Apixaban

DRUG INFORMATION

  ADULT
    - DOSAGE & ADMINISTRATION Reduction of risk of stroke and systemic embolism in
      nonvalvular atrial fibrillation: The recommended dose is 5 mg orally twice daily.
      Source: US FDA label for apixaban (apixaban), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.1 ) In patients with at least 2 of the following characteristics: age greater
      than or equal to 80 years, body weight less than or equal to 60 kg, or serum
      creatinine greater than or equal to 1.5 mg/dL, the recommended dose is 2.5 mg
      orally twice daily.
      Source: US FDA label for apixaban (apixaban), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.1 ) Prophylaxis of DVT following hip or knee replacement surgery: The
      recommended dose is 2.5 mg orally twice daily.
      Source: US FDA label for apixaban (apixaban), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for apixaban (apixaban), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - It is not known whether these concentrations will lead to similar stroke reduction
      and bleeding risk in patients with ESRD on dialysis as was seen in ARISTOTLE.
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29
    - Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery, and
      Treatment of DVT and PE and Reduction in the Risk of Recurrence of DVT and PE No
      dose adjustment is recommended for patients with renal impairment, including those
      with ESRD on dialysis [see Dosage and Administration ( 2.1 )].
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29
    - Clinical efficacy and safety studies with apixaban did not enroll patients with
      ESRD on dialysis or patients with a CrCl <15 mL/min; therefore, dosing
      recommendations are based on pharmacokinetic and pharmacodynamic (anti-FXa
      activity) data in subjects with ESRD maintained on dialysis [see Clinical
      Pharmacology ( 12.3 )]. 8.7 Hepatic Impairment No dose adjustment is required in
      patients with mild hepatic impairment (Child-Pugh class A).
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 8.2 ) Severe Hepatic Impairment: Not recommended.
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29
    - Clinical efficacy and safety studies with apixaban did not enroll patients with
      ESRD on dialysis or patients with a CrCl <15 mL/min; therefore, dosing
      recommendations are based on pharmacokinetic and pharmacodynamic (anti-FXa
      activity) data in subjects with ESRD maintained on dialysis [see Clinical
      Pharmacology ( 12.3 )]. 8.7 Hepatic Impairment No dose adjustment is required in
      patients with mild hepatic impairment (Child-Pugh class A).
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29
    - Because patients with moderate hepatic impairment (Child-Pugh class B) may have
      intrinsic coagulation abnormalities and there is limited clinical experience with
      apixaban in these patients, dosing recommendations cannot be provided [see
      Clinical Pharmacology ( 12.2 )].
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The limited available data on apixaban tablets use in pregnant women
      are insufficient to inform drug-associated risks of major birth defects,
      miscarriage, or adverse developmental outcomes.
      Source: US FDA label for apixaban (apixaban), section 'pregnancy', retrieved
      2026-08-29
    - Treatment may increase the risk of bleeding during pregnancy and delivery.
      Source: US FDA label for apixaban (apixaban), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, no adverse developmental effects were seen when
      apixaban was administered to rats (orally), rabbits (intravenously) and mice
      (orally) during organogenesis at unbound apixaban exposure levels up to 4, 1 and
      19 times, respectively, the human exposure based on area under plasma-
      concentration time curve (AUC) at the Maximum Recommended Human Dose (MRHD) of 5
      mg twice daily.
      Source: US FDA label for apixaban (apixaban), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Females of reproductive potential requiring anticoagulation should discuss
      pregnancy planning with their physician.
      Source: US FDA label for apixaban (apixaban), section 'nursing mothers', retrieved
      2026-08-29
    - The risk of clinically significant uterine bleeding, potentially requiring
      gynecological surgical interventions, identified with oral anticoagulants
      including apixaban should be assessed in females of reproductive potential and
      those with abnormal uterine bleeding.
      Source: US FDA label for apixaban (apixaban), section 'nursing mothers', retrieved
      2026-08-29
    - ( 8.1 ) Lactation : Discontinue drug or discontinue nursing.
      Source: US FDA label for apixaban (apixaban), section 'use in specific
      populations', retrieved 2026-08-29