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April 25, 2022 – Veklury® (remdesivir) is now indicated to treat patients as young as 28 days and weighing at least 3kg (7 pounds) who have positive results of direct SARS-CoV-2 viral testing.
- Veklury was previously approved for adults and for pediatric patients at least 12 years of age and weighing at least 40kg (88 pounds). It is now the first COVID-19 treatment FDA approved for children under 12 years of age. It formerly held emergency use authorization for this younger patient population.
- Per the prescribing information, Veklury should only be used to treat patients who are hospitalized with COVID-19, or who are not hospitalized but have mild-to-moderate COVID-19 at high risk for progression to severe COVID-19. It is given via intravenous infusion over the course of 30 minutes to two hours.
- Recommended dosing is:
- Adults and pediatric patients weighing at least 40kg: A single 200mg loading dose on Day 1 followed by once daily 100mg maintenance doses from Day 2.
- Pediatric patients at least 28 days old weighing 3kg to less than 40kg: A single loading dose of 5mg/kg of the patient’s body weight on Day 1 followed by once-daily maintenance doses of 2.5mg/kg from Day 2.
- The recommended total duration of treatment is:
- Non-hospitalized patients: 3 days.
- Hospitalized patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days, with potential to extend treatment duration to 10 days if the patient does not demonstrate clinical improvement.
- Hospitalized patients requiring invasive mechanical ventilation and/or ECMO: 10 days.