EVUSHELD 150 MG +150 MG INJECTABLE SOLUTION
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How to use EVUSHELD 150 MG +150 MG INJECTABLE SOLUTION
Introduction
Package Leaflet: Information for the User
EVUSHELD 150 mg + 150 mg solution for injection
tixagevimab + cilgavimab
This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- If you get any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the pack
- What is EVUSHELD and what is it used for
- What you need to know before you are given EVUSHELD
- How to use EVUSHELD
- Possible side effects
- Storage of EVUSHELD
- Contents of the pack and other information
1. What is EVUSHELD and what is it used for
EVUSHELD is made up of two active substances, tixagevimab and cilgavimab. Both are medicines called monoclonal antibodies. These antibodies are proteins that bind to a specific protein of the SARS-CoV-2 virus, the virus that causes COVID-19. By binding to this protein, they prevent the virus from entering human cells.
EVUSHELD is used for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents from 12 years of age and weighing at least 40 kg.
EVUSHELD is used to treat adults and adolescents, from 12 years of age and weighing at least 40 kg, with COVID-19 who:
- do not require supplemental oxygen to treat COVID-19, and
- are at higher risk of the disease becoming severe according to their doctor's assessment
2. What you need to know before you are given EVUSHELD
This medicine must not be given
- if you are allergicto tixagevimab, cilgavimab, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given EVUSHELD
- if you have a low number of platelets in your blood (which help your blood to clot), any bleeding problems, or are taking any medicine to prevent blood clots (an anticoagulant).
- if you have ever had a severe allergic reaction or breathing problems after being given EVUSHELD in the past.
COVID-19 is caused by different variants of the SARS-CoV-2 virus that change over time. EVUSHELD may be less effective at preventing COVID-19 caused by some variants than others. Contact your doctor immediately if you have symptoms of COVID-19. COVID-19 affects different people in different ways:
- the most common symptoms include fever, cough, tiredness, and loss of taste or smell;
- the most severe symptoms include difficulty breathing or shortness of breath, loss of speech or mobility, or confusion and chest pain.
Contact a doctor, pharmacist, or nurse, or seek medical attention immediately:
- if you notice any symptoms of a heart attack, such as:
- chest pain;
- shortness of breath;
- a general feeling of discomfort, illness, or unease;
- a feeling of dizziness or fainting.
- if you notice any signs of a severe allergic reaction, such as:
- difficulty breathing or swallowing;
- swelling of the face, lips, tongue, or throat;
- severe itching of the skin, with rash.
Children and adolescents
EVUSHELD must not be given to children under 12 years of age or weighing less than 40 kg.
Other medicines and EVUSHELD
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because it is not yet known if this medicine affects other medicines, or if it is affected by them.
Pregnancy and breastfeeding
Talk to your doctor or nurse if you are pregnant, think you may be pregnant, or plan to become pregnant.
- This is because there is not enough information to ensure that the medicine is safe to use during pregnancy.
- This medicine will only be given if the potential benefits of treatment outweigh the potential risks to the mother or unborn child.
Tell your doctor or nurse if you are breastfeeding.
- This is because it is not known if this medicine passes into breast milk, or what effects it may have on the baby or milk production.
- Your doctor will help you decide whether to continue breastfeeding or start treatment with this medicine.
Driving and using machines
It is unlikely that EVUSHELD will affect your ability to drive or use machines.
EVUSHELD contains polysorbate 80
This medicine contains 0.6 mg of polysorbate 80 in each vial of tixagevimab and in each vial of cilgavimab. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How EVUSHELD is given
The recommended dose for pre-exposure prophylaxis (prevention) is 300 milligrams (mg), given as two injections:
- 150 mg of tixagevimab
- 150 mg of cilgavimab
The recommended dose for the treatment of mild to moderate COVID-19 is 600 milligrams (mg), given as two injections:
- 300 mg of tixagevimab
- 300 mg of cilgavimab
EVUSHELD consists of two separate solutions, one containing tixagevimab and one containing cilgavimab. Your doctor or nurse will give you each injection into a different muscle, usually one into each gluteal muscle. The two injections will be given one after the other.
Your doctor or nurse will decide how long you should be clinically monitored after being given the medicine. This is in case you experience any side effects.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects
Common(may affect up to 1 in 10 people)
- hypersensitivity reaction (rash or redness with itching or hives)
- injection site reaction (pain, redness, itching, inflammation near the injection site)
Uncommon(may affect up to 1 in 100 people)
- injection-related reaction (examples include headache, chills, and redness, discomfort, or pain near the injection site)
Rare(may affect up to 1 in 1,000 people)
- severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness (anaphylaxis)
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of EVUSHELD
Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist, or nurse is responsible for the storage of this medicine and for disposing of any unused product. The following information is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP. The expiry date is the last day of the month stated.
Unopened vials:
- Store in a refrigerator (between 2 °C and 8 °C).
- Do not freeze.
- Do not shake.
- Keep in the original packaging to protect from light.
Prepared syringes should be used immediately. If necessary, prepared syringes can be stored for no more than 4 hours between 2 °C and 25 °C.
6. Contents of the pack and other information
Composition of EVUSHELD
The active substances are:
- tixagevimab – 150 mg in 1.5 ml of solution.
- cilgavimab – 150 mg in 1.5 ml of solution.
The other ingredients are histidine, histidine hydrochloride monohydrate, sucrose, polysorbate 80 (E 433), and water for injections.
Appearance and packaging
EVUSHELD contains two glass vials of solution for injection:
- Tixagevimab solution for injection (dark grey cap) is a clear to opalescent, colorless to slightly yellow solution.
- Cilgavimab solution for injection (white cap) is a clear to opalescent, colorless to slightly yellow solution.
Each pack of EVUSHELD contains 2 vials: 1 vial of tixagevimab and 1 vial of cilgavimab.
Marketing authorisation holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
You can ask for more information about this medicine from your local representative of the marketing authorisation holder:
België/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11 | Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 |
| Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11 |
Ceská republika AstraZeneca Czech Republic s.r.o. Tel.: +420 222 807 111 | Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500 |
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62 | Malta Associated Drug Co. Ltd Tel: +356 2277 8000 |
Deutschland AstraZeneca GmbH Tel: +49 40 809034100 | Nederland AstraZeneca BV Tel: +31 85 808 9900 |
Eesti AstraZeneca Tel: +372 6549 600 | Norge AstraZeneca AS Tlf: +47 21 00 64 00 |
Ελλáδα AstraZeneca A.E. Τηλ: +30 210 6871500 | Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0 |
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00 | Polska AstraZeneca Pharma Poland Sp. z o.o. Tel: +48 22 245 73 00 |
France AstraZeneca Tél: +33 1 41 29 40 00 | Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00 |
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000 | România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 |
Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100 | Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777 |
Italia AstraZeneca S.p.A. Tel: +39 02 00704500 | Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010 |
Κ?προς Αλ?κτωρ Φαρµακευτικ? Λτδ Τηλ: +357 22490305 | Sverige AstraZeneca AB Tel: +46 8 553 26 000 |
Latvija SIA AstraZeneca Latvija Tel: +371 67377100 |
Date of last revision of this leaflet:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
__________________________________________________________________________________________________________________________________
This information is intended for healthcare professionals only:
Administration
- This medicine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.
- Tixagevimab and cilgavimab should be inspected visually for particles and discoloration before administration. Both tixagevimab and cilgavimab are clear to opalescent, colorless to slightly yellow solutions. Discard the vials if the solution is cloudy, discolored, or visible particles are observed.
- Do not shake the vials.
- After initial puncture, if not used immediately, the medicine in the vial may be stored for 4 hours between 2 °C and 25 °C. In-use storage times and conditions are the responsibility of the user.
- Withdraw the required dose of tixagevimab into a syringe and withdraw the required dose of cilgavimab into a separate syringe. The two separate syringes should be administered by intramuscular injection into two different muscles, preferably into the gluteal muscles.
- An overfill is included in each vial to allow for the withdrawal of 1.5 ml. Discard any unused portion remaining in the vial.
- Prepared syringes should be administered immediately.
- If immediate administration is not possible, in-use storage times and conditions are the responsibility of the user and normally should not exceed 4 hours between 2 °C and 25 °C.
Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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