Restricted
For the treatment of COVID-19 in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen.
Central nervous system: headache (common ≥1/100 to <1/10))
Dermatologic: rash (Common≥1/100 to <1/10)
Gastrointestinal: nausea (Common≥1/100 to <1/10)
Hepatic: Transaminase elevations (very common: ≥1/10). Liver function tests should be performed prior to starting and daily while receiving remdesivir. Remdesivir should not be administered in patients with ALT ≥5x ULN at baseline and should be discontinued in patients who develop ALT ≥5x ULN during treatment or ALT elevation in the presence of symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase or INR. May be restarted when ALT<5x ULN in asymptomatic patients.
Renal: renal toxicity has been observed in animal studies and relevance in humans cannot be excluded. Contains cyclodextrin which may accumulate in renal failure.
Hypersensitivity: Hypersensitivity and infusion reactions (Rare ≥1/10,000 to <1/1000). Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering. Slower infusion rates with a maximum duration of 120 minutes can be considered to potentially prevent infusion reactions.
Cardiovascular: risk of QT prolongation has not been fully evaluated in humans,
Miscellaneous: Fever (5%), No human data on fertility is available. Animal trials did not demonstrate an impact in female rats. There is no human data in pregnant women. Do not use in pregnant women unless the benefits outweigh the risks. Remdesivir may be excreted in breast milk, consider discontinuing/abstaining from breast feeding while on therapy.
Intermittent IV Infusion: Prepare under aseptic conditions. Refer to preparation instructions in Vitalité Parenteral Drug Manual. Administer doses of 200 mg or 100 mg over 30-120 minutes. Slower infusion rates may prevent infusion related reactions. Flush line with at least 30 mL NS after remdesivir infusion is complete
Available Preparations:
Remdesivir 100 mg/vial POWDER for solution for infusion (5 mg/mL reconstituted)
Remdesivir SOLUTION 100 mg/20 mL (5 mg/mL)
Antimicrobial Class: Antiviral agent - Adenosine nucleotide analog prodrug.
Average serum half life:
Remdesivir: ~1 hour
GS-441524: 25.3 hours
GS-441524 intracellular: 40 hours