Adult Dosing
Reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- 5 mg PO bid
- Decrease dose to 2.5 mg PO bid in patients with at least 2 of the following characteristics: age = > 80 years, weight < = 60 kg, or serum creatinine = >1.5 mg/dL
Prophylaxis of deep vein thrombosis following hip or knee replacement surgery
- Initial dose: 2.5 mg PO bid, 12-24 hours after surgery
Note:
- Recommended duration of treatment in hip replacement is for 35 days
- Recommended duration of treatment in knee replacement is for 12 days
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment: (Based on CrCl)
- <15 mL/min: No data are available; use not recommended
>1.5 mg/dL: Decrease dose to 2.5 mg BID if patient has 1 additional characteristic of age > or = 80 years or weight < or = 60 kg
Hepatic Dose Adjustment:
- Mild impairment: No dose adjustment
- Moderate impairment: Patients with moderate hepatic impairment may have intrinsic coagulation abnormalities; data are limited and no recommendations are available
- Severe impairment: Not recommended
- Discontinuing apixaban in a patient without adequate continous anticoagulation places the patient at an increased risk of thrombotic events (US Black box warning)
- An increased rate of stroke was observed following discontinuation of apixaban in clinical trials in patients with nonvalvular atrial fibrillation (US Black box warning)
- If anticoagulation with apixaban must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered (US Black box warning)
- Risk of epidural or spinal hematoma when used with neuraxial anesthesia (US Black box warning)
- Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of the therapy; and the next dose should not be administered earlier than 5 hours after the removal of the catheter (US Black box warning)
- Monitor for signs and symptoms of neurological impairment and if noted urgent treatment is necessary (US Black box warning)
- Therapy increases the risk of bleeding and can cause serious, potentially fatal, bleeding. Discontinue therapy in patients with active pathological hemorrhage.
- Coadministration with other drugs that affect hemostasis (aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, NSAIDs) increases bleeding risk.
- No specific antidote is available to reverse the anticoagulant effect, which is expected to persist for about 24 hours after the last dose
- Safety and efficacy has not been studied in patients with prosthetic heart valves; therefore, use is not recommended
<Cautions>Use cautiously in:
- Co-administration of drugs affecting hemostasis
- Other antiplatelet agents
- Strong dual inhibitors of CYP3A4 and P-gp
- Pregnancy
Pregnancy Category:B
Breastfeeding: It is unknown whether apixaban or its metabolites are excreted in human milk. Women should discontinue breastfeeding or discontinue therapy, taking into account the importance of the drug to the mother.
