IMULDOSA® 45 mg solution for injection in pre-filled syringe – patient leaflet, side effects, dosage

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:

• Plaque psoriasis - in adults and children aged 6 years and older
• Psoriatic arthritis - in adults

•

Moderate to severe Crohn’s disease - in adults and children who

weigh at least 40 kg

• Moderate to severe ulcerative colitis - in adults.

Plaque psoriasis

Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails. IMULDOSA will reduce the inflammation and other signs of the disease.

IMULDOSA is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.

IMULDOSA is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments did not work.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given IMULDOSA 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 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 each 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

•

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 with psoriasis under 6 years of age, children with Crohn’s disease who weigh less than 40 kg or for use in children under 18 years of age with psoriatic arthritis or ulcerative colitis because it has not been studied in this age group.

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 0.02 mg polysorbate 80 (E433) in each dosage unit which is equivalent to 0.04 mg/mL.

Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How to use IMULDOSA

IMULDOSA is intended for use under the guidance and supervision of a doctor experienced in treating conditions for which IMULDOSA 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 IMULDOSA is given

Your doctor will decide how much IMULDOSA 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 IMULDOSA. 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 IMULDOSA 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 IMULDOSA 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

IMULDOSA may be given every 8 weeks. Your doctor will decide when you should receive your next dose.

Children and adolescents aged 6 years or older

Psoriasis

•

The doctor will work out the right dose for you, including the amount

(volume) of IMULDOSA to be injected to give the right dose. The right dose for you will depend on your body weight at the time each dose is given

•

If you weigh less than 60 kg, there is no dosage form for IMULDOSA for children below 60 kg body weight, therefore other ustekinumab products should be used

•

If you weigh 60 kg to 100 kg, the recommended dose is 45 mg

IMULDOSA

•

If you weigh more than 100 kg, the recommended dose is 90 mg

IMULDOSA

•

After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.

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1. 4. Inject the dose:
2. • Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger. Do not squeeze it tightly
3. • Do not pull back on the plunger at any time
4. •

   In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4)

   Figure 4

5. • Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5)

Figure 5

• When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6)

  Figure 6

  • Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7:

    Figure 7

  • After the injection:
  • Press an antiseptic wipe over the injection site for a few seconds after the injection
  • There may be a small amount of blood or liquid at the injection site. This is normal
  • You can press a cotton ball or gauze over the injection site and hold for 10 seconds

  • Do not rub the skin at the injection site. You may cover the injection site with a small adhesive bandage, if necessary.

    1. 6. Disposal:
    2. • Used syringes should be placed in a puncture-resistant container, like a sharps container (see Figure 8). Never re-use a syringe, for your safety and health and for the safety of others. Dispose of your sharps container according to your local regulations
    3. •

       Antiseptic wipes and other supplies can be disposed of in your garbage.

       Figure 8

Children who weigh at least 40 kg Crohn’s disease

•

During treatment, the first dose of approximately 6 mg/kg Imuldosa 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 Imuldosa 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 Imuldosa

may be given every 8 weeks. Your doctor will decide when you should receive your next dose.

How IMULDOSA is given

•

IMULDOSA is given as an injection under the skin (‘subcutaneously’).

At the start of your treatment, medical or nursing staff may inject IMULDOSA

•

However, you and your doctor may decide that you may inject

IMULDOSA yourself. In this case you will get training on how to inject IMULDOSA yourself

•

For instructions on how to inject IMULDOSA, 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 IMULDOSA than you should

If you have used or been given too much IMULDOSA, 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 IMULDOSA

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 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).

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’)
• 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, 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

• Keep this medicine out of the sight and reach of children
• Store in a refrigerator (2°C–8°C). Do not freeze

•

Keep the pre-filled syringe in the outer carton in order to protect from

light

•

If needed, individual IMULDOSA pre-filled syringes may also be stored

at room temperature up to 30°C for a maximum single period of up to 30 days in the original carton in order to protect from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the discard date in the space provided on the outer carton. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to 30°C), it should not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature storage or by the original expiry date, whichever is earlier •

Do not shake the IMULDOSA pre-filled syringes. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine:

•

After the expiry date which is stated on the label and the carton after

‘EXP’. The expiry date refers to the last day of that month

•

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.

IMULDOSA is for single use only. Any unused product remaining in the syringe should be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What IMULDOSA contains

•

The active substance is ustekinumab. Each pre-filled syringe contains

45 mg ustekinumab in 0.5 ml

•

The other ingredients are L-histidine,

L-histidine hydrochloride monohydrate, polysorbate 80, 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. It is supplied as a carton pack containing 1 single-dose, glass 1 ml pre-filled syringe. Each pre-filled syringe contains 45 mg ustekinumab in 0.5 ml of solution for injection.

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.

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