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Indications - Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.

Dosage & Administration - Dosage General Information- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir. Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir. Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection. Adult Patients- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days. The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days) Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes. Pediatric Patients- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight. For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days) For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered. For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days). Administration The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg Infusion bag 250 ml: Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min Infusion bag 100 ml: Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min

Side Effects - An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.

Contraindications - Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.

Others - Precautions & Warnings There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.