Qoyvolma

Package leaflet: Information for the user

Qoyvolma 130 mg concentrate for solution for infusion

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

1. What Qoyvolma is and what it is used for

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

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

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

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, Qoyvolma may be given to reduce the signs and symptoms of your disease.

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

2. What you need to know before using Qoyvolma

Do not use Qoyvolma

• 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 Qoyvolma.
Warnings and precautions
Talk to your doctor or pharmacist before using Qoyvolma. 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 Qoyvolma. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.
Be aware of serious side effects
Qoyvolma may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Qoyvolma. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Qoyvolma, 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 Qoyvolma 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 currently have or have recently had an infection or have abnormal openings on the skin (fistulas).
• 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 may also partially reduce the activity of the immune system. 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 injections – it is not known whether ustekinumab may affect them.
• If you are aged 65 years or older – you may have a higher chance of getting 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 Qoyvolma.
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 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
Qoyvolma is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease, or in children and adolescents under 18 years of age with ulcerative colitis, as it has not been studied in these age groups.
Other medicines, vaccines, and Qoyvolma
Inform your doctor or pharmacist:

• if you are currently 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 Qoyvolma.
• if you received Qoyvolma during pregnancy, inform your child’s paediatrician about the Qoyvolma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Qoyvolma 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 Qoyvolma 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 Qoyvolma and for at least 15 weeks after stopping treatment with Qoyvolma.
• Ustekinumab can pass to the unborn child through the placenta. If you received Qoyvolma during pregnancy, your child may have an increased risk of developing an infection.
• If you received Qoyvolma 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 Qoyvolma 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 Qoyvolma. You cannot do both.

Driving and using machines
Qoyvolma does not affect or affects negligibly the ability to drive or use machines.
Qoyvolma contains sodium
Qoyvolma contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free".
However, before Qoyvolma is administered, it is mixed with a solution containing sodium. Talk to your doctor if you are on a low-salt diet.
Qoyvolma contains polysorbate 80
Qoyvolma 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 Qoyvolma

Qoyvolma is intended for use under the guidance and supervision of a physician experienced in
the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Qoyvolma 130 mg concentrate for solution for infusion will be administered by your doctor
through a drip into a vein in the arm (intravenous infusion) for at least one hour. Discuss with your
doctor when you should have your injections and follow-up appointments.
How much Qoyvolma is administered
Your doctor will decide how much Qoyvolma 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 of Qoyvolma as an injection under the skin (subcutaneous injection), then continue 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 of Qoyvolma as an injection under the skin (subcutaneous injection), then continue every 12 weeks.

How Qoyvolma is administered

• The first dose of Qoyvolma for the treatment of Crohn's disease or ulcerative colitis is administered by your doctor through a drip into a vein in the arm (intravenous infusion). Inform your doctor if you have any questions about the use of Qoyvolma.

If you forget to use Qoyvolma
If you forget or miss your scheduled dose appointment, contact your doctor to reschedule.
If you stop treatment with Qoyvolma
Stopping treatment with Qoyvolma is not dangerous. However, if you stop treatment, 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 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
immediate medical assistance 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).

Infusion-related reactions – If you are being treated for Crohn’s disease or ulcerative
colitis, your first dose of Qoyvolma is given 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 Qoyvolma again.
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).

Qoyvolma may reduce your ability to fight infections. Some infections may become severe and may include those caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur mainly 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 Qoyvolma. 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 Qoyvolma 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, you must 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 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 with possible 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 accompanied by 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 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 Qoyvolma

• Qoyvolma 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 Qoyvolma may also be stored at room temperature up to 30 °C for a single period of up to 31 days, within the outer packaging to protect them from light. Record the date when the vial is first removed from refrigeration 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 vials of Qoyvolma. 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 “Scad.”. The expiry date refers to the last day of the month.
• If the liquid has changed colour, appears cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Qoyvolma and contents of the container”).
• 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.

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

6. Package contents and other information

What Qoyvolma contains

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

Description of the appearance of Qoyvolma and contents of the pack
Qoyvolma 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 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
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 medicine is available on the European Medicines Agency website: https://www.ema.europa.eu .
The following information is intended for healthcare professionals only.
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.
Instructions for dilution.
Qoyvolma concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and number of Qoyvolma vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL vial of Qoyvolma contains 130 mg of ustekinumab.
2. Withdraw and discard a volume of 0.9% (9 mg/mL) sodium chloride solution from the 250 mL infusion bag equal to the volume of Qoyvolma to be added (discard 26 mL of sodium chloride for each required Qoyvolma vial; for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
3. Withdraw 26 mL of Qoyvolma 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 medicine 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 after dilution in the infusion bag. Do not freeze.

Package leaflet: Information for the user

Qoyvolma 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 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 responsible for administering Qoyvolma 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms appear similar to 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 Qoyvolma is and what it is used for
2. What you need to know before using Qoyvolma
3. How to use Qoyvolma
4. Possible side effects
5. How to store Qoyvolma
6. Contents of the pack and other information

1. What Qoyvolma is and what it is used for

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

What Qoyvolma is used for
Qoyvolma 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
• moderate to severe ulcerative colitis in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails. Qoyvolma will reduce
inflammation and other signs of the disease.
Qoyvolma is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine,
methotrexate or phototherapy, or in whom these treatments are ineffective.
Qoyvolma 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 Qoyvolma 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, Qoyvolma
may be given to reduce the signs and symptoms of your disease.

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

2. What you need to know before using Qoyvolma

Do not use Qoyvolma

• 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 Qoyvolma.
Warnings and precautions
Talk to your doctor or pharmacist before using Qoyvolma. 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
someone who may have had tuberculosis. Your doctor will examine you and perform tests for
tuberculosis before administering Qoyvolma. If your doctor believes you are at risk of tuberculosis,
you may be given medicines to treat tuberculosis.

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

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

Heart attack and stroke
In a study of psoriasis patients 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
Qoyvolma is not recommended for the treatment of children with psoriasis under 6 years of age,
children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with
psoriatic arthritis or ulcerative colitis, as it has not been studied in these age groups.

Other medicines, vaccines, and Qoyvolma
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 due to be vaccinated. Some types of vaccines (live vaccines) must not be given while you are using Qoyvolma.
• if you received Qoyvolma during pregnancy, inform the paediatrician of your child about the Qoyvolma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Qoyvolma 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 might 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 Qoyvolma 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 Qoyvolma and for at least 15 weeks after stopping treatment with Qoyvolma.
• Ustekinumab can pass to the unborn child through the placenta. If you received Qoyvolma during pregnancy, your child may have an increased risk of developing an infection.
• If you received Qoyvolma during pregnancy, it is important that you inform the paediatrician and other healthcare providers before your child receives any vaccine. If you received Qoyvolma 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 Qoyvolma. You cannot do both.

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

Qoyvolma contains polysorbate 80
Qoyvolma 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 Qoyvolma

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

How much Qoyvolma is administered

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Qoyvolma. Patients with a body weight greater 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 thereafter. Subsequent doses are usually the same as the initial dose.

Crohn’s disease or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Qoyvolma is administered by your doctor via intravenous infusion (a drip into the vein of the arm). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Qoyvolma, followed by subcutaneous injection (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Qoyvolma 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

There is no Qoyvolma formulation available for children with plaque psoriasis weighing less than 60 kg; therefore, other ustekinumab-containing products must be used.

• Your doctor will calculate the correct dose, including the amount (volume) of Qoyvolma 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 administration.
• If body weight is below 60 kg, Qoyvolma formulation is not available and other ustekinumab-containing products must be used.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Qoyvolma.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Qoyvolma.
• Four weeks after the initial dose, the next dose should be administered, followed by every 12 weeks thereafter.

Children weighing at least 40 kg

Crohn’s disease

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

How Qoyvolma is administered

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

Inform your doctor if you have any questions regarding self-injection.
If you use more Qoyvolma than you should
If you have used or received too much Qoyvolma, 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 Qoyvolma
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 Qoyvolma
It is not dangerous to stop using Qoyvolma. 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 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
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 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
Qoyvolma.
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 type of painful blistering rash) is uncommon (affects up to 1 in 100 patients).

Qoyvolma may reduce your ability to fight infections. Some infections may become severe and may include those caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that occur mainly 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 Qoyvolma. 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 disturbance 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 Qoyvolma 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, you must 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 (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 Qoyvolma

• 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 syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Qoyvolma 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 them from light. Record the date when the pre-filled syringe 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 syringe has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. 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 Qoyvolma. Vigorous and prolonged 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 Qoyvolma and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been vigorously shaken. Qoyvolma 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Qoyvolma contains

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

Description of the appearance of Qoyvolma and contents of the pack
Qoyvolma is a solution for injection that is 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 a dose of ustekinumab 45 mg in 0.5 mL of solution for injection.

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
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 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 your first injection. However, you and your doctor may decide whether you can self-inject Qoyvolma. If so, you will be taught how to inject yourself with Qoyvolma. Inform your doctor if you have any questions about self-injecting.

Important information

• Do not open the sealed carton 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 Qoyvolma 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 Qoyvolma).

Storage of Qoyvolma

• 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 closed packaging to protect it from light.
• If necessary, individual pre-filled syringes of Qoyvolma may also be stored at room temperature up to 30 °C for a single period of up to 31 days, in the outer packaging to protect from light.
• Do not shake the pre-filled syringes of Qoyvolma. 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
Medicine Needle
Needle
Shield
Cap
Figure A
Preparing 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 from the refrigerator the cartons containing the prefilled syringes needed to administer the prescribed dose.
c. Make sure you have the following items available (see Figure B):

• Carton containing the prefilled syringe Not included in the carton:
• Cotton ball or gauze pad

• Adhesive bandage

• Sharps disposal container
• Alcohol swab

Figure B

2. Check the expiry date stated on the carton (see

Figure C).

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

Figure C

3. Wait 30 minutes.

a. Open the carton. Holding the syringe barrel, remove the 30 prefilled syringe
from the carton.
minutes b. Leave the prefilled syringe outside the carton for approximately 30 minutes at
room temperature (20 °C - 25 °C) 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 prefilled syringe using heat sources such as hot water or a microwave.
• Do not handle the syringe by the plunger head, plunger, needle guard wings, or needle protective cap.
• Do not pull back the plunger under any circumstances.

Figure D

4. Inspect the prefilled syringe.

a. Check the prefilled syringe and make sure you have the correct medicine
(Qoyvolma) and correct dosage.
b. Check the prefilled syringes to ensure the number and dosage are correct.

• If the dose is 45 mg, you will have one 45 mg Qoyvolma prefilled syringe.
• If the dose is 90 mg, you will have two 45 mg Qoyvolma prefilled syringes and you will need to administer two injections. Choose two different injection sites for these injections (e.g., 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 prefilled syringe and make sure it is not broken or Figure E damaged.
  d. Check the expiry date on the label of the prefilled syringe (see Figure E).
• Do not use if the expiry date has been exceeded.
• Do not shake the prefilled syringe.

5. Inspect the medicine.

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

• Do not use the pre-filled syringe if the liquid is discoloured or cloudy.

• Air bubbles in the liquid may be visible. This is normal.

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 assisting the patient.

• D o not administer the injection into moles, scars, bruises, or areas where the skin is tender, red, hardened, or damaged. If possible, avoid areas of skin affected by psoriasis.

• D o not inject 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 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. Remove the needle protective cap when ready to inject Qoyvolma, holding the pre-filled syringe body with one hand between thumb and index finger (see Figure J).

• Do not grasp the plunger when removing the cap.
• You may notice air bubbles inside the pre-filled syringe or a few drops of liquid at the needle tip. This is normal.
  b. Immediately dispose of the cap into a sharps disposal container (see Step 14 and Figure J).
• Do not use the pre-filled syringe if it has been dropped without the needle protective cap in place. If this occurs, contact your doctor or pharmacist. Figure J
• Inject the dose immediately after removing the needle protective cap.
• Do not reinsert the cap onto the pre-filled syringe.
• Do not touch the needle to avoid accidental needlestick injury.

10. Insert the pre-filled syringe into the injection site.

a. Hold the body of the pre-filled syringe in one hand between the thumb and
index finger.
b. With the other hand, gently pinch the skin between the thumb and
index finger. Do not squeeze too firmly.
Note: This step is important to ensure that the injection is administered under the skin (into the fatty tissue) and not too deeply (into the muscle).
c. With a quick and firm motion, insert the needle completely into the skin fold at an angle of 45 degrees (see Figure K).

• Do not pull back the plunger under any circumstances.

O
Figure K

11. Administer the injection.

a. After inserting the needle, release the skin.

b. Slowly and completely push the plunger until the full dose of medicine has been injected and the syringe is empty (see Figure L).

• Do not change the position of the pre-filled syringe after starting the injection.
• If the plunger is not fully depressed, the needle shield will not extend to cover the needle upon removal.

Figure L

12. Remove the pre-filled syringe from the injection site.

a. When the pre-filled syringe is empty, slowly remove the needle
by lifting the thumb off the plunger until the needle is
fully covered by the safety shield (see Figure M).

• If the needle does not become covered, carefully dispose of the syringe (see Step 14. Disposal of Qoyvolma).
• Do not reuse the pre-filled syringe.
• Do not rub the injection site.

Figure M
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 Qoyvolma.

a. Place the prefilled syringe into a sharps disposal container immediately after use (see Figure N).
b. Do not dispose of the prefilled syringe in household waste.

• If a sharps disposal container is not available, a puncture-resistant, sealable household container may be used.
• 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 flush any medicine down the toilet or pour it into household waste. Ask your pharmacist how to dispose of medicines you no longer use (Figure N). This will help protect the environment.

Package leaflet: Information for the user

Qoyvolma 90 mg solution for injection in pre-filled syringe

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 is intended for people taking this medicine. If you are a parent or caregiver administering Qoyvolma 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 Qoyvolma is and what it is used for
2. What you need to know before using Qoyvolma
3. How to use Qoyvolma
4. Possible side effects
5. How to store Qoyvolma
6. Package contents and other information

1. What Qoyvolma is and what it is used for

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

What Qoyvolma is used for
Qoyvolma 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
• moderate to severe ulcerative colitis – in adults

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Qoyvolma will reduce inflammation and other signs of the disease.
Qoyvolma is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or in whom these treatments are ineffective.
Qoyvolma 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 Qoyvolma 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 medicines. If you do not respond sufficiently or are intolerant to these medicines, Qoyvolma may be given to reduce the signs and symptoms of your disease.

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

2. What you need to know before using Qoyvolma

Do not use Qoyvolma

• 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, speak with your doctor or
pharmacist before using Qoyvolma.
Warnings and precautions
Talk to your doctor or pharmacist before using Qoyvolma. Your doctor will check your health status
before each treatment. Make sure to inform your doctor, before each treatment, about any diseases 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 perform tests for tuberculosis before giving
you Qoyvolma. If your doctor believes you are at risk of tuberculosis, you may be given medicines to
treat it.
Be aware of serious side effects
Qoyvolma can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Qoyvolma. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Qoyvolma, 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 Qoyvolma 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 concurrent use of these therapies with ustekinumab has not been studied. However, it may increase the likelihood of conditions related to a weakened immune system.
• If you are using or have ever used allergy injections – it is not known whether ustekinumab may affect them.
• If you are aged 65 years or older – you may have a higher chance of getting 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 Qoyvolma.
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
Qoyvolma is not recommended for the treatment of children with psoriasis under 6 years of age,
children with Crohn’s disease weighing less than 40 kg, or for the treatment of children under 18
years of age with psoriatic arthritis or ulcerative colitis, as it has not been studied in these age groups.
Other medicines, vaccines, and Qoyvolma
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 due to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Qoyvolma.
• if you received Qoyvolma during pregnancy, inform your child’s paediatrician about the Qoyvolma treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Qoyvolma 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, 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 Qoyvolma 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 Qoyvolma and for at least 15 weeks after stopping treatment with Qoyvolma.

• Ustekinumab can cross the placenta and reach the unborn child. If you received Qoyvolma during pregnancy, your baby may have an increased risk of developing an infection.

• If you received Qoyvolma 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 Qoyvolma 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 Qoyvolma. You cannot do both.

Driving and using machines
Qoyvolma has no effect or negligible effect on the ability to drive vehicles or use machinery.
Qoyvolma contains polysorbate 80
Qoyvolma 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 Qoyvolma

Qoyvolma is intended for use under the guidance and supervision of a physician experienced in the
treatment of the conditions for which Qoyvolma 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 Qoyvolma is administered
Your doctor will decide how much Qoyvolma you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Qoyvolma. 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 or ulcerative colitis

• During treatment, the first dose of approximately 6 mg/kg of Qoyvolma is administered by your doctor via intravenous infusion into the arm (intravenous infusion). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Qoyvolma, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Qoyvolma 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
There is no Qoyvolma formulation available for children with plaque psoriasis weighing less than
60 kg; therefore, other ustekinumab-containing products must be used.

• Your doctor will calculate the correct dose, including the amount (volume) of Qoyvolma 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 administration.
• If body weight is below 60 kg, a Qoyvolma formulation is not available and other ustekinumab-based products must be used.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Qoyvolma.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Qoyvolma.
• 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 Qoyvolma is administered by your doctor via intravenous infusion into the arm (intravenous infusion). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Qoyvolma, followed by subcutaneous injections (under the skin) every 12 weeks.
• In some patients, after the first subcutaneous injection, the 90 mg dose of Qoyvolma may be administered every 8 weeks. Your doctor will decide when the next dose should be administered.

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

• However, you and your doctor may decide whether you can self-inject Qoyvolma. In this case, you will be trained on how to self-inject Qoyvolma.
• For instructions on how to inject Qoyvolma, 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 Qoyvolma than you should
If you have used or received too much Qoyvolma, 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 Qoyvolma
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 Qoyvolma
It is not dangerous to discontinue the use of Qoyvolma. However, if you stop 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, 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 not use
Qoyvolma 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 skin and underlying tissue ("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).

Qoyvolma 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 Qoyvolma. 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 disturbance 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 serious 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 Qoyvolma 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 areas of skin exposed to sunlight, sometimes accompanied by 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 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 Qoyvolma

• 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 syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Qoyvolma may also be stored at room temperature up to 30 °C for a single period of up to 31 days, kept within the outer packaging to protect from light. Record the date when the pre-filled syringe 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 syringe has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Dispose of 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 Qoyvolma. Vigorous and prolonged 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 you see foreign particles floating in it (see section 6 “Description of the appearance of Qoyvolma and contents of the container”).
• 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. Qoyvolma 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 Qoyvolma 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 Qoyvolma and contents of the pack
Qoyvolma is a solution for injection, from clear to slightly opalescent (pearl-like appearance), from colourless to pale yellow. The solution may contain a few small translucent or white protein particles. It is supplied in a cardboard pack containing one single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains a single dose of 90 mg ustekinumab in 1 mL of solution for injection.

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
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

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 your first injection. However, you and your doctor may decide whether you can self-inject Qoyvolma. If so, you will be taught how to inject yourself with Qoyvolma. Inform your doctor if you have any questions about self-injection.

Important information

• Do not open the sealed carton until you are ready to use the pre-filled syringe.
• Do not remove the cap until the time of injection.
• Do not mix Qoyvolma 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 Qoyvolma).

Storage of Qoyvolma

• 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 closed packaging to protect it from light.
• If necessary, individual pre-filled syringes of Qoyvolma may also be stored at room temperature up to 30 °C for a single period of up to 31 days, within the outer packaging to protect from light.
• Do not shake the pre-filled syringes of Qoyvolma. 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

1. Gather the materials for injection

a. Prepare a clean, flat surface, such as a table or


countertop, in a well-lit area.
b. Remove from the refrigerator the cartons containing the prefilled syringes needed to administer the prescribed dose.
c. Make sure you have the following items available (see Figure B):

• Carton containing the prefilled syringe Not included in the carton:
• Cotton ball or gauze pad

• Adhesive bandage

• Sharps disposal container
• Alcohol swab

Figure B

2. Check the expiry date stated on the carton (see

Figure C).

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

Figure C

3. Wait for 30 minutes.

a. Open the carton. Holding the body of the syringe, remove the
30
prefilled syringe from the carton.
minutes b. Leave the prefilled syringe outside the carton for about
30 minutes at room temperature (20 °C - 25 °C) so it warms up (see Figure D).

• This allows the liquid to reach a comfortable injection temperature (room temperature).

• Do not heat the prefilled syringe using heat sources such as hot water or microwave.
• Do not touch the syringe by the plunger head, plunger, needle guard wings, or needle protective cap. Figure D
• Do not pull back the plunger under any circumstances.

4. Inspect the pre-filled syringe.

a. Check the pre-filled syringe and make sure you have the correct medicine

(Qoyvolma) and correct dosage.
b. Check the pre-filled syringes to ensure the number and
dosage are correct.

• If the dose is 90 mg, you will have one 90 mg pre-filled syringe of Qoyvolma.
  c. Examine the pre-filled syringe and make sure it is not broken or damaged.
  d. Check the expiry date shown on the label of the pre-filled syringe (see Figure E).
• Do not use if the expiry date has been exceeded.
• Do not shake the pre-filled syringe.

Figure E

5. Inspect the medicine.

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

• Do not use the pre-filled syringe if the liquid has changed color or is cloudy.
• Air bubbles in the liquid may be visible. This is normal.

Figure F

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

a. The injection can be administered:

• in the upper thigh;
• in the lower abdomen, except for the area within 5 cm around the navel;
• on the outer area of the upper arm, if

the injection is given by the person assisting.

• Do not inject into moles, scars, bruised areas, or in areas where the skin is painful, red, hard, or not intact. If possible, avoid skin areas with 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 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 touch the injection site or blow on it before administering the injection.

Figure I
Administration of the injection

9. Remove the cap.

a. Remove the needle protective cap when ready to inject Qoyvolma, holding the pre-filled syringe body with one hand between thumb and index finger (see Figure J).

• Do not grasp the plunger when removing the cap.
• You may notice air bubbles inside the pre-filled syringe or a few drops of liquid at the needle tip. This is normal.
  b. Immediately dispose of the cap into a sharps disposal container (see Step 14 and Figure J).
• Do not use the pre-filled syringe if it has been dropped without the needle protective cap in place. If this happens, contact your doctor or pharmacist. Figure J • Inject the dose immediately after removing the needle protective cap.
• Do not reinsert the cap onto the pre-filled syringe.
• Do not touch the needle to avoid accidental needlestick injury.

10. Insert the pre-filled syringe into the injection site.

a. Hold the body of the pre-filled syringe in one hand between the thumb and
index finger.
b. With the other hand, gently pinch the skin between the thumb and
index finger. Do not squeeze too firmly.
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).
c. With a quick and firm motion, insert the needle completely into the skin fold at a 45-degree angle (see Figure K).

• Do not pull back the plunger under any circumstances.

O
Figure K

11. Administer the injection.

a. After inserting the needle, release the skin.
b. Slowly and completely push the plunger until the full dose of medicine has been injected and the syringe is empty (see Figure L).

• Do not change the position of the pre-filled syringe after starting the injection.
• If the plunger is not fully depressed, the needle shield will not extend to cover the needle when it is withdrawn.

Figure L

12. Remove the prefilled syringe from the injection site.

a. When the prefilled syringe is empty, slowly remove the needle
by lifting the thumb off the plunger until the needle is
completely covered by the safety shield (see Figure M).

• If the needle does not become covered, dispose of the syringe carefully (see Step 14. Disposal of Qoyvolma).
• Do not reuse the prefilled syringe.
• Do not rub the injection site.

Figure M
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. If necessary, apply a plaster.

14. Disposal of Qoyvolma.

a. Place the pre-filled syringe into a sharps disposal container immediately after use (see Figure N).
b. Do not dispose of the pre-filled syringe in household waste.

• If a sharps disposal container is not available, a puncture-resistant, resealable household container may be used.
• For your safety and the safety of others, needles and syringes must never be reused. Unused medicine and waste materials 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 you no longer use (Figure N). This will help protect the environment.