Apixaban

Regulatory sources consulted

• openfda-label-6a6e421b-6ed3-403c-b07d-09dbbd6a487c
• ema-epar-EMEA/H/C/002148
• OpenFDA · B01AF02
• AEMPS CIMA · nº registro 11691002 ↗
• RxNorm rxcui 1364430 ↗

Approved indications

• To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
• 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.
• For the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.
• Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.

Contraindications

Clinical warnings

• Boxed warning · Premature discontinuation increases the risk of thrombotic events. Spinal/epidural hematomas may occur in patients receiving neuraxial anesthesia or undergoing spinal puncture, and may result in long-term or permanent paralysis. — FDA

Drug interactions

• HighKetoconazoleJ02AB02

  Mechanism: Inhibition of P-gp and CYP3A4, significantly increasing apixaban exposure and bleeding risk.

  Recommendation: For apixaban doses of 5 or 10 mg BID, reduce the dose by 50%. For doses of 2.5 mg BID, avoid co-administration.

  FDA label

• HighRifampicinJ04AB02

  Mechanism: Induction of P-gp and CYP3A4, decreasing apixaban exposure and increasing the risk of stroke.

  Recommendation: Avoid concomitant use.

  FDA label

• HighOther anticoagulants and antiplatelet agents (e.g. NSAIDs, ASA, clopidogrel)B01AC

  Mechanism: Additive pharmacodynamic effect that increases the risk of bleeding.

  Recommendation: Coadministration increases the risk of bleeding. Carefully evaluate the risk/benefit ratio.

  FDA label

Adverse events

Pregnancy and lactation

Use during pregnancy is not recommended due to increased risk of bleeding. A decision must be made whether to discontinue breast-feeding or to discontinue therapy.