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 Otulfi is Otulfi contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
Otulfi belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.
What Otulfi is used for Otulfi administered using 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. Otulfi will reduce the inflammation and other signs of the disease.
Otulfi administered using pre-filled pen is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given Otulfi 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 Otulfi 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 Otulfi to reduce the signs and symptoms of your disease
Do not use Otulfi • If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection which your doctor thinks is important.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Otulfi.
Warnings and precautions Talk to your doctor or pharmacist before using Otulfi. Your doctor will check how well you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will examine you and do a test for tuberculosis, before you have Otulfi. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Look out for serious side effects Otulfi can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Otulfi. See ‘Serious side effects’ in section 4 for a full list of these side effects.
Before you use Otulfi tell your doctor: • If you ever had an allergic reaction to ustekinumab. Ask your doctor if you are not sure.
• If you have ever had any type of cancer – this is because immunosuppressants like Otulfi weaken part of the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) – the risk of cancer may be higher.
• If you have or have had a recent infection.
• If you have any new or changing lesions within psoriasis areas or on normal skin.
• If you have ever had an allergic reaction to Otulfi injection –See ‘Look out for serious side effects’ in section 4 for the signs of an allergic reaction.
• 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 Otulfi 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 Otulfi 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 Otulfi.
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 Otulfi 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.
Otulfi 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 Otulfi 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 Otulfi.
• If you received Otulfi while pregnant, tell your baby’s doctor about your Otulfi 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 Otulfi during the pregnancy unless your baby’s doctor recommends otherwise.
Pregnancy and breast-feeding • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
• A higher risk of birth defects has not been seen in babies exposed to ustekinumab in the womb. However, there is limited experience with ustekinumab in pregnant women. It is therefore preferable to avoid the use of Otulfi in pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Otulfi and for at least 15 weeks after the last Otulfi treatment.
• Ustekinumab can pass across the placenta to the unborn baby. If you received Otulfi 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 Otulfi 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 Otulfi 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 Otulfi - do not do both.
Driving and using machines Otulfi has no or negligible influence on the ability to drive and use machines.
Otulfi contains polysorbate 80 This medicine contains 0.02 mg of polysorbate 80 in each pre-filled pen of 0.5 ml which is equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Otulfi is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which Otulfi is intended.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Talk to your doctor about when you will have your injections and follow-up appointments.
How much Otulfi is given Your doctor will decide how much Otulfi you need to use and for how long.
Adults aged 18 years or older
Psoriasis or Psoriatic Arthritis
• The recommended starting dose is 45 mg Otulfi. Patients who weigh more than 100 kilograms (kg) may start on a dose of 90 mg instead of 45 mg.
• After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks. The following doses are usually the same as the starting dose.
Crohn’s disease or Ulcerative Colitis
• During treatment, the first dose of approximately 6 mg/kg Otulfi 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 Otulfi 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 Otulfi may be given every 8 weeks. Your doctor will decide when you should receive your next dose.
How Otulfi is given • Otulfi is given as an injection under the skin (‘subcutaneously’). At the start of your treatment, medical or nursing staff may inject Otulfi.
• However, you and your doctor may decide that you may inject Otulfi yourself. In this case you will get training on how to inject Otulfi yourself.
• For instructions on how to inject Otulfi, 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 Otulfi than you should If you have used or been given too much Otulfi, talk to a doctor or pharmacist straight away. Always have the outer carton of the medicine with you, even if it is empty.
If you forget to use Otulfi If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose.
If you stop using Otulfi It is not dangerous to stop using Otulfi. 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 ustekinumab (may affect up to 1 in 1,000 people). Signs include: • difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or light-headedness
• 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 Otulfi 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)
Otulfi 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 Otulfi. 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 Otulfi 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 Yellow Card Scheme Website: 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.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C – 8 °C). Do not freeze.
• Keep the pre-filled pen in the outer carton in order to protect from light.
• If needed, individual Otulfi pre-filled pens 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 pen is first removed from the refrigerator in the space provided on the outer carton. At any time before the end of this period, the product can be put back in the refrigerator once and kept there until the expiry date. Discard the pre-filled pen if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier.
• Do not shake Otulfi pre-filled pens. Prolonged vigorous shaking may damage the medicine.
Do not use this medicine: • After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month.
• If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Otulfi 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.
Otulfi is for single use only. Any unused product remaining in the 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.
What Otulfi contains • The active substance is ustekinumab. Each pre-filled pen contains 45 mg ustekinumab in 0.5 mL.
• The other ingredients are L-histidine, polysorbate 80 (E433), sucrose, water for injections and hydrochloric acid (to adjust pH).
What Otulfi looks like and contents of the pack Otulfi is a clear, colourless to slightly brown-yellow solution for injection. It is supplied as a carton pack containing 1 single-dose, glass 1 mL pre-filled pen Each pre-filled pen contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Marketing Authorisation Holder Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
United Kingdom
Manufacturer Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz
Austria
This leaflet was last revised in May 2026.
Otulfi 45 mg solution for injection in pre-filled pen comes as solution containing 45 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Otulfi 45 mg solution for injection in 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 syringe, Otulfi 90 mg solution for injection in pre-filled syringe, Pyzchiva 130 mg concentrate for solution for infusion, Pyzchiva 45 mg solution for injection in pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Otulfi 45 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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
Otulfi 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)
Otulfi, 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
Otulfi 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
Otulfi 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.
Otulfi is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which Otulfi is indicated.
Posology
Plaque psoriasis
The recommended posology of Otulfi 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 3).
Psoriatic arthritis (PsA)
The recommended posology of Otulfi is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.
Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).
Renal and hepatic impairment
Ustekinumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
The safety and efficacy of ustekinumab in children with psoriasis less than 6 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established. The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. See section 4.2 of the pre-filled syringe SmPC for posology and method of administration in paediatric patients 6 years and older with psoriasis.
Crohn's Disease and Ulcerative Colitis
In the treatment regimen, the first dose of Otulfi is administered intravenously. For the posology of the intravenous dosing regimen, see section 4.2 of the Otulfi 130 mg Concentrate for solution for infusion SmPC.
The first subcutaneous administration of 90 mg Otulfi 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 Otulfi. In patients who have responded to treatment with Otulfi, corticosteroids may be reduced or discontinued in accordance with standard of care.
In Crohn's disease or Ulcerative Colitis, if therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
Elderly (≥ 65 years)
No dose adjustment is needed for elderly patients (see section 4.4).
Renal and hepatic impairment
Ustekinumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population
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. The pre-filled pen has not been studied in the paediatric population and is not recommended for use in paediatric patients. See section 4.2 of the Concentrate for solution for infusion and pre-filled syringe SmPC for posology and method of administration in paediatric patients weighing at least 40 kg with Crohn's disease.
Method of administration
Otulfi 45 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 Otulfi 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 Otulfi 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 Otulfi.
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 Otulfi 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 Otulfi must be made taking into account the benefit of breast-feeding to the child and the benefit of Otulfi therapy to the woman.
Fertility
The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).
Otulfi 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 Otulfi 45 mg solution for injection in 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.
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