Adult Dosing

• 200 mg IV on Day 1 followed by 100 mg once daily. Treatment duration varies; generally 5 to 10 days based on specific patient needs and parameters.

Pediatric Dosing

Children: Below 12 years and Weight 3.5 Kg to 39.9 Kg:

• 5 mg/kg/dose on Day 1 followed by 2.5 mg/kg/dose once daily. Lyophilized powder only

• 5 days for patients not requiring invasive mechanical ventilation and/or ECMO. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days
• Total 10 days recommended for patients requiring invasive mechanical ventilation and/or ECMO.

Children: 12 years and above and Weight 40 Kg:

• 200 mg IV on Day 1, then 100 mg IV once daily, starting from Day 2.

• 5 days for patients not requiring invasive mechanical ventilation and/or ECMO. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days
• Total 10 days recommended for patients requiring invasive mechanical ventilation and/or ECMO.

[Outline]

• Adult Dosing
• Pediatric Dosing

• Patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection (COVID-19) and severe disease (oxygen saturation less than or qual to 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation)
• remdesivir is currently FDA-approved for hospitalized patients; it is approved for Emergency Use Authorization.

• Hypersensitivity.
• eGFR<30 mL/min.
• ALT > 10 times the upper limit of normal.

Renal Dose Adjustment

• No dosage adjustment is required; however, not recommended to use for patients with eGFR < 30 mL/min.

Hepatic Dose Adjustment

• No dosage adjustment is required; however not recommended to use for patients with ALT > 10 times the ULN.

• Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration.
• Use cautiously in patients with eGFR < 30 mL/min.
• Discontinuing if ALT levels increase 10 times the ULN.
• ALT elevation is accompanied by signs or symptoms of liver inflammation.

Pregnancy Category:NR

• Based on preliminary data, use in pregnant women should not be withheld if it is clinically needed.

Breastfeeding: It is not known if remdesivir passes into breast milk. There are no available data on the presence of remdesivir in human milk, the effects on the breastfed infant, or the effects on milk production.

• DERM: Rash
• GI: Nausea, liver enzymes
• GU: Acute kidney injury
• RESP: Respiratory failure
• MISC: Anaphylaxis, angioedema, infusion-related reactions, hypersensitivity, transaminase elevations

• Antiviral drug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
• Remdesivir and metabolites exposure-response relationships and the time course of pharmacodynamics response are unknown.
• Binding to human plasma proteins
• Remdesivir: 88-93.6%
• GS-441524: 2%
• GS-704277: 1%

• Mechanism of Action: Inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.
• Excreted mainly in urine:
• Remdesivir: 10%
• GS-441524: 49%
• GS-704277: 2.9%

• Excreted mainly in feces
• Remdesivir: Not detected
• GS-441524: 0.5%
• GS-704277: Not detected

• Half-life:
• Remdesivir: ~1 hr
• GS-441524: 27 hrs
• GS-704277: 1.3 hrs

US Trade Name(s)

• Veklury

US Availability

Veklury

• PWDR for INJ: Lyophilized powder in a vial of 100 mg
• INJ: 100 mg/20 mL (5 mg/mL)

[Outline]

Infectious Disease

Antiviral