IMULDOSA 130 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

IMULDOSA 130 mg concentrate for solution for infusion

ustekinumab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8, which includes information on how to report them.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

This leaflet has been written for the person taking the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is IMULDOSA and what is it used for
2. What you need to know before you use IMULDOSA
3. How to use IMULDOSA
4. Possible side effects
5. Storage of IMULDOSA
6. Contents of the pack and other information

1. What is IMULDOSA and what is it used for

What is IMULDOSA

IMULDOSA contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that identify and bind to specific proteins in the body.

IMULDOSA belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What is IMULDOSA used for

IMULDOSA is used to treat the following inflammatory diseases:

• Moderate to severe Crohn's disease - in adults

Crohn's disease

Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate 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 ustekinumabor to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infectionthat 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 IMULDOSA.

Warnings and precautions

Talk to your doctor or pharmacist before starting IMULDOSA. Your doctor will check how you are before each treatment. Make sure to tell your doctor about any illness you have before treatment. Also, tell your doctor if you have recently been near someone who may have tuberculosis. Your doctor will examine you and do a test to detect tuberculosis before using IMULDOSA. If your doctor thinks you are at risk of tuberculosis, they may give you medicines to treat it.

Watch for serious side effects

IMULDOSA may cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while using IMULDOSA. See the complete list of these side effects in “Serious side effects” in section 4.

Before using IMULDOSA, tell your doctor:

• If you have ever had an allergic reaction to IMULDOSA.Talk to your doctor if you are not sure.
• If you 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 having cancer.
• If you have received treatment for psoriasis with other biologics (a medicine made from a biological source and usually given by injection)– the risk of getting cancer may be higher.
• If you have had a recent infection or have any open sores (fistula).
• If you have any new or changing lesionswithin the area of psoriasis or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis– such as any other immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet light (UV)). These treatments may also weaken part of the immune system. It has not been studied whether these treatments can be used together with IMULDOSA. However, it is possible that it may increase the likelihood of suffering from diseases related to a weaker immune system.
• If you are receiving or have ever received allergy shots– it is not known if IMULDOSA can affect these treatments.
• If you are 65 years of age or older– you are more likely to get infections.

If you are not sure if you have any of these conditions, talk to your doctor or pharmacist before using IMULDOSA.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Talk to your doctor immediately if you experience a red, raised, and scaly skin rash, sometimes with a darker border, in areas of the skin exposed to the sun or if they are accompanied by joint pain.

Heart attacks and strokes

In a study of patients with psoriasis treated with IMULDOSA, heart attacks and strokes have been observed. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are being treated properly. Seek medical attention immediately if you experience chest pain, weakness, or an unusual sensation on one side of the body, facial paralysis, or abnormalities in speech or vision.

Children and adolescents

IMULDOSA is not recommended for use in children under 18 years of age with Crohn's disease or ulcerative colitis, as it has not been studied in this age group.

Using IMULDOSA with other medicines, vaccines

Tell your doctor or pharmacist:

• If you are using, have recently used, or might use other medicines.
• If you have been vaccinated recently or are going to receive a vaccine. Certain types of vaccines (live vaccines) should not be given while using IMULDOSA.

If you received IMULDOSA during pregnancy, inform your baby's doctor about your treatment with IMULDOSA before your 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 12 months after birth if you received IMULDOSA during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been observed in babies exposed to Imuldosa in the womb. However, experience with Imuldosa in pregnant women is limited. Therefore, it is preferable to avoid using Imuldosa during pregnancy.
• If you are a woman of childbearing age, you are advised to avoid becoming pregnant and use adequate contraceptive measures while using Imuldosa and for at least 15 weeks after the last treatment with Imuldosa.
• Imuldosa may pass through the placenta to the fetus. If you received Imuldosa during pregnancy, your baby may have a higher risk of getting an infection.
• It is important that you inform your baby's doctors and other healthcare professionals if you received Imuldosa during your pregnancy before your baby receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first 12 months after birth if you received Imuldosa during pregnancy, unless your baby's doctor recommends otherwise.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether you should breastfeed or use Imuldosa. Do not do both at the same time.

Driving and using machines

The influence of IMULDOSA on the ability to drive and use machines is negligible.

IMULDOSA contains polysorbate 80

IMULDOSA contains 11.1 mg of polysorbate 80 (E433) per dose, equivalent to 0.40 mg/ml.

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

IMULDOSA contains sodium

IMULDOSA contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”. However, before IMULDOSA is administered 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 to use IMULDOSA

IMULDOSA should be used under the guidance and supervision of a doctor with experience in the diagnosis and treatment of Crohn's disease.

Your doctor will give you IMULDOSA 130 mg concentrate for solution for infusion through a drip into a vein in your arm (intravenous infusion) over at least one hour. Ask your doctor when you should have the injections and about follow-up appointments.

How much IMULDOSA is given

Your doctor will decide how much IMULDOSA you need to receive and how long your treatment will last.

Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose for you based on your body weight.

• After the initial intravenous dose, you will receive the next dose of 90 mg of IMULDOSA by injection under the skin (subcutaneous injection) 8 weeks later and then every 12 weeks.

How IMULDOSA is given

• The first dose of IMULDOSA for the treatment of Crohn's disease or ulcerative colitis is given by a doctor through a drip into a vein in your arm (intravenous infusion).

Talk to your doctor if you have any questions about treatment with IMULDOSA.

If you miss a dose of IMULDOSA

If you miss a dose or do not attend your appointment to receive it, talk to your doctor to schedule another appointment.

If you stop using IMULDOSA

Stopping IMULDOSA is not dangerous. However, if you stop using it, your symptoms may come back.

If you have any other questions about using 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. Contact your doctor or get urgent medical help immediately if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in people using IMULDOSA (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing
• low blood pressure, which can cause dizziness or mild headaches
• 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 receiving treatment for Crohn's disease, the first dose of IMULDOSA is given through a drip into a vein (intravenous infusion). Some patients have experienced severe allergic reactions during the infusion.

In rare cases, allergic reactions in the lungs and lung inflammation have been reported in patients treated with ustekinumab. Tell your doctor immediately if you have symptoms such as cough, difficulty breathing, and fever.

If you have a severe allergic reaction, your doctor may decide that you should not use IMULDOSA again.

Infections – these may need urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Nose or throat infections and the common cold are common (may affect up to 1 in 10 people).
• Chest infections are uncommon (may affect up to 1 in 100 people).
• Inflammation of the tissues under the skin (“cellulitis”) is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful rash with blisters) is uncommon (may affect up to 1 in 100 people).

IMULDOSA may affect your ability to fight infections. Some of these may be serious and be caused by viruses, fungi, bacteria (including tuberculosis), or parasites, and include infections that occur mainly in people with a weakened immune system (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving treatment with ustekinumab.

You should watch for signs of infection while using IMULDOSA. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or having difficulty breathing; cough that does not go away
• having hot, red, and painful skin or having a painful skin rash with blisters
• pain when urinating
• diarrhea
• visual impairment or loss of vision
• headache, stiff neck, sensitivity to light, nausea, or confusion.

Talk to your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as chest infections, skin infections, herpes, or opportunistic infections that may have serious complications. You should also tell your doctor if you have any type of infection that does not go away or comes back. Your doctor may decide that you should not use IMULDOSA until the infection goes away. Also, talk to your doctor if you have any open sores or ulcers that may become infected.

Shedding of the skin – increased redness and shedding of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you should tell your doctor immediately.

Other side effects

Common side effects(may affect up to 1 in 10 people):

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching (“pruritus”)
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects(may affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and sinking of the muscles on one side of the face (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small, yellow, or white bumps on the skin, sometimes accompanied by fever (pustular psoriasis)
• Shedding of the skin (exfoliation of the skin)
• Acne

Rare side effects(may affect up to 1 in 1,000 people):

• Redness and shedding of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms may develop, such as a natural change in the symptoms of psoriasis (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause 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)

• Blisters on the skin, which may be red and itchy and painful (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, and scaly skin rash in areas of the skin exposed to the sun, possibly accompanied by joint pain).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of IMULDOSA

• IMULDOSA 130 mg concentrate for solution for infusion is administered in a hospital or medical center and it is not necessary for patients to store or handle it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C and 8 °C). Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Do not shake IMULDOSA vials. Prolonged vigorous shaking can damage the product.

Do not use this medicine:

• After the expiration date shown on the label and packaging after "EXP". The expiration date is the last day of the month indicated.
• If the liquid changes color, is cloudy, or has foreign particles floating in it (see section 6 "Appearance of IMULDOSA and packaging contents").
• If you know or believe it has been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been vigorously shaken.
• If the seal is broken.

IMULDOSA is for single use. You should discard any unused diluted infusion solution left in the vial or syringe in accordance with local regulations.

6. Packaging contents and additional information

Composition of IMULDOSA

• The active ingredient is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 ml.
• The other ingredients are disodium dihydrate EDTA (E385), L-histidine, L-histidine monohydrate hydrochloride, L-methionine, polysorbate 80 (E433), sucrose, and water for injectable preparations.

Appearance of IMULDOSA and packaging contents

IMULDOSA is a clear to slightly opalescent infusion solution, colorless to slightly yellowish. It comes in a package containing 1 single-dose 30 ml glass vial. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o. ul.

Lutomierska 50,

95-200, Pabianice, Poland

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the last revision of this leaflet: June 2025

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

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The following information is intended exclusively for healthcare professionals:

Traceability:

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.

Instructions for dilution:

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

1. Calculate the dose and the number of IMULDOSA vials needed based on the patient's weight (see section 3, Table 1). Each 26 ml vial of IMULDOSA contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of 9 mg/ml (0.9%) sodium chloride solution from the 250 ml infusion bag equivalent to the volume of IMULDOSA to be added (discard 26 ml of sodium chloride per vial of IMULDOSA needed: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).
3. Withdraw 26 ml of IMULDOSA from each necessary vial and add it to the 250 ml infusion bag. The final volume of the infusion bag should be 250 ml. Mix gently.
4. Perform a visual inspection of the diluted solution before infusion. Do not use if opaque particles, color changes, or foreign particles are detected.
5. Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion must be completed within 24 hours of dilution in the infusion bag.
6. Use only an infusion system with an in-line filter, sterile, apyrogenic, and low protein binding (pore size 0.2 microns).
7. Each vial is for single use and unused medicine should be discarded in accordance with local regulations.

Storage

If necessary, the diluted infusion solution can be stored at room temperature. The infusion must be completed within 24 hours of dilution in the infusion bag. Do not freeze.