Prospect: information for the patient

Uzpruvo 90 mg injectable solution in pre-filled syringe

ustekinumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

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

This prospect has been written for the person using the medicine. If you are the parent or caregiver of a child to whom you will administer Uzpruvo, please read this information carefully.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they present the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospect. See section 4.

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

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

What is Uzpruvo used for

Uzpruvo is used to treat the following inflammatory diseases:

• Plaque psoriasis - in adults and children aged 6 years and above
• Psoriatic arthritis - in adults
• Moderate to severe Crohn's disease - in adults

Plaque psoriasis

Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. Uzpruvo reduces inflammation and other symptoms of the disease.

Uzpruvo is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or where these treatments are not effective.

Uzpruvo is used in children and adolescents aged 6 years and above with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies, or where these treatments are not effective.

Psoriatic arthritis

Psiatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first receive other medications. If you do not respond well to these medications, you may be treated with Uzpruvo to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Reduce damage to your joints.

Crohn's disease

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

No use Uzpruvo

• If you are allergic to ustekinumabor to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infectionthat your doctor thinks is important.

If you are not sure if any of the above points apply to you, talk to your doctor or pharmacist before using Uzpruvo.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Uzpruvo. Your doctor will check how you are before each treatment. Make sure to inform your doctor about any illness you suffer from before each treatment. Your doctor will also ask if you have recently been near someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis detection before using Uzpruvo. If your doctor thinks you are at risk of tuberculosis, they may give you medicine to treat it.

Watch for severe side effects

Uzpruvo may cause severe side effects, including allergic reactions and infections. You must pay attention to certain signs of illness while using Uzpruvo. See the complete list of these side effects in “Severe side effects” of section 4.

Tell your doctor before using Uzpruvo

• If you have ever had an allergic reaction to Uzpruvo.Consult your doctor if you are not sure.
• If you have ever had any type of cancer– this is because the immunosuppressants of the type of Uzpruvo weaken part of the immune system. This may increase the risk of having cancer.
• If you have received treatment for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection)– the risk of having cancer may be higher.
• If you have or have had a recent infection.
• If you have any new lesions or changes to the lesionswithin the psoriasis area or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis– such as any other immunosuppressant 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 use of these treatments together with Uzpruvo has not been studied. However, it may increase the likelihood of having diseases related to a weaker immune system.
• If you are receiving or have received injections to treat allergies– it is unknown if Uzpruvo may affect these treatments.
• If you are 65 years or older– you are more likely to acquire infections.

If you are not sure if you have any of these conditions, talk to your doctor or pharmacist before using Uzpruvo.

Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Talk to your doctor immediately if you experience a red, elevated, and scaly rash, sometimes with a darker border, in sun-exposed areas or accompanied by joint pain.

Heart attacks and strokes

In a study of patients with psoriasis treated with ustekinumab, heart attacks and strokes have been observed. Your doctor will check your risk factors for heart disease and stroke regularly to ensure they are being treated properly. Seek medical attention immediately if you experience chest pain, weakness, or an abnormal sensation in one side of your body, facial paralysis, or abnormalities in speech or vision.

Children and adolescents

Uzpruvo is not recommended for use in children under 6 years of age with psoriasis or in children and adolescents under 18 years of age with psoriatic arthritis and Crohn's disease, as it has not been studied in this age group.

Using Uzpruvo with other medicines, vaccines

Inform your doctor or pharmacist:

• If you are using, have used recently, or may use other medicines.
• If you have been vaccinated recently or are 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 baby's doctor about your treatment with Uzpruvo before your baby receives any vaccine, including live vaccines, such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your baby in the first 12 months after birth if you received Uzpruvo during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or intend 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, there is limited experience with ustekinumab in pregnant women. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are a fertile woman, it is recommended that you avoid becoming pregnant and use suitable contraceptive measures while using Uzpruvo and for at least 15 weeks after the last treatment with Uzpruvo.
• Ustekinumab may pass through the placenta to the fetus. If you received Uzpruvo during pregnancy, your baby may have a higher risk of contracting an infection.
• It is essential to inform your baby's doctors and other healthcare professionals if you received Uzpruvo during pregnancy before your baby receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first 12 months after birth if you received Uzpruvo during pregnancy, unless your baby'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 do so. You and your doctor will decide whether to breastfeed or use Uzpruvo. Do not do both at the same time.

Driving and operating machines

The influence of Uzpruvo on the ability to drive and operate machines is negligible or insignificant.

Uzpruvo contains polysorbate 80

This medicine contains 0.04 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

It has been proven that Uzpruvo should be used under the guidance and supervision of a doctor with experience in treating the conditions for which Uzpruvo is indicated.

Always follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, ask your doctor. Ask your doctor when to administer the injections and about follow-up consultations.

What amount of Uzpruvo is administered

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

Adults 18 years of age and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Uzpruvo. Patients weighing more than 100 kg may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, you will take the next dose 4 weeks later and then every 12 weeks. The subsequent doses are usually the same as the starting dose.

Crohn's disease

• Uzpruvo is not available for administration of the first dose through a drip in a vein of the arm (intravenous infusion). As the first dose, another ustekinumab product will be administered through intravenous infusion.
• Uzpruvo is administered through a subcutaneous injection. You will receive the first dose of 90 mg of Uzpruvo 8 weeks after the intravenous infusion and then every 12 weeks subcutaneously.
• In some patients, after the first subcutaneous injection, 90 mg of Uzpruvo will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents 6 years of age and older

Psoriasis

• Your doctor will indicate the correct dose for you, including the amount (volume) of Uzpruvo to inject to give the correct dose. The suitable dose for you will depend on your body weight at the time each dose is given.
• If you weigh less than 60 kg, there is no Uzpruvo dosage form for children under 60 kg of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Uzpruvo.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.

How Uzpruvo is administered

• Uzpruvo is administered through subcutaneous injection. At the beginning of your treatment, medical or nursing staff may inject Uzpruvo for you.
• However, you and your doctor may decide that Uzpruvo is injected by yourself. In that case, you will be trained on how to inject Uzpruvo yourself.
• For instructions on how to inject Uzpruvo, see "Administration Instructions" at the end of this leaflet.

Consult your doctor if you have any questions about self-injecting.

If you use more Uzpruvo than you should

If you have used or have been given too much Uzpruvo, talk to your doctor or pharmacist immediately. Always carry the medication box with you, even if it is empty.

If you forget to use Uzpruvo

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

If you interrupt treatment with Uzpruvo

Stopping Uzpruvo is not hazardous. However, if you stop, your symptoms may return.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Severe side effects

Some patients may experience severe side 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 (they can affect up to 1 in 1,000 people). The signs include:

• Difficulty breathing and swallowing
• Low blood pressure, which can cause dizziness or mild headaches
• Swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include skin rash and urticaria (these can affect up to 1 in 100 people).

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

If you experience 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.

• Common colds and sore throats are frequent (they can affect up to 1 in 10 people).
• Chest infections are rare (they can affect up to 1 in 100 people).
• Cellulitis, an inflammation of the tissues under the skin, is rare (it can affect up to 1 in 100 people).
• Herpes, a painful rash with blisters, are rare (they can affect up to 1 in 100 people).

Uzpruvo may affect your ability to fight infections. Some of them may be severe and caused by viruses, fungi, bacteria (including tuberculosis) or parasites, and include opportunistic infections that occur mainly in people with weakened immune systems. Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving ustekinumab treatment.

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

• Fever, flu-like symptoms, night sweats, weight loss

• Feeling tired or difficulty breathing; persistent coughing
• Having hot, red, and painful skin or a painful skin rash with blisters
• Urinary burning
• 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 be signs of infections such as pneumonia, skin infections, herpes, or opportunistic infections that could have serious complications. You should also inform your doctor if you have any type of infection that does not disappear or reappears. Your doctor may decide that you should not use Uzpruvo until the infection has cleared up. You should also contact your doctor if you have any open wounds or ulcers that may become infected.

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

Other side effects

Frequent side effects(they can 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

Rare side effects(they can affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Blocked or congested nose
• Bleeding, petechiae, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small skin blisters, sometimes accompanied by fever (psoriasis pustular)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects(they can affect up to 1 in 1,000 people):

• Redness and skin peeling over a large area of the body, which can cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in psoriasis symptoms (psoriasis erythroderma)
• Inflammation of small blood vessels, which can cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects(they can affect up to 1 in 10,000 people):

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directlythrough the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Store in refrigerator (2 °C and 8 °C). Do not freeze.
• Store the pre-filled syringe in the outer packaging to protect it from light.
• Before administration, allow the pre-filled syringe to reach room temperature (approximately 30 minutes).
• Individual pre-filled syringes of Uzpruvo can also be stored at room temperature up to 30 °C for a maximum period of up to 30 days in their original packaging to protect them from light. Once removed from the refrigerator, write the date when it should be discarded in the designated space on the outer packaging. The discard date should not exceed the original expiration date printed on the box. Once a syringe has been stored at room temperature (up to a maximum of 30 °C), it should not be stored back in the refrigerator. Discard the syringe if it is not used within 30 days of storage at room temperature or from the original expiration date, whichever occurs first.
• Do not shake the pre-filled syringes of Uzpruvo. Prolonged vigorous shaking may damage the product.

Do not use this medication

• After the expiration date that appears on the label and packaging after “EXP”. The expiration date is the last day of the month indicated.
• If the liquid changes color, becomes cloudy, or presents large particles floating in it (see section 6 “Appearance of Uzpruvo and contents of the packaging”).
• If you know or suspect you have been exposed to extreme temperatures (such as accidental overheating or freezing).
• If the product has been shaken vigorously.

Uzpruvo is for single use only. Dispose of the unused product remaining in the syringe. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty packaging and unused medications. This will help protect the environment.

Composition of Uzpruvo

• The active ingredient is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are histidine, histidine monohydrochloride, polisorbate 80 (E433), sucrose, and water for injection.

Appearance of Uzpruvo and contents of the pack

Uzpruvo is a transparent, colourless to slightly yellowish, and practically particle-free injectable solution.

It is presented in a pack containing 1 or 2 pre-filled syringes of 1 ml of glass for single use. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2–18

61118 Bad Vilbel

Germany

Manufacturers Responsible for Batch Release

Alvotech Hf

Sæmundargata 15-19

Reykjavik, 102

Iceland

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics

Other sources of information

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

You can access detailed and updated information on this medicinal product, including a video on how to use the pre-filled syringe, by scanning with your smartphone the QR code included below or on the outer packaging. You can also access this information on the following website:uzpruvopatients.com

Incluir código QR

Administration instructions

ADMINISTRATION INSTRUCTIONS

Uzpruvo 90 mg solution for injection in pre-filled syringe

ustekinumab

for subcutaneous use

Read these administration instructions carefully before using Uzpruvo solution for injection in pre-filled syringe.

At the start of treatment, the healthcare professional will help you with your first injection. However, it is possible that you and your doctor may decide that you can administer Uzpruvo yourself. In this case, they will teach you how to administer Uzpruvo. Talk to your doctor if you have any doubts about administering the injections.

Important information you need to know before injecting Uzpruvo solution for injection in pre-filled syringe

Uzpruvo solution for injection in pre-filled syringe is not suitable for intravenous use. Other ustekinumab products should be used for the initiation of treatment of Crohn's disease.

Uzpruvo solution for injection in pre-filled syringe is not suitable for paediatric patients weighing less than 60 kg. Other ustekinumab products that allow weight-based dosing should be used.

Important information:

• Only for subcutaneous injection
• Do not mix Uzpruvo with other injectable solutions.
• Do not shake the pre-filled syringes of Uzpruvo. The medicinal product may deteriorate if shaken vigorously. Do not use the medicinal product if it has been shaken vigorously. Choose a new pre-filled syringe.

Check the pre-filled syringe(s) to ensure that:

• If your dose is 90 mg, you will have a pre-filled syringe containing 90 mg of Uzpruvo

• It is the correct medicinal product
• It has not expired
• The pre-filled syringe is not damaged
• The solution in the pre-filled syringe is transparent and colourless to slightly yellowish and practically free of visible particles
• The solution in the pre-filled syringe is not frozen
• Before administration, allow the pre-filled syringe to reach room temperature (about 30 minutes).

The Figure 1 shows how the pre-filled syringe of Uzpruvo looks like

Figure 1

1. Prepare the materials

Gather the materials you will need to prepare and administer your injection. You will need:

• Antiseptic wipes
• Cotton balls or gauze
• Adhesive bandage
• Your prescribed dose of Uzpruvo (see Figure 1)
• Sharps container for disposal (not included). See Figure 2

Prepare all the materials you need and place them on a clean surface.

1. Choose and prepare the injection site:

Choose the injection site (see Figure 3)

• Uzpruvo is administered by subcutaneous injection
• Choose an injection site. Some suitable injection sites are the upper thigh or the abdomen (the stomach area) at least 5 cm from the navel
• Another person can also use the upper arm as an injection site (see Figure 3)
• Use a different injection site for each injection. Do not apply an injection to an area of skin that is sensitive, bruised, red, or hard

In yellow, the recommended injection sites are indicated

Figure 3

Prepare the injection site

• Wash your hands thoroughly with soap and water
• Clean the skin at the injection site with an antiseptic wipe
• Do not touch this area again before putting on the injection. Let your skin dry before the injection
• Do not ventilate or blow on the cleaned area
• Do not inject through clothing

1. Remove the needle cap (see Figure 4):

• Remove the needle cap when you are ready to inject Uzpruvo
• Do not touch the plunger while removing the needle cap
• Hold the syringe body with one hand, and remove the needle cap (see Figure 4)
• Dispose of the needle cap. Do not reuse it.
• You may observe a drop of liquid at the end of the needle. This is normal
• Do not touch the needle or let it touch any surface
• Inject the dose immediately after removing the needle cap

Figure 4

1. Inject the dose:

Hold the syringe:

• Hold the syringe body with one hand between your thumb and index finger (see Figure 5)
• Do not use the syringe if it has fallen without the needle cap. If this happens, tell your doctor or pharmacist.
• Do not push the plunger back at any time

Figure 5

Pinch the skin and insert the needle:

• Use the other hand to pinch the skin firmly
• Use a quick movement, similar to a dart, to insert the needle into the pinched skin at an angle of about 45 degrees (see Figure 6)

Figure 6

Inject the medicinal product:

• Inject all the liquid using your thumb to push the plunger until the syringe is empty (see Figure 7)

Figure 7

Allow the needle to retract:

Figure 8

1. After the injection:

• After completing the injection, press a cotton ball or gauze onto the skin at the injection site for a few seconds after the injection (see Figure 9)
• You may experience a slight bleeding at the injection site. This is normal
• Do not rub the skin at the injection site
• You can cover the injection site with an adhesive bandage, if necessary

Figure 9

1. Disposal:

• Deposit the used syringes in a sharps container for disposal, similar to a container for disposing of sharp objects, immediately after use, in accordance with your local regulations. Do not throw (dispose of) loose syringes in household waste (see Figure 10)
• Dispose of the antiseptic wipes, cotton balls or gauze, and packaging in the trash
• For your safety and health and for the safety of others, never reuse the syringe

Figure 10