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What is the pediatric dosing for remdesivir? Can the powder form of remdesivir be used in adults?

Comment by InpharmD Researcher

For pediatric patients ≥40 kg on invasive ventilation or ECMO, the dose of remdesivir is 200 mg IV on day 1, followed by 100 mg IV once daily for 9 days (or 4 days if not on ECMO). For pediatric patients 3.5 kg to <40 kg on on invasive ventilation or ECMO, a weight-based loading dose of 5 mg/kg IV should be given on day 1, followed by 2.5 mg/kg once daily for 9 days if on ECMO/invasive ventilation (or 4 days if not). The lyophilized powder can be used in adults (once reconstituted), as can the injection solution.
Background

Remdesivir dosing in pediatric patients is based upon physiologically-based (PBPK) modeling and simulation of pharmacokinetic data from healthy adult subjects.

For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), the dosage regimen is the same as the adult regimen of one loading dose of remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days (days 2 through 10) will be administered. [1-2]

For pediatric patients ≥40 kg not on invasive ventilation or ECMO, the dose of remdesivir is 200 mg IV (infused over 30 to 120 minutes) on day 1, followed by 100 mg IV once daily for 4 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e., up to a total of 10 days). [1-2]

For pediatric patients with body weight between 3.5 kg to <40 kg, use remdesivir for injection lyophilized powder only. A weight-based loading dose of 5 mg/kg IV (infused over 30 to 120 minutes) should be given on day 1, followed by 2.5 mg/kg once daily for 9 days if on ECMO/invasive ventilation (or 4 days if not). [1-2]

Remdesivir is not recommended in full0term neonates (≥7 days and ≤28 days old) with serum creatinine clearance ≥1 mg/dL or pediatric patients >28 days old with a eGFR <30 mL/min. [1-2]

Adults can use either the injection solution or lyophilized powder, but pediatric patients with body weight between 3.5 kg to <40 kg should only use the lyophilized powder. [1-2]

References:

[1] Food and Drug Administration. Remdesivir EUA Letter of Authorization. Available: https://www.fda.gov/media/137564/download. Published May 1, 2020. Accessed May 11, 2020.
[2] The Food and Drug Administration.Fact Sheet For Health Care Providers Emergency Use Authorization (EUA) Of Remdesivir. https://www.fda.gov/media/137566/download. Published May 1, 2020. Accessed May 19, 2020.