Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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: • Moderate to severe Crohn's disease - in adults and children who weigh at least 40 kg • Moderate to severe ulcerative colitis- in adults 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.
• 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 Yesintek. Warnings and precautions Talk to your doctor or pharmacist before using Yesintek. Your doctor will check how well you are before treatment. Make sure you tell your doctor about any illness you have before 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 or if you have any abnormal skin openings (fistulae). • 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 who weigh less than 40 kg with Crohn's disease under 18 years of age with 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 sodium Yesintek contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. However, before Yesintek is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet. Yesintek contains Polysorbate 80 (E433) This medicinal product contains 10.4 mg of polysorbate 80 (E433) in each 130 mg/26 mL vial which is equivalent to 0.4 mg/mL (0.6 mg/kg/day). Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
How Yesintek will be given Yesintek is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis. Yesintek 130 mg concentrate for solution for infusion will be given to you by your doctor, through a drip in the vein of your arm (intravenous infusion) over at least one hour. 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 receive and for how long. Adults aged 18 years or older • The doctor will work out the recommended intravenous infusion dose for you based on your body weight.
Your body weight Dose ≤ 55 kg 260 mg > 55 kg to ≤ 85 kg 390 mg > 85 kg 520 mg • After the starting intravenous dose, you will have the next dose of 90 mg Yesintek by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter. Children with Crohn's disease who weigh at least 40 kg • The doctor will work out the recommended intravenous infusion dose for you based on your body weight.
Your body weight Dose ≥ 40 to ≤ 55 kg 260 mg > 55 kg to ≤ 85 kg 390 mg > 85 kg 520 mg • After the starting intravenous dose, you will have the next dose of 90 mg Yesintek by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter. How Yesintek is given • The first dose of Yesintek for treatment of Crohn's disease or ulcerative colitis is given by a doctor as a drip in the vein of an arm (intravenous infusion). Talk to your doctor if you have any questions about receiving Yesintek. If you forget to use Yesintek If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment. 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.
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). Infusion-related reactions – If you are being treated for Crohn's disease or ulcerative colitis, the first dose of Yesintek is given through a drip into a vein (intravenous infusion). Some patients have experienced serious allergic reactions during the infusion. 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.
hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injection. What Yesintek looks like and contents of the pack Yesintek is a clear, colourless to pale yellow concentrate for solution for infusion. It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial. Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion. 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. The following information is intended for healthcare professionals only: 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.
Instructions for dilution: Yesintek concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique. 1. Calculate the dose and the number of Yesintek vials needed based on patient weight (see section 3, Table 1, Table 2). Each 26 mL vial of Yesintek contains 130 mg of ustekinumab. 2. Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of Yesintek to be added (discard 26 mL sodium chloride for each vial of Yesintek needed, for 2 vials- discard 52 mL, for 3 vials discard 78 mL, for 4 vials- discard 104 mL). 3. Withdraw 26 mL of Yesintek from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix. 4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discolouration or foreign particles are observed. 5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed within twelve hours of the dilution in the infusion bag. 6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer). 7. Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements. Storage If necessary, the diluted infusion solution may be stored at room temperature. The infusion should be completed within 12 hours of the dilution in the infusion bag. Do not freeze. Do not return to the refrigerator after dilution.
Yesintek 130 mg/26 ml Concentrate for Solution for infusion Vial comes as solution containing 130 mg/26. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Yesintek 130 mg/26 ml Concentrate for Solution for infusion Vial is ustekinumab.
Medicines with the same active substance include: Otulfi 130 mg concentrate for solution for infusion, Otulfi 45 mg Solution for injection, Otulfi 45 mg solution for injection in pre-filled pen, Otulfi 45 mg solution for injection in pre-filled syringe, Otulfi 90 mg solution for injection in pre-filled pen, Otulfi 90 mg solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Yesintek 130 mg/26 ml Concentrate for Solution for infusion Vial, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Adult Crohn's Disease
Yesintek 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.
Paediatric Crohn's Disease
Yesintek is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.
Ulcerative colitis
Yesintek 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 or have medical contraindications to such therapies (see section 5.1).
Yesintek concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Yesintek concentrate for solution for infusion should only be used for the intravenous induction dose.
Posology
Adults
Crohn's Disease and Ulcerative Colitis
Yesintek treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of Yesintek 130 mg as specified in Table 1 (see section 6.6 for preparation).
Table 1: Initial intravenous dosing of Yesintek
| Body weight of patient at the time of dosing | Recommended dosea | Number of 130 mg Yesintek Vials |
| ≤ 55 kg > 55 kg to ≤ 85 kg > 85 kg | 260 mg 390 mg 520 mg | 2 3 4 |
aApproximately 6 mg/kg
The first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the Yesintek solution for injection (vial) and solution for injection in pre-filled syringe SPC.
Elderly
No dose adjustment is needed for patients aged 65 years and older (see section 4.4).
Renal and hepatic impairment
Ustekinumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
Paediatric Crohn's disease (patients weighing at least 40 kg)
Yesintek treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of Yesintek130 mg as specified in Table 2 (see section 6.6 for preparation).
Table 2 Initial intravenous dosing of Yesintek
| Body weight of patient at the time of dosing | Recommended dosea | Number of 130 mg Yesintek Vials |
| ≥ 40 kg to ≤ 55 kg > 55 kg to ≤ 85 kg > 85 kg | 260 mg 390 mg 520 mg | 2 3 4 |
a Approximately 6 mg/kg
The first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the Yesintek solution for injection (vial) and solution for injection in prefilled syringe SPC.
The safety and efficacy of ustekinumab 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.
Method of administration
Yesintek 130 mg is for intravenous use only. It should be administered over at least one hour. For instructions on dilution of the medicinal product before administration, see section 6.6.
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).
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 Cytochrome P450 (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).
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).
Yesintek has no or negligible influence on the ability to drive and use machines.
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.
Ask anything about Yesintek 130 mg/26 ml Concentrate for Solution for infusion Vial. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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