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The safety profiles of VEKLURY and placebo were comparable in the ACTT-1 Study¹

Comparable frequency of adverse reactions vs placebo

Types of adverse reactions VEKLURY(n=532)n (%) Placebo(n=516)n (%)
Any adverse reaction, Grades ≥3 41 (8%) 46 (9%)
Serious adverse reactions 2 (0.4%)* 3 (0.6%)
Adverse reactions leading to treatment discontinuation 11 (2%) 15 (3%)

*Seizure (n=1), infusion-related reaction (n=1).

Seizure (n=1), infusion-related reaction (n=1), transaminases increased (n=3), ALT increased and AST increased (n=1), GFR decreased (n=2), acute kidney injury (n=3).

Laboratory abnormalities (Grades 3‑4) reported in ≥3% of patients

Laboratory parameter abnormality VEKLURY(n=532) Placebo(n=516)
ALT increased 3% 6%
AST increased 6% 8%
Bilirubin increased 2% 5%
Creatinine clearance decreased§ 18% 20%
Creatinine increased 15% 16%
eGFR decreased 18% 24%
Glucose increased 12% 13%
Hemoglobin decreased 15% 22%
Lymphocytes decreased 11% 18%
Prothrombin time increased 9% 4%

Frequencies are based on treatment-emergent laboratory abnormalities graded per Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017.

§Based on the Cockcroft-Gault formula.

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.

ALT=alanine aminotransferase; AST=aspartate aminotransferase;COVID-19=coronavirus disease 2019; eGFR=estimated glomerular filtration rate.

Reference: 1. Veklury. Package insert. Gilead Sciences, Inc.; 2020.



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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