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 / 20 ML||SOLUTION||INTRAVENOUS|
Regulatory Decision Summary
Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Public Release of Clinical Information - Bamlanivimab
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 the COVID-19 causing 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 and 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,
Tell your doctor if you get any of these signs or symptoms.
- Have sudden, severe worsening in COVID-19 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.
Bamlanivimab is given once. The recommended dose is 700 mg.
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.
- 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 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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
If you want more information about bamlanivimab:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.
This leaflet was prepared by Eli Lilly Canada, Inc.
Last Revised: April 14, 2021
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