Australian Doctor 8th Dec 2023 8th Dec 23 | Page 17

Multiple real-world studies support the efficacy of PAXLOVID in Omicron variants and vaccinated patients 4 – 9

THINK

IF IT ' S COVID PAXLOVID *

* PAXLOVID indicated in patients ≥ 18 years with mild-moderate COVID-19 , unless contraindicated . Review for drug-drug interactions . Commence within 5 days of symptom onset . 1 PBS restrictions apply . 2

Significantly reduces risk of COVID-19-related hospitalisation or death by

88 %

1 †
When taken within 5 days of symptom onset . Efficacy compared with placebo through Day 28 in the EPIC-HR clinical trial ( P < 0.001 ; secondary endpoint ) 1 , 3
Multiple real-world studies support the efficacy of PAXLOVID in Omicron variants and vaccinated patients 4 – 9
Similar rates of adverse events vs placebo 1 ‡
Incidence of treatment emergent adverse events were similar between PAXLOVID ( 22.6 %) and placebo ( 23.9 %), and m ostly mild or moderate . 1
The EPIC-HR was a phase 2 / 3 , randomised , double-blinded , placebo-controlled trial in unvaccinated adult patients who are at risk for progression to severe disease . PAXLOVID has provisional approval for the treatment of coronavirus disease 2019 ( COVID-19 ) in adults 18 years of age and older , who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death . 3 Standard dose of PAXLOVID is 300 mg nirmatrelvir and 100 mg ritonavir tablets taken together orally every 12 hours for 5 days . Reduce dose to nirmatrelvir / ritonavir 150mg / 100mg every 12 hours for 5 days for patients with moderate renal impairment ( eGFR ≥30 to < 60 mL / min / 1.73m 2 ). 1
PBS Information : Authority Required ( STREAMLINED ). Category : GENERAL - General Schedule ( Code GE ). For verified SARS-CoV-2 infection . Treatment must be initiated within 5 days of symptom onset . Refer to PBS Schedule for full authority information .
BEFORE PRESCRIBING , PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE BY SCANNING THE QR CODE OR VISITING : https :// www . pfi . sr / paxlovid-pi
Warning : Nirmatrelvir with ritonavir has significant drug-drug interactions . Prescribers and dispensers should carefully review a patients concomitant medications .
This medicinal product 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 .
Alternatively , any adverse events which are experienced with PAXLOVID can be reported to Pfizer on 1800 675 229 or by email to AUS . AEReporting @ pfizer . com
References : 1 . PAXLOVID Product Information . 2 . Pharmaceutical Benefits Scheme . Nirmatrelvir & Ritonavir . Available at : https :// www . pbs . gov . au / medicine / item / 12996B-13147Y [ Accessed September 2023 ]. 3 . Hammond J et al . N Eng J Med 2022 ; 386:1397 – 1408 . 4 . Arbel R et al . N Engl J Med . 2022 ; 387 ( 9 ): 790-798 . 5 . Najjar-Debbiny R et al . Clin Infect Dis . 2023 ; 76 ( 3 ): e342-e349 . 6 . Wong CKH et al . Lancet . 2022 ; 400 ( 10359 ): 1213-1222 . 7 . Yip TCF et al . Clin Infect Dis . 2023 ; 76 ( 3 ): e26-e33 . 8 . Ganatra S et al . Clin Infect Dis . 2023 ; 76 ( 4 ): 563-572 . 9 . Lewnard JA et al . Lancet Infect Dis . 2023 Jul ; 23 ( 7 ): 806-815 .
© 2023 . All rights reserved . Pfizer Australia Pty Ltd , Sydney , Australia . www . pfizer . com . au . Medical Information : 1800 675 229 . www . pfizermedicalinformation . com . au . PP-PAX-AUS-0587 . PFIZ4860 . 10 / 23 .