What is Veklury?
Veklury (remdesivir) is an FDA approved antiviral medicine used to treat hospitalized COVID-19 patients who are 12 years and older and who weigh atleast 88 pounds (40 kilograms).
Veklury has an Emergency Use Authorization (EUA) for use in children younger than 12 years old, who weigh at least 8 pounds (3.5 kg) and are hospitalized with COVID-19.
For a medicine to gain FDA approval, the evidence that shows it is effective has to be at a higher level and a larger quantity, compared to gaining EUA approval.
Veklury was shown in a clinical trial (ACTT-1) to shorten the time it took COVID-19 patients to recover. The Veklury patients had a median recovery time of 10 days compared to the placebo group that had a median recovery time of 15 days.
Veklury is for use only in people with COVID-19 who are in a hospital. You must remain under the care of a doctor while receiving Veklury.
COVID-19 is caused by a virus called a coronavirus. People can get coronavirus by breathing in air droplets that contain the virus, these droplets come from an infected person who has breathed the droplets out. This most likely happens when you have close contact with someone who has COVID-19.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Patients who have long term medical conditions like heart disease, lung disease, and diabetes tend to have more serious complications and seem to be at higher risk of being hospitalized with COVID-19.
The symptoms of COVID-19 are fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness including breathing problems can occur and may cause your child's other medical conditions to become worse.
Before taking this medicine
You should not be treated with Veklury if you are allergic to remdesivir.
To make sure Veklury is safe for you, tell your doctor if you have ever had:
liver disease; or
Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.
How is Veklury given?
Veklury is given as an infusion into a vein. A healthcare provider will give you this injection.
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Veklury.
Veklury injection must be given slowly, and the infusion can take 30 to 120 minutes to complete.
Veklury is usually given once per day for 5 to 10 days.
You will need frequent blood tests to check your liver function.
You must remain under the care of a doctor while you are being treated with Veklury for COVID-19.
Usual Adult Dose of Veklury for COVID-19:
Loading dose (Day 1): 200 mg IV as a single dose
Maintenance dose (from Day 2): 100 mg IV once a day.
Usual Pediatric Dose of Veklury for COVID-19:
12 years or older weighing at least 40 kg:
-Loading dose (Day 1): 200 mg IV as a single dose
-Maintenance dose (from Day 2): 100 mg IV once a day.
Duration of Therapy:
-Invasive mechanical ventilation and/or ECMO required: 10 days total
-Invasive mechanical ventilation and/or ECMO not required: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown
-This drug should only be administered in a hospital or in a healthcare setting that can provide acute care comparable to inpatient hospital care.
Use: For the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization
FOR INVESTIGATIONAL USE ONLY
Weight 3.5 to less than 40 kg:
-Loading dose (Day 1): 5 mg/kg IV as a single dose
-Maintenance dose (from Day 2): 2.5 mg/kg IV once a day
Less than 12 years weighing at least 40 kg:
-Loading dose (Day 1): 200 mg IV as a single dose
-Maintenance dose (from Day 2): 100 mg IV once a day
-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this drug for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg.
-Pediatric patients (older than 28 days) must have estimated glomerular filtration rate (eGFR) determined and full-term neonates (7 to 28 days old) must have serum creatinine determined before starting this drug and during therapy as clinically appropriate.
-Hepatic laboratory testing should be performed in all patients before starting this drug and during therapy as clinically appropriate.
-Prothrombin time should be determined in all patients before starting this drug and should be monitored during therapy as clinically appropriate.
-The lyophilized powder formulation is the only authorized dosage form for pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg.
-Empiric treatment of hospitalized patients with suspected COVID-19 can be considered pending laboratory confirmation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
-This drug can be used at any time after onset of symptoms in hospitalized patients.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs
Use: For the treatment of hospitalized pediatric patients weighing 3.5 to less than 40 kg OR hospitalized pediatric patients younger than 12 years weighing at least 3.5 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate
What happens if I miss a dose?
Because you will receive Veklury in a clinical setting, you are not likely to miss a dose.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, you will be treated quickly if an overdose occurs.
What should I avoid while receiving Veklury?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Veklury side effects
Get emergency medical help if you have signs of an allergic reaction to Veklury: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during or after the injection. Tell your caregiver right away if you have:
severe headache, pounding in your neck or ears;
fast, slow, or pounding heartbeats;
wheezing, trouble breathing;
swelling in your face;
fever, chills, or shivering;
itching, sweating; or
a light-headed feeling, like you might pass out;
Common Veklury side effects may include:
abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Veklury?
Other drugs may interact with remdesivir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Frequently asked questions
More about Veklury (remdesivir)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: investigational drugs
- Latest FDA Alerts (2)
- FDA Approval History
Related treatment guides
- Your doctor can provide more information about Veklury.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Veklury only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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