Generic
Apixaban
Indications
Apixaban is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 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
Contraindications
Apixaban can cause a skin rash or severe allergic reaction.
Side Effects
Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus. Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition. Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.
Pregnancy And Lactation
Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
Therapeutic
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.
Storage Conditions
There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.
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