Xabano

• Risk reduction of stroke and systemic embolism in adults with nonvalvular atrial fibrillation
• Prophylaxis of Deep Vein Thrombosis (DVT), and Pulmonary Embolism (PE), in adults who have undergone hip or knee replacement surgery
• Treatment of DVT or PE, and to reduce the risk of recurrent DVT or PE in adults following initial therapy
• Treatment of Venous Thromboembolism (VTE) and reduction of recurrent VTE in pediatric patients from birth and older and after ≥5 days of initial anticoagulant treatment

In adult and pediatric patients weighing greater than or equal to 35 kg:

• Oral, with or without food
• After hip/knee replacement, the initial dose should be administered 12 to 24 hours postoperatively.
• If the patient is unable to swallow whole tablets, may crush 2.5 or 5 mg tablets and suspend in 60 mL of water, D5W, or apple juice or mix with applesauce; administer immediately. Crushed tablets are stable for up to 4 hours.

Warnings & Precautions

Talk to your doctor or pharmacist before you take this medicine if you have any of the following:

• An increased risk of bleeding, such as:
  • Bleeding disorders, including conditions resulting in reduced platelet activity
  • Very high blood pressure, not controlled by medical treatment
  • You are older than 75 years
  • You weigh 60 kg or less
• Severe kidney disease or if you are on dialysis
• A liver problem or a history of liver problems
  • This medicine will be used with caution in patients with signs of altered liver function.
• Had a tube (catheter) or an injection into your spinal column (for anaesthesia or pain reduction), your doctor will tell you to take this medicine 5 hours or more after catheter removal.
• A prosthetic heart valve
• If your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned.
• Antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots).

Pregnancy & Breastfeeding

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine if you are pregnant.
• The effects of apixaban on pregnancy and the unborn child are not known. It is not known if apixaban passes into human breast milk.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including the following:

• Abciximab (Antiplatelet agent)
• Thrombolytics: e.g., Alteplase, Reteplase, Streptokinase, Tenecteplase, Urokinase
• Anticoagulants: e.g., Warfarin, Dabigatran Etexilate, Edoxaban, Rivaroxaban
• Enzalutamide (Antineoplastic agent)
• Inducers of CYP3A4 (Strong) and P-glycoprotein: e.g., Phenobarbital, Phenytoin, Rifampin, and Carbamazepine
• Inhibitors of CYP3A4 (Strong) and P-glycoprotein: e.g., Clarithromycin, Erythromycin, and
• Ketoconazole
• Naproxen
• St John’s Wort

Side effects with incidence greater than 10% include:

• Hemorrhage

If you take more Xabano than you should
Tell your doctor immediately if you have taken more than the prescribed dose of this medicine.

If you forget to take Xbano

• Take the dose as soon as you remember
• Take the next dose of Xabano at the usual time, then continue as normal.
• Do not take a double dose on the next day to make up for the forgotten dose.

• Severe hypersensitivity reaction (i.e., anaphylaxis) to apixaban or any component of the formulation
• Active pathological bleeding

• Keep Xabano at a temperature below 30°C and away from light and moisture.
• Keep Xabano in the original container as long as you use it.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date.

Xabano is supplied as bottle or blisters containing 60 film-coated tablets, each containing 2.5 or 5 mg of apixaban.