Patient leaflet - Usymro 130 mg concentrate for solution for infusion

1. What Usymro is and what it is used for

What Usymro is

Usymro contains the active substance ‘ustekinumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

Usymro belongs to a group of medicines called ‘immunosuppressants’. These medicines work by weakening part of the immune system.

What Usymro is used for

Usymro 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 Usymro 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 Usymro to reduce the signs and symptoms of your disease.

2. What you need to know before you use Usymro

Do not use Usymro

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 Usymro.

Warnings and precautions

Talk to your doctor or pharmacist before using Usymro. 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 Usymro. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Look out for serious side effects

Usymro can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Usymro. See ‘Serious side effects’ in section 4 for a full list of these side effects.

Before you use Usymro tell your doctor:

If you ever had an allergic reaction to Usymro. Ask your doctor if you are not sure.
If you have ever had any type of cancer – this is because immunosuppressants like Usymro 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 or if you have any abnormal skin openings (fistulae).
If you have any new or changing lesions within psoriasis areas or on normal skin.
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 Usymro 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 Usymro 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 Usymro.

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

Usymro 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 Usymro

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 Usymro.
If you received Usymro while pregnant, tell your baby’s doctor about your Usymro 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 Usymro 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 Usymro in pregnancy.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Usymro and for at least 15 weeks after the last Usymro treatment.
Usymro can pass across the placenta to the unborn baby. If you received Usymro 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 Usymro 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 Usymro 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 Usymro - do not do both.

Driving and using machines

Usymro has no or negligible influence on the ability to drive and use machines.

Usymro contains sodium

Usymro contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. However, before Usymro 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.

Usymro contains polysorbate 80

Usymro contains 10.4 mg polysorbate 80 (E433) in each dosage unit which is equivalent to 0.4 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.

3. How Usymro will be given

Usymro 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.

Usymro 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 Usymro is given

Your doctor will decide how much Usymro 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 Usymro 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 Usymro by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.

How Usymro is given

The first dose of Usymro 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 Usymro.

If you forget to use Usymro

If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.

If you stop using Usymro

It is not dangerous to stop using Usymro. 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 Usymro (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 Usymro 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 Usymro 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)

Usymro 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 Usymro. 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 Usymro 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 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.

5. How to store Usymro

Usymro 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 Usymro 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 Usymro 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.

Usymro 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 Usymro contains

The active substance is ustekinumab. Each vial contains 130 mg ustekinumab in 26 mL.
The other ingredients are EDTA disodium salt dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80 (E433), sucrose and water for injections.

What Usymro looks like and contents of the pack

Usymro is a clear, colourless to light yellow concentrate for 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 and Manufacturer

Gedeon Richter Plc.

Gyömrői út 19-21.

1103 Budapest

Hungary

This leaflet was last revised in January 2026.

The following information is intended for healthcare professionals only:

Traceability:

In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.

Instructions for dilution:

Usymro concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of Usymro vials needed based on patient weight (see section 3, Table 1). Each 26 mL vial of Usymro contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of Usymro to be added (discard 26 mL sodium chloride for each vial of Usymro needed, for 2 vials- discard 52 mL, for 3 vials discard 78 mL, for 4 vials- discard 104 mL).
3. Withdraw 26 mL of Usymro from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed within eight hours of the dilution in the infusion bag.
6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.

Storage

After dilution the chemical and physical stability has been demonstrated between 1.04 mg/mL and 2.08 mg/mL for 48 hours at 2 °C-8 °C and for 8 hours at 15 °C-25 °C. Usymro 130 mg

X000

Usymro

130 mg