Wezenla 45 mg solucion inyectable
Introduction
Patient Information Leaflet
WEZENLA 45mg injectable solution
ustekinumab
This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse 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 refer to it again.
-If you have any questions, consult your doctor or pharmacist.
-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.
1.What WEZENLA is 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 ineffective.
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 ineffective.
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, talk to 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.
Be aware of 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 developing 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 in combination with WEZENLA has not been studied. However, it may increase the likelihood of developing immune-related diseases.
- If you are receiving or have ever 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, talk to 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. Talk to 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 treatment with WEZENLA.
- WEZENLA may pass through the placenta to the fetus. If you received WEZENLA during pregnancy, your baby may be at increased risk of contracting an 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 receive injections and about follow-up consultations.
What amount of WEZENLA is administered
Your doctor will decide the amount of WEZENLA 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 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 through a vein in the 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, through a 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.
- 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 through a 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 WEZENLA (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.
- 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 and sore throats are frequent (they can affect up to 1 in 10 people)
- Chest infections are rare (they can affect up to 1 in 100 people)
- Cellulitis (inflammation of the tissues under the skin) is rare (it can affect up to 1 in 100 people)
- Herpes (a painful rash with blisters) are rare (they can affect up to 1 in 100 people)
WEZENLA 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 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.
Inform 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 could 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 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 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
- 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)
- Acne
Very rare side effects(they can affect up to 1 in 10,000 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)
Extremely rare side effects(they can affect up to 1 in 100,000 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's Pharmacovigilance System for Human Use:
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 vial in the outer packaging to protect it from light.
- If necessary, individual vials 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 box to protect them from light. Note the date when the vial is 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 vial has been stored at room temperature (up to a maximum of 30°C), it must not be stored again in the refrigerator. Discard the vial if it is not used within 30 days of storage at room temperature or from the original expiration date, whichever occurs first.
- After loading the solution into a disposable syringe, chemical and physical stability has been demonstrated in use for 24 hours between 15°C and 25°C. Do not store again in the refrigerator. From a microbiological point of view, the product must be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user.
- Do not shake the WEZENLA vials. Prolonged vigorous shaking can 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 you have been exposed to extreme temperatures (such as accidental heating or freezing).
- If the product has been shaken vigorously.
- If the seal is broken.
WEZENLA is for single use. Dispose of the unused product in the vial or syringe. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of 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 vial contains 45mg of ustekinumab in 0.5ml.
- 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, colourless to pale yellow solution for injection. It is presented in a pack containing 1vial of 2ml of glass single-use vial. Each vial contains 45mg of ustekinumab in 0.5ml of solution for injection.
Holder of marketing authorisation and responsible for manufacturing
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Holder of marketing authorisation
Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland
Responsible for manufacturing
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
You can request more information about this medicine by contacting the local representative of the holder of marketing authorisation:
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 Φαρμακευτικ? 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 |
K?προς 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 on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
Instructions for use
At the beginning of treatment, the healthcare professional will help you with your first injection. However, it is possible that you and your doctor may decide that you can administer WEZENLA yourself. In this case, they will teach you how to administer WEZENLA. Talk to your doctor if you have any doubts about the administration of injections.
- Do not mix WEZENLA with other injectable liquids.
- Do not shake the WEZENLA vials. The medicine may deteriorate if it is shaken vigorously. Do not use the medicine if it has been shaken vigorously.
1. Check the number of vials and prepare the materials:
•Take the vial(s) out of the refrigerator. Leave the vial to stand for half an hour. This will allow the liquid to reach a comfortable temperature for administration (room temperature).
Check the vial(s) to ensure that:
- the number of vials and the concentration are correct
-If the dose is 45mg or less, you will be given a vial of WEZENLA containing 45mg.
-If the dose is 90mg, you will be given two vials of WEZENLA containing 45mg each, and you will need to administer two injections. Choose two different injection sites (for example, one injection in the right thigh and the other injection in the left thigh), and administer the injections one immediately after the other. Use a new needle and syringe for each injection.
- it is the correct medicine
- it has not passed the expiry date
- the vial is not damaged and the cap is not broken
- the solution contained in the vial is clear to opalescent and colourless to pale yellow
- the solution has not changed colour or is not turbid and does not contain any foreign particles
- the solution is not frozen.
Children weighing less than 60kg need a dose less than 45mg. Make sure you know the correct amount (volume) to extract from the vial and the type of syringe you need for dosing. If you do not know the amount or the type of syringe needed, contact your healthcare professional for further instructions.
Gather everything you need and lay it out on a clean surface. This includes the syringe, needle, antiseptic wipes, a cotton ball or gauze, and a container for disposing of sharp objects (see figure1).
Figure1
2. Choose and prepare the injection site:
Choose the injection site (see figure2).
- WEZENLA is administered by subcutaneous injection.
- Some suitable injection sites are the upper thigh or the abdominal area, at least 5cm from the navel.
- As far as possible, do not use skin areas that show signs of psoriasis.
- If someone else is administering the injection, they can also choose the upper arm as the injection site.
Upper arm | |
Abdomen | |
Thigh |
The recommended injection sites are shown in grey.
Figure2
Prepare the injection site
- Wash your hands thoroughly with soap and water.
- Clean the skin at the injection site with an antiseptic wipe.
- Do not touch this area again before administering the injection.
3. Prepare the dose:
- Remove the cap that covers the top of the vial (see figure3).
Figure3
- Do not remove the stopper.
- Clean the stopper with an alcohol-soaked cotton ball.
- Place the vial on a flat surface.
- Take the syringe and remove the needle cap.
- Do not touch the needle and prevent it from coming into contact with other objects.
- Pierce the rubber stopper with the needle.
- Turn the vial and syringe over and push the plunger to fill the syringe with the amount of liquid indicated by your doctor.
- It is essential that the needle remains in the liquid at all times. This prevents air bubbles from forming in the syringe (see figure4).
Figure4
- Remove the needle from the vial.
- Hold the syringe with the needle upwards to check if there are any air bubbles in it.
- If there are air bubbles, gently tap the side of the syringe until the bubbles rise to the top (see figure5).
Figure5
- Then push the plunger until all the air is out (but no liquid).
- Do not lean the syringe against anything and prevent the needle from coming into contact with other objects.
4. Administer the dose:
- Pinch the cleaned skin gently with your thumb and index finger, without squeezing. Insert the needle into the skin fold at an angle of 45degrees.
- Push the plunger slowly and steadily until the top of the syringe is reached to inject all the liquid. Do this slowly and steadily, keeping the skin fold pinched gently.
- When you have pushed the plunger to the top, remove the needle and release the skin fold.
5. After the injection:
- Press the injection site with an antiseptic wipe for a few seconds after the injection.
- A small amount of blood or liquid may appear at the injection site. This is normal.
- You can press the injection site with a cotton ball or gauze and hold it for 10seconds.
- Do not rub the skin at the injection site. You can cover the injection site with a bandage, if necessary.
6. Disposal:
- The used syringes and needles must be disposed of in a puncture-resistant container, similar to a sharp object container. For your safety and health and for the safety of others, never reuse the needles and syringes. Dispose of your sharp object container according to local regulations.
- The empty vials, antiseptic wipes, and other materials can be disposed of in the trash.
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