Reasons to consider LAGEVRIO for your patients aged ≥70 years who test positive for COVID-19 1 , 2
LAGEVRIO must be for use when nirmatrelvir-ritonavir is contraindicated . 1 , 2
Proven
In MOVe-OUT , LAGEVRIO reduced the risk for hospitalisation or death vs . placebo through Day 29 by 30 % ( adjusted relative risk reduction ) in adult patients with mild to moderate COVID-19 4
( 95 % CI : 1 %, 51 %; 6.8 % ( 48 / 709 ] vs 9.7 % ( 68 / 699 ). Adjusted risk difference -3.0% ( 95 % CI -5.9%, -0.1%), p-value not available ). Based on a planned interim analysis of LAGEVRIO vs placebo : The adjusted risk difference was -6.8% ( 95 % CI : -11.3%, -2.4; 7.3 % ( 53 / 377 ) vs 14.1 % ( 28 / 385 ); p = 0.0024 ).
Real-world studies , 5-9 including the local Victorian study published in 2023 , 5 also support the use of LAGEVRIO in treating older vaccinated patients with mild to moderate COVID-19 .
Treatment-related adverse events ≥ 1 % ( MOVe-OUT , LAGEVRIO vs placebo ): 3 Diarrhoea ( 2 % vs 2 %), nausea ( 1 % vs 1 %), dizziness ( 1 % vs 1 %)
No
No to reduce risk of hospitalisation or death 3 , 4
known drug interactions based on limited data available 3
dose adjustments required in patients with renal and / or hepatic impairment 3
▼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 3 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 .
Scan to access study design for registration study 4
PBS information : Authority required ( STREAMLINED ): LAGEVRIO must be for use when nirmatrelvir (&) ritonavir is contraindicated . 1 The contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product
1 , 10 , 11
Information for nirmatrelvir (&) ritonavir . Visit www . pbs . gov . au for more information .
References : 1 . Pharmaceutical Benefits Scheme . www . pbs . gov . au ( accessed March 2024 ). 2 . Pharmaceutical Benefits Scheme . Lagevrio ® ( molnupiravir ) Pharmaceutical Benefits Scheme Factsheet – Updated 1 December 2024 . https :// www . pbs . gov . au / publication / factsheets / covid-19-treatments / PBS-Factsheet-lagevrio-molnupiravir-updated- December-2024 . pdf ( accessed December 2024 ). 3 . LAGEVRIO Product Information , October 2023 . 4 . Bernal AJ et al . N Engl J Med 2022 ; 509 – 520 . 5 . Van Heer C et al . Lancet Reg Health West Pac 2023 ; 41:100917 . 6 . Gentry CA et al . J Infect 2023 ; 86 ( 3 ): 248 – 255 . 7 . Lin DY et al . JAMA Netw Open 2023 ; 6 ( 9 ): e2335077 . 8 . Park HR et al Infect Chemother 2023 ; 55 ( 4 ): 490 – 499 . 9 . Abu Ahmad W et al . Clin Microbiol Infect 2024 ; 30 ( 10 ): 1305 – 1311 . 10 . Paxlovid ( nirmatrelvir-ritonavir ) Product Information . December 2024 . 11 . University of Liverpool . COVID-19 Drug Interaction Checker . Available at https :// covid19-druginteractions . org / checker ( accessed March 2024 ).
Before prescribing , please review the full Product Information available at www . msdinfo . com . au / lagevriopi or by scanning the QR code .
Copyright © 2025 Merck & Co ., Inc ., Rahway , NJ , USA and its affi iates . All rights reserved . Merck Sharp & Dohme ( Australia ) Pty Limited . Level 1 – Building A , 26 Talavera Road , Macquarie Park NSW 2113 . MSDA0156 / 01 . AU-ANV-00634 v2.0 . Issued January 2025 .