Apixastal-2.5/Apixastal-5

Prevention of VTE in adults who have undergone elective hip or knee replacement surgery. Risk reduction of stroke, systemic embolism, & death in patients w/ nonvalvular atrial fibrillation w/ ≥1 risk factors, including patients unsuitable for warfarin. Treatment of DVT & pulmonary embolism (PE); prevention of recurrent DVT & PE.

Prevention of VTE in elective hip or knee replacement surgery 2.5 mg bid initiated 12-24 hr after surgery. Patient undergoing hip replacement surgery Duration of treatment: 32-38 days. Patient undergoing knee replacement surgery Duration of treatment: 10-14 days. Prevention of stroke & systemic embolism in nonvalvular atrial fibrillation 5 mg bid. Patient w/ at least 2 of the following characteristics: ≥80 yr, ≤60 kg, or serum creatinine ≥1.5 mg/dL 2.5 mg bid. DVT & PE 10 mg bid for 7 days, followed by 5 mg bid. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of treatment for DVT or PE. Surgery & invasive procedures Patient not previously treated w/ anticoagulant At least 5 doses of 5 mg bid (2.5 mg bid in patient who qualifies for dose reduction) should be given before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses: 10 mg loading dose, followed by 5 mg bid. Reduce to 5 mg loading dose, followed by 2.5 mg bid if patient meets criteria for dose reduction. Loading dose should be given at least 2 hr before cardioversion.

May be taken with or without food: For patients who are unable to swallow whole tab, crush tab & suspend in water, 5% dextrose in water (D5W), or apple juice, or mixed w/ applesauce & promptly administer orally. Alternatively, crush tab & suspend in 60 mL of water or D5W & promptly deliver through nasogastric tube.

Hypersensitivity. Clinically significant active bleeding.

Carefully observe patients for signs of bleeding. Conditions w/ increased risk of hemorrhage eg, congenital or acquired bleeding disorders; active ulcerative GI disease; bacterial endocarditis; thrombocytopenia; platelet disorders; history of hemorrhagic stroke; severe uncontrolled HTN; & recent brain, spinal, or ophthalmological surgery. Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Discontinue administration if severe hemorrhage occurs; treatment & investigate source of bleeding in the event of hemorrhagic complications. Temporary discontinuation places patients at increased risk of thrombosis. Avoid lapses in therapy, & if anticoagulation must be temporarily discontinued for any reason, restart therapy as soon as possible. Patients receiving concomitant systemic treatment w/ strong inhibitors of both CYP3A4 & P-gp eg, azole-antimycotics (ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (ritonavir). Concomitant use w/ strong CYP3A4 & P-gp inducers (eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort). Concomitant use w/ antiplatelet agents increases risk of bleeding. Patients treated concomitantly w/ NSAIDs, including ASA. Not recommended concomitantly w/ other platelet aggregation inhibitors or antithrombotic agents following surgery. Risk of developing epidural or spinal hematoma which can result in long-term or permanent paralysis when neuraxial anesth (spinal/epidural anesth) or spinal/epidural puncture is employed. Remove indwelling epidural or intrathecal catheters at least 5 hr prior to 1st dose. Monitor patients frequently for signs & symptoms of neurological impairment (eg, numbness or weakness of legs, bowel, or bladder dysfunction). Not recommended in patients undergoing hip fracture surgery; w/ prosthetic heart valves, w/ or w/o atrial fibrillation; w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Not recommended as alternative to unfractionated heparin for initial treatment of patients w/ PE who present w/ hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy. Not recommended in patients w/ CrCl <15 mL/min & in patients undergoing dialysis; w/ severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Decide whether to discontinue breastfeeding or to discontinue/abstain from therapy. Efficacy & safety have not been established in childn <18 yr.

Contusion. Post-surgery orthopedic patients: Anemia (including post-op & hemorrhagic anemia, & respective lab parameters); hemorrhage (including hematoma, & vag & urethral hemorrhage); nausea. NVAF patients: Eye hemorrhage (including conjunctival hemorrhage); other hemorrhage, hematoma; epistaxis; GI (including hematemesis & melena) & rectal hemorrhage, gingival bleeding; hematuria. VTE patients: Hematoma; epistaxis; gingival bleeding; hematuria; menorrhagia.

Increased mean AUC & C_max w/ strong CYP3A4 & P-gp inhibitors eg, ketoconazole. Increased plasma conc w/ diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine. Decreased mean AUC & C_max w/ strong CYP3A4 & P-gp inducers eg, rifampin. Reduced plasma conc w/ other strong CYP3A4 & P-gp inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Additive effect on anti-FXa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs, ASA or P2Y12 inhibitors; agents associated w/ serious bleeding eg, unfractionated heparins & heparin derivatives (including LMWH), FXa inhibiting oligosaccharides (eg, fondaparinux), direct thrombin II inhibitors (eg, desirudin), thrombolytic agents, GPIIb/IIIa receptor antagonists, dipyridamole, dextran, sulfinpyrazone, vit K antagonists, & other oral anticoagulants.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AF02 - apixaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

Rx