Veklury (remdesivir)

What is Veklury (remdesivir) for?

Veklury (remdesivir) is an antiviral drug indicated for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen, i.e. the patients with severe disease.^[1]

How does Veklury (remdesivir) work?

Veklury (remdesivir) is a direct acting antiviral drug that functions as a nucleoside analogue.^[1,2] Nucleoside analogues are designed to closely resemble the naturally occurring nucleoside adenine, one of the essential building blocks of RNA, which carries the virus’ genetic information. When these analogues are present in the cell, the viral replication system may use them as a building block in the making of more virus particles.^[2]

Nucleoside analogues work by blocking the action of RNA polymerase, which is one of the key enzymes needed by the virus to replicate its genetic information. Hereby they prevent the virus from multiplying and infecting more cells in the body.^[2]

Velkury (remdesivir) functions as a “prodrug”, which means that upon administration it is not functional yet; once it is inside the body it is converted into its active form via a sequence of steps.^[2]

Where has Veklury (remdesivir) been approved?

Veklury (remdesivir) was approved for the treatment of adults and adolescents from 12 years of age with severe COVID-19 who require supplemental oxygen by:

• Pharmaceuticals and Medical Devices Agency (PMDA), Japan, May 7, 2020.^[3]
• The European Medicines Agency (EMA) on July 3, 2020, which granted a conditional marketing authorisation.^[5]
• Therapeutic Goods Administration (TGA), Australia on July 10, 2020.^[7]
• Health Canada on July 28, 2020.^[8]
• The Food and Drug Administration (FDA), USA, on October 22, 2020.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Veklury (remdesivir) taken?

The standard dosage is:^[1,6]

• 200 mg infusion on the first day,
• Followed by 100 mg infusion once daily for at least 4 days and no more than 9 days.

Veklury (remdesivir) is administered as an intravenous infusion. Its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate.

Warning: Veklury (remdesivir) is authorized only for treatment under the care or consultation of a licensed clinician. Patients should be monitored closely during the course of treatment.

Complete information about Veklury (remdesivir) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known adverse reactions or side effects of Veklury (remdesivir)?

Note: Veklury (remesidivir) is recommended for an emergency use authorisation, meaning that data are still being collected, and further studies are being performed to evaluate safety data and possible adverse reactions.

Common adverse reactions

The most common adverse reactions ( ≥20% of patients) listed in the prescribing information include^[1,6]:

• Increased blood creatinine
• Increased blood glucose levels
• Increased serum aminotransferase levels
• Infusion-related reactions
• Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^[1,6]:

• Acute respiratory failure
• Hypotension
• Viral pneumonia
• Acute kidney injury

These are not the complete adverse reactions: Veklury (remdesivir) is still being studied.

Use in specific populations

It is yet unknown if remdesivir will affect or impact a fetus or pregnancy. Please consult with your doctor if you are pregnant or planning to become pregnant.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. FDA Fact sheet for health care providers, emergency use authorization (EUA) of remdesivir
FDA, July 10, 2020

2. Remdesivir: A Review of Its Discovery and Development Leading to Emergency Use Authorization for Treatment of COVID-19
R. Eastman, ACS Central Science, May 27 2020

3. Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19
Gilead press release, May 7, 2020

4. FDA Approves First Treatment for COVID-19 Gilead, Last checked July 15 2020

5. First COVID-19 treatment recommended for EU authorisation Share
EMA press release, June 25, 2020

6. Remdesivir for the Treatment of Covid-19 — Preliminary Report
J. Beigel, New England Journal of Medicine, May 22, 2020

7. Veklury (remdesivir)
TGA, Jul 2020

8. Health Canada Grants Marketing Authorization with Conditions (NOC/c) for Gilead’s Veklury® (Remdesivir) for the Treatment of Coronavirus Disease 2019 (COVID-19)
Newswire.ca, Jul 2020