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 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. 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. 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 Stelara to reduce the signs and symptoms of your disease.
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 ustekinumab. 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 Yesintek 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 pre-filled syringe or vial should be used instead for children 6 years of age and older and adolescents with psoriasis. The solution for infusion, pre-filled vial or syringe should be used instead for children weighing at least 40 kg with Crohn's disease. Yesintek 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 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 (E 433)
Yesintek contains 0.04 mg of polysorbate 80 (E 433) in each 90 mg/1 mL pre-filled pen which is equivalent to 0.04 mg/0.5 mL (0.0004 mg/kg/day). Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
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 ustekinumab (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, 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 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.
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. Yesintek is for single use only. Any unused product remaining in the 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.
Figure A Preparing Yesintek for Injection 1. Take out 1 Yesintek pre-filled pen Remove the Yesintek pre-filled pen from the carton and set it down on a clean, flat surface (see Figure B).
Do not use the Yesintek pre-filled pen if the carton looks damaged or if tamper evident seal is broken.
Instructions for use Yesintek (ustekinumab) injection, for subcutaneous use Pre-filled pen Read this Instructions for Use each time you use the Yesintek pre-filled pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important Information You Need to Know Before Injecting Yesintek • Yesintek is a prescription medicine that is injected under the skin (subcutaneous) from a singledose pre-filled pen. • Do not reuse the Yesintek pre-filled pen. Always use a new Yesintek pre-filled pen for each injection. • Your healthcare provider may decide that a caregiver can give you the injections at home. You and your caregiver should receive training on the right way to prepare and inject Yesintek before using it for the first time. • Do not inject yourself or someone else until your healthcare provider has shown you how to inject Yesintek the right way. • Do not use the Yesintek pre-filled pen if it is expired or damaged. • If your dose is 90 mg, you will receive one 90 mg pre-filled pen Storage Information • Store the Yesintek pre-filled pen in the refrigerator between 36°F to 46°F (2°C to 8°C). • Keep the Yesintek pre-filled pen in the original carton to protect it from light before use. • If needed, the Yesintek pre-filled pen can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days. • Do not use the Yesintek pre-filled pen if it has been left out at room temperature for more than 30 days. Throw away (dispose of) the Yesintek pre-filled pen into a sharps disposal container. Refer to Step 15 for more information. • Do not freeze the Yesintek pre-filled pen. • Do not shake the Yesintek pre-filled pen. • Keep Yesintek and all medicines out of the reach of children. Yesintek Pre-filled pen Parts
Figure B 2. Check the Yesintek pre-filled pen Check the Yesintek pre-filled pen for damage (see Figure C).
Do not use the Yesintek pre-filled pen if it is damaged.
Figure C 3. Check the expiration date Check the expiration date printed on the Yesintek pre-filled pen label (see Figure D).
Do not use the Yesintek pre-filled pen if it is expired.
Figure D 4. Allow the Yesintek pre-filled pen to Warm to Room Temperature • If the Yesintek pre-filled pen was stored in the refrigerator, let it sit for about 30 minutes to allow it to reach room temperature. Injecting cold medicine can be painful (see Figure E).
Do not warm any other way. For example, do not warm it in a microwave, or hot water, or near other heat sources.
Do not remove the cap until you are ready to inject.
Figure E 5. Gather the supplies • Gather the following additional supplies not included in the carton: 1 Alcohol Wipe (See Figure F)
Figure F 1 Sharp Disposal Container (See Figure G). See Step 15 for instructions on how to throw away (dispose of) the used Yesintek pre-filled pen.
Figure G 1 Gauze Pad or Cotton Ball (See Figure H)
Figure H 1 Adhesive Bandage (See Figure I)
Figure I 6. Check the medicine After the Yesintek pre-filled pen warms to room temperature, check the medicine in the viewing window (see Figure J). The medicine should look clear and colorless to pale yellow. It is normal to see
small air bubbles.
Do not use if the medicine is cloudy, discolored, or has large particles.
Figure J 7. Choose the injection site • You can inject into (see Figure K): - the front of the thigh (Recommended), or - the stomach area (abdomen), at least 5 cm away from the belly button. • If your caregiver is giving you the injection, you may also use the outer area of the upper arms (see Figure K):
Do not inject into skin that is tender, bruised, red, scaly or hard.
Do not inject into areas with scars or stretch marks.
Always rotate (change) injection sites between injections. Your injection site should be at least 5 cm away from your last injection site.
Figure K 8. Wash Hands and Clean the Injection Site Wash your hands well with soap and water (see Figure L).
Figure L Clean the chosen injection site with an alcohol wipe (see Figure M). Then let it air dry.
Do not touch, fan or blow on the injection site after you have cleaned it.
Figure M Injecting Yesintek 9. Remove the Yesintek pre-filled pen cap and throw it away • While holding the body of the Yesintek pre-filled pen with one hand, use the other hand to pull the cap straight off (see Figure N). • Throw away (dispose of) the cap into the household trash.
Do not put the cap back on, this may damage the hidden needle.
Do not touch the yellow needle cover or put your fingers near the needle opening.
Do not use the pre-filled pen if you drop it without the cap on.
Figure N 10. Position the Yesintek pre-filled pen • Position the Yesintek pre-filled pen at the cleaned injection site. Place the yellow needle cover of the pre-filled pen flat against the skin (90 degree angle). Make sure you can see the viewing window (see Figure O).
Figure O 11. Start the injection • To start the injection, press the Yesintek pre-filled pen straight down against the skin (see Figure P). You will hear the "1st CLICK" as the injection starts.
Figure P 12. Hold down • Hold the Yesintek pre-filled pen down against your skin and watch the viewing window. The window will turn completely yellow (see Figure Q), and you will hear a "2nd CLICK". This may take up to 15 seconds.
Figure Q 13. Wait 5 seconds • Continue holding the pre-filled pen down and wait for 5 seconds after the window turns yellow to make sure all the medicine has been injected (see Figure R).
Figure R 14. Remove the pre-filled pen from the skin • Lift the Yesintek pre-filled pen straight up from the skin (see Figure S). • The yellow needle cover will extend to lock into place, covering the needle.
Figure S After Injection 15. Throw away (dispose of) the used Yesintek pre-filled pen • Throw away the used Yesintek pre-filled pen in a sharps disposal container (see Figure T).
Figure T If you do not have a cleared sharps disposal container, you may use a household container that is: • made of a heavy-duty plastic, • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, • upright and stable during use, • leak-resistant, and • properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. 16. Check the injection site • If there is bleeding at the injection site, you can press a cotton ball or gauze pad over the injection site (see Figure U). • If needed, you may cover the injection site with an adhesive bandage.
Figure U
Yesintek 90 mg/1 ml Solution for injection Pre-filled Pen 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 Pen 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 Pen, 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).
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).
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.
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.
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 2).
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. 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 SPC 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 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 ustekinumab. In patients who have responded to treatment with ustekinumab, 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
The safety and efficacy of Yesintek for the treatment of Crohn's disease in children 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 SPC for posology and method of administration in paediatric patients weighing at least 40 kg with Crohn's disease.
Method of administration
Yesintek 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 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 Yesintek.
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 Yesintek 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 Yesintek must be made taking into account the benefit of breast-feeding to the child and the benefit of Yesintek 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 Pen. 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.