Three non-vitamin K antagonist oral anticoagulants (NOACs) are approved for use in Australia: apixaban (Eliquis), dabigatran (Pradaxa) and rivaroxaban (Xarelto).1-3
They are all listed on the PBS general schedule as Authority Required (STREAMLINED). They can be prescribed by medical practitioners and nurse practitioners.4-6
NOAC TGA-approved indications and PBS listings
Prevention of stroke and systemic embolism (SE) in adults with non-valvular atrial fibrillation (NVAF) and at least one additional risk factor for stroke
Apixaban, dabigatran and rivaroxaban are all PBS listed for the prevention of stroke and SE in adults with NVAF and at least one additional risk factor for stroke (see Table 1).4-6
Table 1: NOAC dosing and PBS listings for prevention of stroke and SE in patients with NVAF
|Dosing ||5 mg twice daily||150 mg twice daily||20 mg once daily|
|Dose adjustments||2.5 mg twice daily for patients with ≥ 2 of:||110 mg twice daily in patients with any of:||15 mg once daily in patients with CrCl 30–49 mL/min|
Table 1 abbreviations: CrCl, creatinine clearance.
Prevention of venous thromboembolism (VTE) events in adults who have undergone elective total hip or total knee replacement surgery
Apixaban, dabigatran and rivaroxaban are all PBS-listed for the prevention of VTE events in adults who have undergone elective total hip or knee replacement surgery (see Table 2).4-6
Table 2. NOAC dosing and PBS listings for VTE prevention following hip/knee replacement surgery
|Dosing ||2.5 mg twice daily for 32–38 days (hip) or 10–14 days (knee)||220 mg once daily for 28–35 days (hip) or 10 days (knee)||10 mg once daily for 35 days (hip) or 14 days (knee)|
|Dose adjustments||Not stated in PI||150 mg once daily in patients with CrCl 30–50 mL/min||Not stated in PI|
Table 2 abbreviations: CrCl, creatinine clearance; PI, TGA-approved product information.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), or prevention of recurrent DVT and PE in adults
Apixaban and rivaroxaban, but not dabigatran, are PBS listed for the treatment of DVT and PE, or prevention of recurrent DVT and PE in adults (see Table 3).4-6
Table 3: NOAC dosing and PBS listings for treatment or prevention of DVT and PE
|Dosing ||Treatment: 10 mg twice daily for 7 days, then 5 mg twice daily||150 mg twice daily, following treatment with a parenteral anticoagulant for ≥ 5 days||Treatment: 15 mg twice daily for 21 days|
|Dose adjustments||Not stated in PI||110 mg twice daily in patients with any of:||Not stated in PI|
Table 3 abbreviations: CrCl, creatinine clearance; DVT, deep vein thrombosis; PE, pulmonary embolism; PI, TGA-approved product information.
Risk factors for developing stroke
Risk factors for developing stroke or SE (ischaemic) specified by the PBS are listed below. They are the same for apixaban, dabigatran and rivaroxaban.4-6
- Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system SE
- Age ≥ 75 years
- Diabetes mellitus
- Heart failure and/or left ventricular ejection fraction ≤ 35%
Apixaban, dabigatran and rivaroxaban renal, hepatic and bleed-related contraindications, as well as their contraindicated concomitant medicines, are summarised below (see Table 4).
Table 4: Contraindications listed in the NOAC product information sheets
|Renal ||CrCl < 25 mL/min||CrCl < 30 mL/min||Undergoing dialysis|
CrCl < 30 mL/min
CrCl < 15 mL/min
|Hepatic||Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including severe hepatic impairment (Child-Pugh C)||Hepatic impairment or liver disease expected to have any impact on survival|
Manufacturer also contraindicates use if liver enzymes > 2 x ULN
|Significant hepatic disease (including Child-Pugh B and C), which is associated with coagulopathy leading to a clinically relevant bleeding risk|
|Bleed-related||Spontaneous or pharmacological impairment of haemostasis|
Clinically significant active bleeding
Lesion or condition at significant risk of major bleeding
|Haemorrhagic manifestations, bleeding diathesis, or spontaneous or pharmacological impairment of haemostasis|
Lesion or condition, if considered a significant risk factor for major bleeding
History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
GI haemorrhage within the past year unless the cause has been permanently eliminated
Conditions associated with increased risk of bleeding
|Clinically significant active bleeding|
Lesions at increased risk of clinically significant spontaneous impairment of haemostasis
|Concomitant medicines||Strong inhibitors of both CYP3A4 and P-gp (eg, ketoconazole, ritonavir)|
|Systemic ketoconazole, ciclosporin, itraconazole or dronedarone|
|Strong inhibitors of both CYP3A4 and P-gp (eg, ketoconazole, ritonavir)|
Other anticoagulants not recommended (precaution)
Table 4 abbreviations: CrCl, creatinine clearance; CYP, cytochrome P450; GI, gastrointestinal; P-gp, P-glycoprotein; ULN, upper limit of normal.
- Bristol-Myers Squibb Australia Pty Ltd. Apixaban (Eliquis) product information (accessed 19 October).
- Boehringer Ingelheim Pty Limited. Dabigatran etexilate (Pradaxa) product information (accessed 19 October).
- Bayer Australia Ltd. Rivaroxaban (Xarelto) product information (accessed 19 October).
- Australian Government Department of Health. PBS Schedule. Apixaban. 2017 (accessed 19 October).
- Australian Government Department of Health. PBS Schedule. Dabigatran. 2017 (accessed 19 October).
- Australian Government Department of Health. PBS Schedule. Rivaroxaban. 2017 (accessed 19 October).