Steqeyma 90 mg solucion inyectable en jeringa precargada
Introduction
Prospect: information for the patient
Steqeyma 90 mg injectable solution in pre-filled syringe
ustekinumab
This medicine is subject to additional monitoring, which will facilitate 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 prospect carefully before starting to use this medicine, because it contains important information for you.
This prospect has been written for the person using the medicine. If you are the parent or caregiver of a child to whom you will administer Steqeyma, please read this information carefully.
- Keep this prospect, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed only to you, and you must not give it to other people even if they present the same symptoms as you, as it may harm them.
- If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospect. See section 4.
1. What is Steqeyma and what is it used for
1.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:
- Plaque psoriasis - in adults and children 6 years of age and older
- Psoriatic arthritis - in adults
- Moderate to severe Crohn's disease - in adults
Plaque psoriasis
Plaque psoriasis is a skin disease that causes inflammation affecting the skin and nails. Steqeyma reduces inflammation and other symptoms of the disease.
Steqeyma is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or where these treatments are not effective.
Steqeyma is used in children and adolescents 6 years of age and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies, or where these treatments are not effective.
Psoriatic arthritis
Psiatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first receive other medications. If you do not respond well to these medications, you may be treated with Steqeyma to:
- Reduce the signs and symptoms of your disease.
- Improve your physical function.
- Reduce damage to your joints.
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 Steqeyma to reduce the signs and symptoms of your disease.
2. What you need to know before starting to use Steqeyma
Do not use Steqeyma
- If you are allergic to ustekinumabor to any of the other components of this medication (listed in section 6).
- If you have an active infectionthat your doctor thinks is important.
If you are unsure if any of the above points concern you, speak with 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 suffer from before each treatment. Your doctor will also ask if you have recently been near someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis detection before using Steqeyma. If your doctor thinks you are at risk of tuberculosis, they may give you medication to treat it.
Observe 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 with your doctor if you are unsure.
- If you have ever had any type of cancer– this is because the immunosuppressants of the type of 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 medication produced from a biological source and usually administered by injection)– the risk of having cancer may be higher.
- If you have any new lesions or changes to the lesionswithin the psoriasis area or on intact skin.
- If you have or have had a recent infection.
- 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 if ustekinumab may affect these treatments.
- If you are 65 years or older– you are more likely to acquire infections.
If you are unsure if you have any of these conditions, speak with your doctor or pharmacist before using Steqeyma.
Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including lupus cutaneous or lupus-like syndrome. Speak with your doctor immediately if you experience a red, elevated, and scaly 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 were observed. Your doctor will regularly check your risk factors for heart disease and stroke to ensure they are properly treated. 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 6 years of age with psoriasis or in children under 18 years of age with psoriatic arthritis or Crohn's disease, as it has not been studied in this age group.
Other medications, vaccines, and Steqeyma
Inform your doctor or pharmacist:
- If you are using, have used recently, or may use other medications.
- 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 adequate 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.
3. How to use Steqeyma
Steqeyma should be used under the guidance and supervision of a doctor with experience in treating the conditions for which Steqeyma is indicated.
Always follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, ask your doctor. Ask your doctor when to administer the injections and about follow-up consultations.
What amount of Steqeyma is administered
Your doctor will decide the amount of Steqeyma you need to use and the duration of treatment.
Adults 18 years of age and older Psoriasis or psoriatic arthritis
- The recommended starting dose is 45 mg of Steqeyma. Patients weighing more than 100 kg may start with a dose of 90 mg instead of 45 mg.
- After the initial dose, you will take the next dose 4 weeks later and then every 12 weeks. The subsequent 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 through a vein in your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of Steqeyma 8 weeks later and then every 12 weeks through a subcutaneous injection.
- 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 6 years of age and older Psoriasis
There is no pharmaceutical form of Steqeyma for children with plaque psoriasis weighing less than 60 kg, so other products with ustekinumab should be used.
- Your doctor will indicate the correct dose for you, including the amount (volume) of Steqeyma to inject to give the correct dose. The suitable 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 available pharmaceutical form of Steqeyma, and other products with ustekinumab should be used.
- 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 then every 12 weeks.
How Steqeyma is administered
- Steqeyma is administered through a subcutaneous injection. Initially, medical or nursing staff may administer Steqeyma to you.
- However, you and your doctor may decide that Steqeyma is injected by you. In that case, you will be trained on how to inject Steqeyma yourself.
- For instructions on how to administer Steqeyma, see "Administration Instructions" at the end of this leaflet.
Consult your doctor if you have any questions about self-injecting.
If you use more Steqeyma than you should
If you have used or have been given too much Steqeyma, speak immediately with your doctor or pharmacist. Always carry the medication box with you, even if it is empty.
If you forget to use Steqeyma
If you forget a dose, speak with your doctor or pharmacist. Do not take a double dose to compensate for the missed doses.
If you interrupt Steqeyma treatment
Stopping Steqeyma is not hazardous. However, if you stop, your symptoms may return.
If you have any other doubts about using 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).
In rare cases, pulmonary allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you experience 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, sinusitis, and respiratory tract infections 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, is infrequent (it 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 opportunistic infections that occur mainly in people with weakened immune systems. Cases of opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving ustekinumab treatment.
You should monitor signs of infection while using Steqeyma. These include:
- Fever, flu-like symptoms, night sweats, weight loss
- Feeling tired or difficulty breathing; persistent cough
- Warm, red, and painful skin or a painful skin rash with blisters
- Urinary burning
- Diarrhea
- 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 pneumonia, skin infections, herpes, or opportunistic infections that may have serious complications. You should also inform 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 has cleared up. Also, contact your doctor if you have any open wounds or ulcers that may become infected.
Skin peeling – increased redness and skin peeling over a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are severe skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.
Other side effects
Frequent side effects(they can 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
Infrequent side effects(they can affect up to 1 in 100 people):
- Dental infections
- Vaginal yeast infections
- Depression
- Stuffy or congested nose
- Bleeding, petechiae, induration, 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 over a large area of the body, which may 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 may 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 may 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 reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Steqeyma Storage
- Keep this medication out of the sight and reach of children.
- Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.
- Store the pre-filled syringe in the outer packaging to protect it from light.
- Individual pre-filled Steqeyma syringes 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 pre-filled syringe is first 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 syringe has been stored at room temperature (up to a maximum of 30 °C), it should not be stored back in the refrigerator. Discard the syringe if it is not used within the 31-day storage period at room temperature or from the original expiration date, whichever occurs first.
- Do not shake the pre-filled Steqeyma syringes. Prolonged vigorous shaking may damage the product.
Do not use this medication:
- After the expiration date that appears on the label and the container after “CAD”. The expiration date is the last day of the month indicated.
- If the liquid changes color, becomes cloudy, or presents unusual particles floating in it (see section 6 “Appearance of Steqeyma and contents of the container”).
- If you know or suspect you have been exposed to extreme temperatures (such as accidental overheating or freezing).
- If the product has been shaken vigorously.
Steqeyma is for single use only. Dispose of the unused product remaining in the syringe. Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and unused medicines. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Steqeyma
- The active ingredient is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
- The other components are L-histidine, L-histidine monohydrochloride monohydrate, polisorbate 80, sucrose, and water for injection.
Appearance of Steqeyma and contents of the package
Steqeyma is a transparent or slightly opalescent injectable solution (with a pearlescent sheen), ranging in color from colorless to pale yellow. The solution may contain a few translucent or white protein particles. It is presented in a package containing one pre-filled syringe of 1 ml of glass for single use. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.
Holder of the Marketing Authorization
Celltrion Healthcare Hungary Kft. 1062 Budapest
Váci út 1-3. WestEnd Office Building B tower Hungary
Responsible for manufacturing
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.
Phone: +34 93 700 2525
Last review date of this leaflet <{MM/AAAA}>.
The detailed information about this medication is available on the website of the European Medicines Agency: https:// www.ema.europa.eu
Administration instructions
At the beginning of treatment, your healthcare professional will help you with the first injection. However, you and your doctor may decide that you can administer Steqeyma yourself. If this is the case, you will receive training on how to administer Steqeyma. Talk to your doctor if you have any doubts about self-administering.
Important information
- Do not open the sealed carton packaging until you are about to use the pre-filled syringe.
- Do not remove the cap until just before administering the injection.
- Do not mix Steqeyma with other injectable liquids.
- The pre-filled syringe cannot be reused. Dispose of the used pre-filled syringe immediately after use in a sharps container (see step 14. Disposal of Steqeyma).
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 between 2 °C and 8 °C. Do not freeze.
- Store this medication in its original sealed packaging to protect it from light.
- If necessary, individual pre-filled syringes of Steqeyma can also be stored at room temperature up to 30 °C for a maximum period of 31 days in their original packaging to protect them from light.
- Do not shake the pre-filled syringes of Steqeyma. Strong shaking may damage the medication.
- Do not use the medication if it has been shaken vigorously.
- Do not use the pre-filled syringe if it has fallen.
Parts of the pre-filled syringe (see Figure A)
Preparation for injection
| ALCOHOL SWAB |
| |
| Box containing Alcohol swab and gauze pre-filled syringe | ||
| Figure B | ||
| Figure C |
| 30 minutes Figure D |
| Figure E | |
| Figure F | |
| = ONLY caregiver = Self-injection and caregiver Figure G | |
| Figure H | |
| Figure I | |
| Figure J | |
| Figure K | |
| Figure L | |
| Figure M |
After the injection
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