molnupiravir 200 MG Oral Capsule — Nucleosides and nucleotides excl. reverse transcriptase inhibitors. Mechanism of Action Molnupiravir is a prodrug with antiviral activity against SARS-CoV-2. It is metabolized to the cytidine nucleoside analogue, NHC…
Boxed warning
MANDATORY REQUIREMENTS FOR ADMINISTRATION OF LAGEVRIO UNDER EMERGENCY USE AUTHORIZATION In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of LAGEVRIO, the following steps are required. Use of LAGEVRIO under this EUA is limited to the following (all requirements must be met): Treatment of adults with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate [see Limitations of Authorized Use (1) ] . As the prescribing healthcare provider, review the information contained within the “Fact Sheet for Patients and Caregivers” with your patient or caregiver prior to the patient receiving LAGEVRIO. Healthcare providers must provide the patient/caregiver with an electronic or hard copy of the “Fact Sheet for Patients and Caregivers” prior to the patient receiving LAGEVRIO and must document that the patient/caregiver has been given an electronic or hard copy of the “Fact Sheet for Patients and Caregivers”. The prescribing healthcare providers must inform the patient/caregiver that: LAGEVRIO is an unapproved drug that is authorized for use under this Emergency Use Authorization. Other therapeutics are currently approved for the same use as LAGEVRIO [ see Emergency Use Authorization (1) - Information Regarding Available Alternatives for the EUA Authorized Use ]. There are benefits and risks of taking LAGEVRIO as outlined in the “Fact Sheet for Patients and Caregivers.” There is a pregnancy registry. Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of LAGEVRIO. Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose. The prescribing healthcare provider must assess whether a female of childbearing potential is pregnant or not, if clinically indicated [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ]. Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals. If LAGEVRIO is used during pregnancy, prescribing healthcare providers must communicate to the patient the known and potential benefits and the potential risks of LAGEVRIO use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers” [see Warnings and Precautions (5.1 , 5.3) , Use in Specific Populations (8.1 , 8.3) and Nonclinical Toxicology (13.1) ]. If the decision is made to use LAGEVRIO during pregnancy, the prescriber must document that the known and potential benefits and the potential risks of LAGEVRIO use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers,” were discussed with the patient. The prescribing healthcare provider must document that a pregnant individual was made aware of the pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791. The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to LAGEVRIO within 7 calendar days from the healthcare provider’s awareness of the event [see Adverse Reactions (6.4) ]. For information on clinical studies of LAGEVRIO and other therapies for the treatment of COVID-19, see www.clinicaltrials.gov .
Nucleosides and nucleotides excl. reverse transcriptase inhibitors
Real-world adverse events (FAERS)
Product Use Issue710No Adverse Event630Covid-19481Wrong Technique in Product Usage Process394Product Use in Unapproved Indication311Diarrhoea270Product Use Complaint213Rash210
Dosage
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 missed dose. Should a patient require hospitalization after starting treatment with LAGEVRIO, the patient may complete the full 5 day treatment course per the healthcare provider’s discretion. 2.2 Dosage Adjustments in Specific Populations No dosage adjustment is recommended based on renal or hepatic impairment or in geriatric patients [see Use in Specific Populations (8.5 , 8.6 , 8.7) ] . 2.3 Administration via Nasogastric (NG), Orogastric (OG) and Gastrostomy (G) Tubes that are 12F or Larger or via Gastrojejunostomy (GJ) Tubes that are 14F or Larger Open four (4) capsules and transfer contents into a clean container with a lid. Add 40 mL of water to the container. Put the lid on the container and shake to mix the capsule contents and water thoroughly for 3 minutes. NOTE : Capsule contents may not dissolve completely. The prepared mixture may have visible undissolved particulates and are acceptable for administration. Flush the tube with 5 mL of water prior to administration. Using an appropriate syringe, draw up the entire contents from the container and administer immediately through the tube. If using a GJ tube, administer through the gastric port. Do not keep the mixture for future use. If any portion of the capsule contents are left in the container, add 10 mL of water to the container, mix, and using the same syringe draw up the entire contents of the container and administer through the tube. Repeat as needed until no capsule contents are left in the container or syringe. Flush the tube with 5 mL of water twice (10 mL total) after administration of the mixture.
Warnings
WARNINGS AND PRECAUTIONS There are limited clinical data available for LAGEVRIO. Serious and unexpected adverse events may occur that have not been previously reported with LAGEVRIO use. 5.1 Embryo-Fetal Toxicity Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of LAGEVRIO in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; therefore, LAGEVRIO is not recommended for use during pregnancy. When considering LAGEVRIO for a pregnant individual, the prescribing healthcare provider must communicate the known and potential benefits and the potential risks of using LAGEVRIO during pregnancy to the pregnant individual. LAGEVRIO is authorized to be prescribed to a pregnant individual only after the healthcare provider has determined that the benefits would outweigh the risks for that individual patient. If the decision is made to use LAGEVRIO during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and the potential risks of using LAGEVRIO during pregnancy were communicated to the pregnant individual. Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective method of contraception correctly and consistently, as applicable, during treatment with LAGEVRIO and for 4 days after the final dose [see Use in Specific Populations (8.1 , 8.3 and Nonclinical Toxicology (13.1) ] . Prior to initiating treatment with LAGEVRIO, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated. Pregnancy status does not need to be confirmed in patients who have undergone permanent sterilization, are currently using an intrauterine system or contraceptive implant, or in whom pregnancy is not possible. In all other patients, assess whether the patient is pregnant based on the first day of last menstrual period in individuals who have regular menstrual cycles, is using a reliable method of contraception correctly and consistently or have had a negative pregnancy test. A pregnancy test is recommended if the individual has irregular menstrual cycles, is unsure of the first day of last menstrual period or is not using effective contraception correctly and consistently [see Box ] . 5.2 Hypersensitivity Including Anaphylaxis Hypersensitivity reactions, including anaphylaxis, have been reported with LAGEVRIO. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue LAGEVRIO and initiate appropriate medications and/or supportive care. 5.3 Bone and Cartilage Toxicity LAGEVRIO is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. Bone and cartilage toxicity was observed in rats after repeated dosing [see Nonclinical Toxicity (13.2) ] . The safety and efficacy of LAGEVRIO have not been established in pediatric patients [see Use in Specific Populations (8.4) ] .
Contraindications
CONTRAINDICATIONS No contraindications have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA.
Mechanism of action
Mechanism of Action Molnupiravir is a prodrug with antiviral activity against SARS-CoV-2. It is metabolized to the cytidine nucleoside analogue, NHC which distributes into cells where NHC is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP incorporation (as NHC-monophosphate [NHC-MP]) into SARS-CoV-2 RNA by the viral RNA polymerase (nsp12) results in an accumulation of errors in the viral genome leading to inhibition of replication. The mechanism of action (known as viral error catastrophe or viral lethal mutagenesis) is supported by biochemical and cell culture data, studies of SARS-CoV-2 infection in animal models, and analyses of SARS-CoV-2 genome sequences in human subjects treated with LAGEVRIO.
Source: RxNorm + openFDA + RxClass + FAERS · 2026
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