Remdesivir is indicated for the emergency treatment of suspected or laboratory-confirmed Coronavirus Disease 2019 (COVID-19). Severe COVID-19 includes patients with oxygen saturation (SpO2) below 94% on room air, or those requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized only for hospitalized adult and pediatric patients where intravenous treatment is considered clinically appropriate.

Remdesivir is an adenosine nucleotide prodrug. After entering the cells, it is metabolized into its active nucleoside triphosphate form. This active metabolite acts as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into viral RNA by the SARS-CoV-2 RNA-dependent RNA polymerase. This process causes delayed termination of viral RNA chain replication and helps prevent further viral multiplication. Remdesivir triphosphate is only a weak inhibitor of mammalian DNA and RNA polymerase and has a low risk of mitochondrial toxicity.

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).

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

Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir or any of its components.

In clinical trials involving healthy adult subjects, an observed adverse reaction associated with Remdesivir was an increase in liver transaminase levels.

There are no adequate and well-controlled studies on the use of Remdesivir in pregnant women. It should be used during pregnancy only when the potential benefit outweighs the possible risk to the mother and fetus. There is no available information regarding the presence of Remdesivir in human milk, its effects on breastfed infants, or its effect on milk production. Due to the possible risk of SARS-CoV-2 transmission to uninfected infants and potential drug-related adverse effects, the benefits of breastfeeding should be carefully weighed against the mother’s need for Remdesivir therapy and the possible risks to the child.

Clinical data regarding the use of Remdesivir are limited. Serious and unexpected adverse reactions may occur that have not been previously reported. Careful monitoring is advised during treatment.

Anti-viral drugs

Do not reuse or store unused Remdesivir lyophilized powder, injection solution, or diluted infusion solution for future use, as this product contains no preservatives.

Lyophilized Powder: Store Remdesivir for injection (100 mg vial) below 30°C in a dry place, protected from light and moisture. Do not use after the expiry date.

After Reconstitution: The reconstituted vial may be stored for up to 4 hours at room temperature (20°C–25°C) or up to 24 hours under refrigeration (2°C–8°C). Dilution should be completed on the same day of administration.

Diluted Infusion Solution: The diluted infusion solution may be stored for up to 4 hours at room temperature (20°C–25°C) or up to 24 hours under refrigeration (2°C–8°C).