Stequeyma 130 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Steqeyma 130 mg concentrate for solution for infusion

ustekinumab

?This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. See the end of section 4 for information on how to report adverse reactions.

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 using the medicine.

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

Leaflet contents

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

1. What Steqeyma is and what it is used for

What Steqeyma is

Steqeyma contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to certain proteins in the body.

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

What Steqeyma is used for

Steqeyma is used to treat the following inflammatory diseases:

• Moderately to severely active Crohn’s disease – in adults and 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 first be given other medications. If you do not respond adequately or cannot tolerate those medications, Steqeyma may be given to reduce the signs and symptoms of your disease.

2. What you need to know before using Steqeyma

Do not use Steqeyma

• 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 Steqeyma.

Warnings and precautions

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

Watch for serious side effects

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

Before using Steqeyma, tell your doctor:

• If you have ever had an allergic reaction to ustekinumab. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – this is because immunosuppressants like Steqeyma 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 or have recently had an infection or have any skin breaks (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 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 use of these treatments together with ustekinumab has not been studied, but it could increase the likelihood of developing illnesses related to a weakened immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether ustekinumab 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 Steqeyma.

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, or if it is 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 unusual sensations on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

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

Other medicines, vaccines, and Steqeyma

• 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 given while using Steqeyma.
• If you received Steqeyma during pregnancy, inform your infant’s doctor about your Steqeyma 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 during the first twelve months after birth if you received Steqeyma during pregnancy, unless your infant’s doctor advises otherwise.

Pregnancy and breastfeeding

• If you are pregnant, think you might 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 ustekinumab in the womb. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Steqeyma during pregnancy.

• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use appropriate contraceptive measures while using Steqeyma and for at least 15 weeks after your last dose.

• Ustekinumab can cross the placenta to the fetus. If you received Steqeyma 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 Steqeyma 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 during the first twelve months after birth if you received Steqeyma 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 Steqeyma, but not both simultaneously.

Driving and using machines

The influence of Steqeyma on the ability to drive and use machines is negligible or none.

Steqeyma contains sodium

Steqeyma contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free.” However, before Steqeyma is administered, it is mixed with a solution containing sodium. Speak with your doctor if you are on a low-salt diet.

Steqeyma contains polysorbate 80

Steqeyma contains 10.37 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 any known allergies.

3. How to use Steqeyma

Steqeyma 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 Steqeyma 130 mg concentrate for solution for infusion as a drip into a vein in your arm (intravenous infusion) over a period of at least one hour. Ask your doctor when your infusions should be given and about follow-up visits.

How much Steqeyma is administered

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

Adults aged 18 years 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 Steqeyma via 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 dose of 90 mg of Steqeyma as an injection under the skin (subcutaneous injection) 8 weeks later, and thereafter every 12 weeks.

How Steqeyma is administered

• The first dose of Steqeyma for the treatment of Crohn's disease is given by a doctor as an infusion into a vein in the arm (intravenous infusion).

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

If you forget to use Steqeyma

If you miss a dose or do not attend your appointment for administration, speak with your doctor to schedule another appointment.

If you stop treatment with Steqeyma

Stopping the use of Steqeyma 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 experiences 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 ustekinumab (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 (these may affect up to 1 in 100 people).

Infusion-related reactions – If you are being treated for Crohn's disease, the first dose of Steqeyma is administered via 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 have a severe allergic reaction, your doctor may decide that you should not use Steqeyma again.

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

• Infections of the nose or throat 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 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).

Steqeyma may affect your ability to fight infections. Some infections may become severe and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. These include infections that occur mainly 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 Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath; persistent cough
• skin feeling 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 Steqeyma 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 (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 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 on sun-exposed skin areas, possibly accompanied by joint pains).

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 listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Steqeyma

• Steqeyma 130 mg concentrate for solution for infusion is administered in a hospital or medical centre and patients do not need to store or handle it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• If necessary, individual vials of Steqeyma may also be stored at room temperature up to 30 °C for a single period of up to 31 days in their original carton to protect them from light. Write the date when the vial is first removed from the refrigerator and the date when it must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the carton. Once a vial has been stored at room temperature (up to a maximum of 30 °C), it must not be returned to the refrigerator. Discard the vial if it is not used within 31 days of storage at room temperature or after the original expiry date, whichever occurs first.
• Do not shake Steqeyma vials. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging after “EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains floating foreign particles (see section 6 “Description of Steqeyma and contents of the container”).
• If you know or suspect it has been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been shaken vigorously.
• If the seal is broken.

Steqeyma is for single use only. Any unused diluted infusion solution remaining in the vial or syringe must be disposed of according to local regulations.

6. Contents of the pack and other information

Composition of Steqeyma

• 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 injections.

Appearance of Steqeyma and contents of the pack

Steqeyma is a concentrate for solution for infusion that is clear or slightly opalescent, colourless to pale yellow. 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 Authorization Holder

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Manufacturer

Nuvisan France SARL

2400, Route des Colles

06410, Biot

France

MIDAS Pharma GmbH

Rheinstrasse 49

55218 West Ingelheim Am Rhein

Rhineland-Palatinate

Germany

Kymos S.L.

Ronda de Can Fatjó 7B

Parc Tecnològic del Vallès

08290 Cerdanyola Del Valles

Barcelona

Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary:

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 medicines, the name and batch number of the administered medicine should be clearly recorded.

Instructions for dilution:

Steqeyma 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 Steqeyma vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 ml vial of Steqeyma contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of 0.9% sodium chloride solution from the 250 ml infusion bag equivalent to the volume of Steqeyma to be added (discard 26 ml of sodium chloride per required Steqeyma vial: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).
3. Withdraw 26 ml of Steqeyma from each required 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 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 48 hours of dilution in the infusion bag.
6. Use only an infusion system with an in-line, sterile, pyrogen-free, low protein-binding filter (pore size 0.2 micrometers).
7. Each vial is for single use only, and any unused medicine must be discarded in accordance with local regulations.

Storage

If necessary, the diluted solution for infusion may be stored at room temperature not exceeding 30 °C. The infusion must be completed within 48 hours after dilution in the infusion bag. Do not freeze.