Imuldoza 90 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

IMULDOSA 90 mg solution for injection in pre-filled syringe

ustekinumab

This medicinal product is subject to additional monitoring, which will allow for rapid identification of new safety information. Healthcare professionals are urged to report any suspected adverse reactions. See section 4.8, which includes 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. If you are the parent or caregiver of a child who will be administered IMULDOSA, please read this information carefully.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 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:

• Plaque psoriasis – in adults and children aged 6 years and older
• Psoriatic arthritis – in adults
• Moderate to severe Crohn’s disease – in adults and in children weighing at least 40 kg

Plaque psoriasis

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

IMULDOSA is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or when these treatments are ineffective.

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 when these treatments are ineffective.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond well to these medications, you may be treated with IMULDOSA to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Reduce joint damage.

Crohn’s disease

Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, you may be given IMULDOSA 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 components 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 may have before each treatment. Your doctor will also ask whether you have recently been in contact with someone who might 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.

Watch for 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 section 4 under “Serious adverse effects.”

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 – because immunosuppressants like IMULDOSA weaken part of the immune system, which 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, usually administered by injection) – the risk of developing cancer may be higher.
• If you have any new skin lesions or changes in existing lesions within the psoriasis area or on intact skin.
• If you currently have or have recently had an infection.
• If you are taking any other treatments for psoriasis and/or psoriatic arthritis, such as other immunosuppressants 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 combined use of these treatments with IMULDOSA has not been studied, but it could increase the likelihood of developing illnesses associated with a weakened 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 may be more likely to develop infections.

If you are unsure whether any of these conditions apply to you, 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, on areas of skin exposed to sunlight, especially if accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of psoriasis patients treated with ustekinumab. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are properly managed. Seek immediate medical attention 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 under 6 years of age with psoriasis, in children with Crohn’s disease weighing less than 40 kg, or in children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.

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) must not be administered while using IMULDOSA.
• If you received IMULDOSA during pregnancy, inform your infant’s doctor about your IMULDOSA treatment before your infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant during 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.
• Women of childbearing potential are advised to avoid becoming pregnant and to use adequate contraceptive measures while using IMULDOSA and for at least 15 weeks after the last dose.
• IMULDOSA can cross the placenta to the fetus. If you received IMULDOSA during pregnancy, your infant may have an increased risk of developing an infection.
• It is important to inform your infant’s doctors and other healthcare professionals if you received IMULDOSA during pregnancy before your infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant during 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, but not both simultaneously.

Driving and using machines

The effect of IMULDOSA on the ability to drive and use machines is negligible or none.

IMULDOSA contains polysorbate 80

IMULDOSA contains 0.04 mg of polysorbate 80 (E433) per dosage unit, equivalent to 0.04 mg/ml.

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

3. How to use IMULDOSA

IMULDOSA should be used under the guidance and supervision of a physician experienced in the treatment of the conditions for which IMULDOSA is indicated.

Always follow exactly the dosing instructions provided by your doctor. If in doubt, consult your doctor. Ask your doctor when your injections should be administered and about follow-up appointments.

What dose of IMULDOSA is administered

Your doctor will determine the dose of IMULDOSA you need and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of IMULDOSA. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, the next dose will be given 4 weeks later, and subsequently every 12 weeks. The following doses are usually the same as the starting dose.

Crohn's disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of IMULDOSA as an intravenous infusion (via a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of IMULDOSA 8 weeks later, and then every 12 weeks, via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, 90 mg of IMULDOSA will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents aged 6 years and older

Psoriasis

• Your doctor will determine the correct dose for you, including the amount (volume) of IMULDOSA to inject to achieve the correct dose. The appropriate 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 IMULDOSA dosage form available for children with body weight below 60 kg, and therefore other ustekinumab products should be used.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of IMULDOSA.
• If you weigh more than 100 kg, the recommended dose is 90 mg of IMULDOSA.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks.

Children weighing at least 40 kg

Crohn's disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of IMULDOSA as an intravenous infusion (via a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of IMULDOSA 8 weeks later, and then every 12 weeks, via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, 90 mg of IMULDOSA will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How IMULDOSA is administered

• IMULDOSA is administered by subcutaneous injection (under the skin). At the beginning of your treatment, medical or nursing staff may administer IMULDOSA to you.
• However, you and your doctor may decide that you can self-inject IMULDOSA. In this case, you will be trained in how to self-administer IMULDOSA.
• For instructions on how to inject IMULDOSA, see "Administration instructions" at the end of this leaflet.

Consult your doctor if you have any questions about self-injecting.

If you use more IMULDOSA than you should

If you have used or been given too much IMULDOSA, speak immediately with your doctor or pharmacist. Always carry the medicine carton with you, even if it is empty.

If you forget to use IMULDOSA

If you miss a dose, speak with your doctor or pharmacist. Do not take a double dose to make up for missed doses.

If you stop using IMULDOSA

Stopping treatment with IMULDOSA is not dangerous. However, if you discontinue treatment, 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 (may affect up to 1 in 100 people).

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 not use IMULDOSA again.

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 may become severe 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 having difficulty breathing; 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, photosensitivity, 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 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 blisters, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (skin exfoliation)
• 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 bumps, 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 in sun-exposed areas of skin, 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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 its outer packaging to protect it from light.
• If necessary, individual pre-filled syringes of IMULDOSA may also be stored at room temperature up to 30°C for a single period of up to 30 days in their original carton to protect them from light. Write the date when the pre-filled syringe is first removed from the refrigerator and the date when it must be discarded in the space provided on the outer packaging. 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 a maximum of 30°C), it must not be returned to the refrigerator. Discard the syringe if it is not used within 30 days of storage at room temperature or after the original expiry date, whichever occurs first.
• Do not shake the pre-filled syringes of IMULDOSA. 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.

IMULDOSA is for single use only. Any unused portion remaining in the syringe must be discarded. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

Composition of IMULDOSA

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are L-histidine, monohydrate L-histidine hydrochloride, polysorbate 80 (E433), sucrose and water for injections.

Appearance of IMULDOSA and contents of the pack

IMULDOSA is a clear to slightly opalescent, colourless to slightly yellowish injectable solution. It is supplied in a pack containing 1 single-dose glass pre-filled syringe of 1 ml. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

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 medicine, 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/.

Administration instructions

At the beginning of treatment, a healthcare professional will assist you with your first injection. However, you and your doctor may decide that you can self-inject IMULDOSA. In this case, you will be trained on how to inject IMULDOSA. Speak with your doctor if you have any questions about administering the injections.

• Do not mix IMULDOSA with other injectable solutions.
• Do not shake the pre-filled syringes. The medicine may deteriorate if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows what the pre-filled syringe looks like.

1. Check the number of pre-filled syringes and prepare materials:

Preparing to use the pre-filled syringe

• Remove the pre-filled syringe(s) from the refrigerator. Leave the pre-filled syringe outside the carton for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not remove the needle cap while waiting for the syringe to reach room temperature.
• Hold the pre-filled syringe by the barrel with the capped needle pointing upwards.
• Do not hold the syringe by the plunger head, plunger, needle shield wings, or needle cap.
• Do not pull back the plunger at any time.
• Do not remove the needle cap until instructed to do so.
• Do not touch the needle shield activation clips to prevent premature covering of the needle.

Check the pre-filled syringe(s) to ensure that

• the number of pre-filled syringes and concentration are correct

• If your dose is 90 mg, you will have one 90 mg pre-filled syringe of IMULDOSA

• it is the correct medicine.

• the expiry date has not passed.

• the pre-filled syringe is not damaged.

• the solution in the pre-filled syringe is clear to slightly opalescent and colourless to slightly yellowish.

• the solution in the pre-filled syringe does not have an abnormal colour, is not cloudy, and does not contain foreign particles.

• the solution in the pre-filled syringe has not been frozen.

Prepare all necessary materials and place them on a clean surface. Include antiseptic wipes, cotton wool or gauze, and a sharps container.

1. Choose and prepare the injection site:

Choose the injection site (see Figure 2).

• IMULDOSA is administered by subcutaneous injection (under the skin).
• Suitable injection sites include the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
• Whenever possible, avoid areas of skin showing signs of psoriasis.
• If someone else is administering the injection, they may also choose the upper arm as an injection site.

Prepare the injection site

• Wash your hands thoroughly with soap and lukewarm water.
• Clean the skin at the injection site with an antiseptic wipe.
• Do not touch this area again before administering the injection.

1. Remove the needle cap (see Figure 3):

• The needle cap must not be removed until you are ready to inject.
• Hold the pre-filled syringe and grip the syringe barrel with one hand.
• Remove the needle cap and dispose of it. Do not touch the plunger while doing this.

• You may see an air bubble in the pre-filled syringe or a drop of liquid at the tip of the needle. Both are normal and do not need to be removed.
• Do not touch the needle or allow it to touch any surface.
• Do not use the pre-filled syringe if it has been dropped without the needle cap. If this happens, inform your doctor or pharmacist.
• Inject the dose immediately after removing the needle cap.

1. Inject the dose:

• Hold the pre-filled syringe with one hand between the index and middle fingers, place your thumb on the plunger head, and with the other hand gently pinch a fold of disinfected skin with your thumb and index finger. Do not squeeze tightly.
• Do not pull back the plunger at any time.
• In one quick motion, insert the needle through the skin as far as it will go (see Figure 4).

• Inject the entire medicine by pushing the plunger until the plunger head is completely within the needle shield wings (see Figure 5).

• Once the plunger has been fully depressed, maintain pressure on the plunger head, withdraw the needle, and release the skin (see Figure 6).

• Slowly release your thumb from the plunger head so that the empty syringe advances until the needle is completely covered by the needle shield, as shown in Figure 7.

1. After the injection:

• Press the injection site with an antiseptic wipe for a few seconds after the injection.
• A small amount of blood or fluid may appear at the injection site. This is normal.
• You may press the injection site with cotton wool or gauze for 10 seconds.
• Do not rub the skin at the injection site. You may cover the injection site with a plaster if necessary.

1. Disposal:

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and health, and for the safety of others, never reuse the syringe. Dispose of your sharps container according to local regulations.
• Antiseptic wipes and other materials may be discarded in the regular trash.