Emergency use of Remdesivir for the treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (Covid-19) in adult and children hospitalized with severe disease. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Dosage & Administration
Adults and pediatric patients ≥ 40 kg of weight: 200 mg IV as a loading dose on day 1, followed by 100 mg IV once daily for a total duration of 10 to 14 days.
Pediatric patients <40 kg of weight: 5 mg/kg IV as a single dose on day 1, followed by 2.5 mg/kg IV once daily for a total duration of 10 to 14 days.
Preparation and administration:
Remdesivir 100 mg vial: Each vial must be reconstituted with 19 ml of sterile water for injection in order to obtain a 5 mg/ml solution. The corresponding dose must be diluted with 100-250 ml of saline solution and must be administered over about 30 minutes or longer based on factors such as subject tolerance.
Stability of diluted solution is 4 hours at room temperature and 24 hours in the refrigerator.
Precautions must be taken during use of Remdesivir for severe renal & hepatic impairment.
Use in Pregnancy & Lactation
Pregnancy and contraception requirements: There are no data from the use of Remdesivir in pregnant women. The use of Remdesivir in pregnant woman is not recommended.
Breast-feeding: It is unknown whether Remdesivir/metabolites are excreted in human milk.
Fertility: No human data on the effect of Remdesivir on fertility are available.