About

VEKLURY is the first and only antiviral treatment FDA approved for COVID-191,2

VEKLURY® (remdesivir) is the result of Gilead's long-standing dedication to antiviral research

Timeline of the development of VEKLURY® (remdesivir) Timeline of the development of VEKLURY® (remdesivir)

From clinical trials to emergency use authorization to approval, VEKLURY was approved in response to global need based on phase 3 clinical trials involving >2000 patients hospitalized with mild/moderate to severe COVID-19. Gilead remains committed to further study of VEKLURY in patients across a spectrum of COVID-19 severity.2,10-13

Important Safety Information

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Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of VEKLURY. 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 VEKLURY 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 VEKLURY; 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 VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY 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 VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the antiviral activity of VEKLURY.

Adverse reactions

  • 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 interactions

  • Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Dosage and administration

  • 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 VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
  • Dose preparation and administration: See full Prescribing Information.

Pregnancy and lactation

  • Pregnancy: There are insufficient human data on the use of VEKLURY during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. VEKLURY 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 VEKLURY 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.

INDICATION

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For patients hospitalized with COVID-19: VEKLURY is indicated for treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY is indicated for the treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

For information about emergency use to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg, please see the EUA Fact Sheet and FDA Letter of Authorization available at gilead.com/remdesivir.

Please see full Prescribing Information for VEKLURY.

CDC=Centers for Disease Control and Prevention; COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FDA=US Food and Drug Administration; NIH=National Institutes of Health; WHO=World Health Organization.

References: 1. Centers for Disease Control and Prevention. COVID-19 Overview and Infection Prevention and Control Priorities in non-US Healthcare Settings. Updated August 12, 2020. Accessed January 5, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/overview/index.html. 2. Veklury. Package insert. Gilead Sciences, Inc.; 2020. 3. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506. 4. AJMC Staff. A Timeline of COVID-19 Developments in 2020. Am J Managed Care. Published July 3, 2020. Accessed January 5, 2021. https://www.ajmc.com/view/a-timeline-of-covid19-developments-in-2020. 5. Adaptive COVID-19 Treatment Trial (ACTT). ClinicalTrials.gov identifier: NCT04280705. Updated September 25, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04280705. 6. Study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with severe coronavirus disease (COVID-19). ClinicalTrials.gov identifier: NCT04292899. Updated July 27, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04292899. 7. Study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with moderate coronavirus disease (COVID-19) compared to standard of care treatment. ClinicalTrials.gov identifier: NCT04292730. Updated July 27, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04292730. 8 Florindo HF, Kleiner R, Vaskovich-Koubi D, et al. Immune-mediated approaches against COVID-19. Nat Nanotechnol. 2020;15(8):630-645. 9. Farley J. NDA 214787 approval letter. US Food and Drug Administration. Published October 22, 2020. Accessed January 5, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214787Orig1s000ltr.pdf 10. Study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of remdesivir (GS-5734™) in participants from birth to < 18 years of age with coronavirus disease 2019 (COVID-19) (CARAVAN). ClinicalTrials.gov identifier: NCT04431453. Updated October 9, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04431453. 11. Study to evaluate the efficacy and safety of remdesivir (GS-5734™) treatment of coronavirus disease 2019 (COVID-19) in an outpatient setting. ClinicalTrials.gov identifier: NCT04501952. Updated October 5, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04501952. 12. Adaptive COVID-19 Treatment Trial 2 (ACTT-2). ClinicalTrials.gov identifier: NCT04401579. Updated August 13, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04401579. 13. Adaptive COVID-19 Treatment Trial 3 (ACTT-3). ClinicalTrials.gov identifier: NCT04492475. Updated October 8, 2020. Accessed January 5, 2021. https://clinicaltrials.gov/ct2/show/NCT04492475.



View All

INDICATION

View All

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For patients hospitalized with COVID-19: VEKLURY is indicated for treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY is indicated for the treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

For information about emergency use to treat suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg, please see the EUA Fact Sheet and FDA Letter of Authorization available at gilead.com/remdesivir.

Please see full Prescribing Information for VEKLURY.

Important Safety Information

Collapse

Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of VEKLURY. 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 VEKLURY 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 VEKLURY; 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 VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY 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 VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the antiviral activity of VEKLURY.

Adverse reactions

  • 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 interactions

  • Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Dosage and administration

  • 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 VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.
  • Dose preparation and administration: See full Prescribing Information.

Pregnancy and lactation

  • Pregnancy: There are insufficient human data on the use of VEKLURY during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. VEKLURY 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 VEKLURY 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.

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