Classes
DEA Class; Rx
Common Brand Names; Eliquis
- Anticoagulants, Cardiovascular;
- Factor Xa Inhibitors
Description
Oral and selective factor Xa inhibitor anticoagulant
Used for prevention of stroke and other systemic embolism in patients with nonvalvular atrial fibrillation, prevention of DVT in patients undergoing hip or knee replacement surgery, treatment of DVT or PE, and reduction in risk of recurrence of DVT and PE
Routine laboratory monitoring not required
Indications
Indicated to prevent stroke and systemic embolism in nonvalvular atrial fibrillation
Indicated following hip or knee replacement surgery
Indicated for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
Indicated to reduce the risk of recurrent DVT and PE following initial 6 months treatment for DVT and/or PE
Contraindications
Severe hypersensitivity (ie, anaphylactic reactions)
Active pathological bleeding
Adverse Effects
Bleeding (Aristotle Study)
Major (2.13%, warfarin 3.09%; P <0.0001)
GI (0.83%, warfarin 0.93%)
Intracranial (0.33%, warfarin 0.82%)
Intraocular (0.06%, warfarin 0.14%)
Fatal (0.06%, warfarin 0.24%)
Clinically relevant nonmajor bleeding (2.08%, warfarin 3.0%; P <0.0001)
Bleeding (Averroes Study)
Major (1.41%, aspirin 0.92%; P = 0.07)
Fatal (0.16%, aspirin 0.16%)
Intracranial (0.34%, aspirin 0.35%)
Hypersensitivity reactions (including skin rash and anaphylactic reactions such as allergic edema)
Syncope
Warnings
Discontinuing apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events (see Black Box Warnings)
Risk of epidural or spinal hematoma when used with neuraxial anesthesia (see Black Box Warnings)
Safety and efficacy has not been studied in patients with prosthetic heart valves; therefore, use of is not recommended in these patients
Not recommended as an alternative to unfractionated heparin for the initial treatment of PE in patients who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy
Coadministration with strong dual inhibitors of CYP3A4 and P-gp (see Dosage Modifications)
Avoid coadministration with strong dual inducers of CYP3A4 and P-gp; such drugs decrease apixaban’s systemic exposure
Increases the risk of bleeding and can cause serious, potentially fatal, bleeding; advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room; discontinue therapy in patients with active pathological hemorrhage
Coadministration with other drugs that affect hemostasis increases bleeding risk (eg, aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, NSAIDs)
Prolongs PT and aPTT; however, changes are small and highly variable and are not useful for monitoring anticoagulation effect of apixaban
Direct-acting oral anticoagulants (DOACs), are not recommended for use in patients with triple-positive antiphospholipid syndrome (APS); for patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2- glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women
Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery
Use of anticoagulants, during pregnancy, may increase risk of bleeding in fetus and neonate
There are no data on presence of drug metabolites in human milk, effects on breastfed child, or the effects on milk production
Maximum Dosage
10 mg/day PO for most patients; 20 mg/day PO for initial treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE).
10 mg/day PO for most patients; 20 mg/day PO for initial treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Apixaban
tablet
- 2.5mg
- 5mg