For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalized with moderate to severe disease.
Remdesivir for Injection 100 mg/vial
Lyophilized Powder for Injection for IV Infusion
Remdesivir for injection, 100 mg, is a sterile, preservative-free lyophilized powder that is to be reconstituted with 19 mL of Sterile Water for Injection and diluted into 0.9% saline prior to administration by intravenous infusion. Remdesivir for injection, 100 mg, is supplied in a single-dose clear glass vial. The appearance of the lyophilized powder is white to off-white to yellow.
The inactive ingredients are sulfobutylether-β-cyclodextrin sodium salt (SBECD), Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment. Remdesivir for injection, 100 mg, contains 3 g SBECD.
The optimal dosing and duration of treatment are unknown. The suggested dose and duration may be updated as data from clinical trials become available.
Adult and pediatric patients (>28 days old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of remdesivir.
Hepatic laboratory testing should be performed in all patients before starting remdesivir and daily while receiving remdesivir.
Remdesivir should be administered via intravenous (IV) infusion only. Do not administer as an intramuscular (IM) injection.
The dose of the drug for adults should be a single dose of 200 mg infused intravenously over 30-120 minutes on day 1 followed by a once-daily maintenance dose of 100 mg, infused intravenously over 30-120 minutes for 4 days.
Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 mL 0.9% saline over 30 to 120 minutes [For further information see Dosage and Administration].
Extension of administration of the drug beyond 5 days to 10 days is not recommended.
All adult patients must have creatinine clearance determined before dosing [For further information see Dosage and Administration].
Hepatic laboratory testing should be performed in all patients before starting remdesivir and daily while receiving remdesivir dosing [For further information see Dosage and Administration].
Dosing in pediatric patients is based upon physiologically-based (PBPK) modeling and simulation of pharmacokinetic data from healthy adult subjects. The recommended pediatric dose for pediatric patients weighing between 3.5 kg and <40 kg should be calculated using the mg/kg dose according to the patient’s weight [For further information see Dosage and Administration];
The dose of the drug for pediatric patients weighing more than 40 kg should be a single dose of 200 mg infused intravenously over 30-120 minutes on day 1 followed by a once-daily maintenance dose of 100 mg, infused intravenously over 30-120 minutes for 4 days.
The dose for pediatric patients with bodyweight between 3.5 kg and less than 40 kg should be a single dose of 5 mg/kg infused intravenously over 30-120 minutes on day 1 followed by a once-daily maintenance dose of 2.5 mg/kg, infused intravenously over 30-120 minutes for 4 days.
Extension of administration of the drug beyond 5 days to 10 days is not recommended.
Pediatric patients (>28 days old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing [For further information see Dosage and Administration].
COVID-19: coronavirus disease 2019