Steqeyma 45 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Steqeyma 45 mg solution for injection in a pre-filled syringe
ustekinumab
This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
This leaflet has been written for the person using the medicine. If you are a parent or caregiver administering Steqeyma to a child, please read this information carefully.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Steqeyma is and what it is used for
- What you need to know before using Steqeyma
- How to use Steqeyma
- Possible side effects
- How to store Steqeyma
- 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:
- Plaque psoriasis – in adults and children aged 6 years and older
- Psoriatic arthritis – in adults
- Moderate to severe Crohn’s disease – in adults and children weighing at least 40 kg
Plaque psoriasis
Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. Steqeyma reduces inflammation and other signs of the disease.
Steqeyma is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or when these treatments are ineffective.
Steqeyma 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 medicines, you may be treated with Steqeyma 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 medicines, you may be given Steqeyma 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 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 Steqeyma.
Warnings and precautions
Talk to your doctor or pharmacist before starting Steqeyma. Your doctor will assess your health status before each treatment. Make sure to inform your doctor about any medical conditions you 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 for tuberculosis before you start using Steqeyma. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.
Be aware of serious adverse effects
Steqeyma may cause serious adverse effects, including allergic reactions and infections. You should pay attention to certain signs of illness while using Steqeyma. See the complete list of these adverse effects in the section “Serious adverse 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 – because immunosuppressants like Steqeyma weaken part of the immune system. This may increase the risk of developing cancer.
- If you have previously been treated 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 currently have or have recently had an infection.
- 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 (where 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 in combination with ustekinumab has not been studied. However, it may increase the likelihood of developing illnesses associated with a weaker 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, in sun-exposed areas of skin, 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 numbness 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 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.
Other medicines, vaccines, and Steqeyma
Inform your doctor or pharmacist:
- If you are currently using, have recently used, or might use 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 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 adequate contraception while using Steqeyma and for at least 15 weeks after the last dose of Steqeyma.
- 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 that you received Steqeyma 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 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. Do not do both simultaneously.
Driving and using machines
The influence of Steqeyma on the ability to drive and use machines is negligible or none.
Steqeyma contains polysorbate 80
Steqeyma contains 0.02 mg of polysorbate 80 (E433) per dose unit, equivalent to 0.04 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 treatment of conditions for which Steqeyma is indicated.
Always follow exactly the administration instructions for this medicine provided by your doctor. If in doubt, consult your doctor. Ask your doctor when your injections should be given and about follow-up appointments.
How much Steqeyma is administered
Your doctor will decide the amount of Steqeyma you need to use and the duration of treatment.
Adults aged 18 years and older
Psoriasis or psoriatic arthritis
- The recommended starting dose is 45 mg of Steqeyma. 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 Steqeyma as an intravenous infusion (by drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Steqeyma 8 weeks later, and then every 12 weeks, by subcutaneous injection ("subcutaneous route").
- In some patients, after the first subcutaneous injection, 90 mg of Steqeyma 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 Steqeyma to inject to deliver the correct dose. The appropriate dose for you will depend on your body weight at the time each dose is given.
- A 45 mg vial is available for children who require less than the full 45 mg dose.
- If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Steqeyma.
- If you weigh more than 100 kg, the recommended dose is 90 mg of Steqeyma.
- 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 Steqeyma as an intravenous infusion (by drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Steqeyma 8 weeks later, and then every 12 weeks, by subcutaneous injection ("subcutaneous route").
- In some patients, after the first subcutaneous injection, 90 mg of Steqeyma will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.
How Steqeyma is administered
- Steqeyma is administered by subcutaneous injection ("subcutaneous route"). At the beginning of your treatment, medical or nursing staff may administer Steqeyma to you.
- However, you and your doctor may decide that you will self-inject Steqeyma. In that case, you will be trained in how to self-inject Steqeyma.
- For instructions on how to inject Steqeyma, see "Administration instructions" at the end of this leaflet.
Consult your doctor if you have any questions about self-injection.
If you use more Steqeyma than you should
If you have used or been given too much Steqeyma, speak immediately with your doctor or pharmacist. Always carry the medicine carton with you, even if it is empty.
If you forget to use Steqeyma
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 Steqeyma
Stopping the use of Steqeyma is not dangerous. However, if you stop, 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.
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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.
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Common signs of an allergic reaction include rash and hives (may affect up to 1 in 100 people).
In rare cases, allergic reactions affecting the lungs and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you experience symptoms such as cough, difficulty breathing, or fever.
If you have a severe allergic reaction, your doctor may decide that you should no longer use Steqeyma.
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).
Steqeyma 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. These 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 Steqeyma. 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, light sensitivity, 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 resolve 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 wound or ulcer 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 (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 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Steqeyma
- 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 pre-filled syringe in the outer packaging to protect it from light.
- If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a single period of up to 31 days in their original carton to protect them from light. Write the date when the pre-filled syringe is first removed from the refrigerator in the designated space on the outer packaging. At any time before the end of this 31-day period at room temperature, the product may be returned to the refrigerator once and stored there until the original expiration date. Discard the syringe 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 the pre-filled syringes of Steqeyma. Prolonged vigorous shaking may damage the product.
Do not use this medicine:
- After the expiry date stated on the label and container after “EXP”. The expiry date is the last day of the month indicated.
- If the solution changes colour, becomes cloudy, or contains foreign particles floating in it (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 overheating or freezing).
- If the product has been shaken vigorously.
Steqeyma is for single use only. Any unused product remaining in the syringe must be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Steqeyma
- The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml.
- The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sucrose and water for injections.
Presentation of Steqeyma and contents of the pack
Steqeyma is a clear or slightly opalescent (with a pearly sheen), colourless to pale yellow injectable solution. The solution may contain a few translucent or white protein particles. It is supplied in a pack containing 1 single-use glass pre-filled syringe of 1 ml. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml of injectable solution.
Marketing Authorization Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary
Manufacturer responsible
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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Celltrion Healthcare Belgium BVBA Tel/Tel: + 32 1528 7418 | Lithuania Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 |
| Luxembourg/Luxembourg Celltrion Healthcare Belgium BVBA Tel/Tel: + 32 1528 7418 |
Czech Republic Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 | Hungary Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
Denmark Celltrion Healthcare Denmark ApS Tlf.: +45 3535 2989 | Malta Mint Health Ltd Tel: + 356 2093 9800 |
Germany Celltrion Healthcare Deutschland GmbH Tel: + 49 (0)30 346494150 | Netherlands Celltrion Healthcare Netherlands B.V. Tel: + 31 20 888 7300 |
Estonia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 | Norway Celltrion Healthcare Norway AS |
Spain Kern Pharma, S.L. Tel: +34 93 700 2525 | Austria Astro-Pharma GmbH Tel: + 43 1 97 99 860 |
Greece BIANEX S.A. Tel: + 30 210 8009111 | Poland Celltrion Healthcare Hungary Kft. Tel.: + 36 1 231 0493 |
France Celltrion Healthcare France SAS Tél: + 33 (0)1 71 25 27 00 | Portugal CELLTRION PORTUGAL, UNIPESSOAL LDA Tel: + 351 21 936 8542 |
Croatia Oktal Pharma d.o.o. Tel: + 385 1 6595 777 | Romania Celltrion Healthcare Hungary Kft. Tel: + 36 1 231 0493 |
Ireland Celltrion Healthcare Ireland Limited Tel: + 353 1 223 4026 | Slovenia OPH Oktal Pharma d.o.o. Tel: + 386 1 519 29 22 |
Iceland Celltrion Healthcare Hungary Kft. Sími: + 36 1 231 0493 | Slovakia Celltrion Healthcare Hungary Kft. Tel: + 36 1 231 0493 |
Italy Celltrion Healthcare Italy S.R.L. Tel: + 39 0247927040 | Finland Celltrion Healthcare Finland Oy. Puh/Tel: + 358 29 170 7755 |
Cyprus C.A. Papaellinas Ltd Tel: + 357 22741741 | Sweden Celltrion Sweden AB Tel: +46 8 80 11 77 |
Latvia Celltrion Healthcare Hungary Kft. Tel: + 36 1 231 0493 |
Date of the most recent review of this leaflet: <{MM/YYYY}>.
Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
Instructions for administration
At the beginning of treatment, your healthcare professional will assist you with the first injection. However, you and your doctor may decide that you can self-inject Steqeyma. If so, you will receive training on how to inject Steqeyma. Speak with your doctor if you have any doubts about self-injection.
Important information
- Do not open the sealed cardboard packaging until you are ready to use the pre-filled syringe.
- Do not remove the cap until immediately before administering the injection.
- Do not mix Steqeyma with other injectable liquids.
- The pre-filled syringe must not be reused. Immediately dispose of the used pre-filled syringe in a sharps container (see step 14. Disposal of Steqeyma).
- The syringe cap design may vary depending on the supplied materials and may be flexible or rigid.
Storage of Steqeyma
- Keep the pre-filled syringe out of the sight and reach of children. It contains small parts.
- Store the pre-filled syringe in the refrigerator at between 2 °C and 8 °C. Do not freeze.
- Keep this medicine in its closed packaging to protect it from light.
- If necessary, individual pre-filled syringes of Steqeyma may also be stored at room temperature up to 25 °C for a maximum single period of up to 31 days in their original carton to protect them from light.
- Record the date when the pre-filled syringes were first removed from the refrigerator in the spaces provided for this purpose on the outer carton.
- At any time before the end of the room temperature storage period, the product may be returned to the refrigerator once and stored there until the original expiry date.
- Do not shake the pre-filled syringes of Steqeyma. Vigorous shaking may damage the medicine.
- Do not use the medicine if it has been shaken vigorously.
- Do not use the pre-filled syringe if it has been dropped.
Parts of the pre-filled syringe (see Figure A)
Preparation for injection
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Not included in the box:
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correct medication (Steqeyma) and dose.
number of prefilled syringes and concentration are correct:
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the Figure H). |
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Administration of the injection
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Note: Pinching the skin is important to ensure that the injection is delivered under the skin (into the fatty tissue), and not deeper (into the muscle).
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After the injection
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