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Remdesivir (Veklury) was the first drug approved by the FDA for treating the SARS-CoV-2 virus. It is indicated for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older who weigh at least 40 kg. The broad-spectrum antiviral is a nucleotide analog prodrug.
Full approval was preceded by the US FDA issuing an EUA (emergency use authorization) on May 1, 2020 to allow prescribing remdesivir for severe COVID-19 (confirmed or suspected) in hospitalized adults and children. Upon approval of remdesivir in adults and adolescents, the EUA was updated to maintain the ability for prescribers to treat pediatric patients weighing 3.5 kg to less than 40 kg or children younger than 12 years who weigh at least 3.5 kg
Remdesivir is an investigational drug being studied to treat coronavirus infection, also known as COVID-19. It has not been approved by the FDA for general use. However, the FDA is now allowing remdesivir to be used in human studies and for emergency use in certain hospitalized patients. More information should be provided by the doctor from either the Informed Consent form for a study or the FDA Fact Sheet for Patients and Parents/Caregivers for emergency use.
There is limited information known about the safety and effectiveness of using remdesivir to treat COVID-19. Some study results show that remdesivir may help some patients get better sooner. The information in this document reflects preliminary and emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of investigational drug data, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.
Why is this medication prescribed?
Remdesivir injection is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). Remdesivir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body.
How should this medicine be used?
Remdesivir comes as a solution (liquid) and as a powder to be mixed with liquid and infused (injected slowly) into a vein over 30 to 120 minutes by a doctor or nurse in a hospital. It is usually given once daily for 5 to 10 days. The length of your treatment depends on how well your body responds to the medication.
Remdesivir injection may cause serious reactions during and after the infusion of the medication. A doctor or nurse will monitor you carefully while you are receiving the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after the infusion: chills or shivering; nausea; vomiting; sweating; dizziness upon standing up; rash; wheezing or shortness of breath; abnormally fast or slow heartbeat; or swelling of the face, throat, tongue, lips, or eyes. Your doctor may need to slow down your infusion or stop your treatment if you experience these side effects.
Other uses for this medicine
The FDA has approved an Emergency Use Authorization (EUA) to allow children weighing 8 pounds (3.5 kg) to less than 88 pounds (40 kg) or children less than 12 years of age weighing at least 8 pounds (3.5 kg) who are hospitalized with severe COVID-19 to receive remdesivir.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before receiving remdesivir,
tell your doctor and pharmacist if you are allergic to remdesivir, any other medications, or any of the ingredients in remdesivir injection. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
Be sure to mention any of the following: chloroquine or hydroxychloroquine (Plaquenil). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had liver or kidney disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.