Patient leaflet - Imuldosa 130 mg concentrate for solution for infusion
1. What IMULDOSA is and what it is used for
2.
- 3. How IMULDOSA will be given
- 4. Possible side effects
- 5. How to store IMULDOSA
- 6.
1.
What IMULDOSA is and what it is
used for
What IMULDOSA is
IMULDOSA contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
IMULDOSA belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.
What IMULDOSA is used for
IMULDOSA is used to treat the following inflammatory diseases:
•
Moderate to severe Crohn’s disease - in adults and children who weigh at least 40 kg
- Moderate to severe ulcerative colitis - in adults.
Crohn’s disease
Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given IMULDOSA 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 IMULDOSA to reduce the signs and symptoms of your disease.
2.
What you need to know before you
use IMULDOSA
Do not use IMULDOSA if you:
•
are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6)
•
have an active infection which your doctor thinks is important.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using IMULDOSA.
Warnings and precautions
Talk to your doctor or pharmacist before using IMULDOSA. Your doctor will check how well you are before treatment. Make sure you tell your doctor about any illness you have before treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will examine you and do a test for tuberculosis before you have IMULDOSA. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Look out for serious side effects
IMULDOSA can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking IMULDOSA. See ‘Serious side effects’ in section 4 for a full list of these side effects.
Before you use IMULDOSA tell your doctor if you:
•
have ever had an allergic reaction to IMULDOSA. Ask your doctor if you are not sure
•
have ever had any type of cancer – this is because immunosuppressants like IMULDOSA weaken part of the immune system. This may increase the risk of cancer
•
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
•
have or have had a recent infection or if you have any abnormal skin openings (fistulae)
•
have any new or changing lesions within psoriasis areas or on normal skin
•
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 IMULDOSA has not been studied. However, it is possible it may increase the chance of diseases related to a weaker immune system
•
are having or have ever had injections to treat allergies – it is not known if IMULDOSA may affect these
•
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 apply to you, talk to your doctor or pharmacist before using IMULDOSA.
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
IMULDOSA is not recommended for use in children who weigh less than 40 kg with Crohn’s disease or children under 18 years of age with ulcerative colitis because it has not been studied in this age group.
Other medicines, vaccines and IMULDOSA
Tell your doctor or pharmacist if you:
•
are taking, have recently taken or might take any other medicines
•
have recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using IMULDOSA
•
received IMULDOSA while pregnant, tell your baby’s doctor about your IMULDOSA 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 IMULDOSA 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 IMULDOSA in the womb. However, there is limited experience with IMULDOSA in pregnant women. It is therefore preferable to avoid the use of IMULDOSA in pregnancy
•
If you are a woman of childbearing potential, you
are advised to avoid becoming pregnant and must use adequate contraception while using IMULDOSA and for at least 15 weeks after the last IMULDOSA treatment
•
IMULDOSA can pass across the placenta to the
unborn baby. If you received IMULDOSA 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 healthcare professionals if you received IMULDOSA 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 IMULDOSA 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 IMULDOSA - do not do both.
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 or ulcerative colitis.
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
Package leaflet: Information for the patient
IMULDOSA® 130 mg concentrate
for solution for infusion
ustekinumab
Package leaflet: Information for the patient
IMULDOSA® 130 mg concentrate
for solution for infusion
ustekinumab
BBBC4817 UKP-037 MAT. NO.
BBBC4817 UKP-037 MAT. NO.
Date sent:
Date received: Item number:
Originator:
Origination Date: Revision Date:
Revised By:
1.
2.
3.
4.
5.
6.
CRF number:
1.
2.
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Digital signature
Storage
If necessary, the diluted infusion solution may be stored at room temperature. The infusion should be completed within 8 hours of the dilution in the infusion bag. Do not freeze.
BBBC4817
UKP-037
MAT. NO.
| 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 or ulcerative colitis is given by a doctor as a drip in the vein of an arm (intravenous infusion).
Talk to your doctor if you have any questions about receiving 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.
4. Possible 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:
- 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).
Infusion-related reactions – If you are being treated for Crohn’s disease or ulcerative colitis, 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) is 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’)
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Back, muscle or joint pain
•
Sore throat
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Redness and pain where the injection is given
•
Sinus infection.
Uncommon side effects (may affect up to 1 in 100 people):
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Tooth infections
•
Vaginal yeast infection
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Depression
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Blocked or stuffy nose
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Bleeding, bruising, hardness, swelling and itching where the injection is given
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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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.
5. How to store IMULDOSA
•
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’)
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If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated)
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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.
6.
Contents of the pack and other
information
What IMULDOSA contains
•
The active substance is ustekinumab. Each vial contains 130 mg ustekinumab in 26 ml
•
The other ingredients are EDTA disodium salt dihydrate (E385), L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose and water for injections.
What IMULDOSA looks like and contents of the pack
IMULDOSA is a colourless to slightly yellow and clear to slightly opalescent solution for infusion.
It is supplied as a carton pack containing 1 single-dose, glass 30 ml vial. Each vial contains 130 mg ustekinumab in 26 ml of concentrate for solution for infusion.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF
United Kingdom
Manufacturers
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF, United Kingdom
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50, 95-200
Pabianice, Poland
This leaflet was last revised in February 2026.
If you would like a leaflet with larger text, please contact
01271 385257
BBBC4817
UKP-037
MAT. NO.
Date sent:
Date received: Item number:
Originator:
Origination Date: Revision Date:
Revised By:
1.
2.
3.
4.
5.
6.
CRF number:
1.
2.
3.
4.
5.
6.
Digital signature