Yesintek 45 mg solution for injection – patient leaflet, side effects, dosage

1. What Yesintek is and what it is used for

What Yesintek is

Yesintek contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

Yesintek belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.

What Yesintek is used for

Yesintek is used to treat the following inflammatory diseases:

• Plaque psoriasis - in adults and children aged 6 years and older
• Psoriatic arthritis - in adults
• Moderate to severe Crohn’s disease - in adults and children who weigh at least 40 kg
• Moderate to severe ulcerative colitis – in adults

Plaque psoriasis

Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. Yesintek will reduce the inflammation and other signs of the disease.

Yesintek is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.

Yesintek is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies 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 enough to these medicines, you may be given Yesintek 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 Yesintek 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 Yesintek to reduce the signs and symptoms of your disease.

2. What you need to know before you use Yesintek

Do not use Yesintek

• 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 import ant.

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

Warnings and precautions

Talk to your doctor or pharmacist before using Yesintek. 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 Yesintek. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects

Yesintek can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Yesintek. See ‘Serious side effects’ in section 4 for a full list of these side effects.

Before you use Yesintek tell your doctor:

• If you ever had an allergic reaction to Yesintek. Ask your doctor if you are not sure.
• If you have ever had any type of cancer – this is because immunosuppressants like Yesintek 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 Yesintek 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 Yesintek 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 Yesintek.

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 Yesintek. 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

Yesintek is not recommended for use in children with psoriasis under 6 years of age, children with Crohn's disease who weigh less than 40 kg or for use in children under 18 years of age with psoriatic arthritis, or ulcerative colitis because it has not been studied in this age group.

Other medicines, vaccines and Yesintek

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 Yesintek.
• If you received Yesintek while pregnant, tell your baby’s doctor about your Yesintek 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 Yesintek 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 Yesintek in the womb. However, there is limited experience with Yesintek in pregnant women. It is therefore preferable to avoid the use of Yesintek in pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Yesintek and for at least 15 weeks after the last Yesintek treatment.
• Yesintek can pass across the placenta to the unborn baby. If you received Yesintek 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 Yesintek 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 Yesintek 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 Yesintek - do not do both.

Driving and using machines

Yesintek has no or negligible influence on the ability to drive and use machines.

Yesintek contains Polysorbate 80 (E433)

Yesintek contains 0.02 mg of polysorbate 80 (E433) in each 45mg/0.5mL vial which is equivalent to 0.02 mg/0.5 mL (0.0003 mg/kg/day). Polysorbates may cause allergic reactions.

Tell your doctor if you have or your child has any known allergies.

3. How to use Yesintek

Yesintek is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Yesintek 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 Yesintek is given

Your doctor will decide how much Yesintek 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 Yesintek. 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 Yesintek 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 Yesintek 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 Yesintek may be given every 8 weeks. Your doctor will decide when you should receive your next dose.

Children and adolescents aged 6 years or older

Psoriasis

• The doctor will work out the right dose for you, including the amount (volume) of Yesintek to be injected to give the right dose. The right dose for you will depend on your body weight at the time each dose is given.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Yesintek per kg body weight.
• If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Yesintek.
• If you weigh more than 100 kg, the recommended dose is 90 mg Yesintek.
• After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

Children who weigh at least 40 kg Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg Yesintek 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 Yesintek 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 Yesintek may be given every 8 weeks. Your doctor will decide when you should receive your next dose.

How Yesintek is given

• Yesintek is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, medical or nursing staff may inject Yesintek.
• However, you and your doctor may decide that you may inject Yesintek yourself. In this case you will get training on how to inject Yesintek yourself.
• For instructions on how to inject Yesintek, 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 Yesintek than you should

If you have used or been given too much Yesintek, 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 Yesintek

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 Yesintek

It is not dangerous to stop using Yesintek. 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

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 Yesintek (may affect up to 1 in 1 000 people). Signs include:

  o difficulty breathing or swallowing

  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 Yesintek 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)

Yesintek 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 Yesintek. 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, skin infections, 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 Yesintek 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):

• 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or 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 Yesintek

• 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 carton in order to protect from light.

• Do not shake the Yesintek vials. 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 Yesintek 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.
  • If the seal is broken.

Yesintek is for single use only. Any unused product remaining in the vial and the syringe 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 Yesintek contains

• The active substance is ustekinumab. Each vial contains 45 mg ustekinumab in 0.5 mL.
• The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

What Yesintek looks like and contents of the pack

Yesintek is a clear, colorless to pale yellow solution for injection. It is supplied as a carton pack containing 1 single-dose, glass 2 mL vial. Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection.

Marketing Authorisation Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade

Baldoyle Industrial Estate

Dublin 13, DUBLIN

Ireland, D13 R20R

Manufacturers

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building

Santry Demesne

Dublin

D09 C6X8

Ireland

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

United Kingdom

Biosimilars Newco Limited

Tel: 0080008250910

This leaflet was last revised in April 2026.

BFXXXXX/XX Yesintek

45 mg

solution for injection ustekinumab

BFXXXXX/XX

Yesintek

45 mg

solution for injection

ustekinumab

solution for injection

ustekinumab

45 mg Yesintek

Package leaflet: Information for the user