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Details for: CASIRIVIMAB AND IMDEVIMAB - COVID-19

Company: HOFFMANN-LA ROCHE LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02516691CASIRIVIMAB AND IMDEVIMABCASIRIVIMAB; IMDEVIMAB300 MG / 2.5 ML; 300 MG / 2.5MLSOLUTIONINTRAVENOUS
02516705CASIRIVIMAB AND IMDEVIMABCASIRIVIMAB; IMDEVIMAB1332 MG / 11.1 ML; 1332 MG / 11.1 MLSOLUTIONINTRAVENOUS

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

Casirivimab and imdevimab are medicines being studied together to prevent worsening of COVID-19. They may help limit the amount of the COVID-19 causing virus in your body. Casirivimab and imdevimab may be given if you or your child are 12 years of age or older and weigh at least 40 kg (kilograms) and are not already in the hospital. Casirivimab and imdevimab are only given to patients at high‐risk of being hospitalized or dying due to COVID-19. Your healthcare professional will decide if you or your child should take casirivimab and imdevimab.

  • Casirivimab and imdevimab are not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who are already on oxygen therapy due to other conditions and require a higher rate of oxygen therapy because of COVID-19.

Casirivimab and imdevimab are not for use in treating patients who are in the hospital due to COVID-19. Treatments such as casirivimab and imdevimab may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

What it does

Casirivimab and imdevimab are each a type of protein called "monoclonal antibodies". These antibodies work by attaching to specific targets on the virus that is causing your infection.

Casirivimab and imdevimab attach to the spike protein of the coronavirus, preventing the virus from entering and infecting the cells within your body. This may prevent you from needing to be hospitalized due to your infection getting worse.

When it should not be used

Do not use casirivimab and imdevimab if:

  • you are allergic to casirivimab, imdevimab, or any of the other non-medicinal ingredients in the medicine.
What the medicinal ingredient is

Medicinal ingredients: casirivimab, imdevimab

What the non-medicinal ingredients are

Non-medicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for Injection

What dosage form it comes in

Casirivimab and imdevimab are available in cartons that contain either two single-use 6mL vials or two single-use 20mL vials per package.

Concentrate for solution for infusion. Each vial contains either:

  • 1332 mg casirivimab / 11.1 mL (120 mg/mL) and 1332 mg imdevimab / 11.1 mL (120 mg/mL)
    or
  • 300 mg casirivimab / 2.5 mL (120 mg/mL) and 300 mg imdevimab / 2.5 mL (120 mg/mL).
Warnings and precautions

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

  • have any allergies
  • have a serious illness
  • have sudden, severe worsening of COVID-19 symptoms
  • have received other monoclonal antibodies for the treatment of COVID-19
  • are receiving or plan to receive a COVID-19 vaccine

Pregnancy

  • tell your health professional if you are pregnant or if you plan to become pregnant
    • There is not enough information to be sure that casirivimab and imdevimab are safe for use in pregnancy.
    • Casirivimab and imdevimab will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child.

Breast-feeding

  • are breast-feeding or plan to breast-feed
    • It is not yet known whether casirivimab and imdevimab or the COVID-19 virus pass into human breast milk, or what the effects might be on the baby or milk production.
    • Your health professional will help you decide whether to continue breast-feeding or to start treatment with casirivimab and imdevimab.
    • You will need to consider the potential benefits of treatment for you, compared with the health benefits and risks of breast-feeding for your baby

Driving and using machines

  • Casirivimab and imdevimab are not expected to have any effect on your ability to drive and use machines.
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 casirivimab and imdevimab:

  • Casirivimab and imdevimab must be administered together by intravenous infusion (IV) - a method of putting the medicine directly into the bloodstream through a vein.
    • Casirivimab and imdevimab will be given to you by a healthcare professional for at least 1 hour.
    • Your healthcare professional will monitor you carefully during the infusion and for 1 hour after the infusion.

Usual Dose:

Casirivimab and imdevimab are given once. The recommended dose is 1200 milligrams (mg) of casirivimab and 1200 mg of imdevimab given together.

Overdose:

If you think you, or a person you are caring for, have taken too much casirivimab and imdevimab, 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

What are possible side effects from using casirivimab and imdevimab?

  • Allergic reactions or reactions following the infusion. Symptoms can include but are not limited to:
    • fever
    • chills
    • stomach pain or feeling sick (nausea and vomiting)
    • headache
    • altered mental status
    • difficulty breathing
    • chest tightness
    • abdominal pain
    • fall or increase in blood pressure
    • red face or swelling of the face
    • throat irritation
    • rash with hives
    • itching or an itchy rash
    • muscle pain
    • light-headedness
    • uneven heart-beat
    • low oxygen in blood
    • increased sweating
  • Worsening symptoms after treatment: You may experience new or worsening symptoms after infusion, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these occur, contact your healthcare provider or seek immediate medical attention as some of these events have required hospitalization. It is unknown if these events are related to treatment or are due to the progression of COVID-19.
  • The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

These are not all the possible side effects you may have when taking casirivimab and imdevimab. 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.

It is possible that casirivimab and imdevimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, casirivimab and imdevimab may reduce your 'body's immune response to a vaccine for SARS-CoV-2.

Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.

If you experience any side effects not listed here, tell your healthcare professional.

How to store

Store in a refrigerator at 2°C to 8°C in the original carton to protect from light.

Do not freeze. Do not shake.

Keep this medicine out of reach and sight of children.

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 casirivimab and imdevimab:

This leaflet was prepared by Hoffmann-La Roche AG.

©Copyright 2021, Hoffmann-La Roche Limited

Last Revised: June 9, 2021

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