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Remdesivir

Medically reviewed by Drugs.com. Last updated on July 26, 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. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Veklury: 100 mg/20 mL (20 mL)

Solution Reconstituted, Intravenous:

Generic: 100 mg (1 ea [DSC]); 150 mg (1 ea)

Solution Reconstituted, Intravenous [preservative free]:

Veklury: 100 mg (1 ea)

Brand Names: U.S.

  • Veklury

Pharmacologic Category

  • Antiviral Agent

Pharmacology

Remdesivir is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication. Remdesivir is an adenosine nucleotide prodrug that is metabolized to the pharmacologically active nucleoside triphosphate metabolite after being distributed into cells. Remdesivir triphosphate (GS-443902) acts as an adenosine triphosphate analog and competes for incorporation into RNA chains by the SARS-CoV-2 RdRp, resulting in delayed chain termination during viral RNA replication. Remdesivir triphosphate can also inhibit viral RNA synthesis due to incorporation into the viral RNA template.

Excretion

Urine: Remdesivir: 10%; GS-441524: 49%; GS-704277: 2.9%

Feces: Remdesivir: Not detected; GS-441524: 0.5%; GS-704277: Not detected.

Half-Life Elimination

Remdesivir: ~1 hour; GS-441524: 27 hours; GS-704277: 1.3 hours.

Protein Binding

Remdesivir: 88% to 93.6%; GS-441524: 2%; GS-704277: 1%.

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 exposure that is comparable to adult exposure (FDA 2020a; manufacturer's labeling).

Special Populations Note

Expected drug exposure in adults with normal renal function:

Cmax (peak): IV: 100 mg once daily, steady state: Remdesivir: 2,229 ng/mL; GS-441524: 145 ng/mL; GS-704277: 246 ng/mL.

Cmin (trough): IV: 100 mg once daily, steady state: Remdesivir: Not detected; GS-441524: 69.2 ng/mL; GS-704277: Not detected.

AUC: IV: 100 mg once daily, steady state: Remdesivir: 1,585 ng/hour/mL; GS-441524: 2,229 ng/hour/mL; GS-704277: 462 ng/hour/mL.

Use: Labeled Indications

Coronavirus disease 2019 (COVID-19): Treatment of COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) requiring hospitalization. Remdesivir should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care.

Contraindications

Hypersensitivity to remdesivir or any component of the formulation.

Dosing: Adult

Coronavirus disease 2019 (COVID-19), hospitalized patients: IV:

Note: Based on the Infectious Diseases Society of America (IDSA) and the National Institutes of Health (NIH) guidelines for the therapeutic management of COVID-19, remdesivir appears to provide the most benefit in patients with severe disease on supplemental oxygen rather than in patients on mechanical ventilation or ECMO. Refer to https://www.covid19treatmentguidelines.nih.gov and https://www.idsociety.org/globalassets/idsa/practice-guidelines/covid-19/treatment/idsa-covid-19-gl-tx-and-mgmt-v3.3.0.pdf for more information (IDSA [Bhimraj 2020]; NIH 2020).

Patients not requiring supplemental oxygen: Generally not recommended; however, may be considered based on clinician judgement (eg, patient at high risk for clinical deterioration) (NIH 2020).

Patients requiring low-flow supplemental oxygen: 200 mg as a single dose on day 1, followed by 100 mg once daily for 4 days or until hospital discharge, whichever is first; may extend duration up to 10 days in patients without substantial clinical improvement at day 5 (Beigel 2020; NIH 2020). May give as monotherapy or in combination with dexamethasone (NIH 2020).

Patients requiring high-flow supplemental oxygen or noninvasive ventilation: 200 mg as a single dose on day 1, followed by 100 mg once daily for 4 days or until hospital discharge, whichever is first; may extend duration up to 10 days in patients without substantial clinical improvement at day 5 (Beigel 2020; NIH 2020). Note: NIH guidelines recommend only using in this population in combination with dexamethasone (NIH 2020).

Patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation: 200 mg as a single dose on day 1, followed by 100 mg once daily (Beigel 2020; NIH 2020). Recommendations for duration vary. Total duration is 5 days or until hospital discharge, whichever is first (may extend duration up to 10 days in patients without substantial clinical improvement at day 5) (NIH 2020) or 10 days (IDSA [Bhimraj 2020]). Note: NIH guidelines recommend only using in this population in combination with dexamethasone (NIH 2020).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Note: While remdesivir efficacy has been demonstrated in adults being treated for COVID-19, data in pediatric patients are limited (Chiotos 2020). The role of remdesivir in the treatment of COVID-19 in pediatric patients is still evolving; use in the context of a clinical trial is preferred, especially in patients <12 years or those ≥12 years weighing 3.5 to <40 kg; if a clinical trial is unavailable, an expert panel recommends use in pediatric patients with confirmed severe COVID-19 and may consider use in patients with confirmed critical COVID-19; remdesivir is not recommended for patients with mild to moderate disease (except in a clinical trial) (Chiotos 2020).

Infants and Children <12 years: Lyophilized powder only:

3.5 kg to <40 kg: IV: Loading dose: 5 mg/kg/dose on day 1, followed by 2.5 mg/kg/dose once daily (Chiotos 2020; FDA 2020a).

≥40 kg: IV: Loading dose: 200 mg on day 1, followed by 100 mg once daily (Chiotos 2020; FDA 2020a).

Children ≥12 years and Adolescents:

<40 kg: Lyophilized powder only: IV: Loading dose: 5 mg/kg/dose on day 1, followed by 2.5 mg/kg/dose once daily (Chiotos 2020; FDA 2020a).

≥40 kg: Injection solution or lyophilized powder: IV: Loading dose: 200 mg on day 1, followed by 100 mg once daily (Chiotos 2020; manufacturer's labeling).

Duration: In patients not requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO), recommended treatment duration is 5 days or until hospital discharge, whichever is first (FDA 2020a; Goldman 2020; NIH 2020; manufacturer's labeling). 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; manufacturer's labeling); however, some experts have suggested starting with a 5-day course and extending to 10 days on a case-by-case basis (Chiotos 2020).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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; do not shake. Discard unused portion of the injection solution vial.

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; do not shake. Discard unused portion of the injection solution vial.

Administration

IV: Administer as an IV infusion over 30 to 120 minutes.

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 24 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for 48 hours. Discard unused portion of the injection solution vial.

Lyophilized powder: Store intact vials at <30°C (<86°F). After reconstitution, use vials immediately to prepare diluted solution. Once diluted for infusion, may store at 20°C to 25°C (68°F to 77°F) for 24 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for 48 hours. Discard unused portion of the reconstituted vial.

Drug Interactions

Chloroquine: May diminish the therapeutic effect of Remdesivir. Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Remdesivir. Monitor therapy

Hydroxychloroquine: May diminish the therapeutic effect of Remdesivir. Avoid combination

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Remdesivir is currently under investigation for use in the treatment of coronavirus disease 2019 (COVID-19) (see ClinicalTrials.gov). 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).

1% to 10%:

Endocrine & metabolic: Hyperglycemia (1.8% [placebo 2.1%]) (Beigel 2020), increased serum glucose (2.2% [placebo 1.1%]) (Beigel 2020)

Hepatic: Acute hepatic failure (Carothers 2020), increased serum alanine aminotransferase (1.5% [placebo 1.7%]) (Beigel 2020; FDA 2020a), increased serum aspartate aminotransferase (2.8% [placebo 3.8%]) (Beigel 2020; FDA 2020a)

Renal: Acute renal failure (2.8% [placebo 3.3%]) (Beigel 2020), decreased estimated GFR (eGFR) (3.7% [placebo 3.3%]) (Beigel 2020), increased serum creatinine (1.5% [placebo 0.8%]) (Beigel 2020)

Miscellaneous: Fever (5.0% [placebo 3.3%]) (Beigel 2020)

<1%: Renal: Decreased creatinine clearance (0.6% [placebo 1.0%]) (Beigel 2020)

Frequency not defined: 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 before remdesivir initiation and while receiving remdesivir as clinically appropriate. Consider discontinuation in patients who develop ALT >10 times the ULN and discontinue if ALT elevation is accompanied by signs or symptoms of liver inflammation.

• Hypersensitivity including infusion-related and anaphylactic reactions: Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been reported during and following remdesivir administration. Signs/symptoms may include angioedema, bradycardia, diaphoresis, dyspnea, hypotension, hypertension, hypoxia, fever, nausea, rash, shivering, tachycardia, and wheezing; slowing infusion rate (maximum infusion time: 120 minutes) may be considered to potentially prevent these reactions. Discontinue administration and institute appropriate treatment if a clinically significant hypersensitivity reaction occurs.

Disease-related concerns:

Renal impairment: Although the manufacturer's labeling recommends against use in patients with eGFR <30 mL/minute, significant toxicity with a short duration of therapy (eg, 5 to 10 days) is unlikely (Adamsick 2020). In 1 observational report, 46 patients with acute kidney injury and/or chronic kidney disease (36 of whom were receiving either hemodialysis or slow low efficiency dialysis) received remdesivir (injection solution formulation) at the usual recommended dosage for an average of 5 days and did not experience severe rises in AST/ALT or changes in kidney function attributable to the drug (Thakare 2020).

Dosage form specific issues:

• Injection: Contains the excipient cyclodextrin (sulfobutylether-beta-cyclodextrin; 6 g per 100 mg remdesivir [injection solution] or 3 g per 100 mg remdesivir [lyophilized powder]), which may accumulate in patients with renal impairment.

Monitoring Parameters

Baseline and during remdesivir administration when clinically appropriate: Hepatic function tests (ALT, AST, bilirubin, alkaline phosphatase, prothrombin time); renal function tests (serum creatinine, CrCl); signs/symptoms of infusion reaction.

Pregnancy Considerations

Remdesivir is approved for the treatment of coronavirus disease 2019 (COVID-19). Outcome data are available from a limited number of pregnant (n=67) and postpartum (n=19) patients who received remdesivir through the compassionate use program. COVID-19 was confirmed in all cases, and all patients had an oxygen saturation <94% on room air or required oxygen support. Dosing was the same as nonpregnant adults. Exposure occurred <24 weeks' gestation (n=12), 24 to 32 weeks' gestation (n=44), >32 weeks' gestation (n=11), or within 3 days postpartum (delivery between 24 and 32 weeks' gestation [n=13]; delivery >32 weeks' gestation [n=5]). Sixty-four percent of women had a comorbid medical condition that classified their pregnancy as high risk (obesity 17%, asthma 12%, gestational diabetes 10%, chronic hypertension 8%, diabetes mellitus 8%). In patients given remdesivir, 93% treated during pregnancy and 89% treated postpartum recovered within 28 days. Recovery was defined as discharge from hospital if on room air at baseline, return to room air or discharge if oxygen previously needed, or extubation if previously ventilated. Women not requiring ventilation had a median time to recovery of 5 days. Adverse effects were similar to those in nonpregnant patients; remdesivir was discontinued in 7 pregnant patients (10%) due to adverse events, most commonly due to an increase in liver enzymes (n=5). Based on this preliminary data, maternal treatment with remdesivir during pregnancy had a high rate of recovery (Burwick 2020). Use should not be withheld if otherwise needed (NIH 2020).

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes

• Infusion site reactions like upset stomach or throwing up, sweating a lot, shivering, fast or slow heartbeat, signs of low blood pressure like feeling very dizzy or passing out, or any other effects during or after the infusion

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Frequently asked questions

Further information

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