has provided instructions on the correct way to prepare and administer an injection. Do not attempt to self-inject without receiving proper training from your doctor.
• Do not reuse the pre-filled pen.
• Do not open the sealed box until you are ready to use the pre-filled pen.
• Do not remove the cap until the time of injection.
• Do not mix Steqeyma with other injectable liquids.
• Do not use the pre-filled pen if it is broken or damaged.
• Do not use the medicine after the expiry date has passed.
• Do not share the pre-filled pen with other people.
• The pre-filled pen cannot be reused. Immediately dispose of the used pre-filled pen in a sharps disposal container (see Step 15. Disposal of the pre-filled pen).

Storage of the pre-filled pen

• Keep the pre-filled pen out of sight and reach of children. This product contains small parts.
• Store the pre-filled pen in the refrigerator at 2 °C to 8 °C.
• Do not freeze the pre-filled pen.
• If necessary, individual pre-filled pens of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, in the outer packaging to protect from light.
• Record the date when the pre-filled pen is first removed from the refrigerator in the designated space on the outer packaging.
• At any time before the end of the room temperature storage period, the medicine may be returned to the refrigerator once only, where it can be stored until the original expiry date.
• Keep this medicine tightly closed in the original packaging to protect from light.
• Do not use the pre-filled pen if it has been exposed to direct sunlight.
• Do not shake the Steqeyma pre-filled pens. Vigorous shaking may damage the medicine.
• Do not use the medicine if it has been shaken.
• Do not use the pre-filled pen if it has fallen onto a hard surface.
• Always keep the pre-filled pen dry.

Parts of the Steqeyma pre-filled pen (see Figure A)

Figure A
Preparation for injection

1. Gather the injection materials.

a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
b. Remove the prefilled pen box from the refrigerator.

• Depending on the dose prescribed by the healthcare provider, you may need to prepare one or more prefilled pens and inject the contents of all of them.
  c. Make sure you have the following items available (see Figure B):
  • Box containing the prefilled pen
    Not included in the package:
  • Cotton ball or gauze
  • Alcohol swab
  • Adhesive bandage
  • Sharps disposal container

Figure B

2. Check the expiry date printed on the carton (see Figure C).

• Do not use after the expiry date. If the expiry date has been exceeded, return the entire package to the pharmacy.

Figure C

3. Wait for 30 minutes.

a. Open the box and remove the pre-filled pen.
b. Leave the pre-filled pen at room temperature (20 °C - 25 °C) for approximately 30 minutes to allow it to warm up (see Figure D).

• This will bring the liquid to a comfortable injection temperature (room temperature).
• Do not warm the pre-filled pen using heat sources such as hot water or microwave.

30
Figure D

4. Inspect the pre-filled pen.

a. Check the pre-filled pen and make sure you have the correct medicine (Steqeyma) and strength.
b. Check the pre-filled pens to ensure you have the correct number:

• if the dose is 45 mg, you will have one Steqeyma 45 mg pre-filled pen.
• if the dose is 90 mg, you will have two Steqeyma 45 mg pre-filled pens and you will need to administer two injections. Choose two different injection sites for these injections (for example, one injection in the right thigh and the other in the left thigh) and perform the injections one immediately after the other.
  c. Examine the pre-filled pen and make sure it is not cracked or damaged.
  d. Check the expiry date printed on the label of the pre-filled pen (see Figure E).
  • Do not shake the pre-filled pen.
  • Do not use the pre-filled pen if: it has fallen on a hard surface; it is cracked or damaged; the expiry date has passed.

Figure E

5. Inspect the medicine.

a. Examine the medicine to make sure the liquid is from clear to slightly opalescent,
colorless to pale yellow (see Figure F).

• Do not use the pre-filled pen if the liquid has a changed color, is cloudy, or contains large particles.
• Small air bubbles in the liquid may be visible. This is normal.

Figure F

6. Choose an injection site (see Figure G).

a. The injection can be administered:

• in the upper front part of the thigh;
• in the lower abdomen, except for the area within 5 cm around the navel;
• in the outer area of the upper arm, if the injection is administered by a caregiver assisting the patient.
  • Do not inject into moles, scars, bruises, or in areas where the skin is tender, red, hardened, or damaged. If possible, do not use skin areas showing signs of psoriasis.
  • Do not administer the injection through clothing.

b. Choose a different injection site each time, at least 2.5 cm away from the site used for the previous injection.

Figure G

7. Wash your hands.

a. Wash your hands with water and soap and dry them thoroughly (see Figure H).

Figure H

8. Clean the injection site.

a. Clean the injection site with an alcohol swab using circular motions (see Figure I).
b. Allow the skin to dry before administering the injection.

• Do not blow on or touch the injection site before administering the injection.

Figure I
Administration of the injection

9. Remove the cap.

a. Hold the pre-filled pen in one hand, gripping it by the body, with the cap still attached.
Gently pull the cap off with the other hand (see Figure J).

• Do not remove the cap until you are ready to perform the injection.
• It is normal to see a few drops of liquid at the needle tip.
• Do not touch the needle or the needle shield. Doing so may result in a needlestick injury, as the needle is located inside the shield.
• Inject STEQEYMA within 5 minutes after removing the cap.
• Do not reinsert the cap onto the pre-filled pen.
  b. Immediately dispose of the cap in a sharps disposal container (see Step 15 and Figure J).

Figure J

10. Place the prefilled pen at the injection site.

a. Hold the prefilled pen so that you can see the viewing window.
b. Without pinching or stretching the skin, place the prefilled pen at the injection site at a 90-degree angle (see Figure K).

Figure K

11. Administer the injection.

a. Press the pre-filled pen firmly against the skin. When the injection starts, you will hear
a first "click," and the purple plunger will begin to fill the viewing window (see Figure L).
b. Continue pressing the pre-filled pen firmly against the skin until you hear the
second "click" (see Figure L).

• Do not change the position of the pre-filled pen once the injection has started.

c. After hearing the second "click," continue to hold the pre-filled pen pressed firmly against the skin, and slowly count to 5 to ensure the full dose is injected.

1
2°
Figure L

12. Remove the prefilled pen from the injection site.

a. Look at the prefilled pen and make sure the purple plunger rod with the grey cap has completely filled the viewing window.

• It is normal to see the grey cap inside the viewing window.
• If the viewing window has not completely turned purple or if medicine is still being injected, this means a full dose has not been delivered. Contact the healthcare provider immediately.
  b. Remove the prefilled pen from the skin (see Figure M).
• After removing the prefilled pen from the injection site, the needle will automatically cover (see Figure N). Do not reinsert the cap onto the pen.
• Do not reuse the prefilled pen.
• Do not rub the injection site.

Figure M

Figure N

13. If the prescribed dose requires 2 injections, inject the second dose.

a. If you have two pre-filled pens of 45 mg for a 90 mg dose, immediately repeat steps 5 to 12.

• Administer the injections one right after the other.
• Choose a different injection site for the second injection.

After the injection

14. Care of the injection site.

a. If bleeding occurs, treat the injection site by gently pressing with a cotton ball or gauze without rubbing, and, if necessary, apply a plaster.

15. Disposal of the prefilled pen.

• Do not reinsert the cap onto the prefilled pen.
  a. Dispose of the used prefilled pen in a sharps disposal container as instructed by your doctor, nurse, or pharmacist (see Figure O).
  b. The alcohol swab and packaging may be discarded in household waste.
• Do not dispose of the prefilled pen in household waste.
• If you do not have a sharps disposal container, you may use a household container that:
  • is made of strong plastic,
  • can be securely closed with a puncture-resistant lid to prevent sharps from coming out,
  • remains upright and stable during use,
  • is leak-proof, and
  • is properly labeled to warn of hazardous waste inside.

Figure O

Package leaflet: Information for the user

Steqeyma 90 mg solution for injection in a pre-filled pen

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.
This leaflet has been written for people who take this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Steqeyma is and what it is used for
2. What you need to know before using Steqeyma
3. How to use Steqeyma
4. Possible side effects
5. How to store Steqeyma
6. Contents of the pack and other information

1. What Steqeyma is and what it is used for

What Steqeyma is
Steqeyma contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal
antibodies are proteins that recognise and bind to specific proteins in the body.
Steqeyma belongs to a group of medicines called “immunosuppressants”. These medicines partially reduce the activity of the immune system.

What Steqeyma is used for
Steqeyma administered via a pre-filled pen is used to treat the following inflammatory conditions:

• plaque psoriasis – in adults
• psoriatic arthritis – in adults
• moderate to severe Crohn’s disease – in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails. Steqeyma will reduce inflammation and other signs of the disease.
Steqeyma administered via a pre-filled pen is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or in whom these treatments are ineffective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given Steqeyma to:

• reduce signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be treated with other medications. If you do not respond adequately or are intolerant to these medicines, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using Steqeyma.
Warnings and precautions
Talk to your doctor or pharmacist before using Steqeyma. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any medical conditions you have before each treatment. Additionally, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Steqeyma. If your doctor believes you are at risk for tuberculosis, you may be given medication to treat tuberculosis.

Be aware of serious side effects
Steqeyma can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Steqeyma. See “Serious side effects” in section 4 for a complete list of these side effects.

Before using Steqeyma, contact your doctor

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Steqeyma partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological medicines (a medicinal product derived from a biological source and usually administered by injection) – the risk of cancer may be higher.
• If you currently have or have recently had an infection.
• If you have ever had any new or changing lesions within the area of psoriasis or on normal skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis – such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce immune system activity. The concurrent use of these therapies with ustekinumab has not been studied. However, it may increase the possibility of conditions related to a weakened immune system.
• If you are currently using or have previously used injections for allergy treatment – it is not known whether ustekinumab may affect these.
• If you are aged 65 years or older – you may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with Steqeyma.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.

Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or unusual sensation on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents
The Steqeyma pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children from 6 years of age (and adolescents) with psoriasis, the pre-filled syringe or vial should be used instead. For children with Crohn’s disease weighing at least 40 kg, infusion solution, vial, or pre-filled syringe should be used.
Steqeyma is not recommended for the treatment of children and adolescents under 18 years of age with psoriatic arthritis, or for children with Crohn’s disease weighing less than 40 kg, as it has not been studied in these populations.

Other medicines, vaccines, and Steqeyma
Inform your doctor or pharmacist:

• if you are taking, have recently taken, or might take any other medicines
• if you have recently been vaccinated or are scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Steqeyma.
• if you received Steqeyma during pregnancy, inform your child’s paediatrician about the Steqeyma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Steqeyma during pregnancy, live vaccines are not recommended for your child during the first twelve months of life, unless otherwise advised by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• A higher risk of congenital malformations has not been observed in newborns exposed to ustekinumab in utero. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Steqeyma and for at least 15 weeks after stopping treatment with Steqeyma.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Steqeyma during pregnancy, your baby may have an increased risk of developing infections.
• If you received Steqeyma during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Steqeyma during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Steqeyma. You cannot do both.

Driving and using machines
Steqeyma does not alter or has a negligible effect on the ability to drive vehicles or use machinery.
Steqeyma contains polysorbate 80
Steqeyma contains 0.04 mg of polysorbate 80 (E433) per dose, equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Steqeyma

Steqeyma is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Steqeyma is indicated.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive your injections and follow-up visits.

How much Steqeyma is administered

Your doctor will decide how much Steqeyma you need and for how long.

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Steqeyma. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by subsequent doses every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Steqeyma is administered by your doctor as an intravenous infusion (IV infusion) into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Steqeyma, followed by subsequent doses every 12 weeks via subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Steqeyma may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

How Steqeyma is administered

• Steqeyma is administered by subcutaneous injection (“subcutaneous route”). At the beginning of treatment, medical or nursing staff may administer Steqeyma to you.
• However, you and your doctor may decide whether you can self-inject Steqeyma. In this case, you will be trained on how to self-administer Steqeyma injections.
• For instructions on how to inject Steqeyma, see “Instructions for administration” at the end of this leaflet.

Inform your doctor if you have any questions regarding self-injection.

If you use more Steqeyma than you should

If you have used or received too much Steqeyma, inform your doctor or pharmacist immediately. Always bring the outer packaging of the medicine with you, even if it is empty.

If you forget to use Steqeyma

If you miss a dose, contact your doctor or pharmacist. Do not take a double dose to make up for the missed dose.

If you stop treatment with Steqeyma

Stopping treatment with Steqeyma is not dangerous. However, if you discontinue treatment, symptoms may return.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include:
  o difficulty breathing or swallowing, low blood pressure (which may cause dizziness or lightheadedness), or swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and lung inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.

If you experience a severe allergic reaction, your doctor may decide that you should not use Steqeyma again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, throat infections, and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients).
• Inflammation of the tissue beneath the skin ("cellulitis") is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Steqeyma may reduce your ability to fight infections. Some infections may become serious and may include those caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.

You should be aware of signs of infection while using Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful blistering rash
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea, or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Steqeyma until the infection resolves. Also inform your doctor if you have any cuts or open wounds that could become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, inform your doctor immediately.

Other side effects

Common side effects (affect up to 1 in 10 patients)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infections
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face ("facial paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis).
• Inflammation of small blood vessels, which may lead to a rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters, possibly with redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on sun-exposed areas of skin, sometimes accompanied by joint pain).

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Steqeyma

• Keep this medicine out of the sight and reach of children.
• Store in the refrigerator (2 °C - 8 °C). Do not freeze.
• Keep the pre-filled pen in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled pens of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, kept in the outer packaging to protect from light. Record the date when the pre-filled pen is first removed from the refrigerator in the space provided on the outer packaging. At any time before the end of this 31-day room temperature storage period, the medicine may be returned to the refrigerator once and stored there until the original expiry date. Discard the pre-filled pen if not used within 31 days at room temperature or by the original expiry date, whichever comes first.
• Do not shake the Steqeyma pre-filled pens. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Exp. The expiry date refers to the last day of the month.
• If the liquid has changed colour, is cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Steqeyma and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously.

Steqeyma is for single use only. Any unused product remaining in the pre-filled pen must be discarded.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Steqeyma contains

• The active substance is ustekinumab. Each pre-filled pen contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Steqeyma and contents of the pack
Steqeyma is an injectable solution ranging from clear to slightly opalescent (pearl-like appearance), colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing 1 single dose in a 1 mL glass pre-filled pen. Each pre-filled pen contains one dose of ustekinumab 90 mg in 1 mL of injectable solution.
Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary
Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1528 7418 Tel: +36 1 231 0493
[email protected]
България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Tel.: + 36 1 231 0493 Tél/Tel: + 32 1528 7418
[email protected]
Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: + 36 1 231 0493 Tel.: + 36 1 231 0493
Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd
Tlf.: +45 3535 2989 Tel: +356 2093 9800
[email protected]
Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 (0)30 346494150 Tel: + 31 20 888 7300
[email protected] [email protected]
Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]
España Österreich
Kern Pharma, S.L. Astro-Pharma GmbH
Tel: +34 93 700 2525 Tel: +43 1 97 99 860
Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 Tel.: + 36 1 231 0493
France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL
Tél.: +33 (0)1 71 25 27 00 LDA
Tel: +351 21 936 8542
[email protected]
Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: + 36 1 231 0493
Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]
Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]
Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]
Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]
Latvija
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .
Instructions for administration
At the beginning of treatment, your healthcare provider will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Steqeyma. If so, you will be taught how to inject yourself with Steqeyma. Inform your doctor if you have any questions about self-injection.
Important information

• Use the pre-filled pen only if your healthcare provider has given you instructions on the correct way to prepare and administer an injection. Do not attempt to self-inject without proper training from your doctor.
• Do not reuse the pre-filled pen.
• Do not open the sealed box until you are ready to use the pre-filled pen.
• Do not remove the cap until the time of injection.
• Do not mix Steqeyma with other injectable liquids.
• Do not use the pre-filled pen if it is broken or damaged.
• Do not use the medicine after the expiry date has passed.
• Do not share the pre-filled pen with other people.
• The pre-filled pen cannot be reused. Dispose of the used pre-filled pen immediately after use in a sharps disposal container (see Step 14. Disposal of the pre-filled pen).

Storage of the pre-filled pen

• Keep the pre-filled pen out of the sight and reach of children. This product contains small parts.
• Store the pre-filled pen in the refrigerator at 2 °C to 8 °C.
• Do not freeze the pre-filled pen.
• If necessary, individual pre-filled pens of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days, in the outer packaging to protect from light.
• Record the date when the pre-filled pen is first removed from the refrigerator in the designated space on the outer packaging.
• At any time before the end of the room temperature storage period, the medicine may be returned to the refrigerator once only, where it can be stored until the original expiry date.
• Store this medicine in its original closed packaging to protect it from light.
• Do not use the pre-filled pen if it has been exposed to direct sunlight.
• Do not shake the pre-filled pens of Steqeyma. Vigorous shaking may damage the medicine.
• Do not use the medicine if it has been shaken.
• Do not use the pre-filled pen if it has fallen on a hard surface.
• Always keep the pre-filled pen dry.

Parts of the Steqeyma pre-filled pen (see Figure A)

Figure A
Preparation for injection

1. Gather the materials for the injection.

a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
b. Remove one box containing the pre-filled pen from the refrigerator.
c. Make sure you have the following items available (see Figure B):

• Box containing the pre-filled pen Not included in the package:
• Cotton ball or gauze
• Alcohol swab
• Adhesive bandage
• Sharps disposal container

Figure B

2. Check the expiry date printed on the box (see Figure C).

• Do not use if the expiry date has been exceeded. If the expiry date has passed, return the entire package to the pharmacy.

Figure C

3. Wait for 30 minutes.

a. Open the box and remove the pre-filled pen.
b. Leave the pre-filled pen at room temperature (20 °C - 25 °C) for about 30 minutes to allow it to warm up
(see Figure D).

• This will bring the liquid to a comfortable injection temperature (room temperature).
• Do not heat the pre-filled pen using external heat sources such as warm water or a microwave.

30
Figure D

4. Inspect the prefilled pen.

a. Check the prefilled pen and make sure you have the correct medicine (Steqeyma) and dose:

• if the dose is 90 mg, you will have a Steqeyma 90 mg prefilled pen.
  b. Examine the prefilled pen and make sure it is not cracked or damaged.
  c. Check the expiration date printed on the label of the prefilled pen (see Figure E).
  • Do not shake the prefilled pen.
  • Do not use the prefilled pen if: it has been dropped on a hard surface; it is cracked or damaged; the expiration date has passed.

Figure E

5. Inspect the medicine.

a. Examine the medicine to make sure the liquid is from clear to slightly opalescent,
from colorless to pale yellow (see Figure F).

• Do not use the pre-filled pen if the liquid has changed color, is cloudy, or contains large particles.
• Small air bubbles in the liquid may be visible. This is normal.

Figure F

6. Choosing an injection site (see Figure G):

a. The injection can be administered:

• on the upper front part of the thigh;

• in the lower abdomen, except for the area within 5 cm of the navel;

• on the outer area of the upper arms, if the injection is administered by a caregiver.

  • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or damaged. If possible, do not use skin areas showing signs of psoriasis.
  • Do not administer the injection through clothing.

b. Select a different injection site each time, at least 2.5 cm away from the area used for the previous injection.

Figure G

7. Wash your hands.

a. Wash your hands with water and soap and dry them thoroughly (see Figure H).

Figure H

8. Clean the injection site.

a. Clean the injection site with an alcohol swab using circular motions (see Figure I).
b. Allow the skin to dry before administering the injection.

• Do not blow on or touch the injection site before administering the injection.

Figure I
Administration of the injection

9. Remove the cap.

a. Hold the pre-filled pen in one hand, gripping it by the body, with the cap still attached.
Gently pull off the cap using the other hand (see Figure J).

• Do not remove the cap until you are ready to administer the injection.
• It is normal to see a few drops of liquid at the needle tip.
• Do not touch the needle or the needle guard. Doing so may result in a needlestick injury, as the needle is located inside the guard.
• Inject Steqeyma within 5 minutes after removing the cap.
• Do not re-cap the pre-filled pen.
  b. Immediately dispose of the cap in a sharps disposal container (see Step 14 and Figure J).

Figure J

10. Place the prefilled pen on the injection site.

a. Hold the prefilled pen so that you can see the viewing window.
b. Without pinching or stretching the skin, place the prefilled pen on the injection site at a 90-degree angle (see Figure K).

Figure K

11. Administer the injection.

a. Press the pre-filled pen firmly against the skin. When the injection starts, you will hear
a first "click", and the purple plunger will begin to fill the viewing window (see Figure L).
b. Continue pressing the pre-filled pen firmly against the skin until you hear the
second "click" (see Figure L).

• Do not change the position of the pre-filled pen once the injection has started.

c. After hearing the second "click", continue to hold the pre-filled pen pressed firmly against
the skin and slowly count to 5 to ensure the full dose is injected.

1st
click
2nd
click
Figure L

12. Remove the prefilled pen from the injection site.

a. Look at the prefilled pen and make sure that the purple plunger rod with the gray cap has completely filled the viewing window.

• It is normal to see the gray cap inside the viewing window.
• If the viewing window has not completely turned purple or if medicine injection is still ongoing, a full dose has not been delivered. Contact your healthcare provider immediately.

b. Remove the prefilled pen from the skin (see Figure M).

• After removing the prefilled pen from the injection site, the needle will automatically cover (see Figure N). Do not reinsert the cap onto the pen.
• Do not reuse the prefilled pen.
• Do not rub the injection site.

Figure M

Figure N
After injection

13. Care of the injection site.

a. If bleeding occurs, treat the injection site by gently pressing with a cotton ball or gauze without rubbing, and, if necessary, apply a plaster.

14. Disposal of the pre-filled pen.

• Do not reinsert the cap onto the pre-filled pen.
  a. Dispose of the used pre-filled pen in a sharps disposal container as instructed by your doctor, nurse, or pharmacist (see Figure O).
  b. The alcohol swab and packaging may be discarded in household waste.
• Do not dispose of the pre-filled pen in household waste.
• If you do not have a sharps disposal container, you may use a household container that:
  • is made of heavy-duty plastic,
  • can be securely closed with a puncture-resistant lid to prevent sharp objects from escaping,
  • remains upright and stable during use,
  • is leak-proof, and
  • is properly labeled to warn of hazardous waste inside.

Figure O