Apixaban

Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).

4 for haemodynamically unstable PE patients).

AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS................................................................................................... 4 WARNINGS AND PRECAUTIONS .................................................................................

4 ADVERSE REACTIONS ................................................................................................. 11 DRUG INTERACTIONS .................................................................................................

19 DOSAGE AND ADMINISTRATION ............................................................................. 23 OVERDOSAGE................................................................................................................

30 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 31 STORAGE AND STABILITY ......................................................................................... 35 SPECIAL HANDLING INSTRUCTIONS .......................................................................

1 INDICATIONS & USAGE Apixaban is a factor Xa inhibitor indicated: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 1 ) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

2 ) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. 1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation Apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery Apixaban tablets are indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

3 Treatment of Deep Vein Thrombosis Apixaban tablets are indicated for the treatment of DVT. 4 Treatment of Pulmonary Embolism Apixaban tablets are indicated for the treatment of PE. 5 Reduction in the Risk of Recurrence of DVT and PE Apixaban tablets are indicated to reduce the risk of recurrent DVT and PE following initial therapy.

Adults Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).

4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.