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Remdesivir

Medically reviewed by Drugs.com. Last updated on Apr 18, 2020.

Pronunciation

(rem DE si vir)

Index Terms

  • Coronavirus
  • COVID-19
  • GS-5734

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Generic: 100 mg/20 mL (20 mL)

Solution Reconstituted, Intravenous:

Generic: 100 mg (1 ea); 150 mg (1 ea)

Pharmacologic Category

  • Antiviral Agent

Pharmacology

Remdesivir is an adenosine nucleotide prodrug that is metabolized to the pharmacologically active nucleoside triphosphate metabolite after being distributed into cells. Remdesivir triphosphate acts as an adenosine triphosphate analog and competes for incorporation into RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, resulting in delayed chain termination during viral RNA replication (FDA 2020a).

Excretion

Urine (74% [majority as metabolites]); feces (18%).

Special Populations: Children

Pharmacokinetics have not been evaluated. Pharmacokinetic models predict that use of adult dosing in pediatric patients ≥40 kg and the recommended weight-based dosing regimen in pediatric patients <40 kg will result in remdesivir and metabolite (GS-441524) exposure that is comparable to adult exposure (FDA 2020a).

Off Label Uses

Coronavirus disease 2019

In vitro and animal studies demonstrate the activity of remdesivir against coronaviruses (eg, severe acute respiratory syndrome coronavirus [SARS-CoV], SARS-CoV-2, Middle East respiratory syndrome coronavirus) [Agostini 2018], [Sheahan 2017], [Sheahan 2020], [Wang 2020]. A single case report describes clinical improvement after receipt of remdesivir in a patient infected with SARS-CoV-2 whose clinical status was worsening prior to receiving the drug; however, no conclusions about the safety and efficacy of remdesivir in this case can be made [Holshue 2020]. Preliminary analysis of a randomized, double-blind, placebo-controlled trial in hospitalized adult patients with COVID-19 demonstrated a faster time to recovery in the remdesivir group (median: 11 days versus 15 days in the placebo group) [FDA 2020a], [NIAID 2020].

Contraindications

Hypersensitivity to remdesivir or any component of the formulation (FDA 2020a).

Dosing: Adult

Note: Remdesivir is currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19) (see ClinicalTrials.gov). At this time, safety and efficacy have not been established. However, preliminary dosing information is provided. Whenever possible, treatment should be given as part of a clinical trial. No specific drug-drug interaction data are available. Minimize any unnecessary comedication whenever possible given lack of information about interaction risk.

Coronavirus disease 2019 (COVID-19), severe (hospitalized patients): IV: Limited data available: 200 mg as a single dose on day 1, followed by 100 mg once daily. Recommended total duration is 5 days (patients not requiring invasive mechanical ventilation/extracorporeal membrane oxygenation [ECMO]; may extend for up to 5 additional days in patients who do not demonstrate clinical improvement) or 10 days (patients requiring invasive mechanical ventilation/ECMO) (FDA 2020a).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Coronavirus disease 2019 (COVID-19), severe (hospitalized patients); treatment:

Note: Remdesivir is currently under investigation for use in the treatment of COVID-19 (see ClinicalTrials.gov). Pediatric patients with severe disease are being considered for compassionate use access. At this time, efficacy has not been established in adult or pediatric patients. Optimal dosing is unknown. Whenever possible, treatment should be given as part of a clinical trial. However, the FDA has issued an Emergency Use Authorization for use in pediatric and adult patients hospitalized with severe disease (SpO2 ≤94% on room air or requiring oxygen, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO]) (FDA 2020a). No specific drug-drug interaction data are available. Minimize any unnecessary comedication whenever possible given lack of information about interaction risk.

Infants, Children, and Adolescents (Chiotos 2020; FDA 2020a): Optimal duration is unknown. A 5-day treatment duration is recommended for patients not requiring mechanical ventilation or ECMO. If patient does not improve clinically, may extend duration to a total of 10 days. A 10-day treatment duration is recommended for patients who require mechanical ventilation or ECMO (FDA 2020a).

≥3.5 kg to <40 kg: Lyophilized powder: IV: Loading dose: 5 mg/kg/dose on day 1, followed by 2.5 mg/kg/dose once daily.

≥40 kg: Injection solution, lyophilized powder: IV: Loading dose: 200 mg on day 1, followed by 100 mg once daily.

Reconstitution

Injection solution concentrate (5 mg/mL): Allow injection solution vial to warm to room temperature prior to dilution. Further dilute in 250 mL NS; withdraw and discard the required volume of NS from the infusion bag (40 mL for a 200 mg dose; 20 mL for a 100 mg dose) prior to addition of remdesivir. Transfer required volume of remdesivir to the infusion bag and gently invert 20 times to mix the solution (FDA 2020a).

Lyophilized powder: Reconstitute vial with 19 mL SWFI; shake for 30 seconds. Allow vial contents to settle for 2 to 3 minutes; if not completely dissolved, repeat process as necessary until vial contents are completely dissolved. Reconstituted vial contains 100 mg per 20 mL (5 mg/mL). Further dilute in 100 or 250 mL NS; withdraw and discard the required volume of NS from the infusion bag (40 mL for a 200 mg dose; 20 mL for a 100 mg dose) prior to addition of remdesivir. Transfer required volume of remdesivir to the infusion bag and gently invert 20 times to mix the solution (FDA 2020a).

Administration

IV: Administer as an IV infusion over 30 to 120 minutes. Flush line with at least 30 mL NS after remdesivir infusion is complete (FDA 2020a).

Storage

Injection solution concentrate (5 mg/mL): Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Prior to dilution, allow vial to warm to room temperature; intact vials can be stored up to 12 hours at room temperature prior to dilution. Once diluted for infusion, may store at 20°C to 25°C (68°F to 77°F) for ≤4 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for 24 hours (FDA 2020a).

Lyophilized powder: Store intact vials at <30°C (<86°F). After reconstitution, vials can be stored at 20°C to 25°C (68°F to 77°F) for ≤4 hours prior to administration or refrigerated at 2°C to 8°C (36°F to 46°F) for 24 hours. Dilute within the same day as administration; once diluted for infusion, may store at 20°C to 25°C (68°F to 77°F) for ≤4 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for 24 hours (FDA 2020a).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Remdesivir is currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19) (see ClinicalTrials.gov). At this time, safety and efficacy have not been established. However, the following adverse reactions have been observed. Serious or unexpected adverse reactions not previously reported may occur; refer to emergency use authorization (EUA) for information regarding reporting serious adverse reactions (FDA 2020a).

Frequency not defined:

Hepatic: Increased serum alanine aminotransferase (FDA 2020a), increased serum aspartate aminotransferase (FDA 2020a)

Miscellaneous: Infusion related reaction (including hypotension, nausea, vomiting, diaphoresis, and shivering) (FDA 2020a)

Warnings/Precautions

Concerns related to adverse effects:

• Hepatic effects: Transaminase elevations have been observed in healthy volunteers and patients with coronavirus disease 2019 (COVID-19). Perform hepatic laboratory testing at baseline and daily during remdesivir administration; do not initiate remdesivir in patients with ALT ≥5 times the ULN at baseline. Discontinue remdesivir in patients who develop ALT ≥5 times the ULN (may be restarted when ALT is <5 times the ULN) or ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR (FDA 2020a).

• Infusion reactions: Infusion-related reactions, including diaphoresis, hypotension, nausea, shivering, and vomiting, have been observed during and/or have been temporally associated with remdesivir administration. Discontinue administration and institute appropriate treatment if a clinically significant infusion reaction occurs (FDA 2020a).

Disease-related concerns:

Renal impairment: Use is not recommended in patients with eGFR <30 mL/minute (FDA 2020a).

Dosage form specific issues:

• Injection: Contains the excipient cyclodextrin (sulfobutyl ether beta-cyclodextrin), which may accumulate in patients with kidney impairment (HHS 2020b).

Monitoring Parameters

Baseline and daily during remdesivir administration: Hepatic function tests (ALT, AST, bilirubin, alkaline phosphatase); hematology; renal function tests (serum creatinine, CrCl) and serum chemistries; signs/symptoms of infusion reaction (FDA 2020a).

Pregnancy Considerations

Remdesivir is under study for the treatment of coronavirus disease 2019 (COVID-19). A limited number of pregnant women have received remdesivir through the compassionate use program.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) have developed an algorithm to aid practitioners in assessing and managing pregnant women with suspected or confirmed COVID-19 (https://www.acog.org/topics/covid-19; https://www.smfm.org/covid19). Interim guidance is also available from the CDC for pregnant women who are diagnosed with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/inpatient-obstetric-healthcare-guidance.html).

Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll females exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/) or the PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) (415-754-3729, https://priority.ucsf.edu/).

Patient Education

What is this drug used for?

• It is used in certain people to treat COVID-19.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes

• Infusion site reactions like nausea, vomiting, sweating a lot, shivering, severe dizziness, or passing out

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Remdesivir FDA fact sheets – Health care provider; Patient

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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