LAGEVRIO

What it is

LAGEVRIO is molnupiravir capsules containing 200 mg of molnupiravir per capsule. LAGEVRIO is a prodrug that is metabolised to the cytidine nucleoside analogue NHC, which is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP); NHC-TP incorporation into viral RNA by the viral RNA polymerase results in an accumulation of errors in the viral genome leading to inhibition of replication.

Approved indications

— Treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death.

Dosing overview

The recommended dose of LAGEVRIO in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food. LAGEVRIO should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset in adults who are at risk for progression to severe COVID-19.

Key safety warnings

Hypersensitivity reactions have been reported with LAGEVRIO; if signs or symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue LAGEVRIO and initiate appropriate medications and/or supportive care. The use of LAGEVRIO 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, as based on animal data, LAGEVRIO may cause fetal harm when administered to pregnant women. Breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO. Men who are sexually active with a partner of childbearing potential should use an adequate form of contraception during and 3 months after treatment with molnupiravir. Safety and efficacy of LAGEVRIO have not been established in patients less than 18 years of age, therefore use in paediatric patients is not recommended.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the product information.

PBS listing

LAGEVRIO 200 mg capsules are listed on the PBS with one item under streamlined restrictions, with an ex-manufacturer price of A$988.00.

Regulatory history

LAGEVRIO molnupiravir 200 mg capsules were first registered on the Australian Register of Therapeutic Goods on 20 January 2022. LAGEVRIO is subject to additional monitoring in Australia, which will allow quick identification of new safety information. The approval was based on the analysis of efficacy and safety data from a Phase 3 trial, with continued approval of this indication depending on additional data. In March 2022, the PBAC recommended a change to the PBS listing to allow nurse practitioners to prescribe LAGEVRIO. In September 2022, the PBAC recommended changes to support use in unvaccinated or suboptimally vaccinated patients and listing in the Doctor's Bag Schedule. In November 2023, the PBAC provided advice that molnupiravir is considered appropriate for patients who cannot use nirmatrelvir and ritonavir, and recommended changes to restriction and price reduction.