Black Box Warning is for Use of Remdesivir to Treat COVID-19. Remdesivir Must Be Administered by Intravenous (IV) Infusion.

Health care providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to remdesivir. See Sections 8 and 9 of the Full EUA Prescribing Information for reporting requirements.

• See the Full EUA Prescribing Information for complete dosage, administration, and preparation instructions.
• Remdesivir is available as a lyophilized powder and concentrated solution.
• The recommended dose for adults and pediatric patients weighing 40 kg and higher is a single loading dose of 200 mg on Day 1 followed by once-daily maintenance doses of 100 mg from Day 2.
• For pediatric patients weighing 3.5 kg to less than 40 kg, only use remdesivir for injection, 100 mg, lyophilized powder. The recommended dose for pediatric patients weighing 3.5 kg to less than 40 kg is a single loading dose of remdesivir 5 mg/kg on Day 1 followed by remdesivir 2.5 mg/kg once daily from Day 2 (see FULL EUA PRESCRIBING INFORMATION, SUBSECTION 2.3 RECOMMENDED DOSAGE IN PEDIATRIC PATIENTS).
• The optimal duration of treatment for COVID-19 is unknown.
• For patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), the recommended total treatment duration is 10 days.
• For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.
• Administer remdesivir via IV infusion over 30 to 120 minutes.

For information on clinical trials that are testing the use of remdesivir in COVID-19, please see www.clinicaltrials.gov.