Usgena: detailed information

Package leaflet: Information for the user

Usgena 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, contact your doctor or pharmacist. See section 4.

What is in this leaflet

What Usgena is and what it is used for
What you need to know before using Usgena
How to use Usgena
Possible side effects
How to store Usgena
Contents of the pack and other information

1. What Usgena is and what it is used for

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

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

moderate to severe Crohn's disease in adults.
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, Usgena 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, Usgena may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Usgena

Do not use Usgena

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 Usgena.
Warnings and precautions
Talk to your doctor or pharmacist before using Usgena. Your doctor will assess your health status
before starting treatment. Make sure to inform your doctor about any medical conditions you have.
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
Usgena. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat it.
Be aware of serious side effects
Usgena can cause serious side effects, including allergic reactions and infections. You should pay
attention to certain signs of illness while taking Usgena. See “Serious side effects” in section 4 for a
complete list of these side effects.
Before using Usgena, contact your doctor

If you have ever had an allergic reaction to Usgena – Ask your doctor if you are unsure.
If you have ever had any type of cancer – This is because immunosuppressants like Usgena 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 or if you have abnormal openings in the skin (fistulas).
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 can also partially reduce immune system activity. The concomitant use of these therapies with Usgena 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 Usgena may affect them.
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 Usgena.
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 sun-exposed areas of the skin,
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 a strange sensation
on one side of the body, facial drooping, or problems with speech or vision.
Children and adolescents
Usgena is not recommended for the treatment of children under 18 years of age with Crohn’s disease or
ulcerative colitis, as it has not been studied in this age group.
Other medicines, vaccines, and Usgena
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 Usgena.
If you received Usgena during pregnancy, inform your child’s paediatrician about the Usgena treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usgena during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless your child’s paediatrician recommends otherwise.

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 Usgena during pregnancy.
If you are of childbearing age, it is advisable to avoid becoming pregnant and you should use an effective method of contraception during treatment with Usgena and for at least 15 weeks after stopping treatment with Usgena.
Ustekinumab can cross the placenta and reach the unborn child. If you received Usgena during pregnancy, your child may have an increased risk of developing infections.
If you received Usgena 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 Usgena 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 your child’s paediatrician recommends otherwise.
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 Usgena. You cannot do both.

Driving and using machines
Usgena does not affect or has a negligible effect on the ability to drive or use machines.
Usgena contains sodium and polysorbate 80
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.
However, before Usgena is administered, it is mixed with a solution containing sodium. Talk to your
doctor if you are on a low-salt diet.
This medicine contains 0.4 mg of polysorbate 80 per ml. Polysorbates may cause allergic reactions.
Inform your doctor if you have known allergies.

3. How to use Usgena

Usgena 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.
Usgena 130 mg concentrate for solution for infusion will be administered by your doctor through an intravenous 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 Usgena is administered
Your doctor will decide how much Usgena you need and for how long.

Adults from 18 years of age

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

Your body weight Dose
≤ 55 kg 260 mg

55 kg to ≤ 85 kg 390 mg
85 kg 520 mg

After the initial intravenous dose, you will receive the next dose of 90 mg of Usgena as an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks.

How Usgena is administered

The first dose of Usgena for the treatment of Crohn's disease or ulcerative colitis is given by your doctor via an intravenous infusion into your arm. Inform your doctor if you have any questions about the use of Usgena.

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

If you stop using Usgena
Stopping treatment with Usgena is not dangerous. However, if you stop treatment, your symptoms may return.

If you have any doubts about how to use this medicine, consult 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 (may affect up to 1 in 1,000 people). 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 (may affect up to 1 in 100 people).

Infusion-related reactions – If you are being treated for Crohn’s disease or ulcerative colitis,
the first dose of Usgena is given by intravenous infusion (drip).
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, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Usgena again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

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

Usgena 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 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 aware of the signs of infection while using Usgena. 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 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 Usgena 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 (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 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)

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 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 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 Usgena

Usgena 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, an unopened vial may also be stored at room temperature up to 30°C for a single period of up to 7 days, provided it remains in the outer packaging to protect it from light. 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 7 days at room temperature or by the original expiry date, whichever comes first.
Do not shake Usgena 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”. The expiry date refers to the last day of that month.
If the liquid has changed colour, is cloudy, or contains large floating particles (see section 6 “Description of the appearance of Usgena 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 shaken vigorously.
If the seal is broken.

Usgena is for single use only. Any unused diluted infusion solution or unused product remaining in the vial or syringe must be discarded according to local regulations.

6. Package contents and other information

What Usgena contains

The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
The other components are: disodium EDTA dihydrate, histidine, histidine monohydrochloride, methionine, polysorbate 80 (E433), sucrose and water for injections.

Description of the appearance of Usgena and contents of the pack
Usgena is a clear concentrate for infusion solution, colourless to pale yellow and practically free from visible particles (sterile concentrate). 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 infusion solution (sterile concentrate).
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany
Manufacturers
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 24797878 Tel: +370 52603926
България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 24797878
Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009747
Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008
Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000
Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +372 53072153 Tlf: +45 44859999
Ελλάδα Österreich
DEMO S.A. Pharmaceutical Industry STADA Arzneimittel GmbH
Τηλ: +30 2108161802 Tel: +43 136785850
España Polska
Laboratorio STADA, S.L. STADA Pharm Sp. z.o.o.
Tel: +34 934738889 Tel: +48 227377920
France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870
Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640
Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710
Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933
Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888
Κύπρος Sverige
DEMO S.A. Pharmaceutical Industry STADA Nordic ApS
Τηλ: +30 2108161802 Tel: +45 44859999
Latvija
UAB „STADA Baltics“
Tel: +371 28016404
More detailed information on this medicinal product is available on the website of the European Medicines Agency: 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 trade name and batch number of the administered product must be clearly recorded.
Instructions for dilution:
Usgena concentrate for infusion solution must be diluted, prepared and infused by a healthcare professional using aseptic technique.

Calculate the dose and number of Usgena vials required based on the patient's body weight (see section 3, Table 1). Each 26 mL vial of Usgena contains 130 mg of ustekinumab.
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 Usgena to be added (discard 26 mL of sodium chloride for each required Usgena vial; for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
Withdraw 26 mL of Usgena from each required vial and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.
Visually inspect the diluted solution before infusion. Do not use if opaque particles, discoloration or foreign particles are observed.
Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within eight hours of dilution in the infusion bag.
Use a single infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometres).
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.
The infusion must be completed within 8 hours after dilution in the infusion bag. Do not freeze.

Package leaflet: Information for the user

Usgena 45 mg solution for injection

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 all of this leaflet carefully before using this medicine because it contains important information for you.
This leaflet is intended for people who are taking this medicine. If you are a parent or caregiver of a child who is to be given Usgena, 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

What Usgena is and what it is used for
What you need to know before using Usgena
How to use Usgena
Possible side effects
How to store Usgena
Contents of the pack and other information

1. What Usgena is and what it is used for

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

What Usgena is used for
Usgena 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
moderately to severely active ulcerative colitis in adults

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

2. What you should know before using Usgena

Do not use Usgena

If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
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 Usgena.
Warnings and precautions
Talk to your doctor or pharmacist before using Usgena. 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 Usgena. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.
Be aware of serious side effects
Usgena may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Usgena. See “Serious side effects” in section 4 for a complete list of these side effects.
Before using Usgena, contact your doctor

If you previously had an allergic reaction to Usgena. Ask your doctor if you are unsure.
If you have previously had any type of cancer – because immunosuppressants like Usgena 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 developed any new or changed skin lesions within the area affected by 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 Usgena 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 previously used allergy injections – it is not known whether Usgena could affect them.
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, discuss them with your doctor or pharmacist before starting treatment with Usgena.
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 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
Usgena is not recommended for the treatment of children under 6 years of age with psoriasis or for the treatment of children and adolescents under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis, as it has not been studied in these age groups.
Other medicines, vaccines, and Usgena
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 planning to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Usgena.
If you received Usgena during pregnancy, inform your child’s paediatrician about the Usgena treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usgena 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 Usgena during pregnancy.
If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Usgena and for at least 15 weeks after stopping treatment with Usgena.
Ustekinumab can cross the placenta and reach the unborn child. If you received Usgena during pregnancy, your child may have an increased risk of developing infections.
If you received Usgena 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 Usgena 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 planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Usgena. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has a negligible effect on the ability to drive or use machines.
Usgena contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Usgena

Usgena is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Usgena 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 Usgena is administered

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Usgena. 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. The following 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 Usgena is administered by your doctor via intravenous infusion into a vein in the arm. After the initial dose, you will receive the next dose of 90 mg of Usgena after 8 weeks, then every 12 weeks via subcutaneous injection (subcutaneous route).
In some patients, after the first subcutaneous injection, the 90 mg dose of Usgena 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 Usgena 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.
If body weight is less than 60 kg, the recommended dose is 0.75 mg of Usgena per kg of body weight.
If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Usgena.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Usgena.
Four weeks after the initial dose, the next dose should be administered, followed by subsequent doses every 12 weeks.

How Usgena is administered

Usgena is administered by subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Usgena to you.
However, you and your doctor may decide whether you can self-inject Usgena. In this case, you will be taught how to self-inject Usgena.
For instructions on how to inject Usgena, 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 Usgena than you should

If you have used or received too much Usgena, 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 Usgena

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 Usgena

It is not dangerous to stop using Usgena. However, if you stop treatment, disease symptoms may return.

If you have any doubts about using this medicine, consult 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, 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 (may affect up to 1 in 1,000 people). 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 (may affect up to 1 in 100 people).

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

Nasal, throat infections, and common cold are common (may affect up to 1 in 10 people).
Chest infections are uncommon (may affect up to 1 in 100 people).
Inflammation of the tissue under the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
Herpes zoster (a type of painful rash with blisters) is uncommon (may affect up to 1 in 100 people).

Usgena may reduce your ability to fight infections. Some infections may become serious and may include infections 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 Usgena. 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 can have serious complications. Consult your doctor if you have any type of infection that persists or keeps recurring. Your doctor may decide to stop Usgena 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 (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 with possible 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 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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Usgena

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.
Do not shake the 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 that month.
If the liquid changes colour, becomes cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Usgena 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 shaken vigorously.

Usgena 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. Contents of the pack and other information

What Usgena contains

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

Description of the appearance of Usgena and contents of the pack
Usgena is a clear, injectable solution, colourless to slightly yellow, and practically free from visible particles. It is supplied in a cardboard pack containing one single dose in a 2 mL glass vial. Each vial contains one dose of ustekinumab 45 mg in 0.5 mL of injectable solution.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

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

België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 24797878 Tel: +370 52603926

България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 24797878

Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009747

Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008

Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000

Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +372 53072153 Tlf: +45 44859999

Ελλάδα Österreich
DEMO S.A. Pharmaceutical Industry STADA Arzneimittel GmbH
Τηλ: +30 2108161802 Tel: +43 136785850

España Polska
Laboratorio STADA, S.L. STADA Pharm Sp. z.o.o.
Tel: +34 934738889 Tel: +48 227377920

France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870

Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640

Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710

Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933

Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888

Κύπρος Sverige
DEMO S.A. Pharmaceutical Industry STADA Nordic ApS
Τηλ: +30 2108161802 Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +371 28016404

Other sources of information
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, your doctor or a healthcare professional will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Usgena. In this case, you will be taught how to self-administer Usgena. Inform your doctor if you have any questions about self-injection.

Do not mix Usgena with other injectable liquids.
Do not shake the vials of Usgena, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare materials:

Remove one or more vials from the refrigerator. Leave the vial(s) outside the refrigerator for about
half an hour. This will allow the liquid to reach the appropriate temperature for injection
(room temperature).
Check that:

the number of vials and the dose are correct; if your dose is equal to or less than 45 mg, take one 45 mg Usgena vial; if your dose is 90 mg, take two 45 mg Usgena vials and you will need to perform two injections. Choose two different body areas for these injections (for example, one injection in the right thigh and the other injection in the left thigh) and carry out the injections one after the other. Use a new needle and a new syringe for each injection.
the medicine is the correct one
the medicine has not expired
the vial is not damaged and the cap is not broken
the solution in the vial is clear or slightly opalescent (pearl-like appearance) and colourless or pale yellow
the liquid does not have a changed or cloudy colour and does not contain foreign particles
the liquid is not frozen.

Children with a body weight below 60 kg require a dose lower than 45 mg. Be certain of the appropriate amount (volume) to withdraw from the vial and of the type of syringe required for dosing. If you do not know the amount of medicine or the type of syringe to use, contact your doctor for further instructions.
Gather all necessary supplies and place them on a clean surface. The supplies should include a syringe, needle, antiseptic swabs, cotton ball or gauze, and a sharps container (see Figure 1).

Line drawing of adhesive bandage, antiseptic wipes, cotton ball, vial of Uzpruvo, syringe with needle, and sharps container

Figure 1

2. Choose and prepare the body area for injection:

Choose an injection site (see Figure 2).

Usgena is administered by injection under the skin (subcutaneously).
Recommended injection sites include the upper thigh (legs), buttocks, or around the abdomen (abdominal area), at least 5 cm away from the navel.
If possible, avoid areas of skin affected by psoriasis.
If someone is assisting you with the injection, the upper arm may also be used as an injection site.

Schematic diagrams of a human body indicating drug application sites on the thigh and hip

* The yellow areas indicate recommended injection sites
Figure 2
Preparing the injection site

Wash your hands thoroughly with soap and warm water.
Clean the injection site on the skin with an antiseptic swab.
Do not touch this area again before administering the injection.

3. Prepare the dose:

Remove the cap from the top of the vial (see Figure 3)

Diagram showing a glass vial with transparent liquid and a dark cap being removed following a yellow curved arrow

Figure 3

Do not remove the stopper
Clean the stopper with an antiseptic swab
Place the vial on a flat surface
Take the syringe and remove the protective needle cap
Do not touch the needle, and do not let the needle touch anything
Push the needle through the rubber stopper
Invert the vial and syringe, keeping the needle inserted
Pull back the syringe plunger to draw up the prescribed amount of liquid
It is important that the needle remains fully immersed in the liquid to prevent air bubbles from entering the syringe (see Figure 4)

Two hands preparing the medication: one holding a glass vial while the other

Figure 4

Remove the needle from the vial
Hold the syringe with the needle pointing upward to check for any air bubbles
If air bubbles are present, gently tap the side of the syringe until the air bubbles rise to the top of the syringe (see Figure 5)

Two hands preparing a syringe with needle inserted into a glass vial to draw up the contents with the plunger facing downward

Figure 5

Then gently push the plunger to expel all air (but not the liquid)
Do not place the syringe on any surface, and avoid letting the needle touch anything

4. Inject the dose:

Gently pinch the clean area of skin between your thumb and index finger. Do not squeeze too forcefully.
Insert the needle into the pinched skin.
Push the plunger slowly and steadily with your thumb until all the liquid has been injected, while continuing to gently hold the skin pinched.
When the plunger reaches the end of the syringe, remove the needle and release the skin.

5. After the injection:

Press a sterile swab on the injection site for a few seconds after the injection
A small amount of bleeding or fluid leakage at the injection site may occur. This is normal
You may place a cotton ball or gauze pad on the injection site and press for 10 seconds
Do not rub the skin at the injection site: you may cover the injection site with a small plaster, if necessary

6. Disposal:

Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your health and safety and for the safety of others, never reuse needles or syringes. Dispose of the sharps container according to local regulations.
Empty vials, antiseptic swabs, and other devices may be disposed of in household waste.

Package leaflet: Information for the user

Usgena 45 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 all of 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 of a child who is to be given Usgena, 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 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Usgena is and what it is used for
What you need to know before using Usgena
How to use Usgena
Possible side effects
How to store Usgena
Contents of the pack and other information

1. What Usgena is and what it is used for

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

What Usgena is used for
Usgena 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
moderate to severe ulcerative colitis in adults

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

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

2. What you need to know before using Usgena

Do not use Usgena

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 Usgena.
Warnings and precautions
Talk to your doctor or pharmacist before using Usgena. Your doctor will check your health status before each treatment. Make sure you inform your doctor, before each treatment, about any medical conditions you have. 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 Usgena. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.

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

Before using Usgena, contact your doctor

If you previously had an allergic reaction to Usgena. Ask your doctor if you are unsure.
If you have previously had any type of cancer – because immunosuppressants like Usgena 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 developed any new or changed lesions within the area of psoriasis or on normal skin.
If you are taking any other type of 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 the activity of the immune system. The concomitant use of these therapies with Usgena has not been studied. However, it may increase the likelihood of conditions related to a weakened immune system.
If you are using or have previously used injections for the treatment of allergies – it is not known whether Usgena may affect them.
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 above conditions apply to you, talk to your doctor or pharmacist before starting treatment with Usgena.
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 sun-exposed areas of the 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 a strange sensation on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents
Usgena is not recommended for the treatment of children under 6 years of age with psoriasis, or for the treatment of children and adolescents under 18 years of age with psoriatic arthritis, Crohn’s disease, or ulcerative colitis, as it has not been studied in these age groups.

Other medicines, vaccines, and Usgena
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 Usgena.
if you received Usgena during pregnancy, inform your child’s paediatrician about the Usgena treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Usgena 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 Usgena during pregnancy.
If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Usgena and for at least 15 weeks after stopping treatment with Usgena.
Ustekinumab can cross the placenta and reach the unborn child. If you received Usgena during pregnancy, your child may have an increased risk of developing an infection.
If you received Usgena during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Usgena 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 Usgena. You cannot do both.

Driving and using machines
Ustekinumab does not affect, or affects negligibly, the ability to drive vehicles or use machinery.

Usgena contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Usgena

How much Usgena is administered

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

Adults from 18 years of age

Psoriasis and psoriatic arthritis

The recommended initial dose is 45 mg of Usgena. 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 Usgena is administered by your doctor via an intravenous infusion into your arm. After the initial dose, you will receive a 90 mg dose of Usgena after 8 weeks, then every 12 weeks via subcutaneous injection.
In some patients, after the first subcutaneous injection, the 90 mg dose of Usgena 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 Usgena 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.
For children and adolescents requiring a dose lower than 45 mg, a 45 mg vial is available.
If body weight is below 60 kg, the recommended dose is 0.75 mg of Usgena per kg of body weight.
If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Usgena.
If body weight exceeds 100 kg, the recommended dose is 90 mg of Usgena.
Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

How Usgena is administered

Usgena is administered by subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Usgena to you.
However, you and your doctor may decide whether you can self-inject Usgena. In this case, you will be taught how to self-inject Usgena.
For instructions on how to inject Usgena, 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 Usgena than you should

If you have used or received too much Usgena, 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 Usgena

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 Usgena

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

If you have any doubts about using this medicine, consult 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 (may affect up to 1 in 1,000 people). Signs include:
o difficulty breathing or swallowing, or 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 (may affect up to 1 in 100 people).

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 Usgena again.

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

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

Usgena 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 alert for signs of infection while using Usgena. 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

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 (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
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 (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 cause a rash with small red or purple spots, 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 (red, raised, scaly rash on sun-exposed areas of skin, sometimes with joint pain).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, consult 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 Usgena

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.
Before administration, allow the pre-filled syringe to reach room temperature (approximately 30 minutes).
If necessary, individual pre-filled syringes of Usgena may also be stored at room temperature up to 30°C for a single period of up to 30 days, while remaining in the outer packaging to protect from light. Once removed from the refrigerator, record the date by which they must 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 30 days at room temperature or by the original expiry date, whichever comes first.
Do not shake the pre-filled syringes. 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 that month.
If the liquid changes colour, becomes cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Usgena and contents of the pack”).
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.

Usgena 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 Usgena contains

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

Description of the appearance of Usgena and contents of the pack
Usgena is a clear, colourless to slightly yellow injectable solution, practically free from visible 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 45 mg ustekinumab in 0.5 mL of injectable solution.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

Manufacturers
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany