LAGEVRIO 200 mg/1
molnupiravir · CAPSULE · Merck Sharp & Dohme LLC
LAGEVRIO is a capsule containing molnupiravir at 200 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- LAGEVRIO
- Generic Name
- molnupiravir
- NDC Code (Product)
0006-5055- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 200 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Marketing Start
- 12/23/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Dosage for Emergency Use of LAGEVRIO in Adult Patients The dosage in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food [see Clinical Pharmacology (12.3) ] . Take LAGEVRIO as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset [see Emergency Use Authorization (1) and Clinical Studies (14) ] . Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2 [see Patient Counseling Information (17) ] . LAGEVRIO is not authorized for use for longer than 5 consecutive days because the safety and efficacy have not been established. If the patient misses a dose of LAGEVRIO within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a miss…
Contraindications
4 CONTRAINDICATIONS No contraindications have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA.
Drug Interactions
7 DRUG INTERACTIONS No drug interactions have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA. No clinical drug-drug interaction trials of LAGEVRIO with concomitant medications, including other treatments for mild-to-moderate COVID-19, have been conducted [see Clinical Pharmacology (12.3) ].
Adverse Reactions
6 ADVERSE REACTIONS 6.1 Adverse Reactions from Clinical Studies The following adverse reactions have been observed in the clinical study of LAGEVRIO that supported the EUA. The adverse reaction rates observed in these clinical trials cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Additional adverse events associated with LAGEVRIO may become apparent with more widespread use. Overall, more than 900 subjects have been exposed to LAGEVRIO 800 mg twice daily in clinical trials. The safety assessment of LAGEVRIO is primarily based on an analysis from subjects followed through Day 29 in the Phase 3 study in non-hospitalized subjects with COVID-19 (MOVe-OUT) [see Clinical Studies (14) ] . The safety of LAGEVRIO was evaluated based on an analysis of a Phase 3 double-blind trial (MOVe-OUT) in which 1,411 non-hospitalized subjects with COVID-19 were randomized and treated with LAGEVRIO (N=710) or placebo (N=701) for up to 5 days. Adverse events were those reported while subjects were on study intervention or within 14 days of study intervention completion/discontinuation. Discontinuation of study intervention du…
Frequently Asked Questions
What is LAGEVRIO used for?
LAGEVRIO contains molnupiravir. It is a capsule taken oral. Consult your doctor for specific uses.
Is LAGEVRIO a controlled substance?
LAGEVRIO is not classified as a controlled substance by the DEA.
What is the generic name for LAGEVRIO?
The generic name for LAGEVRIO is molnupiravir. There are no other listed brand versions of molnupiravir.
What is the NDC code for LAGEVRIO 200 mg/1?
The NDC (National Drug Code) for LAGEVRIO 200 mg/1 is 0006-5055, listed by Merck Sharp & Dohme LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)