Veklury is a prescription antiviral medicine used for the treatment of COVID-19.

Veklury contains remdesivir, a nucleotide analog which works by targeting SARS-CoV-2 viral RNA polymerase to stop replication of SARS-CoV-2, the virus that causes COVID-19.

What is Veklury used to treat?

Veklury is used for the treatment of COVID-19 in adults and children (who are at least 28 days of age and older who weigh at least 7 pounds) who are in a hospital; or who are not in a hospital but have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

It is not known if this medicine is safe and effective in children under 28 days of age or weighing less than 7 pounds (3 kg).

COVID-19 is a viral infection caused by a coronavirus called SARS-CoV-2. People can contract COVID-19 by breathing in air containing droplets that have been exhaled by a person infected with COVID-19. This is more likely to happen 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.

Veklury is for use only in people with COVID-19. You must remain under the care of a doctor while receiving this medicine.

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 must be given slowly, and the infusion can take 30 to 120 minutes to complete.

If you are in a hospital, you will receive an infusion once a day for up to 10 days.

If you are not in a hospital, you will receive an infusion once a day for 3 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

Duration of Therapy:
-Hospitalized patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 10 days total
-Hospitalized patients not requiring invasive mechanical ventilation and/or ECMO: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown
-Non-hospitalized patients: 3 days

Use: For the treatment of coronavirus disease 2019 (COVID-19) in patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing who are:
-Hospitalized, or
-Not hospitalized, have mild to moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death

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

28 days of age and older and weighing 3 kg 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

Duration of Therapy:
-Hospitalized patients requiring invasive mechanical ventilation and/or ECMO: 10 days total
-Hospitalized patients not requiring invasive mechanical ventilation and/or ECMO: 5 days; may extend up to 5 additional days (for a total of up to 10 days) if no clinical improvement shown
-Non-hospitalized patients: 3 days

Use: For the treatment of COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing who are:
-Hospitalized, or
-Not hospitalized, have mild to moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death

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.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine may harm your unborn baby if taken during the first trimester of pregnancy. Tell your healthcare provider right away if you are or if you become pregnant.

Pregnancy Registry: There is a pregnancy registry for individuals who receive Veklury during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding

Tell your doctor if you are if you are breastfeeding or plan to breastfeed. Veklury can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby.

Because you will receive Veklury in a clinical setting, you are not likely to miss a dose.

Since Veklury is given by a healthcare professional in a medical setting, you will be treated quickly if an overdose occurs.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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;

• nausea;

• fever, chills, or shivering;

• itching, sweating; or

• a light-headed feeling, like you might pass out;

Common Veklury side effects may include include:

• nausea; or

• 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.

Tell your doctor if you also take chloroquine or hydroxychloroquine. Either of these other medicines could make Veklury less effective.

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.