APEXA

What it is

APEXA contains apixaban as either 2.5 mg or 5 mg film-coated tablets.

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 APEXA can be taken with or without food.

Key safety warnings

APEXA increases the risk of bleeding and can cause serious, potentially fatal bleeding. Patients taking APEXA are to be carefully observed for signs of bleeding complications after initiation of treatment. 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 such as 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, and 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 APEXA in the absence of adequate alternative anticoagulation increases the risks of thrombotic events. An increased risk of stroke was observed during the transition from apixaban to warfarin in clinical trials in atrial fibrillation patients. Discontinuation of apixaban prior to the onset of an effective antithrombotic effect of VKA could result in an increased risk of thrombosis. When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.

Contraindications

APEXA is contraindicated in patients with hypersensitivity to apixaban or to any of the excipients, with spontaneous or pharmacological impairment of haemostasis, with clinically significant active bleeding (such as intracranial bleeding or gastrointestinal bleeding), with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including severe hepatic impairment (Child-Pugh C), with renal impairment creatinine clearance <25 mL/min, receiving concomitant treatment with strong inhibitors of both CYP3A4 and P-gp such as azole-antimycotics or HIV protease inhibitors, and with lesions or conditions at significant risk of major bleeding such as current or recent gastrointestinal ulceration, presence of 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. APEXA is also contraindicated in patients receiving concomitant treatment with any other anticoagulant agent such as unfractionated heparin, low molecular weight heparins, heparin derivatives, or oral anticoagulants except under the circumstances of switching therapy to or from apixaban or when UFH is given at doses necessary to maintain a patent central venous or arterial catheter.

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

APEXA apixaban was registered on the Australian Register of Therapeutic Goods on 5 August 2025, with registrations for both 2.5 mg and 5 mg tablet formulations in blister pack and bottle presentations.