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Molnupiravir

LAGEVRIO

What it isNucleoside analog causing lethal viral mutagenesis; COVID-19 in those at risk.

Why this oneNo significant drug interactions, which is its advantage over nirmatrelvir-ritonavir in polypharmacy.

What limits itLower efficacy than nirmatrelvir. Contraindicated in pregnancy, and it is not recommended under 18 because of effects on growing cartilage.

FDA-approved for

FDA label

BOXED WARNING EUA mandatory requirements: unapproved product; provide Fact Sheet; document pregnancy counseling and contraception requirements; mandatory reporting of serious adverse events.
FDA dosingPopulationStartTargetMax
Mild-to-moderate COVID-19 in high-risk adults (EUA)Adult800 mg BID ×5 days

Renal No adjustment needed

Hepatic No adjustment needed

Missed dose within 10 h: take ASAP and resume schedule; >10 h late: skip. Do not double the dose.

Instructions

Cautions

Adverse reactions

Pregnancy Not recommended — may cause fetal harm based on animal data.

Lactation No human data; breastfeeding not recommended during treatment and for 4 days after the final dose.

NO BOXED WARNINGS

Principal riskNot for pregnancy; mutagenesis concerns

Cost, est. cash$300–$2,000/month

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4
Overdose danger2 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.

Mechanism of action: Molnupiravir ballicule

Molnupiravir ballicule: receptor binding, kinetics and half-life diagram

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