Details for: VEKLURY - COVID-19
Company: GILEAD SCIENCES CANADA INC
|DIN||DIN name||Active Ingredient(s)||Strength||Dosage Form||Route of Administration|
|02502143||VEKLURY||REMDESIVIR||100 MG / VIAL||POWDER FOR SOLUTION||INTRAVENOUS|
Regulatory Decision Summary
Summary Safety Review - Veklury (remdesivir) - Assessing the Potential Risks of Acute Kidney Injury (AKI) and Acute Renal Failure (ARF)
Public Release of Clinical Information - Veklury
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
The active substance of VEKLURY is remdesivir. It is an antiviral medicine for treating coronavirus 2019 (COVID-19). VEKLURY will be given to people with COVID-19. It is suitable for:
- hospitalized adults and adolescents (aged 12 to less than 18 years who weigh 40 kg or more) who have pneumonia, and need extra oxygen to help them breathe;
- non-hospitalized adults with positive SARS-CoV-2 test results, and who are at high risk for progression to severe COVID-19, including being hospitalized and dying.
For the following indications, VEKLURY (remdesivir) has been approved with conditions
(NOC/c). This means it has passed Health Canada’s review and can be bought and sold in
Canada, but the manufacturer has agreed to complete more studies to make sure the drug
works the way it should. For more information, talk to your healthcare professional.
VEKLURY is indicated for:
- the treatment of COVID-19 in:
- hospitalized adults and adolescents (aged 12 to less than 18 years who weigh at least 40 kg) with pneumonia requiring supplemental oxygen;
- non-hospitalized adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization and death.
What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.
What it does
COVID-19 is caused by a virus called a coronavirus. VEKLURY stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection and may help you get better faster.
When it should not be used
Do not use VEKLURY if:
- You are allergic to remdesivir or any of the other ingredients of this medicine (read What the medicinal ingredient is or What the non-medicinal ingredients are below).
What the medicinal ingredient is
Medicinal ingredients: remdesivir. Each vial contains 100 mg.
What the non-medicinal ingredients are
Non-medicinal ingredients: betadex sulfobutyl ether sodium, hydrochloric acid and sodium hydroxide.
What dosage form it comes in
VEKLURY Powder for solution for infusion is a white to off-white to yellow powder, to be reconstituted and then diluted into sodium chloride solution prior to administration by intravenous infusion. It is supplied in a single-use clear glass vial.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VEKLURY. Talk about any health conditions or problems you may have, including if you:
- Have liver problems. Some people developed increased liver enzymes when given VEKLURY. Your doctor will do blood tests before starting treatment to check whether you can be given it safely.
- Have kidney problems. Some people with severe kidney problems may not be given this medicine. Your doctor will do blood tests to check whether you can be given it safely.
- Have any reactions following the infusion. VEKLURY can cause allergic reactions or reactions following the infusion. Symptoms can include:
- Changes to blood pressure or heart rate
- Low oxygen level in blood
- High temperature
- Shortness of breath, wheezing
- Swelling of the face, lips, tongue or throat (angioedema)
- Feeling sick (nausea)
Your healthcare professional will monitor you for allergic reactions or reactions during and after
treatment with VEKLURY.
Other warnings you should know about:
Blood tests before and during treatment
If you are prescribed VEKLURY, you will be given blood tests before treatment starts. Patients being treated with VEKLURY will have blood tests during their treatment as determined by their healthcare provider. These tests are to check for kidney, bleeding or liver problems. VEKLURY will be stopped if your kidney or liver show signs of damage during treatment. See Side effects and what to do about them below.
If you are pregnant or plan to become pregnant:
Tell your doctor or nurse if you are pregnant, or if you might be. There is not enough information to be sure that VEKLURY is safe for use in pregnancy. VEKLURY will only be given if the potential benefits of treatment outweigh the potential risks to the mother and the unborn child. You must use effective contraception while having VEKLURY treatment.
If you are breast-feeding or plan to breast-feed:
Tell your doctor or nurse if you are breast-feeding. It is not yet known whether VEKLURY or the COVID-19 virus pass into human breast milk, or what the effects might be on the baby or milk production. Your doctor will help you decide whether to continue breast-feeding or to start treatment with VEKLURY. 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.
Interactions with this medication
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Do not take chloroquine or hydroxychloroquine at the same time as VEKLURY.
Certain medicines e.g. midazolam should be taken at least 2 hours after VEKLURY as VEKLURY can affect the way they work.
VEKLURY may affect the way certain medicines (e.g. theophylline or midazolam) work.
It is not yet known if VEKLURY affects other medicines or is affected by them. Your healthcare team will monitor you for signs of medicines affecting each other.
Proper use of this medication
How to take VEKLURY:
VEKLURY will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) lasting 30 to 120 minutes, once a day. You will be closely monitored during your treatment.
The recommended dose is:
- a single starting dose of 200 mg on day 1
- then daily doses of 100 mg starting on day 2.
The recommended course of treatment:
- If you are admitted to the hospital, you will be given VEKLURY every day for at least 5 days. Your doctor may extend the treatment up to a total of 10 days.
- If you are not hospitalized, and you are at high risk of COVID-19 disease progression, including being hospitalized, you will be given VEKLURY every day for 3 days and within 7 days of showing symptoms.
If you have missed a dose, tell your nurse or doctor straight away. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking VEKLURY. If you
experience any side effects not listed here, contact your healthcare professional.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects
(these may affect more than 1 in 10 patients)
- Blood tests may show an increase in liver enzymes, called transaminases.
Common side effects
(these may affect up to 1 in 10 patients)
- Feeling sick (nausea)
|Symptom / effect||Talk to your healthcare professional Only if severe||Talk to your healthcare professional In all cases||Stop taking drug and get immediate medical help|
(These may affect up to 1 in 1000 patients)
reactions or reactions following
|Slower than normal heartbeat
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
- Before use, store below 30 °C.
- Once reconstituted, VEKLURY should be diluted immediately.
- Once diluted, VEKLURY should be used immediately. If necessary, bags of diluted solution can be stored for up to 4 hours at below 25°C, or for up to 24 hours in a refrigerator. Do not allow more than 24 hours between dilution and administration.
Do not use this medicine if you see particles in the vial, or if the solution does not appear
colorless to yellow.
Keep 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:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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 VEKLURY:
- 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.gilead.ca, or by calling 1-866-207-4267.
This leaflet was prepared by Gilead Sciences Canada, Inc.
Date of Preparation: April 22, 2022
Gilead Sciences, Inc.
Foster City, CA 94404
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
VEKLURY® is a trademark of Gilead Sciences, Inc. or its related companies.
All other marks referenced herein are the property of their respective owners.
© 2021 Gilead Sciences, Inc. All rights reserved.
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