Uzpruvo 130 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Uzpruvo 130 mg concentrate for solution for infusion

ustekinumab

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read this entire leaflet carefully before starting to use this medicine, because it contains important information for you.

This leaflet has been written for the person using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Uzpruvo is and what it is used for

What Uzpruvo is

Uzpruvo contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to certain proteins in the body.

Uzpruvo belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What Uzpruvo is used for

Uzpruvo is used to treat the following inflammatory diseases:

• Moderately to severely active Crohn’s disease – in adults and children weighing at least 40 kg.

Crohn’s disease

Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate those medicines, Uzpruvo may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Uzpruvo

Do not use Uzpruvo

• If you are allergic to ustekinumab or to any of the other components 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 above apply to you, speak with your doctor or pharmacist before using Uzpruvo.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Uzpruvo. Your doctor will assess your overall health before treatment. Make sure to inform your doctor about any medical conditions you have before treatment. Also, inform your doctor if you have recently been in contact with someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis before you start using Uzpruvo. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Be aware of serious adverse effects

Uzpruvo may cause serious adverse effects, including allergic reactions and infections. You should pay attention to certain signs of illness while using Uzpruvo. See the full list of these adverse effects in the “Serious adverse effects” section under section 4.

Before using Uzpruvo, tell your doctor

• If you have ever had an allergic reaction to Uzpruvo. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Uzpruvo weaken part of the immune system, which may increase the risk of developing cancer.
• If you have previously been treated for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection) – the risk of developing cancer may be higher.
• If you currently have or have recently had an infection, or have any skin breaks (fistula).
• If you have any new lesions or changes in existing lesions within the psoriasis area or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis – such as other immunosuppressants or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. The combined use of these treatments with Uzpruvo has not been studied, but it may increase the likelihood of developing illnesses related to a weakened immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Uzpruvo may affect these treatments.
• If you are 65 years of age or older – you may be more likely to develop infections.

If you are unsure whether any of these conditions apply to you, speak with your doctor or pharmacist before using Uzpruvo.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if it is accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of patients with psoriasis treated with ustekinumab. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are properly managed. Seek immediate medical attention if you experience chest pain, weakness or numbness on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents

The use of Uzpruvo is not recommended in children with Crohn’s disease weighing less than 40 kg, as it has not been studied in this age group.

Use of Uzpruvo with other medicines, vaccines

Inform your doctor or pharmacist

• If you are currently using, have recently used, or might use other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered while using Uzpruvo.
• If you received Uzpruvo during pregnancy, inform your infant’s doctor about your Uzpruvo treatment before the infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant during the first twelve months after birth if you received Uzpruvo during pregnancy, unless your infant’s doctor advises otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been observed in babies exposed to ustekinumab in the womb. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use adequate contraception while using Uzpruvo and for at least 15 weeks after the last dose of Uzpruvo.
• Uzpruvo can cross the placenta to the fetus. If you received Uzpruvo during pregnancy, your infant may have an increased risk of developing an infection.
• It is important to inform your infant’s doctors and other healthcare professionals if you received Uzpruvo during your pregnancy before the infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant during the first twelve months after birth if you received Uzpruvo during pregnancy, unless your infant’s doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether to breastfeed or use Uzpruvo. Do not do both at the same time.

Driving and using machines

The influence of Uzpruvo on the ability to drive and use machines is negligible or none.

Uzpruvo contains sodium and polysorbate 80

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free.” However, before Uzpruvo is administered, it is mixed with a solution containing sodium. Speak with 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 any known allergies.

3. How to use Uzpruvo

Uzpruvo should be used under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease.

Your doctor will administer Uzpruvo 130 mg concentrate for solution for infusion by intravenous drip into a vein in your arm over a period of at least one hour. Ask your doctor when your infusions should be given and about follow-up visits.

What amount of Uzpruvo is administered

Your doctor will decide the amount of Uzpruvo you need to receive and the duration of treatment.

Adults aged 18 years and older

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

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

Children with Crohn's disease weighing at least 40 kg

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

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

How Uzpruvo is administered

• The first dose of Uzpruvo for the treatment of Crohn's disease is given by a doctor as an infusion into a vein in the arm (intravenous infusion).

Talk to your doctor if you have any questions about treatment with Uzpruvo.

If you forget to use Uzpruvo

If you miss a dose or fail to attend your appointment for administration, speak with your doctor to schedule another appointment.

If you stop using Uzpruvo

Stopping the use of Uzpruvo is not dangerous. However, if you discontinue treatment, your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

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

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

• Severe allergic reactions ("anaphylaxis") are rare in the population using ustekinumab (may affect up to 1 in 1,000 people). Signs include:

  • difficulty breathing and swallowing
  • low blood pressure, which may cause dizziness or mild headaches
  • 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, the first dose of Uzpruvo is administered via intravenous infusion (drip into a vein). Some patients have experienced severe allergic reactions during the infusion.

In rare cases, lung-related allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, difficulty breathing, or fever.

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

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Nasal or throat infections and the 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 tissues beneath the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

Uzpruvo may affect your ability to fight infections. Some of these infections may become serious and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. They include 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 receiving ustekinumab treatment.

You should monitor for signs of infection while taking Uzpruvo. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath; persistent cough
• skin that feels warm, red, and painful, or a painful blistering skin rash
• burning sensation when urinating
• diarrhea
• visual deterioration or loss of vision
• headache, neck stiffness, photosensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use Uzpruvo until the infection resolves. Also contact your doctor if you have any open cuts or sores 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 disorders. If you notice any of these symptoms, you must inform your doctor immediately.

Other adverse effects

Frequent adverse effects (may affect up to 1 in 10 people)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching ("pruritus")
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

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

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and sinking of the muscles 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 (skin exfoliation)
• Acne

Rare adverse 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 cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a skin rash with small red or purple raised spots, fever, or joint pain (vasculitis)

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

• Blisters on the skin, which may be red and cause itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash in sun-exposed areas of skin, possibly accompanied by joint pain).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Uzpruvo

• Uzpruvo 130 mg concentrate for solution for infusion is administered in a hospital or medical centre and patients do not need to store or handle 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 it from light.
• If necessary, the unopened vial may also be stored at room temperature up to 30 °C for a single period of up to 7 days in its original carton to protect it from light. Once the vial has been stored at room temperature (up to a maximum of 30 °C), it must not be returned to the refrigerator. Discard the vial if it is not used within 7 days of storage at room temperature or by the original expiry date, whichever occurs first.
• Do not shake Uzpruvo vials. Prolonged vigorous shaking may damage the product.

Do not use this medicine

• After the expiry date stated on the label and packaging after “EXP”. The expiry date is the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains large floating particles (see section 6 “What Uzpruvo looks like and contents of the pack”).
• If you know or suspect it has been exposed to extreme temperatures (such as accidental overheating or freezing).
• If the product has been vigorously shaken.
• If the seal is broken.

Uzpruvo is for single use only. Any unused diluted solution remaining in the vial or syringe must be discarded in accordance with local regulations.

6. Contents of the pack and other information

Composition of Uzpruvo

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

Appearance of Uzpruvo and contents of the pack

Uzpruvo is a sterile, clear, colourless to pale yellow concentrate for solution for infusion, practically free from particles. It is supplied in a container containing one single-dose 30 ml glass vial. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion (sterile concentrate).

Marketing Authorization 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

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

The following information is intended exclusively for healthcare professionals:

Traceability:

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine should be clearly recorded.

Dilution instructions:

Uzpruvo concentrate for solution for infusion must be diluted, prepared, and infused by a healthcare professional using an aseptic technique.

1. Calculate the dose and number of Uzpruvo vials required based on the patient's weight (see section 3, Table 1, Table 2). Each 26 ml vial of Uzpruvo contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of 0.9% (9 mg/ml) sodium chloride solution from the 250 ml infusion bag equivalent to the volume of Uzpruvo to be added (discard 26 ml of sodium chloride per required Uzpruvo vial: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).
3. Withdraw 26 ml of Uzpruvo from each required vial and add it to the 250 ml infusion bag. The final volume of the infusion bag must be 250 ml. Mix gently.
4. Visually inspect the diluted solution before infusion. Do not use if particulate matter, discoloration, or foreign particles are observed.
5. Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion must be completed within eight hours of dilution in the infusion bag.
6. Use only an in-line filter infusion system that is sterile, pyrogen-free, and with low protein binding (pore size 0.2 micrometers).
7. Each vial is for single use only, and any unused medicine must be discarded in accordance with local regulations.

Storage

If necessary, the diluted solution for infusion may be stored at room temperature. The infusion must be completed within 8 hours after dilution in the infusion bag. Do not freeze.