APIXABAN-APX

What it is

APIXABAN-APX is available as film-coated tablets containing either 2.5 mg or 5 mg of apixaban. The 2.5 mg tablets are yellow, round and biconvex, while the 5 mg tablets are pink, oval-shaped and biconvex.

Approved indications

— Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery. — Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. — Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients. — Prevention of recurrent DVT and PE in adult patients.

Dosing overview

Key safety warnings

APIXABAN-APX increases the risk of bleeding and can cause serious, potentially fatal bleeding. Patients taking APIXABAN-APX should be carefully observed for signs of bleeding complications after initiation of treatment, and any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site. Cautious use is recommended in patients with increased risk of haemorrhage, including those with congenital or acquired bleeding disorders, bacterial endocarditis, thrombocytopenia, platelet disorders, history of haemorrhagic stroke, severe uncontrolled hypertension, age greater than 75 years, concomitant use of medications affecting haemostasis, or bronchiectasis or history of pulmonary bleeding. Patients should be made aware of signs and symptoms of blood loss and instructed to report them immediately or go to Accident and Emergency of the nearest hospital. Premature discontinuation of APIXABAN-APX in the absence of adequate alternative anticoagulation increases the risks of thrombotic events, and an increased risk of stroke was observed during the transition from APIXABAN-APX to warfarin in clinical trials in atrial fibrillation patients. If anticoagulation with APIXABAN-APX must be discontinued for any reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with APIXABAN-APX are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis, and the risk may be increased by post-operative use of indwelling epidural catheters or concomitant use of medicinal products affecting haemostasis.

Contraindications

APIXABAN-APX is contraindicated in patients with hypersensitivity to apixaban or its excipients, spontaneous or pharmacological impairment of haemostasis, clinically significant active bleeding (such as intracranial or gastrointestinal bleeding), hepatic disease associated with coagulopathy and clinically relevant bleeding risk including severe hepatic impairment (Child-Pugh C), renal impairment with creatinine clearance less than 25 mL/min, or receiving concomitant treatment with strong inhibitors of both CYP3A4 and P-gp such as systemic azole-antimycotics (for example ketoconazole) or HIV protease inhibitors (for example ritonavir). APIXABAN-APX is also contraindicated in patients with a lesion or condition at significant risk of major bleeding such as current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities. APIXABAN-APX is contraindicated in patients receiving concomitant treatment with any other anticoagulant agent (such as unfractionated heparin, low molecular weight heparins, heparin derivatives, or oral anticoagulants including warfarin, rivaroxaban and dabigatran) except under the circumstances of switching therapy to or from apixaban or when unfractionated heparin is given at doses necessary to maintain a patent central venous or arterial catheter.

PBS listing

APIXABAN-APX is registered on the ARTG with two listings: apixaban 2.5 mg film-coated tablets (ARTG 517131) and apixaban 5 mg film-coated tablets (ARTG 517165), both first listed on 22 January 2026.

Regulatory history

APIXABAN-APX was first listed on the Australian Register of Therapeutic Goods on 22 January 2026.