Imuldosa

Do not take it if

From the package leaflet in EMA’s product information, p. 59–60.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 60–61.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 61.

Driving and using machines

• IMULDOSA has no or negligible influence on the ability to drive and use machines.
• IMULDOSA contains Polysorbate 80 IMULDOSA contains 11.1 mg of polysorbate 80 (E433) in each unit volume, which is equivalent to 10.4 mg per 130 mg dose.
• Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
• IMULDOSA contains sodium IMULDOSA contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
• However, before IMULDOSA is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.
• 3. How IMULDOSA will be given IMULDOSA is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn’s disease .
• IMULDOSA 130 mg concentrate for solution for infusion will be given to you by your doctor, through a drip in the vein of your arm (intravenous infusion) over at least one hour. Talk to your doctor about when you will have your injections and follow-up appointments.
• How much IMULDOSA is given Your doctor will decide how much IMULDOSA you need to receive and for how long.
• Adults aged 18 years or older
• The doctor will work out the recommended intravenous infusion dose for you based on your body weight.
• Your body weight Dose ≤ 55 kg 260 mg > 55 kg to ≤ 85 kg 390 mg > 85 kg 520 mg
• After the starting intravenous dose, you will have the next dose of 90 mg IMULDOSA by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.
• Children with Crohn’s disease who weigh at least 40 kg
• The doctor will work out the recommended intravenous infusion dose for you based on your body weight.
• Your body weight Dose ≥ 40 to ≤ 55 kg 260 mg > 55 kg to ≤ 85 kg 390 mg > 85 kg 520 mg
• After the starting intravenous dose, you will have the next dose of 90 mg Imuldosa by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.
• How IMULDOSA is given
• The first dose of IMULDOSA for treatment of Crohn’s disease is given by a doctor as a drip in the vein of an arm (intravenous infusion).
• Talk to your doctor if you have any questions about receiving IMULDOSA.
• If you forget to use IMULDOSA If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.
• If you stop using IMULDOSA It is not dangerous to stop using IMULDOSA. 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.

From the package leaflet in EMA’s product information, p. 61–62.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Serious side effects Some patients may have serious side effects that may need urgent treatment.
• Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs.
• Serious allergic reactions (‘anaphylaxis’) are rare in people taking IMULDOSA (may affect up to 1 in 1,000 people). Signs include:
• o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).
• Infusion-related reactions – If you are being treated for Crohn’s disease, the first dose of IMULDOSA is given through a drip into a vein (intravenous infusion). Some patients have experienced serious allergic reactions during the infusion.
• In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab. Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever.
• If you have a serious allergic reaction, your doctor may decide that you should not use IMULDOSA 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)
• IMULDOSA 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 IMULDOSA. 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 IMULDOSA 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 1000 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 62–64.

How to store it

• IMULDOSA 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C–8°C). Do not freeze.
• •
• Keep the vial in the outer carton in order to protect from light.
• Do not shake the IMULDOSA vials. Prolonged vigorous shaking may damage the medicine.
• Do not use this medicine:
• After the expiry date which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month.
• If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What IMULDOSA looks like and contents of the pack’).
• If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).
• If the product has been shaken vigorously.
• If the seal is broken.
• IMULDOSA is for single use only. Any diluted infusion solution or unused product remaining in the vial and the syringe should be thrown away in accordance with local requirements.

From the package leaflet in EMA’s product information, p. 64.

Same active substance, strength and form in other countries

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

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