Zuellig Pharma
Concise Prescribing Info
Reduce the risk of stroke, systemic embolism, & death in patients w/ nonvalvular atrial fibrillation (NVAF) w/ ≥1 risk factors including patients unsuitable for warfarin. Prevention of venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery. DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE.
Dosage/Direction for Use
Prevention of stroke & systemic embolism: NVAF 5 mg bid. Patients w/ at least 2 of the following characteristics: Age ≥80 yr, wt ≤60 kg or serum creatinine ≥1.5 mg/dL 2.5 mg bid. Prevention of VTE 2.5 mg bid. Initial dose should be taken 12-24 hr after surgery. Recommended duration of treatment: Hip replacement surgery 32-38 days. Knee replacement surgery 10-14 days. DVT & PE 10 mg bid for 7 days, followed by 5 mg taken bid. Prevention of recurrent DVT & PE 2.5 mg bid after at least 6 mth of treatment for DVT or PE. Surgery & invasive procedures Patients not previously treated w/ anticoagulants 5 doses of Eliquis 5 mg bid before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of Eliquis: 10 mg as loading dose, followed by 5 mg bid. Reduce to 5 mg loading dose followed by 2.5 mg bid if patient meets the criteria for dose reduction. Loading dose should be given at least 2 hr before cardioversion.
May be taken with or without food.
Hypersensitivity. Clinically significant active bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition 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 or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant use w/ any other anticoagulants eg, unfractionated heparin, LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (warfarin, rivaroxaban, dabigatran).
Special Precautions
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 hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk & undergoing hip fracture surgery, prosthetic heart valves w/ or w/o atrial fibrillation; as an alternative to unfractionated heparin for initial treatment of patients w/ PE who present w/ hemodynamic instability or receive thrombolysis or pulmonary embolectomy; history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Discontinue in severe hemorrhage, active bleeding, elective surgery or invasive procedures. Renal impairment (CrCl <15 mL/min) & patients undergoing dialysis. Mild to severe (not recommended) hepatic impairment. Concomitant use w/ strong CYP3A4 & P-gp inhibitors [eg, azole-antimycotics (ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (ritonavir)] or inducers (eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort), antiplatelet agents, NSAIDs. Patients w/ atrial fibrillation & condition that warrants mono or dual antiplatelet therapy. Monitor for signs & symptoms of neurological impairment when neuraxial anesth is employed. Remove indwelling epidural or intrathecal catheters at least 5 hr prior to 1st dose of Eliquis. Pregnancy (not recommended) & lactation. Childn <18 yr.
Adverse Reactions
Anemia (post-op & hemorrhagic anemia); hemorrhage (hematoma, & vag & urethral hemorrhage); nausea; contusion; eye haemorrhage (including conjunctival hemorrhage), other haemorrhage, haematoma; epistaxis; GI haemorrhage (including hematemesis & melaena), rectal haemorrhage, gingival bleeding; haematuria; menorrhagia.
Drug Interactions
Increased AUC & Cmax w/ ketoconazole or other strong CYP3A4 & P-gp inhibitors; naproxen. Decreased AUC & Cmax w/ rifampin or other strong CYP3A4 or 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. 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.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF02 - apixaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Eliquis FC tab 2.5 mg
Eliquis FC tab 5 mg
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