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* When initiated within 5 days of symptom onset , compared with placebo through Day 28 ( P < 0.001 ; secondary endpoint ; Data collected up to December 2021 ). 2 , 3 An 89 % risk reduction was seen when initiated within 3 days of symptom onset ( primary endpoint ). 2 The most frequent adverse events were dysgeusia , diarrhea , and vomiting . They were mostly grade 1 or 2 and resolved . 3

PAXLOVID is now PBS listed for people between 60 to 69 years , with just one risk factor for developing severe disease ( previously two ). 1

From 1 April 2023 , PAXLOVID is PBS listed for the following high risk groups 1

Patient Age PBS eligibility criteria 1

≥70

No high risk factors required for PBS eligibility

60-69 + 1 high risk factor for severe disease

50-59 + 2 high risk factors for severe disease

≥30

Aboriginal or Torres Strait Islander

≥18

+ 1 high risk factor for severe disease

Moderately to severely immunocompromised

* This expansion of PBS patient eligibility ( people aged 60-69 years with one risk factor ) applies until Commonwealth purchased stock is exhausted or has expired .

PAXLOVID has provisional approval for the treatment of COVID-19 in adults 18 years of age and older , who do not require initiation of supplemental oxygen and are at increased risk of progression to hospitalisation or death . 2

PAXLOVID has to be taken orally twice daily for 5 days ( 300 mg nirmatrelvir and 100 mg ritonavir OR 150 mg nirmatrelvir and 100 mg ritonavir in moderate renal impairment ). 2

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 .

References : 1 . Pharmaceutical Benefits Scheme . Nirmatrelvir & Ritonavir . Available at : https :// www . pbs . gov . au [ Accessed June 2023 ]. 2 . PAXLOVID Product Information . 3 . Hammond J et al . N Engl J Med . 2022 ; 386 ( 15 ): 1397-1408 .

© 2023 . Pfizer Australia Pty Ltd . Sydney , Australia . All rights reserved . This information is intended only for healthcare professionals . www . pfizer . com . au . Medical Information : 1800 675 229 . www . pfizermedicalinformation . com . au . PFIZ4862 . PP-PAX-AUS-0518 . 06 / 23

OR

All people ≥18y hospitalised as a result of a prior COVID-19 infection

PAXLOVID has similar rates of adverse events vs placebo 2 , 3 †

PAXLOVID is the one COVID-19 oral anti-viral medicine to receive this expanded PBS eligibility criteria * 1

†

Incidence of treatment emergent adverse events were similar between PAXLOVID ( 22.6 %) and placebo ( 23.9 %), and mostly mild or moderate . 2 , 3

BEFORE PRESCRIBING , PLEASE REVIEW 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 patient ’ s 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

Rachel Fieldhouse THE TGA has slapped safety warnings on all oral anticoagulants following post-marketing reports of anticoagulant-related nephropathy presenting as acute kidney injury .

The medicines watchdog has urged doctors to be aware of the “ rare but serious ” adverse event that results from profuse glomerular bleeding , with the potential to cause irreversible kidney damage and death .

The product information for all oral anticoagulants marketed in Australia — apixaban ( Eliquis ), dabigatran ( Pradaxa ), rivaroxaban ( Xarelto ) and warfarin ( Coumadin , Marevan ) — now carries a warning on the risk of anticoagulant-related nephropathy ( ARN ).

While most cases of ARN have occurred overseas , one has been reported in Australia .

The 85-year-old patient had been on warfarin for six years and recently completed a course of antibiotics when she was referred with acute renal impairment and serum creatinine levels that more than doubled over two months .

The TGA said : “ Early detection and intervention of ARN is critical to minimising its associated morbidity and mortality … Awareness of this adverse event among health professionals is important .”

“ Close monitoring , including renal testing , is recommended for those with excessive anticoagulation ( or supratherapeutic INR for those on warfarin ) and haematuria .

“ Be aware that ARN has been reported in patients who do not have pre-existing kidney disease .”

Patients taking direct thrombin inhibitors or factor Xa inhibitors should also be monitored if they have excessive anticoagulation , haematuria or compromised renal function , the watchdog added .

The Advisory Committee on Medicines also recommended a classwide warning because of the drugs ’ widespread use and the serious nature of the side effect .

“[ ARN ] is likely underdiagnosed and requires prescriber education around its presentation ( as acute kidney injury ) and management ,” the committee said in a statement .