Torapix 2.5/Torapix 5

Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation (NVAF), w/ ≥1 risk factor [eg, prior stroke or transient ischemic attack, ≥75 yr, HTN, DM, symptomatic heart failure (NYHA class ≥II)] including patients unsuitable for warfarin. Treatment of DVT & pulmonary embolism (PE) & prevention of their recurrence in adults. Prevention of VTE in adults who have undergone elective hip or knee replacement surgery.

Prevention of stroke & systemic embolism in patient w/ NVAF 5 mg bid. Patient w/ at least 2 of the following characteristics: ≥80 yr, ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromol/L) 2.5 mg bid. Treatment of 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. Prevention of VTE in elective hip or knee replacement surgery 2.5 mg bid. Initial dose should be taken 12-24 hr after surgery. Recommended duration: 32-38 days for hip replacement surgery & 10-14 days for knee replacement surgery.

May be taken with or without food: Swallow w/ water. For patients unable to swallow, crush tab & suspend in water/5% dextrose in water (D5W)/apple juice or mix w/ apple puree & drink immediately (soln stable for up to 4 hr). Alternatively, crush tab & suspend in 60 mL water/D5W & administer via nasogastric tube.

Hypersensitivity. Clinically significant active bleeding.

Discontinue use at least 48 hr prior to elective surgery or invasive procedures 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 in location & easily controlled. Restart treatment after surgical or other procedure as soon as adequate hemostasis has been established. Carefully observe for signs of bleeding. Use w/ caution in 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. Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk; w/ prosthetic heart valves w/ or w/o atrial fibrillation. Discontinue use if severe haemorrhage occurs. Concomitant treatment w/ any other anticoagulants is contraindicated. Caution in concomitant use w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (eg, ritonavir). Caution in concomitant use w/ strong CYP3A4 & P-gp inducers (eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort); antiplatelet agents; NSAIDs including ASA. Not recommended to be concomitantly used w/ other platelet aggregation inhibitors or other antithrombotic agents following surgery. Not recommended in patients w/ severe hepatic impairment. Use w/ caution in patients w/ mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Discontinue breast-feeding or discontinue/abstain from therapy. Safety & efficacy in childn & adolescents <18 yr have not been established. Increasing age may increase haemorrhagic risk eg, elderly. Prevention of stroke & systemic embolism in patients w/ NVAF: No clinical experience in patients w/ CrCl <15 mL/min. Not recommended in patients undergoing dialysis. Treatment of DVT or PE: Not recommended in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inducers. Not recommended in patients w/ CrCl <15 mL/min & those undergoing dialysis.

Hematoma; epistaxis; gingival bleeding; hematuria; confusion. NVAF: Eye hemorrhage (including conjunctival hemorrhage); other hemorrhage; GI (including hematemesis & melena) & rectal hemorrhage. VTE: Menorrhagia.

Increased mean AUC & C_max w/ ketoconazole (strong CYP3A4 & P-gp inhibitor). Increased plasma conc to lesser extent w/ active substances not considered strong inhibitors of CYP3A4 & P-gp eg, amiodarone, clarithromycin, diltiazem, fluconazole, naproxen, quinidine, verapamil. Decreased mean AUC & C_max w/ rifampicin (strong CYP3A4 & P-gp inducer). Plasma conc may be reduced w/ other strong CYP3A4 & P-gp inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Increased risk of bleeding w/ antiplatelet agents. Additive effect on anti-Factor Xa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs (including ASA). Not recommended in concomitant use w/ 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. Affects clotting tests eg, PT, INR & aPTT.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

Rx