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Drug-Drug InteractionsĬurrently, no clinical drug-drug interaction studies of remdesivir have been conducted. 16 These observational data suggest that remdesivir can be used in patients with an eGFR of <30 mL/min if the potential benefits outweigh the risks. 15,16 In 1 study, 20 patients had an estimated CrCl of <30 mL/min and 115 had an estimated CrCl of ≥30 mL/min 15 the other study included 40 patients who had an estimated CrCl of <30 mL/min and 307 patients who had an estimated CrCl of ≥30 mL/min. In 2 observational studies that evaluated the use of the solution formulation of remdesivir (not the reconstituted lyophilized powder formulation) in hospitalized patients with COVID-19, no significant differences were reported in the incidences of adverse effects or acute kidney injury between patients with an estimated creatinine clearance (CrCl) of <30 mL/min and those with an estimated CrCl of ≥30 mL/min. The FDA product label does not recommend using remdesivir in patients with an eGFR of <30 mL/min due to a lack of data. Clinicians may consider preferentially using the lyophilized powder formulation (which contains less SBECD) in patients with renal impairment.īecause both remdesivir formulations contain SBECD, patients with an eGFR of <50 mL/min were excluded from some clinical trials of remdesivir other trials had an eGFR cutoff of <30 mL/min. 13 Accumulation of SBECD in patients with renal impairment may result in liver and renal toxicities. This amount of SBECD is within the safety threshold for patients with normal renal function. A patient with COVID-19 who receives a loading dose of remdesivir 200 mg would receive 6 g to 12 g of SBECD, depending on the formulation. 5 SBECD is a vehicle that is primarily eliminated through the kidneys. Considerations in Patients With Renal InsufficiencyĮach 100 mg vial of remdesivir lyophilized powder contains 3 g of sulfobutylether beta-cyclodextrin sodium (SBECD), and each 100 mg/20 mL vial of remdesivir solution contains 6 g of SBECD. The role of combination antiviral therapy is not yet known. Additional studies are needed to assess this risk. There is a theoretical concern that the use of a single antiviral agent in these patients may result in the emergence of resistant virus. Patients who are severely immunocompromised may have prolonged SARS-CoV-2 replication, which may lead to rapid viral evolution. Patients should be monitored during the infusion and observed for at least 1 hour after the infusion as clinically appropriate. Remdesivir should be administered in a setting where severe hypersensitivity reactions, such as anaphylaxis, can be managed and the emergency medical system can be activated. 12 Remdesivir may need to be discontinued if a patient’s alanine transaminase (ALT) level increases to >10 times the upper limit of normal, and it should be discontinued if increases in ALT levels and signs or symptoms of liver inflammation are observed. It is also available through an FDA Emergency Use Authorization (EUA) for the treatment of COVID-19 in nonhospitalized and hospitalized pediatric patients weighing 3.5 kg to 48 kg. It is approved for the treatment of mild to moderate COVID-19 in high-risk, nonhospitalized patients (i.e., a 3-day course initiated within 7 days of symptom onset) and for the treatment of hospitalized patients with COVID-19 (i.e., a 5-day course). Intravenous remdesivir is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in adult and pediatric patients (aged ≥12 years and weighing ≥40 kg). 2 Remdesivir is expected to be active against the B.1.1.529 (Omicron) variant of concern. 1 In a rhesus macaque model of SARS-CoV-2 infection, remdesivir treatment was initiated soon after inoculation the remdesivir-treated animals had lower virus levels in the lungs and less lung damage than the control animals. Remdesivir has demonstrated in vitro activity against SARS-CoV-2. It binds to the viral RNA-dependent RNA polymerase and inhibits viral replication by terminating RNA transcription prematurely.
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Remdesivir is a nucleotide prodrug of an adenosine analog.