Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pyzchiva 90 mg solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ustekinumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Pyzchiva is Pyzchiva contains the active substance 'ustekinumab', a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body. Pyzchiva belongs to a group of medicines called 'immunosuppressants'. These medicines work by weakening part of the immune system. What Pyzchiva is used for Pyzchiva administered using the pre-filled pen is used to treat the following inflammatory diseases: • Plaque psoriasis – in adults • 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 that causes inflammation affecting the skin and nails. Pyzchiva will reduce the inflammation and other signs of the disease. Pyzchiva administered using the pre-filled pen is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work. Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well 1
enough to these medicines, you may be given Pyzchiva to: • Reduce the signs and symptoms of your disease. • Improve your physical function. • Slow down the damage to your joints. Crohn's disease Crohn's disease is an inflammatory disease of the bowel. If you have Crohn's disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Pyzchiva to reduce the signs and symptoms of your disease. Ulcerative colitis Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Pyzchiva to reduce the signs and symptoms of your disease.
2.
What you need to know before you take it
e Pyzchiva
Do not use Pyzchiva • If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6). • If you have an active infection which your doctor thinks is important. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Pyzchiva. Warnings and precautions Talk to your doctor or pharmacist before using Pyzchiva. Your doctor will check how well you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will examine you and do a test for tuberculosis, before you have Pyzchiva. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it. Look out for serious side effects Pyzchiva can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Pyzchiva. See 'Serious side effects' in section 4 for a full list of these side effects. Before you use Pyzchiva tell your doctor: • If you ever had an allergic reaction to Pyzchiva. Ask your doctor if you are not sure. • If you have ever had any type of cancer – this is because immunosuppressants like Pyzchiva weaken part of the immune system. This may increase the risk of cancer. • If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) – the risk of cancer may be higher. • If you have or have had a recent infection. • If you have any new or changing lesions within psoriasis areas or on normal skin. • If you are having any other treatment for psoriasis and/or psoriatic arthritis – such as another 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. Using these therapies together with Pyzchiva has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system. • If you are having or have ever had injections to treat allergies – it is not known if Pyzchiva may affect these. • If you are 65 years of age or over – you may be more likely to get infections. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Pyzchiva. 2
Some patients have experienced lupus-like reactions including skin lupus or lupus-like syndrome during treatment with ustekinumab. Talk to your doctor right away if you experience a red, raised, scaly rash sometimes with a darker border, in areas of the skin that are exposed to the sun or with joint pains. Heart attack and strokes Heart attack and strokes have been observed in a study in patients with psoriasis treated with Pyzchiva. Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities. Children and adolescents The Pyzchiva pre-filled pen is not recommended for use in children and adolescents under 18 years of age with psoriasis or Crohn's disease because it has not been studied in this age group. The prefilled syringe should be used instead for children 6 years of age and older and adolescents with psoriasis. The solution for infusion, pre-filled syringe should be used instead for children weighing at least 40 kg with Crohn's disease. Pyzchiva is not recommended for use in children and adolescents under 18 years of age with psoriatic arthritis, or ulcerative colitis or children with Crohn's disease who weigh less than 40 kg because it has not been studied in this age group. Other medicines, vaccines and Pyzchiva Tell your doctor or pharmacist: • If you are taking, have recently taken or might take any other medicines. • If you have recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Pyzchiva. • If you received Pyzchiva while pregnant, tell your baby's doctor about your Pyzchiva treatment before the 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 twelve months after birth if you received Pyzchiva during the pregnancy unless your baby's doctor recommends otherwise. Pregnancy and breast-feeding • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. • A higher risk of birth defects has not been seen in babies exposed to ustekinumab in the womb. However, there is limited experience with ustekinumab in pregnant women. It is therefore preferable to avoid the use of ustekinumab in pregnancy. • If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Pyzchiva and for at least 15 weeks after the last Pyzchiva treatment. • Pyzchiva can pass across the placenta to the unborn baby. If you received Pyzchiva during your pregnancy, your baby may have a higher risk for getting an infection. • It is important that you tell your baby's doctors and other health care professionals if you received Pyzchiva during your pregnancy before the baby receives any vaccine. Live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby in the first twelve months after birth if you received Pyzchiva during the pregnancy unless your baby's doctor recommends otherwise. • Ustekinumab may pass into breast milk in very small amounts. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use Pyzchiva -do not do both. Driving and using machines Pyzchiva has no or negligible influence on the ability to drive and use machines. Pyzchiva contains polysorbate 80 (E433) 3
This medicine contains 0.04 mg of polysorbate 80 (E433) in each pre-filled pen (1 ml) which is equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3.
How to use Pyzchiva
Pyzchiva is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Pyzchiva is intended. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Talk to your doctor about when you will have your injections and follow-up appointments. How much Pyzchiva is given Your doctor will decide how much Pyzchiva you need to use and for how long. Adults aged 18 years or older Psoriasis or Psoriatic Arthritis • The recommended starting dose is 45 mg Pyzchiva. Patients who weigh more than 100 kilograms (kg) may start on a dose of 90 mg instead of 45 mg. • After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The following doses are usually the same as the starting dose. Crohn's disease or Ulcerative Colitis • During treatment, the first dose of approximately 6 mg/kg Pyzchiva will be given by your doctor through a drip in a vein in your arm (intravenous infusion). After the starting dose, you will receive the next dose of 90 mg Pyzchiva after 8 weeks, then every 12 weeks thereafter by an injection under the skin ('subcutaneously'). • In some patients, after the first injection under the skin, 90 mg Pyzchiva may be given every 8 weeks. Your doctor will decide when you should receive your next dose.
How to take it
• Pyzchiva is given as an injection under the skin ('subcutaneously'). At the start of your treatment, medical or nursing staff may inject Pyzchiva. • However, you and your doctor may decide that you may inject Pyzchiva yourself. In this case you will get training on how to inject Pyzchiva yourself. • For instructions on how to inject Pyzchiva, see 'Instructions for administration' at the end of this leaflet. Talk to your doctor if you have any questions about giving yourself an injection. If you use more Pyzchiva than you should If you have used or been given too much Pyzchiva, talk to a doctor or pharmacist straight away. Always have the outer carton of the medicine with you, even if it is empty. If you forget to use Pyzchiva If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose. If you stop using Pyzchiva It is not dangerous to stop using Pyzchiva. However, if you stop, your symptoms may come back. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
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Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Some patients may have serious side effects that may need urgent treatment. Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs. • Serious allergic reactions ('anaphylaxis') are rare in people taking Pyzchiva (may affect up to 1 in 1,000 people). Signs include: o difficulty breathing or swallowing
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o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat. Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).
In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab. Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever. If you have a serious allergic reaction, your doctor may decide that you should not use Pyzchiva again. Infections – these may need urgent treatment. Tell your doctor straight away if you notice any of the following signs. • Infections of the nose or throat and common cold are common (may affect up to 1 in 10 people) • Infections of the chest are uncommon (may affect up to 1 in 100 people) • Inflammation of tissue under the skin ('cellulitis') is uncommon (may affect up to 1 in 100 people) • Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people) Pyzchiva may make you less able to fight infections. Some infections could become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur in people with a weakened immune system (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eye have been reported in patients receiving treatment with ustekinumab. You must look out for signs of infection while you are using Pyzchiva. These include: • fever, flu-like symptoms, night sweats, weight loss • feeling tired or short of breath; cough which will not go away • warm, red and painful skin, or a painful skin rash with blisters • burning when passing water • diarrhoea • visual disturbance or vision loss • headache, neck stiffness, light sensitivity, nausea or confusion. Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, or skin infections or shingles or opportunistic infections that could have serious complications. Tell your doctor if you have any kind of infection that will not go away or keeps coming back. Your doctor may decide that you should not use Pyzchiva until the infection goes away. Also tell your doctor if you have any open cuts or sores as they might get infected. Shedding of skin – increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. You should tell your doctor straight away if you notice any of these signs. Other side effects Common side effects (may affect up to 1 in 10 people): 5
• • • • • • • • •
Diarrhoea Nausea Vomiting Feeling tired Feeling dizzy Headache Itching ('pruritus') Back, muscle or joint pain Sore throat
• •
Redness and pain where the injection is given Sinus infection
Uncommon side effects (may affect up to 1 in 100 people): • Tooth infections • Vaginal yeast infection • Depression • Blocked or stuffy nose • Bleeding, bruising, hardness, swelling and itching where the injection is given • Feeling weak • Drooping eyelid and sagging muscles on one side of the face ('facial palsy' or 'Bell's palsy'), which is usually temporary • A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis) • Peeling of the skin (skin exfoliation) • Acne Rare side effects (may affect up to 1 in 1,000 people): • Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis) • Inflammation of small blood vessels, which can lead to a skin 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 of the skin that may be red, itchy, and painful (Bullous pemphigoid). • Skin lupus or lupus-like syndrome (red, raised scaly rash on areas of the skin exposed to the sun possibly with joint pains). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcardor search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Pyzchiva
• • • •
Keep this medicine out of the sight and reach of children. Store in a refrigerator (2 °C-8 °C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light. If needed, individual Pyzchiva pre-filled pens may also be stored at room temperature up to 30 °C for a maximum single period of up to 35 days in the original carton in order to protect from light. Record the date when the pre-filled pen is first removed from the refrigerator in the space provided on the outer carton. At any time before the end of this period, the product can be put back in the refrigerator once and kept there until the expiry date. Discard the pen if not used after the maximum period of 35 days at room temperature storage or by the original expiry date, 6
•
whichever is earlier. Do not shake Pyzchiva pre-filled pen. Prolonged vigorous shaking may damage the medicine.
Do not use this medicine: • After the expiry date which is stated on the label and the carton after 'EXP'. The expiry date refers to the last day of that month. • If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 'What Pyzchiva looks like and contents of the pack'). • •
If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated). If the product has been shaken vigorously.
Pyzchiva is for single use only. Any unused product remaining in the syringe or pre-filled pen should be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Pyzchiva contains • The active substance is ustekinumab. Each pre-filled pen contains 90 mg ustekinumab in 1 mL. • The other ingredients are Histidine, Histidine hydrochloride monohydrate, Polysorbate 80, Sucrose, Water for injections. What Pyzchiva looks like and contents of the pack Pyzchiva is a clear, colourless to light yellow solution for injection. The solution may contain a few small translucent or white particles of protein. It is supplied as a carton pack containing 1 singledose, glass 1 mL pre-filled pen. Each pre-filled pen contains 90 mg ustekinumab in 1 mL of solution for injection. Marketing Authorisation Holder Samsung Bioepis UK Limited 5th floor Profile West 950 Great West Road Brentford Middlesex TW8 9ES United Kingdom Manufacturer Samsung Bioepis NL B.V. Olof Palmestraat 10 2616 LR Delft The Netherlands
This leaflet was last revised in 11/2025.
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INSTRUCTIONS FOR USE Pyzchiva (ustekinumab) injection, for subcutaneous use Pre-filled pen Instructions for injecting Pyzchiva using a pre-filled pen. Read this Instructions for Use before you start using Pyzchiva. Your healthcare professional should show you how to prepare and give your injection of Pyzchiva the right way. If you cannot give yourself the injection: • •
ask your healthcare professional to help you, or ask someone who has been trained by a healthcare professional to give your injections.
Do not try to inject Pyzchiva yourself until you have been shown how to inject Pyzchiva by your health professional. Need help? Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information. Guide to parts: Before use
After use
Figure A Important information You Need to Know Before Injecting Pyzchiva • • •
For subcutaneous injection only (inject directly under the skin) Do not remove the needle cap before you are ready to inject. Do not shake the pre-filled pen at any time. Shaking your pre-filled pen may damage your Pyzchiva medicine.
Storing Pyzchiva pre-filled pen:
- Store Pyzchiva in the refrigerator between 2 °C to 8 °C.
- Store Pyzchiva in the original carton to protect from light or physical damage.
- If needed, individual Pyzchiva pre-filled pens may also be stored at room temperature up to 30 °C for a maximum single period of up to 35 days in the original carton in order to protect from light. Record the date when the pre-filled pen is first removed from the refrigerator in the space provided on the outer carton. At any time before the end of this 8
•
period the product can be put back in the refrigerator once and kept there until the expiry date. Discard the pen if not used after the maximum period of 35 days at room temperature storage or by the original expiry date, whichever is earlier. Do not store Pyzchiva in extreme heat or cold. Do not freeze.
Preparing to Inject Pyzchiva pre-filled pen Step 1. Before you start, check the carton to make sure that it is the right dose. You will have either 45 mg or 90 mg as prescribed by your doctor.
- If your dose is 45 mg, you will receive one 45 mg pre -filled pen.
- If your dose is 90 mg, you will receive either one 90 mg pre -filled pen or two 45 mg prefilled pens. If you receive two 45 mg pre-filled pens for a 90 mg dose, you will need to give yourself two injections, one right after the other. Step 2. Gather supplies
- Step 2.1: Choose a well-lit, clean, flat work surface.
- Step 2.2: Gather the supplies you will need to prepare and to give your injection (Figure B).
- You will need the following supplies. ◦ Included in the carton:
- Pyzchiva pre-filled pen ◦ Not included in the carton:
- Alcohol swab
- Cotton balls or gauze pads
- Adhesive bandage
- Sharps disposal container (See "Disposing of Pyzchiva pre-filled pen.")
Figure B Step 3. Inspect the pre-filled pen (Figure C)
- Step 3.1: Check the expiration date on the pre-filled pen or carton.
- Step 3.2: Check the medicine in the window for any particles or discoloration. The medicine should look clear and colorless to light yellow with few white particles.
- Step 3.3: Make sure the pen is not damaged.
- Do not use Pyzchiva if: ◦ the expiration date has passed or if the pre-filled pen has been kept at room temperature up to 30 oC for longer than a maximum single period of 35 days or if the pre-filled pen has been stored above 30 oC. ◦ it is frozen, discolored, cloudy or has large particles. ◦ it is damaged. ◦ it is dropped and appears cracked or broken.
- It is normal to see 1 or more bubbles in the window.
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Figure C Step 4. Allow the medicine to reach room temperature
- For a more comfortable injection, leave Pyzchiva pre-filled pen at room temperature for about 30 minutes before injecting , after removing it from the refrigerator.
- Do not warm the pre-filled pen in any other way (for example, not warm it in a microwave or in hot water).
do
Step 5. Wash your hands
- Wash your hands well with soap and warm water (Figure D).
Figure D Step 6. Choose the injection site
- Choose an injection site around your upper legs (thighs) or lower stomach area (lower abdomen) except for a 5-centimetre area right around your navel (belly-button). If a caregiver is giving you the injection, the outer area of the upper arms may also be used. (Figure E)
- Use a different injection site for each injection.
- Do not give an injection in an area of the skin that is tender, bruised, red, or hard or shows signs of psoriasis.
Figure E
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Step 7. Clean the skin at the injection site
- Clean the skin with a new alcohol swab where you plan to give your injection. (Figure F)
- Do not touch this area again before giving the injection. Let your skin dry before injecting.
- Do not fan or blow on the clean area.
Figure F Injecting Pyzchiva pre-filled pen Step 8. Pull the needle cap straight off when you are ready to inject your Pyzchiva (Figure G).
- Throw away the needle cap.
- It is normal to see a few drops of liquid come out of the needle.
- Do not twist or bend the needle cap while removing it, as this may damage the needle.
- Do not use the pre-filled pen if it is dropped after removing the needle cap. Call your health professional for instructions.
Figure G Step 9. Position the pre-filled pen straight on your skin at 90 degrees (Figure H).
Figure H Step 10. Firmly push the pre-filled pen down onto the skin to start the injection (Figure I).
- You may hear a first click when the injection begins.
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Figure I Step 11. Continue to press down onto the skin until the yellow indicator stops moving. (Figure J). Your injection could take up to 10 seconds.
- You may hear a second click. This means the injection is finished.
- Do not release pressure against the injection site before the injection is complete.
- Do not move the pre-filled pen during the injection.
Figure J Step 12. Check that the viewing window has turned yellow to make sure the full dose has been delivered and remove the empty pen from your skin (Figure K).
- The needle guard will completely cover the needle.
- As in Figure K, a small gray band may still be visible in the viewing window.
- When the needle is pulled out of your skin, there may be a little bleeding or a few drops at the injection site. This is normal. You can press a cotton ball or gauze pad to the injection site if needed. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.
Figure K If your dose is 90 mg, you will receive either one 90 mg pre-filled pen or two 45 mg pre-filled pens. If you receive two 45 mg pre-filled pens for a 90 mg dose, you will need to give yourself a second injection right after the first. Repeat Steps 1-12 for the second injection using a new pen. Choose a 12
different site for the second injection. Disposing of Pyzchiva pre-filled pen Step 13. Put the used pen in a sharps disposal container right away after use (Figure L).
- Do not throw away (dispose of) loose pens in your household trash.
- Do not recycle your used sharps disposal container.
Figure L Keep Pyzchiva and all medicines out of the reach of children.
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Frequently asked questions about Pyzchiva 90 mg solution for injection in pre-filled pen
How do I take Pyzchiva 90 mg solution for injection in pre-filled pen?
Pyzchiva 90 mg solution for injection in pre-filled pen comes as injection containing 90mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pyzchiva 90 mg solution for injection in pre-filled pen?
The active substance in Pyzchiva 90 mg solution for injection in pre-filled pen is ustekinumab.
Are there equivalent medicines to Pyzchiva 90 mg solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: Otulfi 90 mg solution for injection in pre-filled syringe, Pyzchiva 90 mg solution for injection in pre-filled syringe, STELARA 90 mg solution for injection in pre-filled syringe. In total there are 9 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pyzchiva 90 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Pyzchiva 90 mg solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ustekinumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Plaque psoriasis
Pyzchiva is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).
Psoriatic arthritis (PsA)
Pyzchiva, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Crohn's Disease
Pyzchiva is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.
Ulcerative colitis
Pyzchiva is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic.
4.2. Posology and method of administration
Pyzchiva is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Pyzchiva is indicated.
Posology
Plaque psoriasis
The recommended posology of Pyzchiva is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Patients with body weight > 100 kg
For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter. In these patients, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy. (see section 5.1, Table 4).
Psoriatic arthritis (PsA)
The recommended posology of Pyzchiva is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).
Renal and hepatic impairment
Pyzchiva has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
The safety and efficacy of Pyzchiva in children with psoriasis less than 6 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established. The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. See section 4.2 of the pre-filled syringe SmPC for posology and method of administration in paediatric patients 6 years and older with psoriasis.
Crohn's Disease and Ulcerative Colitis
In the treatment regimen, the first dose of Pyzchiva is administered intravenously. For the posology of the intravenous dosing regimen, see section 4.2 of the Pyzchiva 130 mg Concentrate for solution for infusion SmPC.
The first subcutaneous administration of 90 mg Pyzchiva should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended.
Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time (see section 5.1).
Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see section 5.1, section 5.2).
Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment (see section 5.1).
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose or 16 weeks after switching to the 8-weekly maintenance dose.
Immunomodulators and/or corticosteroids may be continued during treatment with Pyzchiva. In patients who have responded to treatment with Pyzchiva, corticosteroids may be reduced or discontinued in accordance with standard of care.
In Crohn's disease or Ulcerative Colitis, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).
Renal and hepatic impairment
Pyzchiva has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
The safety and efficacy of Pyzchiva for the treatment of Crohn's disease in paediatric patients weighing less than 40 kg or ulcerative colitis in children less than 18 years have not yet been established. No data are available. The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. See section 4.2 of the Concentrate for solution for infusion and pre-filled syringe SmPC for posology and method of administration in paediatric patients weighing at least 40 kg with Crohn's disease.
Method of administration
Pyzchiva 45 mg and 90 mg pre-filled pens are for subcutaneous injection only. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
After proper training in subcutaneous injection technique, patients or their caregivers may inject Pyzchiva if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients or their caregivers should be instructed to inject the prescribed amount of Pyzchiva according to the directions provided in the package leaflet. Comprehensive instructions for administration are given in the package leaflet.
For further instructions on preparation and special precautions for handling, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clinically important, active infection (e.g. active tuberculosis; see section 4.4).
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Infections
Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. In clinical studies and a post-marketing observational study in patients with psoriasis, serious bacterial, fungal, and viral infections have been observed in patients receiving ustekinumab (see section 4.8).
Opportunistic infections including reactivation of tuberculosis, other opportunistic bacterial infections (including atypical mycobacterial infection, listeria meningitis, pneumonia legionella, and nocardiosis), opportunistic fungal infections, opportunistic viral infections (including encephalitis caused by herpes simplex 2), and parasitic infections (including ocular toxoplasmosis) have been reported in patients treated with ustekinumab.
Caution should be exercised when considering the use of ustekinumab in patients with a chronic infection or a history of recurrent infection (see section 4.3).
Prior to initiating treatment with ustekinumab , patients should be evaluated for tuberculosis infection. ustekinumab must not be given to patients with active tuberculosis (see section 4.3). Treatment of latent tuberculosis infection should be initiated prior to administering ustekinumab . Anti-tuberculosis therapy should also be considered prior to initiation of ustekinumab in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving ustekinumab should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and ustekinumab should not be administered until the infection resolves.
Malignancies
Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some patients who received ustekinumab in clinical studies and in a post- marketing observational study in patients with psoriasis developed cutaneous and non-cutaneous malignancies (see section 4.8). The risk of malignancy may be higher in psoriasis patients who have been treated with other biologics during the course of their disease.
No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving ustekinumab. Thus, caution should be exercised when considering the use of ustekinumab in these patients.
All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of skin cancer (see section 4.8).
Systemic and respiratory hypersensitivity reactions
Systemic
Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of ustekinumab should be discontinued (see section 4.8).
Respiratory
Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab. Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids. If infection has been excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see section 4.8).
Cardiovascular events
Cardiovascular events including myocardial infarction and cerebrovascular accident have been observed in patients with psoriasis exposed to ustekinumab in a post- marketing observational study. Risk factors for cardiovascular disease should be regularly assessed during treatment with ustekinumab.
Vaccinations
It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with ustekinumab. Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving ustekinumab. Before live viral or live bacterial vaccination, treatment with ustekinumab should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination. Prescribers should consult the Summary of Product Characteristics for the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for twelve months following birth or until ustekinumab infant serum levels are undetectable (see sections 4.5 and 4.6). If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable.
Patients receiving ustekinumab may receive concurrent inactivated or non-live vaccinations.
Long term treatment with ustekinumab does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines (see section 5.1).
Concomitant immunosuppressive therapy
In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab . In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of ustekinumab . Caution should be exercised when considering concomitant use of other immunosuppressants and ustekinumab or when transitioning from other immunosuppressive biologics (see section 4.5).
Immunotherapy
ustekinumab has not been evaluated in patients who have undergone allergy immunotherapy. It is not known whether ustekinumab may affect allergy immunotherapy.
Serious skin conditions
In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment (see section 4.8). Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease. As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriate therapy should be instituted. ustekinumab should be discontinued if a drug reaction is suspected.
Lupus-related conditions
Cases of lupus-related conditions have been reported in patients treated with ustekinumab, including cutaneous lupus erythematosus and lupus-like syndrome. If lesions occur, especially in sun exposed areas of the skin or if accompanied by arthralgia, the patient should seek medical attention promptly. If the diagnosis of a lupus-related condition is confirmed, ustekinumab should be discontinued and appropriate treatment initiated.
Special populations
Elderly (≥ 65 years)
No overall differences in efficacy or safety in patients age 65 and older who received ustekinumab were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Polysorbate 80
Ustekinumab contains 0.04 mg (90 mg/1.0mL) or 0.02 mg (45 mg/0.5 mL) of polysorbate 80 (E433) in each dosage unit which is equivalent to 0.04 mg/mL. Polysorbates may cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
Live vaccines should not be given concurrently with ustekinumab.
Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for twelve months following birth or until ustekinumab infant serum levels are undetectable (see sections 4.4 and 4.6). If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable.
In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products. The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn's disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.
The results of an in vitro study and a phase 1 study in subjects with active Crohn's disease do not suggest the need for dose adjustments in patients who are receiving concomitant CYP450 substrates (see section 5.2).
In psoriasis studies, the safety and efficacy of ustekinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of ustekinumab. In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of ustekinumab (see section 4.4).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Pregnancy
Data from a moderate number of prospectively collected pregnancies following exposure to ustekinumab with known outcomes, including more than 450 pregnancies exposed during the first trimester, do not indicate an increased risk of major congenital malformations in the newborn.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
However, the available clinical experience is limited. As a precautionary measure, it is preferable to avoid the use of ustekinumab in pregnancy.
Ustekinumab crosses the placenta and has been detected in the serum of infants born to female patients treated with ustekinumab during pregnancy. The clinical impact of this is unknown, however, the risk of infection in infants exposed in utero to ustekinumab may be increased after birth.
Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for twelve months following birth or until ustekinumab infant serum levels are undetectable (see sections 4.4 and 4.5). If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint, if infant ustekinumab serum levels are undetectable.
Breast-feeding
Limited data from published literature suggests that ustekinumab is excreted in human breast milk in very small amounts. It is not known if ustekinumab is absorbed systemically after ingestion. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with ustekinumab must be made taking into account the benefit of breast-feeding to the child and the benefit of ustekinumab therapy to the woman.
Fertility
The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).
4.7. Effects on ability to drive and use machines
Ustekinumab has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for ustekinumab is serious hypersensitivity reactions including anaphylaxis (see section 4.4). The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Tabulated list of adverse reactions
The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3 studies in 6,710 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn's disease and 826 patients with ulcerative colitis). This includes exposure to ustekinumab in the controlled and non-controlled periods of the clinical studies in patients with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis for at least 6 months (4,577 patients) or at least 1 year (3,648 patients). 2,194 patients with psoriasis, Crohn's disease or ulcerative colitis were exposed for at least 4 years while 1,148 patients with psoriasis or Crohn's disease were exposed for at least 5 years.
Table 1 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience. The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1: List of adverse reactions
System Organ Class
Frequency: Adverse reaction
Infections and infestations
Common: Upper respiratory tract infection, nasopharyngitis, sinusitis
Uncommon: Cellulitis, dental infections, herpes zoster, lower respiratory tract infection, viral upper respiratory tract infection, vulvovaginal mycotic infection
Immune system disorders
Uncommon: Hypersensitivity reactions (including rash, urticaria)
Rare: Serious hypersensitivity reactions (including anaphylaxis, angioedema)
Psychiatric disorders
Uncommon: Depression
Nervous system disorders
Common: Dizziness, headache
Uncommon: Facial palsy
Respiratory, thoracic and mediastinal disorders
Common: Oropharyngeal pain
Uncommon: Nasal congestion
Rare: Allergic alveolitis, eosinophilic pneumonia
Very rare: Organising pneumonia*
Gastrointestinal disorders
Common: Diarrhoea, nausea, vomiting
Skin and subcutaneous tissue disorders
Common: Pruritus
Uncommon: Pustular psoriasis, skin exfoliation, acne
Rare: Exfoliative dermatitis, hypersensitivity vasculitis
Very rare: Bullous pemphigoid, cutaneous lupus erythematosus
Musculoskeletal and connective tissue disorders
Common: Back pain, myalgia, arthralgia
Very rare: Lupus-like syndrome
General disorders and administration site conditions
Common: Fatigue, injection site erythema, injection site pain
Uncommon: Injection site reactions (including haemorrhage, haematoma, induration, swelling and pruritus), asthenia
* See section 4.4, Systemic and respiratory hypersensitivity reactions.
Description of selected adverse reactions
Infections
In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo. In the placebo-controlled period of these clinical studies, the rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in placebo-treated patients. Serious infections occurred at the rate of 0.03 per patient-year of follow-up in ustekinumab-treated patients (30 serious infections in 930 patient-years of follow-up) and 0.03 in placebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see section 4.4).
In the controlled and non‑controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 15,227 patient‑years of ustekinumab exposure in 6,710 patients, the median follow-up was 1.2 years; 1.7 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 2.3 years for ulcerative colitis studies. The rate of infection was 0.85 per patient‑year of follow‑up in ustekinumab‑treated patients, and the rate of serious infections was 0.02 per patient‑year of follow‑up in ustekinumab‑treated patients (289 serious infections in 15,227 patient‑years of follow‑up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, gastroenteritis and viral infections.
In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis.
Malignancies
In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up). The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).
In the controlled and non-controlled periods of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, representing 15,205 patient‑years of exposure in 6,710 patients, the median follow-up was 1.2 years; 1.7 years for psoriatic disease studies, 0.6 year for Crohn's disease studies and 2.3 years for ulcerative colitis studies. Malignancies excluding non‑melanoma skin cancers were reported in 76 patients in 15,205 patient‑years of follow‑up (incidence of 0.50 per 100 patient-years of follow-up for ustekinumab‑treated patients). The incidence of malignancies reported in ustekinumab‑treated patients was comparable to the incidence expected in the general population (standardised incidence ratio = 0.94 [95% confidence interval: 0.73, 1.18], adjusted for age, gender and race). The most frequently observed malignancies, other than non‑melanoma skin cancer, were prostate, melanoma, colorectal, and breast cancers. The incidence of non‑melanoma skin cancer was 0.46 per 100 patient‑years of follow‑up for ustekinumab‑treated patients (69 patients in 15,165 patient‑years of follow‑up). The ratio of patients with basal versus squamous cell skin cancers (3:1) is comparable with the ratio expected in the general population (see section 4.4).
Hypersensitivity and infusion reactions
In Crohn's disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose. In these studies, 2.2% of 785 placebo-treated patients and 1.9% of 790 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion. Serious infusion-related reactions including anaphylactic reactions to the infusion have been reported in the post-marketing setting (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
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- Pyzchiva 45 mg solution for injection in pre-filled pen
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