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VEKLURY is the first and only FDA-approved antiviral treatment for COVID-19 across a broad range of ages, clinical settings, and disease severity2-4
- Gilead responded immediately to the global health crisis, working with governments and health authorities to make VEKLURY available to those impacted by COVID-195
- Mobilization of clinical trial development occurred quickly, with the goal of understanding the potential role VEKLURY could play in the treatment of COVID-195-14:
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; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 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.
Dosage and administration
- Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
- Treatment duration:
- For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
- For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
- For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
- For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
- Testing prior to and during treatment: Perform hepatic laboratory and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
- Renal impairment: No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment, including patients on dialysis. VEKLURY may be administered without regard to the timing of dialysis.
Pregnancy and lactation
- Pregnancy: A pregnancy registry has been established for VEKLURY. Available clinical trial data for VEKLURY in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of VEKLURY exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy.
- Lactation: VEKLURY can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEKLURY and any potential adverse effects on the breastfed child from VEKLURY or from an underlying maternal condition. 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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VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg), who are:
VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg), who are:
Please see full Prescribing Information for VEKLURY.
EUA=emergency use authorization; WHO=World Health Organization.
References: 1. Data on file. Gilead Sciences, Inc. 2. National Institutes of Health. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Antiviral drugs that are approved, authorized, or under evaluation for the treatment of COVID-19. Updated September 26, 2022. Accessed October 4, 2022. https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/summary-recommendations 3. FDA approves first treatment for COVID-19. News release. US Food and Drug Administration. October 22, 2020. Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 4. Veklury. Prescribing Information. Gilead Sciences, Inc.; 2023. 5. Gilead Sciences statement on the company's ongoing response to the 2019 novel coronavirus (2019-nCoV). News release. Gilead Sciences, Inc. January 31, 2020. Accessed August 16, 2022. https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-the-company-ongoing-response-to-the-2019-new-coronavirus 6. Centers for Disease Control and Prevention. CDC museum COVID-19 timeline. Updated August 16, 2022. Accessed August 16, 2022. https://www.cdc.gov/museum/timeline/covid19.html 7. Adaptive COVID-19 Treatment Trial (ACTT). ClinicalTrials.gov identifier: NCT04280705. February 21, 2020. Updated March 14, 2022. Accessed August 16, 2022. https://clinicaltrials.gov/ct2/show/NCT04280705 8. Study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with severe coronavirus disease (COVID-19). ClinicalTrials.gov identifier: NCT04292899. March 3, 2020. Updated December 31, 2020. Accessed August 16, 2022. https://clinicaltrials.gov/ct2/show/NCT04292899 9. 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. March 3, 2020. Updated January 26, 2021. Accessed August 16, 2022. https://clinicaltrials.gov/ct2/show/NCT04292730 10. Coronavirus (COVID-19) update: FDA issues emergency use authorization for potential COVID-19 treatment. News release. US Food and Drug Administration. May 1, 2020. Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment 11. 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. June 16, 2020. Updated September 7, 2022. Accessed October 4, 2022. https://clinicaltrials.gov/ct2/show/NCT04431453 12. 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. August 6, 2020. Updated November 16, 2021. Accessed August 16, 2022. https://clinicaltrials.gov/ct2/show/NCT04501952 13. FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19. News release. US Food and Drug Administration. January 21, 2022. Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-takes-actions-expand-use-treatment-outpatients-mild-moderate-covid-19 14. Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children. News release. US Food and Drug Administration. April 25, 2022. Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-approves-first-covid-19-treatment-young-children
View All
INDICATION
View All
Collapse
VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg), who are:
VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to <18 years of age weighing ≥1.5 kg), who are:
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; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 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.
Dosage and administration
- Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
- Treatment duration:
- For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
- For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
- For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
- For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
- Testing prior to and during treatment: Perform hepatic laboratory and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
- Renal impairment: No dosage adjustment of VEKLURY is recommended in patients with any degree of renal impairment, including patients on dialysis. VEKLURY may be administered without regard to the timing of dialysis.
Pregnancy and lactation
- Pregnancy: A pregnancy registry has been established for VEKLURY. Available clinical trial data for VEKLURY in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of VEKLURY exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy.
- Lactation: VEKLURY can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VEKLURY and any potential adverse effects on the breastfed child from VEKLURY or from an underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
