Veklury

— THERAPEUTIC CATEGORIES —
  • Viral infections

Veklury Generic Name & Formulations

General Description

Remdesivir 100mg/vial lyophilized pwd for IV infusion after reconstitution and dilution; or 100mg/20mL (5mg/mL) soln for IV infusion after dilution; preservative-free.

Pharmacological Class

SARS-CoV-2 nucleotide analogue RNA polymerase inhibitor.

How Supplied

Single-dose vial—1

Manufacturer

Generic Availability

NO

Mechanism of Action

Remdesivir is an adenosine nucleotide prodrug that inhibits the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA-dependent RNA polymerase. Its active metabolite, remdesivir triphosphate, acts as an analog of adenosine triphosphate (ATP) and competes with high selectivity (3.65-fold) over the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, resulting in delayed chain termination during replication of the viral RNA.

Veklury Indications

Indications

COVID-19 in patients who are: hospitalized, or not hospitalized and have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Veklury Dosage and Administration

Adults and Children

<1.5kg: not established. Give by IV infusion over 30–120mins. Term neonates (gestational age >37 weeks) and infants <28 days of age (≥1.5kg): initially 2.5mg/kg on Day 1, followed by 1.25mg/kg once daily from Day 2. ≥28 days of age (1.5–<3kg): initially 2.5mg/kg on Day 1, followed by 1.25mg/kg once daily from Day 2; (3–<40kg): initially 5mg/kg on Day 1, followed by 2.5mg/kg once daily from Day 2; (≥40kg): Initially 200mg once on Day 1, followed by 100mg once daily from Day 2. Hospitalized patients not requiring invasive mechanical ventilation and/or ECMO: treat for 5 days; if no improvement, may extend for a total duration of up to 10 days. Hospitalized patients requiring invasive mechanical ventilation and/or ECMO: treat for 10 days. Nonhospitalized patients: treat for 3 days. For pediatric pts weighing 1.5–<40kg: use only the lyophilized pwd dosage form.

Veklury Contraindications

Not Applicable

Veklury Boxed Warnings

Not Applicable

Veklury Warnings/Precautions

Warnings/Precautions

Should only be administered in a hospital or in a healthcare setting providing acute care. Obtain LFTs and prothrombin time prior to and during treatment. Consider discontinuing if ALT levels increase to >10×ULN. Discontinue if ALT elevation is accompanied by signs/symptoms of liver inflammation. Monitor for hypersensitivity reactions during and for at least 1hr after infusion; discontinue immediately if significant reactions occur. Elderly (monitor). Pregnancy. Nursing mothers.

Veklury Pharmacokinetics

Absorption

Time to maximum peak concentration: 0.67–0.68 hour.

Distribution

Plasma protein bound: 88–93.6%.

Metabolism

Carboxylesterase 1 (major), cathepsin A, CYP3A.

Elimination

Renal (10%). Half-life: 1 hour.

Veklury Interactions

Interactions

Do not administer the diluted solution simultaneously with any other medication. Concomitant chloroquine phosphate or hydroxychloroquine sulfate: not recommended.

Veklury Adverse Reactions

Adverse Reactions

Nausea, increased ALT/AST; hypersensitivity reactions, generalized seizure, rash.

Veklury Clinical Trials

See Literature

Veklury Note

Not Applicable

Veklury Patient Counseling

See Literature

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