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Details for: BAMLANIVIMAB - Authorized By Interim Order / Autorisée par arrêté d'urgence - COVID-19

Company: ELI LILLY CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02508176 BAMLANIVIMAB BAMLANIVIMAB 700 MG / ML SOLUTION INTRAVENOUS

Summary Reports

Regulatory Decision Summary
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
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

Bamlanivimab is a medicine being studied for the treatment of COVID-19. Bamlanivimab may help limit the amount of virus in your body; this may help you get better faster. Bamlanivimab may be given if you or your child are 12 years of age or older who weigh at least 40 kg (kilograms) and are not already in the hospital. Bamlanivimab is only given to patients at high-risk of having the disease get worse. Your healthcare professional will decide if you or your child should take bamlanivimab.

What it does

COVID-19 is caused by a virus called a coronavirus. Bamlanivimab may help limit the amount of virus in your body, which may help you get better faster.

What the medicinal ingredient is

Medicinal ingredients: bamlanivimab

What the non-medicinal ingredients are

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, sucrose, water for injection

What dosage form it comes in

Bamlanivimab solution, 700 mg/20 mL (35 mg/mL)

Warnings and precautions

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

  • Have any allergies
  • Are pregnant or plan to become pregnant
  • Are breast-feeding a child
  • Have any serious illnesses
  • Are taking any medications (prescription, over-the-counter, vitamins, or herbal products)
  • Have reactions during or after the infusion. Symptoms of a possible allergic reaction include:
    • Changes to blood pressure or heart rate, low oxygen level in the blood, high temperature, shortness of breath, wheezing, swelling of the face, lips, tongue, or throat, rash/hives/itching, feeling sick or nauseous, sweating, shivering, muscle soreness, dizziness, headache

    Tell your doctor if you get any of these signs or symptoms.

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 bamlanivimab:

  • Bamlanivimab will be given to you by a healthcare professional through a vein (intravenous or IV) for at least 1 hour.

Usual Dose

Bamlanivimab is given once. The recommended dose is 700 mg.

Overdose

If you think you, or a person you are caring for, have taken too much bamlanivimab, 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

Possible side effects of bamlanivimab are:

  • Allergic reactions. Allergic reactions can happen during and after infusion with bamlanivimab. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever, chills, nausea, headache, shortness of breath, low blood pressure, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, and dizziness.

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 of bamlanivimab. Not a lot of people have been given bamlanivimab. Serious and unexpected side effects may happen. Bamlanivimab is still being studied so it is possible that all of the risks are not known at this time.

It is possible that bamlanivimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bamlanivimab 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.

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 bamlanivimab:

This leaflet was prepared by Eli Lilly Canada, Inc.

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