Lagevrio Aug 2025
SELECTED SAFETY INFORMATION: LAGEVRIO® (molnupiravir)
Pregnancy Category D: The use of LAGEVRIO is not recommended during pregnancy. In women of childbearing potential, health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test.
▼This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
SELECTED SAFETY INFORMATION: LAGEVRIO (molnupiravir)
INDICATION:
LAGEVRIO has provisional approval for the 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. The decision to approve this indication was based on efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.
CONTRAINDICATIONS: Hypersensitivity to the active substance or any of the excipients. 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.
PRECAUTIONS:
Pregnancy Category D: The use of LAGEVRIO is not recommended during pregnancy. In women of childbearing potential, health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test.
Contraception: Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO. Sexually active men with a partner of childbearing potential should use contraception during and for 3 months after treatment. Based on animal data, LAGEVRIO may cause foetal harm when administered to pregnant women.
Breastfeeding: Based on the potential for adverse reactions on the infant from LAGEVRIO, breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO.
Paediatric patients: Use in patients under the age of 18 years is not recommended.
ADVERSE REACTIONS:
Common: nausea, diarrhoea, dizziness. The following have been reported in post-marketing experience: hypersensitivity, angioedema, erythema, pruritus, rash, urticaria, vomiting.
AU-ANV-00670 v1. Issued August 2025.
▼This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
SELECTED SAFETY INFORMATION: LAGEVRIO (molnupiravir)
INDICATION:
LAGEVRIO has provisional approval for the 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. The decision to approve this indication was based on efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.
CONTRAINDICATIONS: Hypersensitivity to the active substance or any of the excipients. 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.
PRECAUTIONS:
Pregnancy Category D: The use of LAGEVRIO is not recommended during pregnancy. In women of childbearing potential, health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test.
Contraception: Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO. Sexually active men with a partner of childbearing potential should use contraception during and for 3 months after treatment. Based on animal data, LAGEVRIO may cause foetal harm when administered to pregnant women.
Breastfeeding: Based on the potential for adverse reactions on the infant from LAGEVRIO, breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO.
Paediatric patients: Use in patients under the age of 18 years is not recommended.
ADVERSE REACTIONS:
Common: nausea, diarrhoea, dizziness. The following have been reported in post-marketing experience: hypersensitivity, angioedema, erythema, pruritus, rash, urticaria, vomiting.
AU-ANV-00670 v1. Issued August 2025.