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.
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.
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:
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.
• 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
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.
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.
Other medicines, vaccines and Yesintek Tell your doctor or pharmacist:
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:
• 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.
• Reduce the signs and symptoms of your disease. • Improve your physical function. • Slow down the damage to your joints.
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.
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.
Product Name Component
YESINTEK 90 mg PFS LEAFLET
Dimensions Artwork Code
390(W) x 659(H) mm; Folded Size : 40(W) x 98(H) mm
Country Pharmacode
Specification: Font Type
Helvetica Neue LT Pro
40 GSM ITC Paper Booklet to be sealed with self adhesive tape.
10 pt
Font Size
Colors CMYK
Keyline
07-08-2025-V1 | 11-08-2025-V2 | 14.08.25-V3 | 20-08-25 \ V4 | 08-04-2026 \ V5 | 27-04-2026 \ V6
• 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.
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.
90 mg Yesintek
ustekinumab
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.
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.
How much Yesintek is given Your doctor will decide how much Yesintek you need to use and for how long.
If you have a serious allergic reaction, your doctor may decide that you should not use Yesintek again.
Adults aged 18 years or older Psoriasis or Psoriatic Arthritis
Infections – these may need urgent treatment. Tell your doctor straight away if you notice any of the following signs.
• 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.
• 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)
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.
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.
Children and adolescents aged 6 years or older Psoriasis
You must look out for signs of infection while you are using Yesintek. These include:
• 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. • A 45 mg vial is available for children who need to receive less than the full 45 mg dose. • 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.
• 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.
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.
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):
How Yesintek is given
• 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):
• 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.
• Tooth infections • Vaginal yeast infection • Depression • Blocked or stuffy nose • Bleeding, bruising, hardness, swelling and itching where the injection is given • Feeling weak
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.
• 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Driving and using machines Yesintek has no or negligible influence on the ability to drive and use machines.
Serious side effects Some patients may have serious side effects that may need urgent treatment.
Yesintek contains Polysorbate 80 (E433) Yesintek contains 0.04 mg of polysorbate 80 (E433) in each 90mg/1mL PFS which is equivalent to 0.04 mg/mL (0.0004 mg/kg/day). Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.
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).
• 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 syringe in the outer carton in order to protect from light. • If needed, individual Yesintek pre-filled syringes may also be stored at room temperature up to 30°C for a maximum single period of up to 30 days in the original carton in order to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the discard date in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier. • Do not shake Yesintek pre-filled syringes. 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. • After discard date recorded on the carton once stored at room temperature, i.e., more than 30 days at 30°. • 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.
Yesintek is for single use only. Any unused product remaining in 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.
What Yesintek contains
• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg ustekinumab in 1 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, colourless to pale yellow solution for injection. It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled syringe. Each pre-filled syringe contains 90 mg ustekinumab in 1 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
Instructions for administration Figure 1 shows what the pre-filled syringe looks like
Get everything together that you need and lay out on a well-lit, clean, and flat surface. This includes • antiseptic wipes, • a cotton ball or gauze, • and a sharps container, • your prescribed dose of Yesintek injection (See Figure 2)
Before Usage After Usage
Used Plunger head Plunger head
Plunger
Used Syringe Barrel
Needle guard wings
Finger grips
Viewing window Label and Expiration date
Used Needle
Syringe Barrel (Body)
Needle Safety Guard
Used Needle Safety Spring
Needle safety spring Needle cover
Needle Cover
Figure 2
Instructions for administration
2. Choose and prepare the injection site:
At the start of treatment, your healthcare provider will assist you with your first injection. However, you and your doctor may decide that you may inject Yesintek yourself. If this happens, you will get training on how to inject Yesintek. Talk to your doctor if you have any questions about giving yourself an injection. • Do not mix Yesintek with other liquids for injection • Do not shake Yesintek pre-filled syringes. This is because strong shaking may damage the medicine. Do not use the medicine if it has been shaken strongly.
Choose an injection site (see Figure 3) • Yesintek is given by injection under the skin (subcutaneously). • Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button). • If possible, do not use areas of skin that show signs of psoriasis. • If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site
1. Check the number of pre-filled syringes and prepare the materials: Preparing for use of the pre-filled syringe • Take the pre-filled syringe(s) out of the refrigerator. Let the pre-filled syringe stand outside the box for about half an hour. This will let the liquid come to a comfortable temperature for injection (room temperature). Do not remove the syringe's needle cover while allowing it to reach room temperature • Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward • Do not hold by the plunger head, plunger, needle guard wings, or needle cover • Do not pull back on the plunger at anytime • Do not attempt to remove the needle safety guard from the pre-filled syringe • Do not remove the needle cover from the pre-filled syringe until instructed to do so • Check the pre-filled syringe(s) to make sure the number of pre-filled syringes and strength is correct If your dose is 90 mg you will get one 90 mg pre-filled syringe of Yesintek • it is the right medicine • it has not passed its expiry date • the pre-filled syringe is not damaged • the solution in the pre-filled syringe is clear, colourless to pale yellow • the solution on the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles. • the solution in the pre-filled syringe is not frozen. • Get everything together that you need and lay out on a well-lit clean and flat surface. This includes antiseptic wipes, cotton ball or gauze, and a sharps container
Figure 3
*Areas in blue are recommended injection sites. Prepare the injection site • Wash your hands very well with soap and warm water. Do not touch face or hair after washing hands. • Wipe the injection site on the skin with an antiseptic wipe • Do not touch this area again before giving the injection. • Remove prefilled syringe tray from carton • Open the tray by peeling away the cover. Hold the Needle safety guard (as shown in the Figure 4) to remove the prefilled syringe from the tray
Yesintek
Yesintek
Grasp Here
Figure 4
• Hold the prefilled syringe with the covered needle pointing upward.
3. Remove the needle cover (see Figure 5):
• The needle cover should not be removed until you are ready to inject the dose • Pick up the pre-filled syringe, hold the body of the syringe with one hand • Pull the needle cover straight off and throw it away. Do not touch the plunger while you do this
Storage information
Prefilled syringes must be refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light until the time of use. • Do not freeze. Do not shake. • If needed, individual prefilled syringes may be stored at room temperature up to 30 °C (86 °F) for a maximum single period of up to 30 days in the original carton to protect from light. • Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. • Discard the syringe if not used within 30 days at room temperature storage
Figure 5
Product Name Component
Yesintek, PFS IFU
Dimensions Artwork Code
390(W) x 600(H) mm ; Folded Size : 100(W) x 40(H) mm
Country Pharmacode
Font Type
Specification:
Helvetica Neue LT Pro
Paper: 60gsm Maplitho Paper Booklet to be sealed with self adhesive tape
10 pt
Font Size
Colors CMYK
Keyline
Gather the supplies 5. After the injection:
• Press an antiseptic wipe over the injection site for a few seconds after the injection. • There may be a small amount of blood or liquid at the injection site. This is normal. • You can press a cotton ball or gauze over the injection site and hold for 10 seconds. • Do not rub the skin at the injection site. You may cover the injection site with a small adhesive bandage, if necessary.
• You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle. These are both normal and do not need to be removed • Do not touch the needle or allow it to touch any surface • Do not use the pre-filled syringe if it is dropped without the needle cover in place. If this happens, please contact your doctor or pharmacist • lnject the dose promptly after removing the needle cover.
4. lnject the dose 6. Disposal:
• Used syringes should be placed in a puncture-resistant container, like a sharps container (see Figure 10). Never re-use a syringe, for your safety and health and for the safety of others. Dispose of your sharps container according to your local regulations. • Antiseptic wipes and other supplies can be disposed of in your garbage
• Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly • Do not pull back on the plunger at anytime • In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 6)
Figure 6
Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 7)
Needle guard wings
Manufactured by: Biosimilar Collaborations Ireland Limited Block B, The Crescent Building, Santry Demesne Dublin
Figure 7
When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 8)
Ireland
Marketed by: Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, DUBLIN Ireland, D13
Revised: April/ 2026
Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 9:
Figure 9
Yesintek 90 mg/1 ml Solution for injection Pre-filled syringe comes as solution containing 90 mg/1. 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 90 mg/1 ml Solution for injection Pre-filled syringe 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 90 mg/1 ml Solution for injection Pre-filled syringe, 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.
Plaque psoriasis
Yesintek 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).
Paediatric plaque psoriasis
Yesintek is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).
Psoriatic arthritis (PsA)
Yesintek, 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).
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 is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Yesintek is indicated.
Posology
Plaque psoriasis
The recommended posology of Yesintek 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 Yesintek 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
No dose adjustment is needed for patients aged 65 years and older (see section 4.4).
Renal and hepatic impairment
Yesintek has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
The safety and efficacy of Yesintek 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.
Paediatric plaque psoriasis
The recommended dose of Yesintek for 6 years and older based on body weight is shown below (Tables 1 and 2). Yesintek should be administered at Weeks 0 and 4, then every 12 weeks thereafter
Table 1: Recommended dose of Yesintek for paediatric psoriasis
| Body weight at the time of dosing | Recommended Dose |
| < 60 kg | 0.75 mg/kg |
| ≥ 60-≤ 100 kg | 45 mg |
| > 100 kg | 90 mg |
To calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body weight (kg) x 0.0083 (mL/kg) or see Table 2. The calculated volume should be rounded to the nearest 0.01 mL and administered using a 1 mL graduated syringe. A 45 mg vial is available for paediatric patients who need to receive less than the full 45 mg dose.
Table 2: Injection volumes of Yesintek for paediatric psoriasis patients < 60 kg
| Body weight at time of dosing (kg) | Dose (mg) | Volume of injection (mL) |
| 15 | 11.3 | 0.12 |
| 16 | 12.0 | 0.13 |
| 17 | 12.8 | 0.14 |
| 18 | 13.5 | 0.15 |
| 19 | 14.3 | 0.16 |
| 20 | 15.0 | 0.17 |
| 21 | 15.8 | 0.17 |
| 22 | 16.5 | 0.18 |
| 23 | 17.3 | 0.19 |
| 24 | 18.0 | 0.20 |
| 25 | 18.8 | 0.21 |
| 26 | 19.5 | 0.22 |
| 27 | 20.3 | 0.22 |
| 28 | 21.0 | 0.23 |
| 29 | 21.8 | 0.24 |
| 30 | 22.5 | 0.25 |
| 31 | 23.3 | 0.26 |
| 32 | 24.0 | 0.27 |
| 33 | 24.8 | 0.27 |
| 34 | 25.5 | 0.28 |
| 35 | 26.3 | 0.29 |
| 36 | 27.0 | 0.30 |
| 37 | 27.8 | 0.31 |
| 38 | 28.5 | 0.32 |
| 39 | 29.3 | 0.32 |
| 40 | 30.0 | 0.33 |
| 41 | 30.8 | 0.34 |
| 42 | 31.5 | 0.35 |
| 43 | 32.3 | 0.36 |
| 44 | 33.0 | 0.37 |
| 45 | 33.8 | 0.37 |
| 46 | 34.5 | 0.38 |
| 47 | 35.3 | 0.39 |
| 48 | 36.0 | 0.40 |
| 49 | 36.8 | 0.41 |
| 50 | 37.5 | 0.42 |
| 51 | 38.3 | 0.42 |
| 52 | 39.0 | 0.43 |
| 53 | 39.8 | 0.44 |
| 54 | 40.5 | 0.45 |
| 55 | 41.3 | 0.46 |
| 56 | 42.0 | 0.46 |
| 57 | 42.8 | 0.47 |
| 58 | 43.5 | 0.48 |
| 59 | 44.3 | 0.49 |
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Adults
Crohn's Disease and Ulcerative Colitis
In the treatment regimen, the first dose of Yesintek is administered intravenously. For the posology of the intravenous dosing regimen, see section 4.2 of the Yesintek 130 mg Concentrate for solution for infusion SPC.
The first subcutaneous administration of 90 mg Yesintek 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 Yesintek. In patients who have responded to treatment with Yesintek, 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
No dose adjustment is needed for patients aged 65 years and older (see section 4.4).
Renal and hepatic impairment
Yesintek 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)
In the treatment regimen, the first dose of Yesintek is administered intravenously. For the posology of the intravenous dosing regimen, see section 4.2 of the Yesintek 130 mg Concentrate for solution for infusion SPC.
The first subcutaneous administration of 90 mg Yesintek should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended.
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 dose adjustment.
Immunomodulators, 5-aminosalicylate (5-ASA) compounds, antibiotics, and/or corticosteroids may be continued during treatment with Yesintek. In patients who have responded to treatment with Yesintek, these medications maybe reduced or discontinued in accordance with standard of care.
The safety and efficacy of Yesintek in treatment of Crohn's disease for 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 90 mg pre-filled syringes 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 Yesintek 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 Yesintek 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.
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 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 90 mg/1 ml Solution for injection Pre-filled syringe. 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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