Imuldosa 130 mg concentrate for solution for infusion

Package leaflet: Information for the user

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 enable rapid identification of new safety information. Healthcare professionals are urged to report any suspected adverse reactions. See section 4.8 for information on how to report them.

Read the entire 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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 specifically recognize and bind 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:

• Moderately to severely active Crohn’s disease – in adults and in children weighing at least 40 kg

Crohn’s disease

Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will usually have been treated with other medicines first. If you do not respond adequately or cannot tolerate those medicines, IMULDOSA may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using IMULDOSA

Do not use IMULDOSA

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers significant.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using IMULDOSA.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with IMULDOSA. Your doctor will assess your condition before each treatment. Make sure to inform your doctor about any illness you have before treatment. Also inform your doctor if you have recently been in contact with someone who may have tuberculosis. Your doctor will examine you and perform a test to detect tuberculosis before you start using IMULDOSA. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Be aware of serious adverse effects

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

Before using IMULDOSA, tell your doctor:

• If you have ever had an allergic reaction to IMULDOSA. Consult your doctor if you are unsure.
• 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 developing cancer.
• If you have previously received treatment for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection) – the risk of developing cancer may be higher.
• If you have or have recently had an infection or have any skin openings (fistula).
• If you have any new skin lesions or changes in existing lesions within 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 the immune system. The use of these treatments together with IMULDOSA has not been studied. However, it may increase the likelihood of developing illnesses related to a weaker immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether IMULDOSA may affect these treatments.
• If you are 65 years of age or older – you are more likely to develop infections.

If you are unsure whether you have any of these conditions, speak with 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. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if it is accompanied by joint pain.

Heart attacks and strokes

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

Children and adolescents

The use of IMULDOSA is not recommended in children weighing less than 40 kg with Crohn's disease, as it has not been studied in this age group.

Use of IMULDOSA with other medicines and vaccines

Inform your doctor or pharmacist:

• If you are currently using, have recently used, or might use any other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered while using IMULDOSA.
• If you received IMULDOSA during pregnancy, inform your infant’s doctor about your IMULDOSA treatment before the infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant within the first twelve months after birth if you received IMULDOSA during pregnancy, unless your infant’s doctor advises 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 potential, you are advised to avoid becoming pregnant and to use adequate contraception while using IMULDOSA and for at least 15 weeks after the last dose of IMULDOSA.
• Ustekinumab may pass through the placenta to the fetus. If you received IMULDOSA during pregnancy, your infant may have an increased risk of developing infections.
• It is important to inform your infant’s doctors and other healthcare professionals if you received IMULDOSA during pregnancy before the infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant within the first twelve months after birth if you received IMULDOSA during pregnancy, unless your infant’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 to breastfeed or use IMULDOSA. Do not do both simultaneously.

Driving and using machines

The effect of IMULDOSA on the ability to drive and operate machinery is negligible or none.

IMULDOSA contains polysorbate 80

IMULDOSA contains 11.1 mg of polysorbate 80 (E433) per dosage unit, 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, which is essentially “sodium-free.” However, before administration, IMULDOSA is mixed with a solution containing sodium. Speak with 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 physician experienced in the diagnosis and treatment of Crohn's disease.

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

How much IMULDOSA is administered

Your doctor will decide the amount of IMULDOSA you should receive and the duration of treatment.

Adults aged 18 years and older

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

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

Children with Crohn's disease weighing at least 40 kg

• 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 90 mg dose of IMULDOSA as an injection under the skin (subcutaneous injection) 8 weeks later, and subsequently every 12 weeks.

How IMULDOSA is administered

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

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

If you forget to use IMULDOSA

If you miss a dose or fail to attend your appointment for administration, speak with your doctor to schedule another appointment.

If you interrupt treatment with IMULDOSA

Stopping treatment with IMULDOSA is not dangerous. However, if you discontinue it, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects

Some patients may experience serious adverse 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 (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing

• low blood pressure, which may cause dizziness or mild headaches

• swelling of the face, lips, mouth, or throat

• Common signs of an allergic reaction include rash and hives (urticaria) (these may affect up to 1 in 100 people).

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

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

If you experience a severe allergic reaction, your doctor may decide that you should no longer use IMULDOSA.

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

• Nasal 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 beneath the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

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

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

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath; persistent cough
• skin that feels hot, red, and painful, or a painful blistering skin rash
• burning sensation when urinating
• diarrhea
• visual deterioration or vision loss
• headache, neck stiffness, photophobia, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use IMULDOSA until the infection resolves. Also contact your doctor if you have any open cuts or ulcers that could become infected.

Skin peeling – increased redness and peeling 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 must inform your doctor immediately.

Other adverse effects

Common adverse 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

Uncommon adverse 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 muscle weakness 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 blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• Redness and peeling of the skin over a large area of the body, which may cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a skin rash with small red or purple raised spots, fever, or joint pain (vasculitis)

Very rare adverse effects (may affect up to 1 in 10,000 people):

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 facility and does not need to be stored or handled by patients.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C to 8 °C). Do not freeze.
• Keep the vial in its outer packaging to protect it from light.
• Do not shake IMULDOSA vials. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging following “EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains foreign particles floating in it (see section 6 “What IMULDOSA looks like and contents of the pack”).
• If you know or suspect it has 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 only. Any unused diluted infusion solution remaining in the vial or syringe must be discarded according to local regulations.

6. Pack contents and other information

Composition of IMULDOSA

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

Appearance of IMULDOSA and contents of the container

IMULDOSA is a transparent to slightly opalescent solution for infusion, ranging from colourless to slightly yellowish. It is supplied in a pack containing one single-use 30 ml glass vial. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion.

Marketing Authorisation Holder

Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6a Planta
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, The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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 most recent revision of this leaflet: {MM/YYYY}

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

The following information is intended exclusively for healthcare professionals:

Traceability:

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

Dilution instructions:

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

1. Calculate the dose and number of IMULDOSA vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 ml vial of IMULDOSA contains 130 mg of ustekinumab.
2. Withdraw and discard a volume of 0.9% sodium chloride solution from the 250 ml infusion bag equal to the volume of IMULDOSA to be added (discard 26 ml of sodium chloride per vial of IMULDOSA required: 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 required vial and add it to the 250 ml infusion bag. The final volume in the infusion bag must be 250 ml. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if particulate matter, discoloration, or foreign particles are observed.
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, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometres).
7. Each vial is for single use only, and any unused medicinal product must be discarded in accordance with local regulations.

Storage

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