Usual Adult Dose for Deep Vein Thrombosis - Prophylaxis

DEEP VEIN THROMBOSIS (DVT) PROPHYLAXIS FOLLOWING HIP OR KNEE REPLACEMENT SURGERY:
2.5 mg orally twice a day

Duration of therapy:

• Hip replacement: 35 days
• Knee replacement: 12 days

Comments: The initial dose should be taken 12 to 24 hours after surgery.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

RECURRENT DVT AND PE RISK REDUCTION:
2.5 mg orally twice a day

Use: Reduction in the risk of recurrence of DVT and PE after at least 6 months of treatment for DVT or PE.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery

DEEP VEIN THROMBOSIS (DVT) PROPHYLAXIS FOLLOWING HIP OR KNEE REPLACEMENT SURGERY:
2.5 mg orally twice a day

Duration of therapy:

• Hip replacement: 35 days
• Knee replacement: 12 days

Comments: The initial dose should be taken 12 to 24 hours after surgery.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

RECURRENT DVT AND PE RISK REDUCTION:
2.5 mg orally twice a day

Use: Reduction in the risk of recurrence of DVT and PE after at least 6 months of treatment for DVT or PE.

Usual Adult Dose for Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery

DEEP VEIN THROMBOSIS (DVT) PROPHYLAXIS FOLLOWING HIP OR KNEE REPLACEMENT SURGERY:
2.5 mg orally twice a day

Duration of therapy:

• Hip replacement: 35 days
• Knee replacement: 12 days

Comments: The initial dose should be taken 12 to 24 hours after surgery.

Use: Prophylaxis of DVT, which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

RECURRENT DVT AND PE RISK REDUCTION:
2.5 mg orally twice a day

Use: Reduction in the risk of recurrence of DVT and PE after at least 6 months of treatment for DVT or PE.

Usual Adult Dose for Prevention of Thromboembolism in Atrial Fibrillation

5 mg orally 2 times a day

Use: Reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Usual Adult Dose for Thromboembolic Stroke Prophylaxis

5 mg orally 2 times a day

Use: Reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Usual Adult Dose for Deep Vein Thrombosis

Initial dose: 10 mg orally 2 times a day for 7 days
Maintenance dose: 5 mg orally 2 times a day

Use: Treatment of deep vein thrombosis and pulmonary embolism.

Usual Adult Dose for Pulmonary Embolism

Initial dose: 10 mg orally 2 times a day for 7 days
Maintenance dose: 5 mg orally 2 times a day

Use: Treatment of deep vein thrombosis and pulmonary embolism.

Renal Dose Adjustments

Stroke and systemic embolism risk reduction in patients with nonvalvular atrial fibrillation:

• Reduce dose to 2.5 mg orally 2 times a day for patients with any 2 of the following:
• Age 80 years or older
• Body weight 60 kg or less
• Serum creatinine 1.5 mg/dL or higher

Deep vein thrombosis prophylaxis after hip or knee replacement: No adjustment required.
Deep vein thrombosis (DVT) and pulmonary embolism (PE) treatment: No adjustment required.
Recurrent DVT and PE risk reduction: No adjustment required.

Liver Dose Adjustments

Mild liver impairment (Child-Pugh A): No adjustment recommended

Moderate liver impairment (Child-Pugh B): These patients may have intrinsic coagulation abnormalities and there is limited experience with apixaban in these patients; therefore, data is not available.

Severe liver impairment (Child-Pugh C): Not recommended

Dose Adjustments

Coadministration with strong dual CYP450 3A4 and P-gp inhibitors:

• Patients receiving over 2.5 mg orally 2 times a day: Reduce dose by 50%
• Patients receiving 2.5 mg orally 2 times a day: Avoid coadministration

Nonvalvular atrial fibrillation patients:

• Reduce dose to 2.5 mg orally 2 times a day for patients with any 2 of the following:
• Age 80 years or older
• Body weight 60 kg or less
• Serum creatinine 1.5 mg/dL or higher

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for apixaban. It includes a communication plan. For additional information: www.fda.gov/REMS

US BOXED WARNINGS:
PREMATURE DISCONTINUATION INCREASES THE RISK OF THROMBOTIC EVENTS:

• Premature discontinuation of any anticoagulant increases the risk of thrombotic events.
• To reduce this risk, consider coverage with another anticoagulant if apixaban is discontinued for a reason other than pathological bleeding or completion of therapy.

SPINAL/EPIDURAL HEMATOMA:

• Epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture.
• These hematomas may result in long term or permanent paralysis.
• Consider these risks when scheduling patients for spinal procedures.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis:
Nonvalvular atrial fibrillation patients with end stage renal disease: 5 mg orally 2 times a day
Reduce dose to 2.5 mg orally 2 times a day if patient is 80 years or older OR body weight is 60 kg or less.

Deep vein thrombosis prophylaxis after hip or knee replacement: No adjustment required.
Deep vein thrombosis (DVT) and pulmonary embolism (PE) treatment: No adjustment required.
Recurrent DVT and PE risk reduction: No adjustment required.

Other Comments

Administration advice:

• May take with or without food.
• Missed dose: Take as soon as possible on the same day then resume twice daily administration. Do not double up to make up for a missed dose.
• Stop medication 48 hours prior to surgery or invasive procedures with moderate to high risk of unacceptable or clinically significant bleeding.
• Stop medication 24 hours prior to surgery or invasive procedures with low bleeding risk or where bleeding would be in a non-critical location and easily controlled.
• Bridging anticoagulation is generally not required.
• Restart after surgery/procedure as soon as adequate hemostasis has been established.
• Patients unable to swallow whole tablets: The manufacturer product information should be consulted.

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