Sign Out
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Hypersensitivity including infusion-related and anaphylactic reactions: Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed during and following administration of Remdesivir. 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 infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of Remdesivir and initiate appropriate treatment.
Increased Risk of Transaminase Elevations: Transaminase elevations have been observed in the Remdesivir clinical trials, including in healthy volunteers and patients with COVID-19. Liver function should be determined in all patients prior to starting Remdesivir and should be monitored while receiving it as clinically appropriate. No clinical studies with Remdesivir have been conducted in patients with hepatic impairment. Remdesivir should only be used in patients with hepatic impairment if the potential benefit outweighs the potential risk.
Remdesivir should not be initiated in patients with Alanine Aminotransferase (ALT) ≥5 times the upper limit of normal at baseline.
Remdesivir should be discontinued in patients who develop: ALT ≥5 times the upper limit of normal during treatment with Remdesivir. It may be restarted when ALT is <5 times the upper limit of normal. OR; ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR).
Renal impairment: In animal studies on rats and monkeys, severe renal toxicity was observed. The mechanism of this renal toxicity is not fully understood. A relevance for humans cannot be excluded. All patients should have eGFR determined prior to starting Remdesivir and while receiving it as clinically appropriate. Remdesivir should not be used in patients with eGFR <30 mL/min.
Excipients: Remdesivir contains betadex sulfobutyl ether sodium, which is renally cleared and accumulates in patients with decreased renal function, which may potentially adversely affect renal function. Therefore Remdesivir should not be used in patients with eGFR <30 mL/min.
Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Remdesivir and chloroquine phosphate or hydroxychloroquine sulphate is not recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of Remdesivir.
