Remdisivir is indicated for the treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19.
Remdisivir should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.
Remdisivir is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Remdisivir or any of its components.
- Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Remdisivir. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of Remdisivir. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Remdisivir and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Remdisivir; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Remdisivir if ALT levels increase to >10x ULN. Discontinue Remdisivir if ALT elevation is accompanied by signs or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Remdisivir with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture, which may lead to a decrease in antiviral activity of Remdisivir.
- The most common adverse reaction (≥5% all grades) was nausea.
- The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.
- Drug interaction trials of Remdisivir and other concomitant medications have not been conducted in humans.
- Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.
- Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
- Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating Remdisivir and during use as clinically appropriate.
- Renal impairment: Remdisivir is not recommended in individuals with eGFR <30 mL/min.
- Dose preparation and administration: See full Prescribing Information.
- Pregnancy: There are insufficient human data on the use of Remdisivir during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. Remdisivir should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
- Lactation: It is not known whether Remdisivir can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
Please see full Prescribing Information for Remdisivir.