Remdesivir

Remdesivir

Remdesivir

What is Remdesivir?

• in a hospital; or

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

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

Remdesivir side effects

If necessary, get emergency medical helpSigns 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 immediately if you have:

• severe headache, throbbing in the neck or ears;

• fast, slow, or pounding heartbeat;

• wheezing, difficulty breathing;

• facial swelling;

• nausea;

• fever, chills, or tremors;

• itching, sweating; or

• a light-headed feeling, as if you were going to faint;

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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

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

Before you take this medicine

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, planning to become pregnant, or if you are breast-feeding.

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

How is remdesivir administered?

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

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

Remdesivir must be administered slowly and the infusion may take 30 to 120 minutes.

If you are in hospital: Remdesivir is usually given once a day for up to 10 days.

If you are not in hospital: Remdesivir is usually given once a day for three days.

Frequent blood tests are required to check your liver function.

You must remain under the care of a doctor during treatment with remdesivir for COVID-19.

Remdesivir dosage information

Usual Adult Dose for COVID-19:

Initial dose (day 1): 200 mg i.v. as a single dose
Maintenance dose (from day 2): 100 mg i.v. 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 (up to 10 days total) if clinical improvement is not demonstrated
-Non-hospitalized patients: 3 days in total

Use: For the treatment of coronavirus disease 2019 (COVID-19) in patients who:
-Hospitalization, or
– You are not hospitalized, have mild to moderate COVID-19 illness, and are at high risk of developing severe COVID-19 illness, including hospitalization or death

Usual Pediatric Dose for COVID-19:

28 days old and older:
Weight 3 to less than 40 kg:
-Loading dose (Day 1): 5 mg/kg i.v. as a single dose
-Maintenance dose (from day 2): 2.5 mg/kg i.v. once a day

Weight at least 40 kg:
-Loading dose (Day 1): 200 mg i.v. as a single dose
-Maintenance dose (from day 2): 100 mg i.v. 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 (up to 10 days total) if clinical improvement is not demonstrated
-Non-hospitalized patients: 3 days in 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:
-Hospitalization, or
– You are not hospitalized, have mild to moderate COVID-19 illness, and are at high risk of developing severe COVID-19 illness, including hospitalization or death

What happens if I miss a dose?

Because you will receive remdesivir in a clinical setting, you are unlikely to miss a dose.

What happens if I overdose?

Because remdesivir is administered by healthcare professionals in a medical setting, you will receive rapid treatment in the event of an overdose.

What should I avoid while taking remdesivir?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs affect remdesivir?

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

Other medications can affect remdesivir, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

• Kann Remdesivir zur Behandlung von COVID-19 (Coronavirus) eingesetzt werden?

More information

• Ihr Arzt kann Ihnen weitere Informationen zu Remdesivir geben.

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.