Patient Information Leaflet

IMULDOSA 130 mg Concentrate for Solution for Infusion

ustekinumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. Healthcare professionals are invited to report any suspected adverse reactions. See section 4.8, which includes information on how to report them.

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

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

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

What is IMULDOSA

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

IMULDOSA belongs to a group of medicines called “immunosuppressants”. These medicines act 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 be given other medicines first. If you do not respond adequately or do not tolerate those medicines, you may be given IMULDOSA to reduce the signs and symptoms of your disease.

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 points apply to you, talk to your doctor or pharmacist before using IMULDOSA.

Warnings and precautions

Consult your doctor or pharmacist before starting to use 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 for tuberculosis before using IMULDOSA. If your doctor thinks you are at risk of tuberculosis, they may give you medicine to treat it.

Watch for serious side effects

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

Tell your doctor:

• If you have ever had an allergic reaction to IMULDOSA.Consult your doctor if you are not sure.
• If you have ever had any type of cancer– this is because the type of immunosuppressant in IMULDOSA weakens part of your immune system. This may increase your risk of getting 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 or have had a recent infection or have any skin cracks (fistula).
• If you have any new lesions or changes in lesionswithin the psoriasis area 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 (UV) light). These treatments may also weaken part of your immune system. The use of these treatments together with IMULDOSA has not been studied. However, it may increase the likelihood of getting diseases related to a weaker immune system.
• If you are receiving or have ever received injections to treat allergies– it is unknown if IMULDOSA may affect these treatments.
• If you are 65 years 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 reactions similar to lupus during treatment with ustekinumab, including lupus skin or lupus-like syndrome. Talk to your doctor immediately if you experience a red, raised, and scaly skin rash, sometimes with a darker border, on sun-exposed areas or accompanied by joint pain.

Heart attacks and strokes

In a study of patients with psoriasis treated with IMULDOSA, heart attacks and strokes were observed. Your doctor will check your risk factors for heart disease and stroke regularly to ensure they are treated properly. Seek medical attention immediately if you experience chest pain, weakness, or abnormal sensation in 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

Inform your doctor or pharmacist:

• If you are using, have used recently, or may use other medicines.
• If you have been vaccinated recently or are 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, there is limited experience with Imuldosa in pregnant women. Therefore, it is preferable to avoid using Imuldosa during pregnancy.
• If you are a fertile woman, it is recommended that you avoid becoming pregnant and use suitable 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 essential to inform your baby's doctors and other healthcare professionals if you received Imuldosa during 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 do so. You and your doctor will decide whether to breastfeed or use Imuldosa. Do not do both at the same time.

Driving and operating machines

The influence of IMULDOSA on the ability to drive and operate machines is negligible or insignificant.

IMULDOSA contains polysorbate

IMULDOSA contains 11.1 mg of polysorbate 80 in each volume unit, equivalent to 10.4 mg per dose of 130 mg.

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; that is, it 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 follow a low-sodium diet.

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

Your doctor will administer IMULDOSA 130 mg concentrate for infusion via a vein in your arm (intravenous infusion) for at least one hour. Ask your doctor when they should give you the injections and about follow-up appointments.

What amount of IMULDOSA is administered

Your doctor will decide how much IMULDOSA you need to receive and the duration of treatment.

Adults 18 years of age and older

• 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 via a subcutaneous injection 8 weeks later, and then every 12 weeks thereafter.

How IMULDOSA is administered

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

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

If you forget to use IMULDOSA

If you forget a dose or miss an appointment, speak with your doctor to schedule another appointment.

If you interrupt IMULDOSA treatment

Stopping IMULDOSA is not hazardous. However, if you stop using it, your symptoms may return.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Some patients may experience severe side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in the population using IMULDOSA (they may affect up to 1 in 1,000 people). The 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 urticaria (these may affect up to 1 in 100 people).

Reactions related to infusion – If you are being treated for Crohn's disease, the first dose of IMULDOSA is administered through a drip in a vein (intravenous infusion). Some patients have experienced severe allergic reactions during the infusion.

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

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

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

• Common colds and sore throats are frequent (they may affect up to 1 in 10 people).
• Chest infections are rare (they may affect up to 1 in 100 people).
• Cellulitis, an inflammation of the tissues under the skin, is rare (it may affect up to 1 in 100 people).
• Herpes, a painful rash with blisters, are rare (they may affect up to 1 in 100 people).

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

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

• Fever, flu-like symptoms, night sweats, weight loss
• Feeling tired or difficulty breathing; persistent cough
• Warm, red, and painful skin or a painful skin rash with blisters
• Difficulty urinating
• Diarrhea
• Visual deterioration or loss of vision
• Headache, neck stiffness, photosensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as pneumonia, skin infections, herpes, or opportunistic infections that may have serious complications. You should also inform your doctor if you have any type of infection that does not go away or reappears. Your doctor may decide that you should not use IMULDOSA until the infection has cleared up. You should also contact your doctor if you have any open wounds or ulcers that may become infected.

Skin peeling – increased redness and skin peeling on a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are severe skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.

Other side effects

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

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

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

• Dental infections
• Vaginal yeast infections
• Depression
• Blocked or congested nose
• Bleeding, petechiae, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small skin blisters, sometimes accompanied by fever (psoriasis pustular)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Redness and skin peeling on a large area of the body, which may cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in psoriasis symptoms (psoriasis erythroderma)
• 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 cause itching and pain (pemphigoid bullous).
• Cutaneous lupus or lupus-like syndrome (red, elevated, and scaly skin rash in sun-exposed areas, possibly accompanied by joint pain).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication:

• After the expiration date that appears on the label and packaging after “CAD”. The expiration date is the last day of the month indicated.
• If the liquid changes color, is cloudy or presents foreign particles floating in it (see section 6 “Appearance of IMULDOSA and contents of the packaging”).
• If you know or suspect you have been exposed to extreme temperatures (such as accidental overheating or freezing).
• If the product has been shaken vigorously.
• If the seal is broken.

IMULDOSA is for single use. Dispose of the unused diluted infusion solution remaining in the vial or syringe in accordance with local regulations.

Composition of IMULDOSA

• The active ingredient is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 ml.
• The other components are disodium edetate dihydrate (E385), L-histidine, monohydrated L-histidine chloride, L-methionine, polisorbate 80 (E433), sucrose, and water for injection.

Appearance of IMULDOSA and contents of the package

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

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n

Edifici Est, 6th Floor

08039 Barcelona

Spain

Responsible for manufacturing

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 medication 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 review of this leaflet:{MM/AAAA}

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

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The following information is exclusively directed to healthcare professionals:

Traceability:

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

Dilution instructions:

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

1. Calculate the dose and the number of vials of IMULDOSA needed based on the patient's weight (see section 3, Table 1). Each vial of 26 ml of IMULDOSA contains 130 mg of ustekinumab.
2. Extract and then discard a volume of 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 for each vial of IMULDOSA needed: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).
3. Extract 26 ml of IMULDOSA from each needed vial and add it to the 250 ml infusion bag. The final volume of the infusion bag must 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 after dilution in the infusion bag.
6. Use only a perfusion system with an in-line, sterile, apyrogenic, low-protein binding filter (pore size of 0.2 micrometers).
7. Each vial is for single use and the unused medication must 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 after dilution in the infusion bag. Do not freeze.