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Remdevir IV Injection Remdesivir 5 mg/ml -100 mg vial
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Remdesivir has an FDA Emergency Use Authorization for use in adults and children with suspected or confirmed COVID-19 in hospital with an oxygen saturation ≤ 94%
Remdesivir, or GS-5734, is an adenosine triphosphate analog first described in the literature in 2016 as a potential treatment for Ebola. In 2017, its activity against the coronavirus family of viruses was also demonstrated. Remdesivir is also being researched as a potential treatment to SARS-CoV-2, the coronavirus responsible for COVID-19. Remdesivir was granted an FDA Emergency Use Authorization on 1 May 2020. This is not the same as an FDA approval.
Remdesivir is a nucleoside analog that is expected to inhibit the action of RNA polymerase. By incorporating into RNA, additional nucleotides cannot be added, terminating RNA transcription. Viruses with mutations in RNA polymerase to develop partial resistance to remdesivir have been shown to be less infective.
Dosage & Administration
The FDA Emergency Use Authorization suggests a loading dose of 200 mg once daily in patients ≥ 40 kg or 5 mg/kg once daily in patients 3.5 kg to less than 40 kg, followed by a maintenance dose of 100 mg once daily in patients ≥ 40 kg or 2.5 mg/kg once daily in patients 3.5 kg to less than 40 kg. Patients not needing invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) should be treated for 5 days (including the loading dose on day 1), up to 10 days if they do not show improvement. Patients requiring invasive mechanical ventilation or ECMO should be treated for 10 days.
Clinical trials used a regimen of 200mg once daily on the first day, followed by 100mg once daily for another 9 days. Early data suggests that some patients may benefit from only 5 days of treatment.
Remdesivir was originally investigated as a treatment for Ebola virus, but has potential to treat a variety of RNA viruses. Its activity against the coronavirus (CoV) family of viruses, such as SARS-CoV and MERS-CoV, was described in 2017, and it is also being investigated as a potential treatment for SARS-CoV-2 infections.
Remdesivir is contraindicated in patients with known hypersensitivity to any ingredient of remdesivir.
An adverse reaction associated with remdesivir in clinical trials in healthy adult subjects was increased liver transaminases. Additional adverse reactions associated with the drug, some of which may be serious, may become apparent with more widespread use.
Pregnancy & Lactation
Remdesivir should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
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.
Use in Special Populations
The pharmacokinetics of remdesivir have not been evaluated in patients with renal impairment. The pharmacokinetics of remdesivir have not been evaluated in patients with hepatic impairment. It is not known if dosage adjustment is needed in patients with hepatic impairment and remdesivir should only be used in patients with hepatic impairment if the potential benefit outweighs the potential risk.
Store diluted remdesivir solution for infusion up to 4 hours at room temperature (20°C to 25°C) or 24 hours at refrigerated temperature (2°C to 8°C).
Prior to dilution, equilibrate remdesivir injection to room temperature (20°C to 25°C). Sealed vials can be stored up to 12 hours at room temperature prior to dilution.
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