Remidia

Remidia

remdesivir

Manufacturer:

Darya-Varia
Concise Prescribing Info
Contents
Remdesivir
Indications/Uses
Lab confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients ≥12 yr weighing at least 40 kg w/ severe disease (O2 saturation ≤94% on room air or requiring supplemental O2, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Dosage/Direction for Use
Adult & adolescent ≥12 yr, weighing at least 40 kg Single loading dose of 200 mg IV infusion over 30-120 min on day 1 followed by 100 mg once daily on day 2 onwards for at least 5 days & not >10 days. Duration of treatment: Patient requiring invasive mechanical ventilation &/or ECMO 10 days. Patient not requiring invasive mechanical ventilation &/or ECMO 5 days. Patient w/o clinical improvement May be extended up to 5 additional days for a total of up to 10 days.
Contraindications
Special Precautions
Not to be given as IM inj. Discontinue use if signs & symptoms of hypersensitivity including infusion-related & anaphylactic reactions occur; ALT elevation accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase or INR. Monitor liver function & eGFR prior to & during treatment. Not recommended to be used w/ chloroquine phosphate or hydroxychloroquine sulphate. May adversely affect renal function due to betadex sulfobutyl ether Na. Not to be used in patients w/ eGFR <30 mL/min. Determine liver function prior to treatment & monitor while in therapy. Not to be initiated in patients w/ ALT ≥5 times the upper limit of normal at baseline. Women of childbearing potential should use effective contraception during treatment. Not to be used during pregnancy. Discontinue breastfeeding or discontinue/abstain from therapy. Childn <12 yr & weighing <40 kg.
Adverse Reactions
Increased transaminases. Headache; nausea; rash.
Drug Interactions
Antagonism effect w/ concomitant use of chloroquine phosphate or hydroxychloroquine sulphate. Increased exposure w/ strong inhibitors. Decreased plasma conc w/ strong inducers eg, rifampicin. Transient increased plasma conc of CYP3A4 or OATP1B1/1B3 substrates. May lead to loss of efficacy w/ CYP1A2 or CYP3A4 substrate w/ narrow therapeutic index.
MIMS Class
Antivirals
ATC Classification
J05AB16 - remdesivir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Remidia lyo powd for inj 100 mg
Packing/Price
(lyo) 1's (Rp1,450,000/boks)
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