Remdesivir for injection 100 mg
Each vial contains: 100 mg of Remdesivir
AUTHORIZED USE: Remdesivir is authorized for use under an EUA (Emergency Use Authorization) for treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV2 infection and severe disease.
DOSAGE AND ADMINISTRATION: Should be administered via intravenous (IV) infusion only. Do not administer as an intramuscular (IM) injection. Adult and pediatric patients (greater than 28 days old) must have an eGFR determined and full-term neonates (at least 7 days to less than or equal to 28 days old) must have serum creatinine determined before dosing of remdesivir and daily while receiving remdesivir. Hepatic laboratory testing should be performed in all patients prior to starting remdesivir and daily while receiving remdesivir.
- Adults: Administer remdesivir via IV infusion in a total volume of up to 250 mL 0.9% sodium chloride over 30 to 120 minutes. Recommended dosage in adults is a single loading dose of remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of remdesivir 100 mg from day 2 via IV infusion. For patients requiring invasive mechanical ventilation and / or ECMO, total treatment duration is 10 days. For patients not requiring invasive mechanical ventilation and/or ECMO, total treatment duration is 5 days. If a patient does not show clinical improvement, treatment may be extended for up to 5 days.
- Pediatrics: For pediatric patients weighing 3.5 kg to less than 40 kg, use remdesivir for injection, 100 mg, lyophilized powder only. Do not use remdesivir injection, 100 mg/20 mL (5 mg/mL) Hepatic impairment: Remdesivir should only be used in patients with hepatic impairment if the potential benefit outweighs the potential risk. Renal impairment: Not recommended in adults and pediatric patients (greater than 28 days old) with eGFR less than 30 mL per minute or in full-term neonates (at least 7 days and less than or equal to 28 days old) with serum creatinine clearance greater than or equal to 1 mg/dL unless the potential benefit outweighs the potential risk.
SAFETY - RELATED INFORMATION
Contraindications: Contraindicated in patients with known hypersensitivity to any ingredient of remdesivir.
Warnings: Remdesivir causes hypersensitivity reactions including infusion-related and anaphylactic reactions. Discontinue the administration of remdesivir if symptoms like hypotension, tachycardia, bradycardia, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering occurs. Remdesivir when coadministered with chloroquine phosphate or hydroxychloroquine sulfate causes an antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of remdesivir and hence is not recommended in combination.
Precaution: Before initiation of remdesivir all patients should be tested for hepatic laboratory testing. Remdesivir should not be initiated in patients with ALT greater than or equal to 5 times the upper limit of normal. The use should be discontinued in patients who develop ALT greater than or equal to 5 times the upper limit of normal during treatment with remdesivir. Use of remdesivir may be restarted when ALT is less than 5 times the upper limit of normal or ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase.
Pregnancy: No adequate and well-controlled studies of remdesivir use in pregnant women have been conducted. Remdesivir should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
Renal impairment: Remdesivir is not recommended in adults and pediatric patients with eGFR less than 30 mL/min or in full-term neonates with serum creatinine greater than or equal to 1 mg/dL unless the potential benefit outweighs the potential risk.
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.
Adverse reaction: Most common adverse reaction associated with remdesivir is increase in liver transaminase