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Remdesivir

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

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  • Product Details

    Description

    Remdesivir is a broad-spectrum antiviral agent that acts as a nucleotide analog prodrug. It is indicated for the treatment of COVID-19 in adults and pediatric patients (=28 days old and weighing =3 kg) who are either hospitalized or not hospitalized but at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir inhibits RNA-dependent RNA polymerase (RdRp), which is essential for viral replication in SARS-CoV-2, the virus responsible for COVID-19. It was the first antiviral granted full FDA approval for COVID-19 treatment.

    Fact Table

    Formula

    C27H35N6O8P

    License

    US FDA (2020), EMA, WHO Emergency Use Listing

    Bioavailability

    Low (IV administration required)

    Legal status

    Rx-only

    Chemical Name

    Remdesivir

    Elimination half-life

    ~1 hour (remdesivir); ~25 hours (GS-441524, active metabolite)

    Dosage (Strength)

    200 mg IV on Day 1, then 100 mg IV once daily for 4–9 days

    Pregnancy

    Use only if clearly needed (limited human data)

    Brands

    Veklury

    Protein binding

    ~88–93%

    PubChem CID

    121304016

    MedlinePlus

    a620033

    ChEBI

    CHEBI:145994

    ATC code

    J05AB16

    DrugBank

    DB14761

    KEGG

    D11974

    Routes of administration

    Intravenous infusion

    Directions

    Remdesivir is administered via intravenous (IV) infusion:

    • Hospitalized patients:
    • Day 1: 200 mg IV on day 1
    • Days 2–5: 100 mg IV once daily
    • May be extended to 10 days based on clinical response (e.g., patients on mechanical ventilation)
    • Non-hospitalized patients at high risk (outpatient use):
    • 200 mg IV on day 1
    • 100 mg IV on days 2 and 3

    Infusions should be administered over 30–120 minutes. Adjustments or discontinuation may be necessary based on renal or hepatic function.

    Ingredients

    Remdesivir is supplied as either:

    • Lyophilized powder (100 mg per vial)
    • Solution for injection (100 mg/20 mL)

    Each vial contains:

    • Remdesivir 100 mg
    • Betadex sulfobutyl ether sodium (SBECD; solubilizing agent)
    • Water for injection (in liquid formulation)

    Reconstitution and dilution are required before IV administration. Final preparation should be performed under sterile conditions.

    Contraindications

    Remdesivir is contraindicated in patients with:

    • Known hypersensitivity to remdesivir or any excipients
    • Alanine aminotransferase (ALT) levels =10× ULN
    • Severe renal impairment (eGFR <30 mL/min), for formulations containing SBECD, unless benefits outweigh risks

    Cautions

    • Hepatotoxicity: Monitor liver function prior to and during treatment. Discontinue if ALT increases significantly or if signs of liver inflammation occur.
    • Renal toxicity: Accumulation of SBECD in renal impairment may pose risks; use caution in patients with reduced renal function.
    • Infusion-related reactions (hypotension, nausea, diaphoresis, shivering) have been reported.
    • Limited data on use in pregnant and lactating women—use only if clearly needed.

    Side Effects

    Common side effects include:

    • Nausea
    • Headache
    • Elevated liver enzymes (ALT/AST)
    • Hypokalemia
    • Diarrhea

    Serious adverse effects may include:

    • Hepatotoxicity
    • Hypersensitivity and anaphylactic reactions
    • Renal impairment
    • Bradycardia (rare)

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 13379

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