Molnupiravir

There are no data from the use of molnupiravir in pregnant women. Studies in animals have shown reproductive toxicity.

Molnupiravir is not recommended during pregnancy. Women of childbearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of molnupiravir.

It is unknown whether molnupiravir or any of the components of molnupiravir are present in human milk, affect human milk production, or have effect on the breastfed 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.

Fertility

There were no effects on female or male fertility in rats at NHC exposures approximately 2 and 6 times respectively, the exposure in humans at the recommended human dose (RHD).

No studies on the effects on the ability to drive and use machines have been performed.

Summary of safety profile

In an interim analysis of a Phase 3 trial of subjects with mild to moderate COVID-19 treated with molnupiravir (n=386), the most common adverse reactions (≥1% of subjects) reported during treatment and during 14 days after the last dose were diarrhoea (3%), nausea (2%), dizziness (1%) and headache (1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

Tabulated list of adverse reactions

The adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000).