LAGEVRIO ® is an effective & simple * treatment choice for your at-risk adult patients with mild to moderate COVID-19 1
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Demonstrated efficacy 1 Simple * treatment choice
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In MOVe-OUT , LAGEVRIO reduced risk for hospitalisation or death vs . placebo 1
* No known drug interactions based on limited data available 1
* No dose adjustments required in patients with renal or hepatic impairment 1
( LAGEVRIO 6.8 % vs placebo 9.7 %, adjusted risk difference -3.0% ( 95 % CI : -5.9 to -0.1%)) in all randomised modified intent-to-treat populations who were not hospitalised with mild to moderate Demonstrated safety and tolerability profile 1 COVID-19 . The adjusted relative risk reduction of LAGEVRIO compared to placebo for all randomised subjects was 30 % ( 95 % CI : 1 %, 51 %, P value not available for final analysis , statistical
Treatment related adverse events ≥ 1 % ( LAGEVRIO vs placebo ): power assigned to interim analysis ). 1
Diarrhoea ( 2 % vs 2 %); Nausea ( 1 % vs 1 %); Dizziness ( 1 % vs 1 %).
Based on a planned interim analysis : 7.3 % of patients who received LAGEVRIO were either hospitalised or died through Day 29 ( 28 / 385 ), vs 14.1 % of placebo ( 53 / 377 ). The adjusted risk difference was -6.8%
For MOVe-OUT study design , with a 95 % CI of ( -11.3%, -2.4%) and 2-sided p-value = 0.0024 . 1 please scan QR code located on the right .
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 1
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 .
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 .
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 .
PBS Information : Authority required ( STREAMLINED ). Please refer to www . pbs . gov . au for eligibility criteria . Before prescribing , please review the full Product Information available at www . msdinfo . com . au / lagevriopi or scan QR Code .
References : 1 . LAGEVRIO Product Information . May 2023 . Copyright © 2023 Merck & Co ., Inc ., Rahway , NJ , USA and its affiliates . All rights reserved . Merck Sharp & Dohme ( Australia ) Pty Limited . Level 1 – Building A , 26 Talavera Road , Macquarie Park NSW 2113 . MSDA0074 . AU-ANV-00413 . Issued October 2023 .