Steqeyma 130 mg concentrado para solucion para perfusion
Introduction
Product Information for the Patient
Steqeyma 130 mg Concentrate for Solution for Infusion
ustekinumab
This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.
Read this entire product information carefully before starting to use this medicine, as it contains important information for you.
This product information has been written for the person using the medicine.
- Keep this product information, as you may need to refer to it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.
1. What is Steqeyma and what is it used for
What is Steqeyma
Steqeyma contains the active ingredient “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 medications called “immunosuppressants”. These medications act by weakening part of the immune system.
What is Steqeyma 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 be given other medications first. If you do not respond adequately or do not tolerate those medications, you may be given Steqeyma to reduce the symptoms of your disease.
2. What you need to know before starting to use Steqeyma
No use Steqeyma
- If you are allergic to ustekinumabor to 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 unsure whether any of the above points apply to you, talk to your doctor or pharmacist before using Steqeyma.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Steqeyma. Your doctor will check how you are before each treatment. Make sure to inform your doctor about any illness you have before each treatment. Also inform your doctor if you have recently been near someone who may have tuberculosis. Your doctor will examine you and do a test for tuberculosis detection before using Steqeyma. If your doctor thinks you are at risk of tuberculosis, they may give you medicine to treat it.
Watch for severe side effects
Steqeyma may cause severe side effects, including allergic reactions and infections. You must pay attention to certain signs of illness while using Steqeyma. See the complete list of these side effects in “Severe side effects” of section 4.
Tell your doctor before using Steqeyma:
- 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 the 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 administered by injection)– the risk of having cancer may be higher.
- If you have or have had a recent infection or have any skin cracks (fistula).
- If you have any new lesions or changes in lesionswithin the psoriasis area or on intact skin.
- If you are taking any other treatment for psoriasis and/or psoriatic arthritis– such as any other immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. Although these treatments have not been studied together with ustekinumab, it is possible that they may increase the likelihood of having immune-related diseases.
- If you are receiving or have ever received injections to treat allergies– it is unknown whether ustekinumab may affect these treatments.
- If you are 65 years or older– you are more likely to acquire infections.
If you are unsure whether you have any of these conditions, talk to your doctor or pharmacist before using Steqeyma.
Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Talk to your doctor immediately if you experience red, raised, and scaly skin rash, sometimes with a darker border, in sun-exposed areas or 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 check your risk factors for heart disease and stroke regularly to ensure they are being treated properly. Seek medical attention immediately if you experience chest pain, weakness, or abnormal sensation in one side of the 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
Inform your doctor or pharmacist:
- If you are using, have used recently, or may use other medicines.
- If you have been vaccinated recently or are to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered 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 preferable to avoid using Steqeyma during pregnancy. The effects of ustekinumab on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use suitable contraceptive measures while using Steqeyma and for at least 15 weeks after the last treatment with Steqeyma.
- Inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant.
- Ustekinumab may pass through the placenta to the fetus. If you received Steqeyma during pregnancy, your baby may be at a higher risk of contracting an infection.
- It is essential 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 do so. You and your doctor will decide whether to breastfeed or use Steqeyma. Do not do both at the same time.
Driving and operating machines
The influence of Steqeyma on the ability to drive and operate machines is negligible or insignificant.
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 follow a low-sodium diet.
3. How to use Steqeyma
Steqeyma should be used under the guidance and supervision of a doctor with experience in diagnosing and treating Crohn's disease.
Your doctor will administer Steqeyma 130 mg concentrate for infusion solution through a vein in your arm (intravenous infusion) for at least one hour. Ask your doctor when they should give you the injections and about follow-up appointments.
What amount of Steqeyma is administered
Your doctor will decide how much Steqeyma you need to receive and the duration of treatment.
Adults 18 years of age and older
- Your doctor will calculate the recommended intravenous infusion dose based on your body weight.
- After the initial intravenous dose, you will receive the next dose of 90 mg of Steqeyma through an injection under the skin (subcutaneous injection) 8 weeks later, and then every
12 weeks.
How Steqeyma is administered
- The first dose of Steqeyma for the treatment of Crohn's disease is administered by a doctor through a drip in the vein of an arm (intravenous infusion).
Consult with your doctor if you have any questions about Steqeyma treatment.
If you forgot to use Steqeyma
If you forget a dose or miss an appointment, talk to your doctor to schedule another appointment.
If you interrupt Steqeyma treatment
Stopping Steqeyma is not hazardous. However, if you stop using it, your symptoms may return.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects
Some patients may experience severe side 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 (they can affect up to 1 in 1,000 people). The 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 urticaria (these can affect up to 1 in 100 people).
Reactions related to infusion – If you are being treated for Crohn's disease, the first dose of Steqeyma is administered through a drip in a vein (intravenous infusion). Some patients have experienced severe allergic reactions during the infusion.
In rare cases, pulmonary allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you have symptoms such as coughing, difficulty breathing, and fever.
If you experience 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.
- Common colds and sore throats are frequent (they can affect up to 1 in 10 people).
- Chest infections are infrequent (they can affect up to 1 in 100 people).
- Cellulitis, an inflammation of the tissues under the skin, is infrequent (it can affect up to 1 in 100 people).
- Herpes, a painful rash with blisters, are infrequent (they can affect up to 1 in 100 people).
Steqeyma may affect your ability to fight infections. Some of them may be severe and caused by viruses, fungi, bacteria (including tuberculosis) or parasites, and include infections that occur mainly in people with a weakened immune system (opportunistic infections). Cases of opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving treatment with ustekinumab.
You should monitor the signs of infection while using Steqeyma. These include:
- Fever, flu-like symptoms, night sweats, weight loss
- Feeling tired or difficulty breathing; cough that does not go away
- Having hot, red, and painful skin or having a painful skin rash with blisters
- Urinary burning
- Diarrea
- Visual deterioration or loss of vision
- Headache, neck stiffness, photosensitivity, nausea, or confusion.
Notify 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 notify your doctor if you have any type of infection that does not go away or reappears. Your doctor may decide that you should not use Steqeyma until the infection goes away. You should also contact your doctor if you have any open wounds or ulcers that may become infected.
Skin peeling – the increase in redness and skin peeling on a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are serious skin disorders. If you notice any of these symptoms, you should notify your doctor immediately.
Other side effects
Frequent side effects(they can affect up to 1 in 10 people):
- Diarrea
- Nausea
- Vomiting
- Feeling tired
- Dizziness
- Headache
- Itching (“pruritus”)
- Back, muscle, or joint pain
- Sore throat
- Redness and pain at the injection site
- Sinusitis
Infrequent side effects(they can affect up to 1 in 100 people):
- Dental infections
- Vaginal yeast infections
- Depression
- Stuffy or congested nose
- Bleeding, petechiae, hardening, swelling, and itching at the injection site
- Feeling weak
- Drooping eyelid and facial muscle weakness (“facial paralysis” or “Bell's palsy”), which is usually temporary
- A change in psoriasis with redness and new small skin blisters, sometimes accompanied by fever (psoriasis pustular)
- Skin peeling (exfoliation of the skin)
- Acne
Rare side effects(they can affect up to 1 in 1,000 people):
- Redness and skin peeling on a large area of the body, which can cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in psoriasis symptoms (psoriasis erythroderma)
- Inflammation of small blood vessels, which can cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)
Very rare side effects(they can affect up to 1 in 10,000 people)
- Blisters on the skin, which can be red and cause itching and pain (pemphigoid bullous).
- Cutaneous lupus or lupus-like syndrome (red, elevated, and scaly skin rash in sun-exposed areas, possibly accompanied by joint pain).
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.
5. Steqeyma Conservation
- Steqeyma 130 mg concentrate for solution for infusion is administered in a hospital or medical center and does not require patients to conserve or handle it.
- Maintain this medication out of the sight and reach of children.
- Store in refrigerator (between 2 °C and 8 °C). Do not freeze.
- Store the vial in the outer packaging to protect it from light.
- If necessary, individual Steqeyma vials can also be stored at room temperature up to 30 °C for a maximum period of up to 31 days in their original box to protect them from light. Write the date when the vial is removed from the refrigerator and the date when it should be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiration date printed on the box. Once a vial has been stored at room temperature (up to a maximum of 30 °C), it should not be stored again in the refrigerator. Discard the vial if it is not used within 31 days of storage at room temperature or from the original expiration date, whichever occurs first.
- Do not shake Steqeyma vials. Prolonged vigorous shaking may damage the product.
Do not use this medication:
- After the expiration date appearing on the label and packaging after “CAD”. The expiration date is the last day of the month indicated.
- If the liquid changes color, becomes turbid, or presents unusual particles floating in it (see section 6 “Appearance of Steqeyma and contents of the packaging”).
6. Contents of the packaging 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 edetate dihydrate, L-histidine, monochloride monohydrate of L-histidine, L-methionine, polysorbate 80, sucrose, and water for injection preparations.
Appearance of Steqeyma and contents of the package
Steqeyma is a concentrate for solution for infusion, transparent or slightly opalescent, colorless or pale yellow. It is presented in a package containing 1 vial of 30 ml of glass single-use. 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
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Spain
Kern Pharma, S.L.
Tel: +34 93 700 2525
Last review date of this leaflet:
The detailed information about this medication 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 medication must be clearly recorded.
Dilution instructions:
Steqeyma concentrate for solution for infusion must be diluted, prepared, and infused by a healthcare professional using an aseptic technique.
- Calculate the dose and the number of Steqeyma vials needed based on the patient's weight (see section 3, Table 1). Each vial of 26 ml of Steqeyma contains 130 mg of ustekinumab.
- Extract 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 for each Steqeyma vial needed: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).
- Extract 26 ml of Steqeyma from each necessary vial and add them to the 250 ml infusion bag. The final volume of the infusion bag must be 250 ml. Mix gently.
- Perform a visual inspection of the diluted solution before infusion. Do not use if opaque particles, color changes, or foreign particles are detected.
- 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.
- Use only a perfusion system with an in-line, sterile, apyrogenic, low-protein-binding filter (pore size of 0.2 micrometers).
- Each vial is for single use and the 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.
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