Language selection

Search

Details for: EVUSHELD - COVID-19

Company: ASTRAZENECA CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02526271EVUSHELDCILGAVIMAB; TIXAGEVIMAB150 MG / 1.5 ML; 150 MG / 1.5 MLSOLUTIONINTRAMUSCULAR

Summary Reports

Regulatory Decision Summary
Product Monograph

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for
  • EVUSHELD is used for the pre-exposure prophylaxis (prevention) of Coronavirus Disease 2019 (COVID-19) illness in adults and adolescents (aged 12 years and older weighing at least 40 kg) who:
    • have a weaker immune system and are unlikely to be protected by a COVID-19 vaccine
    • or when vaccination is not recommended.

EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

What it does

EVUSHELD contains the active substances tixagevimab and cilgavimab. Tixagevimab and cilgavimab are types of protein called ‘monoclonal antibodies’. EVUSHELD work specifically against the SARS-CoV-2 virus (the virus that causes COVID-19 illness) by preventing the virus from infecting healthy cells in your body. This can help prevent you from getting COVID-19 illness.

When it should not be used

Do not use EVUSHELD if:

  • if you are allergic to tixagevimab, cilgavimab or any of the other ingredients of this medicine (see What are the ingredients in EVUSHELD).
What the medicinal ingredient is

Medicinal ingredients: tixagevimab and cilgavimab

What the non-medicinal ingredients are

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose and water.

What dosage form it comes in

A carton containing two clear glass vials:

  • 1 vial of tixagevimab (100 mg/mL) solution for injection (dark grey vial cap)
  • 1 vial of cilgavimab (100 mg/mL) solution for injection (white vial cap)

Both solutions are a clear to opalescent, colourless to slightly yellow solution.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EVUSHELD. Talk about any health conditions or problems you may have, including if you:

  • have low numbers of blood platelets (which help blood clotting), a bleeding disorder or are taking an anticoagulant medicine (to prevent blood clots).
  • are pregnant, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before receiving this medicine. There is not enough information to be sure that EVUSHELD is safe for use in pregnancy. EVUSHELD will only be given if the potential benefits of use outweigh the potential risks to you and your unborn child.
  • are breast-feeding, ask your healthcare professional for advice before receiving this medicine. It is unknown if EVUSHELD or the COVID-19 virus pass into human breast milk. You will need to consider the potential benefits of use for you, compared with the health benefits and risks of breast-feeding for your baby.
  • have a history of severe allergic reaction to this drug.
  • have had a heart attack or stroke, have other heart problems, or are at high-risk of cardiac (heart) events.

Serious allergic reaction
Tell your healthcare professional or seek medical help right away if you notice any signs of serious allergic reaction during or following administration of EVUSHELD including: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin, with a red rash or raised bumps.

Other warnings you should know about:
EVUSHELD should not be given to children below 12 years of age or weighing less than 40 kg.

Interactions with this medication

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Proper use of this medication

How to take EVUSHELD:

EVUSHELD will be given to you by a healthcare professional as two intramuscular injections, usually one into each of your buttocks.

Usual Dose:

EVUSHELD consists of two medicines, tixagevimab and cilgavimab. You will receive 2 injections one after the other.

The recommended dose for pre-exposure prophylaxis (prevention) of COVID-19 is 300 milligrams (mg) given as two 1.5 mL injections:

  • 150 mg of tixagevimab
  • 150 mg of cilgavimab

The recommended dose for pre-exposure prophylaxis (prevention) of some variants of COVID- 19 is 600 milligrams (mg), given as two 3.0 mL injections:

  • 300 mg of tixagevimab
  • 300 mg of cilgavimab

Your healthcare professional will decide which dose you need to receive.

Overdose:

If you think you, or a person you are caring for, have taken too much EVUSHELD, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Side effects and what to do about them

These are not all the possible side effects you may have when taking EVUSHELD. If you experience any side effects not listed here, tell your healthcare professional.

Allergic reactions may be serious and occur during or following administration of monoclonal antibodies (see Serious allergic reaction above).

A higher percentage of people who received EVUSHELD compared to people who did not receive EVUSHELD reported serious cardiac adverse events in a clinical trial. It is not known if these events are related to EVUSHELD or underlying medical conditions. Contact your healthcare professional or get medical help right away if you get any symptoms of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck, back, stomach or jaw, as well as shortness of breath, feeling tired or weak (fatigue), feeling sick (nausea), or swelling in your ankles or lower legs.

If you notice any side effects, please tell your healthcare professional right away:

Common: may affect up to 1 in 10 people

  • hypersensitivity reaction (rash or hives - an itchy red rash or raised bumps)
  • injection site reaction (pain, redness, itching, swelling where the injection was given)

Uncommon: may affect up to 1 in 100 people

  • injection related reaction (examples of these include headache, chills and redness, discomfort or soreness near where the injection was given)

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

How to store

The following information about storage, expiry and use and handling is intended for the healthcare professional:

  • Keep out of reach and sight of children.
  • Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2°C to 8°C).
  • Do not freeze. Do not shake.
  • Store in the original package in order to protect from light.
  • Prepared syringes should be used immediately. If necessary, store the prepared syringes for no more than 4 hours either: at 2°C to 8°C, or at room temperature up to 25°C.
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about EVUSHELD:

This leaflet was prepared by AstraZeneca Canada Inc., Mississauga, Ontario L4Y 1M4

EVUSHELD™ is a trademark of AstraZeneca UK Ltd., used under license by AstraZeneca Canada Inc. The AstraZeneca logo is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

© AstraZeneca 2022

Last Revised: April 14, 2022

Report a problem on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, please contact us.

Date modified: