Molnupiravir is an oral antiviral agent given Emergency Use Authorization (EUA) in US, UK, and Japan for the treatment of adults with COVID-19 with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death.[3, 4, 5]

Molnupiravir belongs to a class of broad-spectrum antiviral drugs called nucleoside analogues. They act by interfering with the function of viral RNA polymerases – which are enzymes that make new viral RNA in infected cells.[3, 4] Molnupiravir inhibits SARS-CoV-2 replication in human lung tissue, blocks SARS-CoV-2 transmission in ferrets and reduces SARS-CoV-2 RNA in patients, thus keeps the illness from escalating.[6]

In India, Molnupiravir has been given restricted use license for emergency situations, and is to be used to treat adults with COVID-19 with SpO2 >93% and who have high risk of progression of the disease, including hospitalization or death.[5]

Molnupiravir is available as a capsule for oral use with a strength of 200 mg per capsule.[3, 4, 5]

The adult recommended dose of Molnupiravir is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. Molnupiravir 200 mg capsules can be taken with or without food. The capsules should be swallowed whole with a sufficient amount of fluid (e.g., a glass of water). The capsules should not be opened, crushed or chewed.[3, 4]

Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset. The adult recommended dose of Molnupiravir is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. The safety and efficacy of Molnupiravir when administered for periods longer than 5 days have not been established.[3, 4]

Yes, it should only be used in out-patient setting. Molnupiravir can be used to treat adults with COVID-19 with SpO2 >93% and who are at high risk of progression of disease, including hospitalization and death.[3, 4]

Patients with known hypersensitivity to the active substance, Molnupiravir, or to any of the excipients.[3, 4] Molnupiravir is not authorized – [3, 4, 5] i. For use in patients <18 years of age; ii. For initiation of treatment in patients requiring immediate hospitalization due to COVID-19 at that stage. However, if it was initiated before hospitalization due to COVID-19 it may be continued; iii. For use for longer than 5 consecutive days; iv. For pre-exposure or post-exposure prophylaxis for prevention of COVID-19; v. For pregnant women; vi. Females of child-bearing 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 Molnupiravir; vii. Males of reproductive potential, who are sexually active with females of child-bearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.

The safety and efficacy of Molnupiravir have not been established in pediatric patients. Molnupiravir is not authorized for use in patients <18 years of age.[3, 4]

There is no data for the use of Molnupiravir in pregnant women. Studies in animals have shown reproductive toxicity. Molnupiravir is not recommended during pregnancy. Women of child-bearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of Molnupiravir. Males of reproductive potential who are sexually active with females of child-bearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.[3, 4]

It is unknown whether Molnupiravir or any of the components of Molnupiravir are present in human milk, affect human milk production, or have an effect on the breast-fed infant. Animal lactation studies with Molnupiravir have not been conducted. Based on the potential for adverse reactions on the infant from Molnupiravir, breast-feeding is not recommended during treatment and for 4 days after the last dose of Molnupiravir.[3, 4]

Molnupiravir can be given to elderly patients / geriatric population. Pharmacokinetic analyses showed that age, gender, race, and ethnicity do not meaningfully influence the pharmacokinetics of Molnupiravir/NHC. (Molnupiravir is an Oral Prodrug of N-hydroxycytidine, NHC).[3, 4]

No dose adjustment in patients with any degree of renal impairment is needed. Renal clearance is not a meaningful route of elimination for Monupiravir/NHC. In a population PK analysis, mild or moderate renal impairment did not have a meaningful impact on the pharmacokinetics of Molnupiravir/NHC. The pharmacokinetics of Molnupiravir and NHC has not been evaluated in patients with eGFR <30 mL/min/1.73m2 or on dialysis.[3, 4]

No dose adjustment in patients with hepatic impairment is needed. The pharmacokinetics of Molnupiravir and NHC has not been evaluated in patients with hepatic impairment. Preclinical data indicate that hepatic elimination is not expected to be a major route of Molnupiravir/NHC elimination, therefore hepatic impairment is unlikely to affect Molnupiravir/NHC exposure.[3, 4]

In the MOVe-OUT phase III clinical trial, the incidence of most frequent drug-related adverse events were ≥1%. These include - diarrhea (1.7%), nausea (1.4%), and dizziness (1.0%).

Yes. The MOVe-OUT clinical trial published in November 2021 in the New England Journal of Medicine, showed that treatment with Molnupiravir reduces the risk of hospitalization and death by 30%.[2]

Molnupiravir is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.[2]

Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset. Currently, Molnupiravir can be used to treat adults with COVID-19 with SpO2 >93% and who are at high risk of progression of disease including hospitalization and death.[3, 4, 5]

Molnupiravir or any other COVID treatment - is not a substitute for COVID-19 vaccines.[3]