ELIQUIS

What it is

ELIQUIS is a film-coated tablet containing apixaban in strengths of 2.5 mg and 5 mg. The 2.5 mg tablets are yellow round tablets, while the 5 mg tablets are pink oval-shaped tablets. ELIQUIS can be taken with or without food.

Approved indications

— Prevention of venous thromboembolic events 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 and pulmonary embolism in adult patients. — Prevention of recurrent deep vein thrombosis and pulmonary embolism in adult patients.

Dosing overview

Key safety warnings

ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Patients taking ELIQUIS 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. Patients should be made aware of signs and symptoms of blood loss and instructed to report them immediately or go to the accident and emergency department of the nearest hospital. When neuraxial anaesthesia or spinal/epidural puncture is employed, patients treated with ELIQUIS are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis, and this risk may be increased by post-operative use of indwelling epidural catheters or concomitant use of medicines affecting haemostasis. Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior to the first dose of ELIQUIS. Premature discontinuation of ELIQUIS in the absence of adequate alternative anticoagulation increases the risks of thrombotic events.

Contraindications

ELIQUIS is contraindicated in patients with hypersensitivity to apixaban or to any excipients and those with spontaneous or pharmacological impairment of haemostasis, or clinically significant active bleeding such as intracranial or gastrointestinal bleeding. <cite index index="1-68">It is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including severe hepatic impairment (Child-Pugh C).</cite> ELIQUIS is contraindicated in patients with renal impairment (creatinine clearance <25 mL/min). Concomitant treatment with strong inhibitors of both CYP3A4 and P-gp, such as systemic azole-antimycotics or HIV protease inhibitors, is contraindicated. ELIQUIS is contraindicated in patients with lesions or conditions 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 intracranial haemorrhage, known or suspected oesophageal varices, or vascular aneurysms. Concomitant treatment with any other anticoagulant agent is contraindicated except under circumstances of switching therapy or when unfractionated heparin is given at doses necessary to maintain a patent central venous or arterial catheter.

PBS listing

ELIQUIS 2.5 mg tablets are listed on the PBS with streamlined restriction at an ex-manufacturer price of A$51.78, whilst the 5 mg tablets are listed with streamlined restriction at an ex-manufacturer price of A$50.40.

Regulatory history

ELIQUIS 2.5 mg tablets were first registered on the ARTG on 21 July 2011, and the 5 mg tablets were first registered on 2 May 2013. An AusPAR was issued on 15 May 2015, approving ELIQUIS for the treatment of deep vein thrombosis and pulmonary embolism in adult patients, and for prevention of recurrent DVT and PE. In November 2017, the PBAC recommended an amendment to the PBS listing to allow apixaban to be used for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who are unsuitable for warfarin.