FDA approved Veklury (remdesivir) for COVID-19 in Adults and Pediatric PatientsFDA approved Veklury to treat COVID-19 in adults and children.

Veklury is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleotide analog RNA polymerase inhibitor. It works by inhibiting viral RNA polymerase, thereby reducing viral replication.

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are: - Hospitalized, or - Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

- **Testing:** Before starting Veklury and during treatment as clinically appropriate, perform hepatic laboratory testing. Assess prothrombin time before starting and monitor as clinically appropriate. - **Recommended dosage for adults and pediatric patients weighing at least 40 kg:** Single loading dose of 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2, via intravenous infusion. - **Pediatric patients (birth to less than 18 years) weighing 1.5 kg to less than 40 kg:** Dosage is weight-based. Refer to Table 1 in the full prescribing information. - **Hospitalized patients:** Initiate treatment as soon as possible after diagnosis of symptomatic COVID-19. For those requiring invasive mechanical ventilation and/or ECMO, total duration is 10 days. For those not requiring such support, duration is 5 days; may extend up to 10 days if no clinical improvement. - **Non-hospitalized patients:** Initiate as soon as possible after diagnosis and within 7 days of symptom onset. Total duration is 3 days. - **Renal impairment:** No dosage adjustment recommended in any degree of renal impairment, including dialysis. - **Administration:** Administer via IV infusion over 30 to 120 minutes. Veklury must be reconstituted with Sterile Water for Injection and diluted with 0.9% sodium chloride injection. It contains no preservative.

Trial data not available in label.

- Veklury may only be administered in settings where healthcare providers have immediate access to medications to treat severe infusion or hypersensitivity reactions, such as anaphylaxis, and the ability to activate the emergency medical system (EMS). - Hepatic laboratory testing and prothrombin time monitoring are recommended before and during treatment. - No contraindications are listed in the label.

Veklury is an antiviral treatment for COVID-19 in both hospitalized and non-hospitalized patients at high risk for progression. It is administered intravenously and requires monitoring of hepatic function and prothrombin time. It should be initiated as soon as possible after diagnosis, with duration depending on hospitalization status and clinical response.