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Molnupiravir (United States: Authorized for use): Drug information

Molnupiravir (United States: Authorized for use): Drug information
(For additional information see "Molnupiravir (United States: Authorized for use): Pediatric drug information" and see "Molnupiravir (United States: Authorized for use): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Lagevrio
Pharmacologic Category
  • Antiviral Agent
Dosing: Adult
COVID-19, treatment, mild to moderate

COVID-19, treatment, mild to moderate (outpatients with high risk of progression to severe illness) (alternative agent): Oral: 800 mg every 12 hours for 5 days; initiate as soon as possible after COVID-19 diagnosis, and within 5 days of symptom onset. After initiating treatment with molnupiravir, if hospitalization is required, completion of 5-day course is at the health care provider's discretion (FDA 2021; Jayk Bernal 2021; NIH 2021).

Missed dose:If a dose is missed within 10 hours of usual administration time, administer the missed dose as soon as possible, and resume normal dosing schedule. If a dose is missed by more than 10 hours, do not administer the missed dose, and resume dosing at the next scheduled administration time. Do not double the dose to make up for a missed dose (FDA 2021).

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary (FDA 2021).

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary (FDA 2021).

Dosing: Pediatric

(For additional information see "Molnupiravir (United States: Authorized for use): Pediatric drug information")

Note: Do not use in patients <18 years of age due to the potential for bone and cartilage toxicity (FDA 2021).

COVID-19, treatment, mild to moderate (outpatients with high risk of progression to severe illness) (alternative agent):

Adolescents ≥18 years: Oral: 800 mg every 12 hours for 5 days; initiate as soon as possible after COVID-19 diagnosis, and within 5 days of symptom onset. After initiating treatment with molnupiravir, if hospitalization is required, completion of 5-day course is at the health care provider's discretion (FDA 2021; Jayk Bernal 2021).

Dosing: Kidney Impairment: Pediatric

Adolescents ≥18 years: No dosage adjustment necessary (FDA 2021).

Dosing: Hepatic Impairment: Pediatric

Adolescents ≥18 years: No dosage adjustment necessary (FDA 2021).

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Lagevrio: 200 mg

Generic Equivalent Available: US

No

Product Availability

Molnupiravir approved for emergency use authorization by the FDA December 2021.

Prescribing and Access Restrictions

Molnupiravir is not commercially available; it is available as part of ongoing clinical trials and under an emergency use authorization (EUA) from the FDA. Molnupiravir is available from the distributor, AmerisourceBergen.

As part of the EUA, information consistent with fact sheets pertaining to emergency use of molnupiravir are required to be available for health care providers and patients/caregivers, and certain mandatory requirements for molnupiravir administration under the EUA must be met as outlined in the FDA EUA letter; the fact sheets may be accessed at https://www.molnupiravir.com. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with molnupiravir use by either submitting a MedWatch form (https://www.fda.gov/medwatch/report.htm), FDA Form 3500 (health professional; available at: https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500) by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-0178), or by calling 1-800-FDA-1088 to request a reporting form; a copy of all MedWatch forms should also be provided to Merck & Co., Inc. (phone: 1-800-672-6372; fax: 1-215-616-5677; e-mail: dpoc.usa@msd.com).

Administration: Adult

Oral: Administer with or without food. Swallow capsules whole; do not open, break, or crush (FDA 2021).

Administration: Pediatric

Oral: Administer with or without food. Swallow capsules whole; do not open, break, or crush (FDA 2021).

Missed dose: If a dose is missed within 10 hours of usual administration time, administer the missed dose as soon as possible, and resume normal dosing schedule. If a dose is missed by >10 hours, do not administer the missed dose, and resume dosing at the next scheduled administration time. Do not double the dose to make up for a missed dose (FDA 2021).

Use: Labeled Indications

See "Use: Off Label."

Use: Off-Label: Adult

COVID-19, treatment, mild to moderate (outpatients with high risk of progression to severe illness) (alternative agent)

Adverse Reactions

Adverse reactions and incidences are derived from the FDA-issued emergency use authorization (EUA). Adverse reactions reported in adults. Refer to EUA for information regarding reporting adverse reactions (FDA 2021).

Postmarketing:

Dermatologic: Erythema of skin, skin rash, urticaria

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Contraindications

There are no contraindications listed in the FDA emergency use authorization (EUA) fact sheet for health care providers.

Warnings/Precautions

Concerns related to adverse effects:

• Bone and cartilage effects: Bone and cartilage toxicity was observed in animals after repeat dosing; molnupiravir is not authorized for use in patients <18 years of age because it may affect bone and cartilage growth (FDA 2021).

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, have been reported. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care (FDA 2021).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

Reproductive Considerations

Evaluate and verify pregnancy status prior to use in patients who may become pregnant.

Pregnancy testing is recommended for patients who do not have regular menstrual cycles, who are unsure of the first day of their last cycle, or who do not use contraception correctly and consistently. Pregnancy status does not need confirmed in patients using an intrauterine system or contraceptive implant, patients who have undergone permanent sterilization, or when pregnancy is otherwise not possible.

Patients who may become pregnant should use reliable contraception correctly and consistently during therapy and for 4 days after the last dose of molnupiravir. Sexually active males with partners who may become pregnant should also use effective contraception during therapy and for at least 3 months after the last molnupiravir dose.

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to molnupiravir may cause fetal harm. Molnupiravir is currently available under FDA emergency use authorization (EUA) for the treatment of COVID-19; pregnant patients were not eligible for inclusion in a phase 3 study (Jayk Bernal 2021).

The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID-19. Pregnant patients with symptoms may require ICU admission, mechanical ventilation, or ventilatory support (ECMO) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2022; NIH 2021).

Use of molnupiravir in pregnancy is not recommended if other therapies are available. In pregnant patients at high risk of progressing to severe disease, use may be considered after the period of embryogenesis (eg, >10 weeks' gestation) when preferred treatments are not available (NIH 2021). If the decision is made to use molnupiravir in a pregnant patient, the prescriber must document that the known and potential risks, as outlined in the Fact Sheet for Patients and Caregivers, have been communicated to the patient.

Data collection to monitor pregnancy and infant outcomes following exposure to molnupiravir is ongoing. Healthcare providers must document that pregnant patients have been made aware of a molnupiravir pregnancy surveillance program. Health care providers should enroll patients who agree to participate (1-877-888-4231 or pregnancyreporting.msd.com). Patients may also enroll themselves.

Breastfeeding Considerations

It is not known if molnupiravir is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 4 days after the last molnupiravir dose; patients may express and discard milk during this time.

Interim guidance is available from the CDC for the care of lactating patients who are diagnosed with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/care-for-breastfeeding-women.html). Information related to COVID-19 and breastfeeding is also available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).

Monitoring Parameters

Pregnancy test prior to initiation, as clinically indicated (FDA 2021).

Mechanism of Action

Molnupiravir is metabolized to the cytidine nucleoside analog, NHC, which is further phosphorylated to the active ribonucleoside triphosphate (NHC-TP). NHC-TP is incorporated into SARS-CoV-2 RNA by viral RNA polymerase, resulting in errors in viral genome and subsequently inhibition of replication (FDA 2021).

Pharmacokinetics

Distribution: NHC: 142 L (FDA 2021).

Protein binding: NHC: Does not appear to be protein bound (FDA 2021).

Metabolism: Molnupiravir is metabolized to NHC; NHC undergoes phosphorylation to pharmacologically active ribonucleoside triphosphate.

Half-life elimination: NHC: 3.3 hours (FDA 2021).

Time to peak: NHC: 1.5 hours (FDA 2021).

Excretion: NHC: Urine (3%) (FDA 2021).

Pricing: US

Capsules (Lagevrio Oral)

200 mg (per each): $0.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Lagevrio (AU, DE, GB, NZ, PT)


For country abbreviations used in Lexicomp (show table)
  1. American College of Obstetricians and Gynecologists (ACOG). COVID-19 FAQs for obstetricians-gynecologists, obstetrics. https://www.acog.org/clinical-information/physician-faqs/covid-19-faqs-for-ob-gyns-obstetrics. Accessed March 15, 2022.
  2. Jayk Bernal A, Gomes da Silva MM, Musungaie DB, et al; MOVe-OUT Study Group. Molnupiravir for oral treatment of covid-19 in nonhospitalized patients. N Engl J Med. Published online December 16, 2021. doi:10.1056/NEJMoa2116044 [PubMed 34914868]
  3. Molnupiravir [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; February 2022.
  4. National Institutes of Health. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated December 30, 2021. Accessed January 3, 2022.
  5. US Food and Drug Administration (FDA). Fact sheet for healthcare providers: emergency use authorization for molnupiravir. https://www.merck.com/eua/molnupiravir-hcp-fact-sheet.pdf. Published December 23, 2021. Revised August 1, 2022. Accessed August 15, 2022.
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