molnupiravir: clinical use

Prescribing considerations

• Confirm a positive SARS-CoV-2 diagnostic test, mild to moderate illness, adult status and at least one risk factor for severe disease.
• Assess pregnancy possibility, breastfeeding and the ability to swallow capsules whole.
• The product remains subject to additional monitoring and is authorised under exceptional circumstances.

Contraindications and cautions

• Hypersensitivity to molnupiravir or any product excipient.
• Not recommended during pregnancy.
• Safety and efficacy have not been established below age 18.

Monitoring

• Watch for hypersensitivity and discontinue promptly if a clinically significant reaction occurs.
• Review clinical progress and suspected adverse reactions; no medicine-specific routine laboratory monitoring is specified in the selected SmPC.
• Report suspected adverse reactions through the MHRA Yellow Card scheme.

Clinical pharmacology

Molnupiravir is a prodrug hydrolysed to N4-hydroxycytidine, which is phosphorylated intracellularly to the active triphosphate. Incorporation into viral RNA produces accumulated replication errors. Major CYP enzymes and drug transporters are not expected to have a clinically important role in its disposition.

Formulation and product differences

• The selected product is an oral hard capsule supplied in a bottle.
• Capsules must be swallowed whole and must not be opened, crushed or chewed.
• The selected formulation may be taken with or without food.

Capsule

Route: Oral

Strengths: 200 mg