# Apixaban ```text 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)