On May 1, the Food and Drug Administration (FDA) granted Emergency Use Authorization to the investigational drug remdesivir for the treatment of severe coronavirus disease 2019 (COVID-19) in hospitalized adults and children. The FDA defines COVID-19 as severe when a patient's oxygen saturation level is 94% or less on room air or when supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation is needed. This authorization follows early clinical trial results of remdesivir indicating that the drug can decrease the duration of serious COVID-19 illness.
Emergency Use Authorization status should not be confused with approval; remdesivir is an unapproved, investigational drug. However, remdesivir may be used while clinical trials to determine its safety and effectiveness are ongoing. Reasons for this include the serious and potentially fatal nature of the illness, the fact that there are no other treatment options, and the belief that the benefits of remdesivir outweigh the risks.
Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor. It was originally developed as a potential treatment for Ebola. In cell cultures and animal models it is effective against other coronaviruses, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
Two possible serious adverse effects of remdesivir have been identified: infusion reactions (hypotension, nausea, vomiting, diaphoresis, and shivering) and elevated liver enzymes. Clinically significant infusion reactions require immediate cessation of drug administration. Because elevated liver enzymes can also occur with COVID-19, it can be difficult to determine if these are an adverse effect of the drug. Hepatic testing should be done prior to starting remdesivir and throughout treatment. Because clinical trials are still underway, not all adverse effects have been identified. Nurses and other health care providers should report medication errors and serious adverse effects to the FDA MedWatch program at http://www.fda.gov/medwatch/report.htm and to Gilead Sciences at mailto:[email protected] within seven days of onset of the event.
Remdesivir requires reconstitution with normal saline using strict aseptic technique, as there is no preservative or bacteriostatic agent in the vial. Nurses should administer remdesivir as an IV infusion over 30 to 120 minutes. A loading dose is given on the first day of the 10-day regimen. Pediatric doses are based on body weight. After the infusion, the IV line should be flushed with at least 30 mL of normal saline. Specific information regarding reconstitution and dosing can be found in the Fact Sheet for Health Care Providers (http://www.fda.gov/media/137566/download). It is understood that the drug might need to be started prior to the patient being able to provide consent. Patients have the right to refuse remdesivir treatment.
To read the FDA's Emergency Use Authorization letter, go to http://www.fda.gov/media/137564/download.