Remdesivir is used to treat adults and children at least 28 days and older who weigh at least 7 pounds (3 kilograms) with positive results for COVID-19 who are:

• in a hospital; or

• not in a hospital and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Remdesivir may also be used for purposes not listed in this medication guide.

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

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using remdesivir.

Remdesivir is given as an infusion into a vein. A healthcare provider will give you this injection.

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

If you are hospitalized: remdesivir is usually given once per day for up to 10 days.

If you are not hospitalized: remdesivir is usually given once per 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 remdesivir for COVID-19.

Usual Adult Dose 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
-Nonhospitalized patients: 3 days total

Use: For the treatment of coronavirus disease 2019 (COVID-19) in patients 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 for COVID-19:

28 Days of Age and Older:
Weight 3 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

Weight 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:
-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
-Nonhospitalized patients: 3 days total

Comments:
-The lyophilized powder formulation is the only approved dosage form for pediatric patients weighing 3 to less than 40 kg.

Use: For the treatment of COVID-19 in patients 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 remdesivir if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease; or

• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of remdesivir on the baby.

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

Since remdesivir 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: 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 side effects of remdesivir may 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 remdesivir less effective.

Other drugs may affect 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.

In clinical trials, patients generally tolerated remdesivir well and reported lower rates of adverse events compared with a placebo.

The recommended dosage for adults and children age 12 years and older who weigh at least 88 lb is 200 milligrams (mg) of remdesivir on day 1, followed by once-daily maintenance doses of 100 mg starting on day 2.

Your doctor will determine how long you’ll need to take this medicine.

When the FDA approved remdesivir, the agency also issued a new, temporary emergency use authorization allowing the drug to be used to treat:

• Hospitalized children under age 12 who weigh at least 3.5 kg (about 8 lb)
• Hospitalized children weighing from 3.5 kg (8 lb) to less than 40 kg (88 lb) with suspected or confirmed COVID-19 for whom an IV agent is clinically appropriate