SIMPLE * treatment choice
REDUCED hospitalisation and death vs placebo 1 §
> 500,000 Australian patients have been treated with LAGEVRIO by GPs 2
Reasons to say
YES
for your eligible patients 1 with COVID-19 on medication for chronic conditions
1
2
3
SIMPLE * treatment choice
*
No known drug interactions based on limited data available 1
*
No dose adjustments required in patients with renal and / or hepatic impairment 1
REDUCED hospitalisation and death vs placebo 1 §
See below for MOVe-OUT study details
> 500,000 Australian patients have been treated with LAGEVRIO by GPs 2
§
In the MOVe-OUT study , LAGEVRIO reduced the risk for hospitalisation or death vs . placebo ( LAGEVRIO 6.8 % ( 48 / 709 ) vs placebo 9.7 % ( 69 / 699 )) in all randomised modified intent-to-treat populations who were not hospitalised with mild to moderate COVID-19 . 1
Scan here for study design
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 % with a 95 % CI of ( -11.3 %, -2.4 %) and 2-sided p-value = 0.0024 . ( Difference , 3.0 percentage points ; 95 % CI , -5.9 to -0.1.1 ) 1
The adjusted relative risk reduction of LAGEVRIO compared to placebo for all randomised subjects was 30 % ( 95 % CI : 1 %, 51 %). 1 ADVERSE REACTIONS : Common : diarrhoea ( 2 % vs placebo at 2 %), nausea ( 1 % vs placebo at 1 %), and dizziness ( 1 % vs placebo at 1 %) 1
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 :
PBS Information : LAGEVRIO is listed on the PBS – refer to www . pbs . gov . au for more information . Before prescribing , please review the full Product Information available at www . msdinfo . com . au / lagevriopi
Pregnancy Category D . 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 .
References : 1 . LAGEVRIO Product Information . April 2022 . 2 . MSD , Data on file . 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 . AU-ANV-00329 Issued April 2023 .