WARNINGS AND PRECAUTIONS
There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use.
Infusion-related reactions have been observed during, and/or been temporally associated with, administration of remdesivir. Signs and symptoms may include hypotension, nausea, vomiting, diaphoresis, and shivering. If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. The use of remdesivir is contraindicated in patients with known hypersensitivity to remdesivir or any components of the product.[see Contraindications].
Remdesivir is contraindicated in patients with a history of clinically significant hypersensitivity reactions to remdesivir or any components of the product. [see Warnings and Precautions (5.1)].
Increased Risk of Transaminase Elevations
Transaminase elevations have been observed in healthy volunteers who received 200 mg of remdesivir followed by 100 mg doses for up to 10 days; the transaminase elevations were mild (Grade 1) to moderate (Grade 2) in severity and resolved upon discontinuation of remdesivir. Transaminase elevations have also been reported in patients with COVID-19 who received remdesivir Because transaminase elevations have been reported as a clinical feature of COVID-19, including in patients receiving placebo in clinical trials of remdesivir, and the incidence was similar in patients receiving placebo versus remdesivir in clinical trials of remdesivir, discerning the contribution of remdesivir to transaminase elevations in patients with COVID-19 can be challenging.
- Perform hepatic laboratory testing in all patients before starting remdesivir and daily while receiving remdesivir.
- Consider discontinuing remdesivir if ALT levels increase to greater than 10 times the upper limit of normal.
- Discontinue remdesivir if ALT elevation is accompanied by signs or symptoms of liver inflammation
Risk of Reduced Antiviral Activity When Coadministered with Chloroquine Phosphate or Hydroxychloroqulne Sulfate
Coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on cell culture data demonstrating an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of Remdesivir. [see Drug Interactions, Microbiology/Resistance Information].