Axibel

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

Adult DVT & PE 10 mg bid for 7 days, followed by 5 mg bid. Prevention of VTE (elective hip or knee replacement surgery) 2.5 mg bid. Administer initial dose at least 12-24 hr after surgery. Recommended duration of treatment: Patient undergoing hip replacement surgery 32-38 days, knee replacement surgery 10-14 days. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of treatment for DVT or PE. Prevention of stroke & systemic embolism (NVAF) 5 mg bid. Patient w/ at least 2 of the following: ≥80 yr, weighing ≤60 kg or w/ serum creatinine ≥1.5 mg/dL (133 micromole/L) Reduce dose to 2.5 mg bid. Severe renal impairment (CrCl 15-29 mL/min) Prevention of stroke & systemic embolism (NVAF) 2.5 mg bid. Conversion from warfarin or other vit K antagonist (VKA) therapy to apixaban Start apixaban when INR is <2. Conversion from apixaban to warfarin or other VKA therapy Continue treatment for 48 hr after 1st dose of warfarin or other VKA therapy. Patient not previously treated w/ anticoagulants Administer at least 5 doses of 5 mg bid, or 2.5 mg bid for those who qualify for dose reduction, before cardioversion. If cardioversion is required before 5 doses Give 10 mg loading dose, followed by 5 mg bid. Reduce to 5 mg loading dose followed by 2.5 mg bid if the patient meets the criteria for dose reduction. Give loading dose at least 2 hr before cardioversion.

May be taken with or without food: Swallow whole. May crush & suspend tab, & administer orally or via nasogastric tube. Take immediately.

Hypersensitivity. Active clinically significant bleeding; lesion or condition if considered significant risk factor for major bleeding including current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain, spinal or ophth surgery, recent intracranial hemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment w/ any other anticoagulants eg, unfractionated heparin, LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, rivaroxaban, dabigatran). Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.

Discontinue treatment if severe hemorrhage occur; in the event of hemorrhagic complications; for active bleeding, elective surgery, or invasive procedures due to increased risk of thrombosis; at least 48 hr prior to elective surgery or invasive procedure w/ moderate or high risk of unacceptable or clinically significant bleeding, or at least 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding or where bleeding would be non-critical. Avoid lapses in therapy, restart therapy as soon as possible if anticoagulation must be temporarily discontinued. Not recommended as alternative to unfractionated heparin for initial treatment of patients w/ PE w/ haemodynamic instability or who may receive thrombolysis or pulmonary embolectomy. Conditions w/ increased risk of hemorrhage eg, congenital or acquired bleeding disorders, active ulcerative GI disease, bacterial endocarditis, thrombocytopenia, platelet disorders, history of haemorrhagic stroke, severe uncontrolled HTN, & recent brain, spinal, or ophthalmological surgery; developing epidural or spinal hematoma resulting to long-term or permanent paralysis when neuraxial anaesth (spinal/epidural anaesth) or spinal/epidural puncture is employed. Patients w/ atrial fibrillation & conditions that warrant mono or dual antiplatelet therapy. Not recommended in patients undergoing hip fracture surgery; w/ prosthetic heart valves, w/ or w/o atrial fibrillation; history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Carefully observe for signs of bleeding. Consider initiation of appropriate treatment eg, surgical hemostasis or transfusion of fresh frozen plasma; prothrombin complex concentrates or recombinant factor VIIa. Frequently monitor for signs & symptoms of neurological impairment (eg, numbness or weakness of legs, bowel or bladder dysfunction). Concomitant use w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (ketoconazole, itraconazole, voriconazole, posaconazole), HIV PIs (ritonavir), & inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb or St. John’s wort). Increased risk of bleeding in concomitant use w/ NSAIDs including ASA. Not recommended in concomitant use w/ other platelet aggregation inhibitors or antithrombotic agents. Not recommended in hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk; patients w/ CrCl <15 mL/min or those undergoing dialysis; severe hepatic impairment. Severe renal impairment (CrCl 15-29 mL/min). Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Lactation. Childn <18 yr.

Anemia (including post-op & hemorrhagic anemia, & respective lab parameters); hemorrhage (including hematoma, & vag & urethral hemorrhage); nausea, GI (including hematemesis & melaena) & rectal haemorrhage, gingival bleeding; contusion; eye haemorrhage (including conjunctival haemorrhage); epistaxis; haematuria; menorrhagia.

Increased mean AUC & C_max w/ ketoconazole; diltiazem; naproxen; clarithromycin. Increased plasma conc w/ CYP3A4 & P-gp inhibitors eg, amiodarone, clarithromycin, diltiazem, fluconazole, naproxen, quinidine, verapamil. Decreased mean AUC & C_max w/ rifampicin. Reduced plasma conc w/ strong CYP3A4 & P-gp inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Additive effect on anti-Factor Xa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs, ASA or P2Y12 inhibitors. Not recommended in concomitant use w/ 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, VKA, & other oral anticoagulants. Concomitant use w/ clotting tests eg, prothrombin time, INR, & aPTT.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

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