Xaliquis

Apixaban

Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke in patients w/ non-valvular atrial fibrillation (NVAF) w/ ≥1 risk factors (eg, patients unsuitable for warfarin/vit K antagonist therapy (VKA). DVT & pulmonary embolism (PE); prevention of recurrent DVT & PE.

Prevention of VTE: Elective hip or knee replacement surgery 2.5 mg twice daily. Initial dose should be taken 12-24 hr after surgery. Duration of treatment: 32-38 days (hip replacement surgery); 10-14 days (knee replacement surgery). Prevention of stroke Patient w/ NVAF 5 mg twice daily. Patient w/ NVAF & at least 2 of the following characteristics: ≥80 yr, ≤60 kg or serum creatinine ≥1.5 mg/dL 2.5 mg twice daily, should be continued as long-term therapy. Severe renal impairment (CrCl 15-29 mL/min) 2.5 mg twice daily. DVT & PE 10 mg twice daily for 7 days, followed by 5 mg twice daily for max of 6 mth. Prevention of recurrent DVT & PE following completion of 6 mth of treatment for DVT or PE 2.5 mg twice daily (max duration: 12 mth). Cardioversion Patient not previously treated w/ anticoagulants At least 5 doses of 5 mg twice daily (2.5 mg twice daily in patient who qualify for a dose reduction) should be given before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of Xaliquis: 10 mg loading dose, followed by 5 mg twice daily. Reduce to 5 mg loading dose, followed by 2.5 mg twice daily if the patient meets the criteria for dose reduction. Loading dose should be given at least 2 hr before cardioversion. Patient switching from Xaliquis to warfarin or other VKA therapy Continue treatment for 48 hr after 1st dose of warfarin or other VKA therapy.

May be taken with or without food: For patients who are unable to swallow, tab may be crushed & suspended in water. Drink immediately. Alternatively, crush & suspend in 60 mL water & administer via nasogastric tube.

Hypersensitivity. Clinically significant active bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition if considered a significant risk factor for major bleeding (eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain/spinal/ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalites). Concomitant treatment w/ other anticoagulant agent eg, unfractionated heparin (UFH), LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (eg, warfarin, rivaroxaban, dabigatran) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter.

Carefully observe for signs of bleeding. Conditions w/ increased risk of haemorrhage 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 ophth surgery; discontinue if severe haemorrhage occurs. Discontinue in the event of hemorrhagic complications & consider initiation of appropriate treatment (eg, surgical hemostasis or fresh frozen plasma transfusion). Discontinue use at least 48 hr prior to elective surgery or invasive procedures w/ moderate or high risk of bleeding; at least 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding. Bridging anticoagulation during 24-48 hr after stopping apixaban & prior to intervention is not generally required in patients w/ NVAF. Temporarily discontinue for active bleeding, elective surgery, or invasive procedures; avoid lapses in therapy & restart as soon as possible. Risk of developing spinal or epidural hematoma during spinal/epidural anesth or puncture which can result in long-term or permanent paralysis. Indwelling epidural or intrathecal catheters must be removed at least 5 hr prior to the 1st dose. Frequently monitor for signs & symptoms of neurological impairment. Extreme caution is recommended when used in the presence of neuraxial blockade. Not recommended as an alternative to unfractionated heparin for the initial treatment of patients w/ PE who present w/ hemodynamic instability or who may receive thrombolysis of pulmonary embolectomy. Assess patients w/ active cancer that can be high risk of both VTE & bleeding events prior treatment. Not recommended for patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Carefully assess patients w/ atrial fibrillation & conditions that warrants mono or dual antiplatelet therapy. Not recommended in patients undergoing hip fracture surgery; prosthetic heart valves w/ or w/o atrial fibrillation. Concomitant use w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (eg, ritonavir); strong CYP3A4 & P-gp inducers (eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort); antiplatelet agents; NSAIDs including ASA; platelet aggregation inhibitors or other antithrombotic agents. Clotting tests (eg, prothrombin time, INR & aPTT) are affected. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ CrCl <15 mL/min or those undergoing dialysis or w/ severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Lactation. Childn <18 yr. Elderly; potential higher bleeding risk in co-administration w/ ASA. Low body wt (<60 kg) may increase haemorrhagic risk.

Haemorrhagic anemia; hypersensitivity (including drug hypersensitivity eg, skin rash, & anaphylactic reaction eg, allergic edema); ocular haemorrhage (including conjunctival haemorrhage); haemorrhage (including haematoma); vag haemorrhage; epistaxis, hemoptysis, pulmonary alveolar haemorrhage; GI haemorrhage (including hematemesis & melaena), rectal haemorrhage, gingival bleeding, haemorrhoidal haemorrhage, haematochezia, mouth haemorrhage; muscle haemorrhage; hematuria (including respective lab parameters); contusion, post procedural haemorrhage (including post procedural haematoma, wound haemorrhage, vessel puncture site haematoma), incision/inj site haemorrhage; occult blood +ve. Post-surgery orthopedic patients: Anemia (including post-op anemia & respective lab parameters), thrombocytopenia (including decreased platelet count); urethral haemorrhage, hypotension (including procedural hypotension); nausea; increased transaminases (including ALT & AST), increased γ-glutamyl transferase, abnormal LFT, increased blood alkaline phosphatase & blood bilirubin; catheter site haemorrhage, wound secretion, operative haemorrhage. Stroke & systemic embolism (NVAF patients): Brain & other intracranial or intraspinal haemorrhage (including subdural & spinal haematoma, & subarachnoid haemorrhage); intraabdominal haemorrhage; resp tract haemorrhage (including laryngeal & pharyngeal haemorrhage); retroperitoneal haemorrhage; urogenital haemorrhage; application site bleeding; traumatic haemorrhage. VTE (VTEtx patients): Haemorrhagic diathesis, spontaneous haematoma; cerebral haemorrhage, haemorrhagic stroke; retinal, schlera, & vitreous haemorrhage; ear haemorrhage; pericardial haemorrhage; intraabdominal haematoma, shock haemorrhagic; anal, gastric, gastric ulcer, peptic ulcer, & small intestine haemorrhage, abdominal wall haematoma, Mallory-Weiss syndrome; ecchymosis, skin & skin ulcer haemorrhage, petechiae purpura, increased bleeding, blood blister; urinary tract haemorrhage; menorrhagia, metrorrhagia, menometrorrhagia, uterine, genital, & postmenopausal haemorrhage, breast haematoma, haematospermia; infusion site haematoma; blood urine present, occult blood, RBC urine +ve; traumatic & periorbital haematoma, vascular pseudoaneurysm, procedural, post-procedural, extradural, renal, SC, & subdural haematoma.

Increased mean AUC & C_max w/ strong CYP3A4 & P-gp inhibitors (eg, ketoconazole). Increased plasma conc to a lesser extent 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-Factor Xa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs (eg, ASA) &/or platelet aggregation inhibitors or other anticoagulants. Agents associated w/ serious bleeding eg, thrombolytic agents, GPIIb/IIIa receptor antagonists, thienopyridines (eg, clopidogrel), dipyridamole, dextran, & sulfinpyrazone. Reduced exposure w/ activated charcoal.

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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