APIXOR

What it is

APIXOR is a film-coated tablet containing either 2.5 mg or 5 mg apixaban. The 2.5 mg tablet is yellow, round and biconvex. The 5 mg tablet is pink, oval-shaped and biconvex. APIXOR can be taken with or without food.

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

For prevention of VTE after elective hip or knee replacement surgery, the recommended dose is 2.5 mg taken twice daily, with the initial dose taken 12 to 24 hours after surgery. In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days. In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days. For prevention of stroke and systemic embolism in non-valvular atrial fibrillation, the recommended dose is 5 mg taken twice daily. However, 2.5 mg taken twice daily is recommended in patients with at least two of the following characteristics: aged 80 years or older, body weight 60 kg or less, or serum creatinine 133 μmol/L or greater. For treatment of DVT and PE, the recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily. For prevention of recurrent DVT and PE, the recommended dose is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE.

Key safety warnings

APIXOR increases the risk of bleeding and can cause serious, potentially fatal bleeding. Patients taking APIXOR are to 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. 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. When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents such as APIXOR are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis. Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior to the first dose of APIXOR. Premature discontinuation of APIXOR in the absence of adequate alternative anticoagulation increases the risks of thrombotic events. The concomitant use of APIXOR with antiplatelet agents increases the risk of bleeding.

Contraindications

APIXOR is contraindicated in patients with hypersensitivity to apixaban or to any of the excipients, with spontaneous or pharmacological impairment of haemostasis, or with clinically significant active bleeding such as intracranial or gastrointestinal bleeding. It is also contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including severe hepatic impairment (Child-Pugh C). APIXOR is contraindicated in patients with renal impairment with creatinine clearance less than 25 mL/min. APIXOR is contraindicated in patients receiving concomitant treatment with strong inhibitors of both CYP3A4 and P-gp, such as systemic treatment with azole-antimycotics (for example, ketoconazole) or HIV protease inhibitors (for example, ritonavir). APIXOR is contraindicated in patients with a lesion or condition 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, or recent intracranial haemorrhage. APIXOR is contraindicated in patients receiving concomitant treatment with any other anticoagulant agent 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

APIXOR apixaban is registered on the ARTG with the 2.5 mg and 5 mg strengths available in both blister pack and bottle presentations.

Regulatory history

APIXOR apixaban 2.5 mg and 5 mg tablets were first listed on the Australian Register of Therapeutic Goods on 5 August 2025.