VEKLURY is a prescription medicine used to treat COVID-19 in adults and children weighing at least 3 pounds who are hospitalized; or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Talk to a healthcare provider to see if VEKLURY may be an option for you.
VEKLURY has demonstrated proven results across a wide range of COVID-19 disease severity in both adults and children
VEKLURY was studied in over 2600 patients across multiple clinical trials. Select tab to see individual study results.
In a clinical study, VEKLURY helped reduce progression to more severe disease plus shortened recovery time by 5 days
In a study, the effectiveness of VEKLURY was compared to placebo* in 1062 adult men and women of different races and ethnic backgrounds who were hospitalized with mild-to-moderate or severe COVID-19.
The median† number of days to recovery for patients treated with VEKLURY was 10 days vs 15 days for patients who received placebo. Recovery referred to patients who were no longer hospitalized or hospitalized but did not require ongoing medical care for COVID-19.
*A placebo is a treatment that does not contain medication. It is used as a comparison when testing treatments.
†The medians demonstrate that half of patients treated with VEKLURY recovered within 10 days while half of patients receiving placebo recovered within 15 days.
More improvements on VEKLURY included:
- Patients on VEKLURY spent less days on oxygen: 913 patients were on oxygen at the start of the study, and those taking VEKLURY spent a median of 8 days less on oxygen compared to placebo.
- Fewer patients taking VEKLURY needed to go on a ventilator: 52 out of 402 (13%) patients taking VEKLURY needed to go on a ventilator compared to 82 out of 364 (23%) patients on placebo. These patients were not on a ventilator at the start of the study.
Side effects with VEKLURY were similar to those in the group taking placebo.
Serious side effects of VEKLURY may include:
- Allergic reactions. VEKLURY can cause allergic reactions during or after infusion. Tell your healthcare provider right away if you get any of the following symptoms: changes to heart rate, rash, fever, nausea, sweating, shortness of breath, or wheezing, or swelling of the lips, face, or throat.
- Increase in liver enzymes. Increases in the amount of liver enzymes are common in people who have received VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your liver enzymes before and during treatment and may stop your treatment with VEKLURY if you develop new or worsening liver problems.
The most common side effect in people receiving VEKLURY is nausea. Tell your healthcare provider if you have any side effects that bother you or do not go away.
In a clinical study, early use of VEKLURY helped prevent hospitalization
The study tested how well VEKLURY worked compared to placebo* to prevent hospitalization or death in patients who were not hospitalized. These patients had at least one medical condition that put them at high risk for developing severe COVID-19. A total† of 562 patients were treated with either VEKLURY or placebo within 7 days of symptoms beginning. No patients in the study needed supplemental oxygen. No deaths occurred in this study.
*A placebo is a treatment that does not contain medication. It is used as a comparison when testing treatments.
†279 patients were treated with VEKLURY and 283 patients were given placebo.
- Patients taking VEKLURY had an 87% lower risk of COVID-19–related hospitalization compared to placebo. These results were analyzed 28 days after patients began treatment.
- Hospitalization due to COVID-19 occurred in 2 patients out of 279 in the VEKLURY group and in 15 patients out of 283 in the placebo group.
Side effects with VEKLURY were similar to those in the group taking placebo.
Serious side effects of VEKLURY may include:
- Allergic reactions. VEKLURY can cause allergic reactions during or after infusion. Tell your healthcare provider right away if you get any of the following symptoms: changes to heart rate, rash, fever, nausea, sweating, shortness of breath, or wheezing, or swelling of the lips, face, or throat.
- Increase in liver enzymes. Increases in the amount of liver enzymes are common in people who have received VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your liver enzymes before and during treatment and may stop your treatment with VEKLURY if you develop new or worsening liver problems.
The most common side effect in people receiving VEKLURY is nausea. Tell your healthcare provider if you have any side effects that bother you or do not go away.
In a clinical study, VEKLURY was found to improve clinical status in hospitalized children starting at birth
A study tested how well VEKLURY worked in 58 infants and children hospitalized with mild, moderate, or severe COVID-19. Patients in this study included children from birth to less than 18 years old, weighing at least 3 lbs. This was an open-label study, which means the doctors knew that all patients received VEKLURY during the study.
Among 53 infants and children:
- 62% recovered within 10 days of starting VEKLURY
- Median* time to recovery was 7 days
Among 5 neonates and infants:
- 3 patients recovered with up to 10 days of treatment with VEKLURY
- Time to recovery ranged from 9 to 19 days
*A median is defined by the middle of a set of numbers, where half of the value is less than the median and half of the value is greater.
Side effects with VEKLURY in children were similar to those in clinical studies of adults.
Serious side effects of VEKLURY may include:
- Allergic reactions. VEKLURY can cause allergic reactions during or after infusion. Tell your healthcare provider right away if you get any of the following symptoms: changes to heart rate, rash, fever, nausea, sweating, shortness of breath, or wheezing, or swelling of the lips, face, or throat.
- Increase in liver enzymes. Increases in the amount of liver enzymes are common in people who have received VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your liver enzymes before and during treatment and may stop your treatment with VEKLURY if you develop new or worsening liver problems.
The most common side effect in people receiving VEKLURY is nausea. Tell your healthcare provider if you have any side effects that bother you or do not go away.
IMPORTANT SAFETY INFORMATION
Who should not take VEKLURY?
Do not take VEKLURY if you:
- Are allergic to remdesivir or any of the other ingredients in VEKLURY.
What are the possible side effects of VEKLURY?
Serious side effects of VEKLURY may include:
- Allergic reactions. VEKLURY can cause allergic reactions during or after infusion. Tell your healthcare provider right away if you get any of the following symptoms: changes to heart rate, rash, fever, nausea, sweating, shortness of breath, or wheezing, or swelling of the lips, face, or throat.
- Increase in liver enzymes. Increases in the amount of liver enzymes are common in people who have received VEKLURY and may be a sign of liver injury. Your healthcare provider will do blood tests to check your liver enzymes before and during treatment and may stop your treatment with VEKLURY if you develop new or worsening liver problems.
The most common side effect in people receiving VEKLURY is nausea. Tell your healthcare provider if you have any side effects that bother you or do not go away.
What should I tell my healthcare provider before receiving VEKLURY?
- All your health problems. Be sure to tell your healthcare provider if you have or have had any allergies, liver problems, or any serious illnesses.
- If you are pregnant or breastfeeding: It is not known if VEKLURY may harm your unborn baby if taken during the first trimester. VEKLURY can pass into your breast milk. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
- All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how VEKLURY works. Especially tell your healthcare provider if you are taking any medicines that contain chloroquine phosphate or hydroxychloroquine sulfate.
How is VEKLURY given?
- Hospitalized: VEKLURY is given to you through a vein by intravenous (IV) infusion one time each day for up to 10 days. Your healthcare provider will decide how many doses you need.
- Not hospitalized: VEKLURY is given to you through a vein by IV infusion one time each day for 3 days.
WHAT IS VEKLURY?
VEKLURY is a prescription medicine used to treat COVID-19 in adults and children weighing at least 3 pounds who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
Talk to a healthcare provider to see if VEKLURY may be an option for you.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.
Please see Patient Prescribing Information for VEKLURY.