Remdesivir

Remdesivir is used to treat COVID-19 in adults and children from birth who weigh at least 3 pounds (1.5 kilograms) and are hospitalized or are not hospitalized 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 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.

Remdesivir doses are based on weight. Your dose may change if you gain or lose weight. You will receive remdesivir once a day for 3 to up to 10 days, depending on whether you are hospitalized. Your doctor will determine how long you should receive remdesivir.

You will be watched during and for at least one hour after the injection to make sure you do not have an allergic reaction.

You will need certain blood tests before starting and during treatment with remdesivir.

You must remain under the care of a doctor while you are being treated with remdesivir.

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

You should not be treated with remdesivir if you are allergic to it or any of its ingredients.

Tell your doctor if you have or have ever had:

• liver disease.

It is not known if remdesivir will harm an unborn baby if received during the first trimester of pregnancy. Having COVID-19 during pregnancy may cause complications or medical problems in both mother and baby. The benefit of treating COVID-19 may outweigh any risks to the baby. Tell your doctor right away if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your medical caregivers if you feel dizzy, nauseated, light-headed, itchy, sweaty, have a headache or uneven heart rate, chest tightness, back pain, trouble breathing, or swelling in your face.

Remdesivir may cause serious side effects. Call your doctor at once if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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 the FDA at 1-800-FDA-1088.

Usual Remdesivir 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 is 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 Remdesivir Pediatric Dose for COVID-19:

Less than 28 days old and at least 1.5 kg:

-Loading dose (Day 1): Remdesivir 2.5 mg/kg IV as a single dose -Maintenance dose (from Day 2): Remdesivir 1.25 mg/kg IV once a day

At least 28 days old and 1.5 to 3 kg:

-Loading dose (Day 1): Remdesivir 2.5 mg/kg IV as a single dose -Maintenance dose (from Day 2): Remdesivir 1.25 mg/kg IV once a day

At least 28 days old and 3 kg to less than 40kg:

-Loading dose (Day 1): Remdesivir 5 mg/kg IV as a single dose -Maintenance dose (from Day 2): Remdesivir 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 1.5 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

In a medical setting, you are not likely to miss a dose.

In a medical setting, an overdose would be treated quickly.

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

Tell your doctor about all your other medicines, especially if you are taking chloroquine or hydroxychloroquine. Either of these medicines could make remdesivir less effective.

Other drugs may affect remdesivir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Can Remdesivir be used to treat COVID-19 (coronavirus)?