STEQEYMA 130 MG CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Steqeyma 130 mg Concentrate for Solution for Infusion

Ustekinumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Steqeyma and what is it used for

What is Steqeyma

Steqeyma contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically identify 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:

• 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 Steqeyma to reduce the signs and symptoms of your disease.

2. What you need to know before you use Steqeyma

Do not use Steqeyma

• If you are allergic to ustekinumabor 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 Steqeyma.

Warnings and precautions

Talk to your doctor or pharmacist before starting Steqeyma. Your doctor will check how you are before each treatment. Make sure you tell your doctor about any illness you have before each 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 you use Steqeyma. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.

Observe 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 “Serious side effects” in section 4.

Before using Steqeyma, tell your doctor:

• If you have ever had an allergic reaction to ustekinumab.Talk to your doctor if you are not sure.
• If you have ever had any type of cancer– this is because immunosuppressants like Steqeyma 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 produced from a biological source and usually given by injection)– the risk of having cancer may be higher.
• If you have had a recent infection or have any open sores on your skin (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 ustekinumab. 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 ustekinumab 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 Steqeyma.

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 accompanied by joint pain.

Heart attacks and strokes

In a study of patients with psoriasis treated with ustekinumab, 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 your body, facial paralysis, or abnormalities in speech or vision.

Children and adolescents

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

Other medicines, vaccines, and Steqeyma

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 Steqeyma.
• If you received Steqeyma during pregnancy, inform your baby's doctor about your treatment with Steqeyma 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 six months after birth if you received Steqeyma during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• It is recommended to avoid using Steqeyma during pregnancy. The effects of ustekinumab in pregnant women are not known. If you are a woman of childbearing age, you are advised to avoid becoming pregnant and use adequate contraceptive measures while using Steqeyma and for at least 15 weeks after the last treatment with Steqeyma.
• Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Ustekinumab may pass through the placenta to the fetus. If you received Steqeyma during pregnancy, your baby may have a higher risk of getting an infection.
• It is important to inform your baby's doctors and other healthcare professionals if you received Steqeyma 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 six months after birth if you received Steqeyma 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 Steqeyma. Do not do both at the same time.

Driving and using machines

Steqeyma has no influence on the ability to drive and use machines.

Steqeyma contains sodium

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

Steqeyma 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 Steqeyma 130 mg concentrate for solution for infusion by 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 Steqeyma is given

Your doctor will decide how much Steqeyma 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 Steqeyma by injection under the skin (subcutaneous injection) 8 weeks later and then every

12 weeks.

How Steqeyma is given

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

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

If you miss a dose of Steqeyma

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 Steqeyma

Stopping Steqeyma 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.

• Serious allergic reactions (“anaphylaxis”) are rare in people using ustekinumab (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 being treated for Crohn's disease, the first dose of Steqeyma is given by drip into a vein (intravenous infusion). Some patients have experienced serious 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 serious allergic reaction, your doctor may decide that you should not use Steqeyma 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).

Steqeyma 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 Steqeyma. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or having trouble 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
• vision loss or blurred 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 infection that does not go away or comes back. Your doctor may decide that you should not use Steqeyma until the infection goes away. Also, talk to your doctor if you have any open cuts or sores 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 (skin exfoliation)
• 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 change in the natural 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, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. Storing Steqeyma

• Steqeyma 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 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 should be discarded on the space provided on the outer packaging. The expiration date should not exceed the original expiration date printed on the carton. Once a vial has been stored at room temperature (up to 30 °C), it should not be refrigerated again. Discard the vial if it is not used within 31 days of storage at room temperature or by the original expiration date, whichever comes first.
• Do not shake Steqeyma vials. Prolonged vigorous shaking may damage the product.

Do not use this medication:

• 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 turbid, or has foreign particles floating in it (see section 6 "Appearance of Steqeyma and package contents").

6. Package contents and additional information

Composition of Steqeyma

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

Appearance of Steqeyma and package contents

Steqeyma is a transparent or slightly opalescent concentrate for solution for infusion, colorless to pale yellow. It is presented in a package containing 1 vial of 30 ml of single-dose glass. 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

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Spain

Kern Pharma, S.L.

Tel: +34 93 700 2525

Date of the last revision of this leaflet:

Detailed information on this medicinal product 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 medicinal product must 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 needed based on the patient's weight (see section 3, Table 1). Each 26 ml vial of Steqeyma 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 Steqeyma to be added (discard 26 ml of sodium chloride per vial of Steqeyma needed: 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 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 48 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 micrometers).
7. Each vial is for single use, and unused medication must be discarded in accordance with local regulations.

Storage

If necessary, the diluted infusion solution can be stored at room temperature up to a maximum of 30 °C. The infusion must be completed within 48 hours of dilution in the infusion bag. Do not freeze.