Australian Doctor 16th June 2023 16JUNE2023 issue | Page 22

ADVERTORIAL

Reasons to say YES to LAGEVRIO ®

There are many reasons to say YES to LAGEVRIO , particularly for your eligible COVID-19 patients 1 on medication for chronic conditions :
1 . LAGEVRIO remains a simple * and effective ** treatment choice
known drug interactions based on limited data available 1
dose adjustments required in patients with renal and / or hepatic impairment 1
2 . Demonstrated reduction in hospitalisation and death vs placebo ** 1
3 . Real-world Australian experience . GPs have treated more than 500,000 Australian patients . 2
**
MOVe-OUT Study :
For study design scan here .
In the MOVe-OUT study , LAGEVRIO reduced the risk for hospitalisation / death vs placebo ( 6.8 % ( 48 / 709 ) vs 9.7 % ( 68 / 699 )) in all randomised modified intent-to-treat populations who were not hospitalised with mild to moderate COVID-19 . 1
Based on a planned interim analysis , 7.3 % ( 28 / 385 ) of patients who received LAGEVRIO vs 14.1 % of placebo ( 53 / 377 ) were hospitalised / died through Day 29 . The adjusted risk difference was -6.8 % ( 95 % CI [ -11.3 %, -2.4 %]) and 2-sided p-value = 0.0024 . 1
The adjusted relative risk reduction of LAGEVRIO vs 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 %)
MSD is proud to have introduced LAGEVRIO , our COVID-19
What you need to know about the PBS
oral antiviral into Australia 1 and to have worked closely with GPs to help keep at-risk patients out of hospital . If you would like more information about LAGEVRIO please scan this QR code to arrange for a visit from our team .
Administrative and caution notes for current COVID-19 oral antivirals
LAGEVRIO The PBS has included a note for prescribing LAGEVRIO
“ This drug should be considered for use only if nirmatrelvir / ritonavir is contraindicated or otherwise unsuitable ” 3
Why this is important to know ?
1 . Older patients often live with a range of chronic conditions which may need pharmaceutical treatment . 4 , 5
2 . 50 % of Australians aged 65 or older live with at least 2 comorbidities . 4
3 . People who take multiple medications for their comorbidities may be at increased risk of potential drug-drug interactions 5
PAXLOVID ( nirmatrelvir and ritonavir ) The PBS has a caution for prescribing Paxlovid
“ Nirmatrelvir with ritonavir has significant drug-drug interactions . Prescribers and dispensers should carefully review a patient ’ s concomitant medications including over-thecounter medications , herbal supplements , and recreational drugs .” 3
Why this is important to know ?
1 . Paxlovid has over 100 known drug-drug interactions , including drugs that are highly dependent on CYP3A4 for clearance and for which elevated concentrations are associated with serious and / or life-threatening reactions . 6
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 .
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 .
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
References :
1 . LAGEVRIO Product Information . May 2023 . 2 . MSD , Data on file . 3 . Pharmaceutical Benefits Scheme www , pbs . gov . au . Accessed 1 April 2023 . 4 . Australian Institute of Health and Welfare . ( 2022 ) Chronic conditions and multimorbidity . 5 . Ross SB et al . ( 2022 ) Drug Interactions With Nirmatrelvir-Ritonavir in Older Adults Using Multiple Medications . JAMA Netw Open . 2022 ; 5 ( 7 ): e2220184 . doi : 10.1001 / jamanetworkopen . 2022.20184 . 6 . Paxlovid Product Information . 20 January 2022 .
Copyright © 2023 Merck & Co ., Inc ., Rahway , NJ , USA and its affiliates . All rights reserved .
Advertorial sponsored by Merck Sharp & Dohme ( Australia ) Pty Limited . Level 1 – Building A , 26 Talavera Road , Macquarie Park NSW 2113 .
AU-ANV-00331 . Issued May 2023 .