Bemsivir 5mg ml IV Infusion

Indications

Emergency use of Bemsivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (SpO2) less than 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Bemsivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.

Pharmacology

Remdesivir is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Remdesivir Triphosphate acts as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.

Dosage & Administration

Adult Patients requiring invasive mechanical ventilation and/or ECMO: A single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.

Adult Patients not requiring invasive mechanical ventilation and/or ECMO: 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 does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (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 weighing between 3.5 kg to less than 40 kg: One loading dose of Remdesivir 5 mg/kg IV on day 1 followed by Remdesivir 2.5 mg/kg IV once daily for subsequent days.

Pediatric Patients with body weight 40 kg and above: Use adult dosage regimen.

Side Effects

An adverse reaction associated with Bemsivir in clinical trials in healthy adult subjects was increased liver transaminases.

Precautions & Warnings

There are limited clinical data available for Bemsivir. Serious and unexpected adverse events may occur that have not been previously reported with Bemsivir use.

Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.

Contraindications

Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.

Pregnancy & Lactation

No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential benefit for the mother and fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfed infants, or the effects on milk production.

Storage Conditions

Bemsivir Lyophilized Powder: Store at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date. After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C).

Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult your physician or pharmacist before starting any medication.