Wezenla 90 mg solucion inyectable en jeringa precargada
Introduction
Patient Information Leaflet
WEZENLA 45mg pre-filled syringe solution for injection
WEZENLA 90mg pre-filled syringe solution for injection
ustekinumab
This medicine is subject to additional monitoring. This will help speed up the detection of any new safety information. You can help by reporting any side effects you get. The final part of section 4 includes information on how to report these side effects.
Read 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. If you are the parent or carer of a child to whom you will administer WEZENLA, 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1.What is WEZENLA and what it is used for
2.What you need to know before starting to use WEZENLA
3.How to use WEZENLA
4.Possible side effects
5.Storage of WEZENLA
6.Contents of the pack and additional information
1. What is WEZENLA and what is it used for
What is WEZENLA
WEZENLA contains the active ingredient “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically identify and bind to certain proteins in the body.
WEZENLA belongs to a group of medicines called “immunosuppressants”. These medicines act by weakening part of the immune system.
What is WEZENLA used for
WEZENLA is used to treat the following inflammatory diseases:
- Plaque psoriasis - in adults and children aged 6 years and above
- 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. WEZENLA reduces inflammation and other symptoms of the disease.
WEZENLA is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or where these treatments are not effective.
WEZENLA is used in children and adolescents aged 6 years and above 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 WEZENLA 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 WEZENLA to reduce the signs and symptoms of your disease.
2. What you need to know before starting to use WEZENLA
No use WEZENLA
- If you are allergic to ustekinumabor to any of the other components of this medication (listed in section6).
- If you have an active infectionthat your doctor thinks is important.
If you are unsure whether any of the above points apply to you, speak with your doctor or pharmacist before using WEZENLA.
Warnings and precautions
Consult your doctor or pharmacist before starting to use WEZENLA. Your doctor will check how you are before each treatment. Make sure to inform your doctor about any illness you have 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 WEZENLA. If your doctor thinks you are at risk of tuberculosis, they may give you medication to treat it.
Watch for severe side effects
WEZENLA may cause severe side effects, including allergic reactions and infections. You must pay attention to certain signs of illness while using WEZENLA. See the complete list of these side effects in “Severe side effects” of section4.
Tell your doctor:
- If you have ever had an allergic reaction to WEZENLA.Consult your doctor if you are unsure.
- If you have ever had any type of cancer– this is because the immunosuppressants of the type of WEZENLA 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 or have had a recent infection.
- If you have any new lesions or changes to existing 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. The use of these treatments together with WEZENLA has not been studied. However, it may increase the likelihood of developing immune-related diseases.
- If you are receiving or have received injections to treat allergies– it is unknown whether WEZENLA may affect these treatments.
- If you are 65years or older– you are more likely to acquire infections.
If you are unsure whether you have any of these conditions, speak with your doctor or pharmacist before using WEZENLA.
Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including cutaneous lupus 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
WEZENLA is not recommended for use in children under 6 years of age with psoriasis or in children under 18years of age with psoriatic arthritis or Crohn's disease, as it has not been studied in this age group.
Using WEZENLA with other medications, vaccines
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 WEZENLA.
- If you received WEZENLA during pregnancy, inform your baby's doctor about your treatment with WEZENLA 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 12 months after birth if you received WEZENLA during pregnancy, unless your baby's doctor recommends otherwise.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.
- No increased risk of birth defects has been observed in babies exposed to WEZENLA in the womb. However, there is limited experience with WEZENLA in pregnant women. Therefore, it is preferable to avoid using WEZENLA during pregnancy.
- If you are a fertile woman, it is recommended that you avoid becoming pregnant and use adequate contraceptive measures while using WEZENLA and for at least 15weeks after the last WEZENLA treatment.
- WEZENLA may pass through the placenta to the fetus. If you received WEZENLA during pregnancy, your baby may be at increased risk of infection.
- It is essential to inform your baby's doctors and other healthcare professionals if you received WEZENLA 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 12 months after birth if you received WEZENLA 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 WEZENLA. Do not do both at the same time.
Driving and operating machinery
The influence of WEZENLA on the ability to drive and operate machinery is negligible or insignificant.
3. How to use WEZENLA
WEZENLA should be used under the guidance and supervision of a doctor with experience in treating the conditions for which WEZENLA is indicated.
Always follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor. Ask your doctor when to administer the injections and about follow-up consultations.
What amount of WEZENLA is administered
Your doctor will decide on the amount of WEZENLA you need to use and the duration of treatment.
Adults 18 years of age and older years of age
Psoriasis or psoriatic arthritis
- The recommended starting dose is 45 mg of WEZENLA. Patients weighing more than 100 kg may start with a dose of 90 mg instead of 45 mg.
- After the initial dose, you will receive the next dose 4 weeks later and then every 12 weeks. The subsequent doses are usually the same as the initial dose.
Crohn's disease
- During treatment, your doctor will administer the first dose of approximately 6 mg/kg of WEZENLA via infusion into a vein in your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of WEZENLA 8 weeks later and then every 12 weeks via subcutaneous injection.
- In some patients, after the first subcutaneous injection, 90 mg of WEZENLA 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
- Your doctor will indicate the correct dose for you, including the amount (volume) of WEZENLA 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.
- A 45 mg vial is available for children who need to receive less than the total dose of 45 mg.
- If you weigh less than 60 kg, the recommended dose is 0.75 mg of WEZENLA per kg of body weight.
- If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of WEZENLA.
- If you weigh more than 100 kg, the recommended dose is 90 mg of WEZENLA.
- After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks.
How WEZENLA is administered
- WEZENLA is administered via subcutaneous injection. Initially, medical or nursing staff may administer WEZENLA to you.
- However, you and your doctor may decide that WEZENLA is injected by you. In that case, you will be trained on how to inject WEZENLA yourself.
- For instructions on how to inject WEZENLA, see "Instructions for use" at the end of this leaflet.
Consult your doctor if you have any questions about self-injecting.
If you use more WEZENLA than you should
If you have used or have been given too much WEZENLA, speak immediately with your doctor or pharmacist. Always carry the medication box with you, even if it is empty.
If you forget to use WEZENLA
If you forget a dose, speak with your doctor or pharmacist. Do not take a double dose to make up for the missed doses.
If you interrupt treatment with WEZENLA
Stopping WEZENLA is not hazardous. However, if you stop, your symptoms may return.
If you have any other questions 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.
- Allergic reactions (anaphylaxis) are rare in the population using ustekinumab (they can affect up to 1 in 10,000 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.
- The 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 have symptoms such as cough, difficulty breathing, and fever.
If you have a severe allergic reaction, your doctor may decide that you should not use WEZENLA again.
Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.
- Common colds, sore throats, and nasal 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 (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)
WEZENLA may affect your ability to fight infections. Some of them may be serious and caused by viruses, fungi, bacteria (including tuberculosis) or parasites, and include opportunistic infections that occur mainly in people with weakened immune systems (opportunistic infections). Cases of opportunistic brain infections (encephalitis, meningitis), lung infections, and eye infections have been reported in patients receiving ustekinumab treatment.
You should monitor signs of infection while using WEZENLA. These include:
- Fever, flu-like symptoms, night sweats, weight loss
- Feeling tired or difficulty breathing; persistent cough
- Having hot, red, and painful skin or having 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 chest infections, 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 disappear or reappears. Your doctor may decide that you should not use WEZENLA until the infection has cleared up. You should 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 serious 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
Rare side effects(they can affect up to 1 in 100 people):
- Dental infections
- Vaginal yeast infections
- Depression
- Blocked 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 10,000 people):
- Redness and skin peeling over 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 (see details below). By reporting side effects, you can contribute to providing more information about the safety of this medicine.
Spanish Medicines Agency:
5. Conservation of WEZENLA
- Maintain 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.
- If necessary, individual pre-filled syringes of WEZENLA can also be stored at room temperature up to 30°C for a maximum period of up to 30 days in their original packaging to protect them from light. Note the date when the pre-filled syringe is first removed from the refrigerator and the date when it should be discarded. 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 must not be stored again in the refrigerator. Discard the syringe if it is not used within 30 days of storage at room temperature or from the original expiration date, whichever occurs first.
- Do not shake the pre-filled syringes of WEZENLA. Prolonged vigorous shaking may damage the product.
Do not use this medication:
- After the expiration date appearing on the label and packaging after “CAD” or “EXP”. 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 WEZENLA and contents of the packaging”).
- If you know or suspect that you have been exposed to extreme temperatures (such as accidental overheating or freezing).
- If the product has been shaken vigorously.
WEZENLA is for single use only. Dispose of the product without use remaining in the syringe. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of WEZENLA
- The active ingredient is ustekinumab. Each pre-filled syringe contains 45mg of ustekinumab in 0.5ml or 90mg of ustekinumab in 1ml.
- The other components are L-histidine, L-histidine hydrochloride monohydrate, polisorbate 80, sucrose, and water for injection.
Appearance of WEZENLA and contents of the pack
WEZENLA is a clear to opalescent solution, colourless to pale yellow in colour. It is presented in a pack containing 1pre-filled syringe of 1ml of glass single-use syringe. Each pre-filled syringe contains 45mg of ustekinumab in 0.5ml or 90mg of ustekinumab in 1ml of solution for injection.
Marketing authorisation holder and manufacturer
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Marketing authorisation holder
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:
België/Belgique/Belgien s.a. Amgen n.v. Tél/Tel: +32 (0)2 7752711 | Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474 |
Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tél/Tel: +32 (0)2 7752711 | |
Ceská republika Amgen s.r.o. Tel: +420 221 773 500 | Magyarország Amgen Kft. Tel.: +36 1 35 44 700 |
Danmark Amgen, filial af Amgen AB, Sverige Tlf.: +45 39617500 | Malta Amgen S.r.l. Italy Tel: +39 02 6241121 |
Deutschland Amgen GmbH Tel: +49 89 1490960 | Nederland Amgen B.V. Tel: +31 (0)76 5732500 |
Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09553 | Norge Amgen AB Tlf: +47 23308000 |
Ελλάδα Amgen Ελλάς Φαρμακευτική Ε.Π.Ε. Τηλ: +30 210 3447000 | Österreich Amgen GmbH Tel: +43 (0)1 50 217 |
España Amgen S.A. Tel: +34 93 600 18 60 | Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000 |
France Amgen S.A.S. Tél: +33 (0)9 69363363 | Portugal Amgen Biofarmacêutica, Lda. Tel: +351 21 4220606 |
Hrvatska Amgen d.o.o. Tel: +385 (0)1 562 57 20 | România Amgen România SRL Tel: +4021 527 3000 |
Ireland Amgen Ireland Limited Tel: +353 1 8527400 | Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Amgen Slovakia s.r.o. Tel: +421 2321114 49 |
Italia Amgen S.r.l. Tel: +39 02 6241121 | Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 |
Kύπρος C.A. Papaellinas Ltd Τηλ: +357 22741 741 | Sverige Amgen AB Tel: +46 (0)8 6951100 |
Latvija Amgen Switzerland AG Rigas filiale Tel: +371257 25888 |
Last update of this leaflet:
Other sources of information
The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
INSTRUCTIONS FOR USE
These “Instructions for use” contain information on how to administer WEZENLA with a pre-filled syringe.
This pre-filled syringe administers WEZENLA by subcutaneous injection. See the leaflet for information on the medicine.
Parts of the pre-filled syringe | ||
Tip cap | ||
Plunger rod | ||
Needle guard clips | ||
Plunger stop | ||
Thumb grip | ||
Label | Body View window | |
Needle cap (needle inside) | ||
1 Important information you should know before injecting WEZENLA | |||
Dose:
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Using the WEZENLA pre-filled syringe:
- It is essential that you do not attempt to administer the injection unless you have received training for it from your doctor or a healthcare professional.
- In children aged 12years or older with psoriasis and a weight of 60kg or more, it is recommended that WEZENLA be administered by a parent or caregiver or under their supervision.
- Do notuse the pre-filled syringe if the box is damaged or if the seal is broken.
- Do notuse the pre-filled syringe after the expiry date shown on the label.
- Do notshake the pre-filled syringe.
- Do notremove the needle cap from the pre-filled syringe until you are ready to administer the injection.
- Do notuse the pre-filled syringe if it has been frozen.
- Do notuse the pre-filled syringe if it has been dropped onto a hard surface. Although it may not be visible to the naked eye, some part of the pre-filled syringe may have been damaged. Use a new pre-filled syringe if available and contact your doctor or healthcare professional.
2 Preparing for the injection of WEZENLA |
2a Remove the pre-filled syringe from the box by holding it by the body. |
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2b Wait 30minutes for the pre-filled syringe to reach room temperature. |
WAIT 30 minutes |
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2c Gather the objects needed for the injection and place them on a clean and well-lit surface. | ||
Alcohol wipe | ||
Swab | ||
Sharps container | Swab or gauze | |
•WEZENLA pre-filled syringe (at room temperature) | ||
•Sharps container | ||
•Alcohol wipe | ||
•Swab |
3 Preparing for the injection | ||
3a Inspect the medicine. It should be a clear to opalescent solution, colourless to pale yellow in colour. | ||
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3b Check the expiry date (EXP) and inspect the pre-filled syringe. | ||
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3c Inject in one of these places. | ||||
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3d Wash your hands thoroughly with soap and water. |
3e Clean the injection site with an alcohol wipe. |
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4 Injecting WEZENLA |
4a Pull the needle cap off while holding the syringe by the body. |
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4b Pinch the skin at the injection site before the injection. |
PINCH |
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4c Insert the needle into the pinched skin. |
INSERT |
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4d Press the plunger rod slowly downwards until it is completely between the needle guard clips. |
INJECT
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4e Maintain pressure on the plunger rod and withdraw the needle from the skin. |
WITHDRAW |
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If a second injection is needed… |
4f Repeat steps 2a-4e if a second injection is needed. |
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5 End of the injection and disposal of WEZENLA |
5a Dispose of the used syringe and needle cap in the sharps container. |
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5b Check the injection site. |
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You must dispose of any unused product that remains in the syringe. Medicines should not be disposed of by flushing them down the toilet or by throwing them away. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.
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