Concise Prescribing Info
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery & stroke in patients w/ non-valvular atrial fibrillation (NVAF) w/ ≥1 risk factors including patients unsuitable for warfarin/vit K antagonist (VKA) therapy.
Dosage/Direction for Use
Prevention of VTE: Elective hip or knee replacement surgery 2.5 mg twice daily. Initial dose should be taken 12-24 hr post-op. Recommended duration of treatment: Patient undergoing hip replacement surgery 32-38 days. Patient undergoing knee replacement surgery 10-14 days. Prevention of stroke in patient w/ NVAF 5 mg twice daily. May be reduced to 2.5 mg twice daily [at least 2 of the following: Age ≥80 yr, body wt ≤60 kg or serum creatinine ≥1.5 mg/dL (133 micromole/L). Severe renal impairment (CrCl 15-29 mL/min) 2.5 mg twice daily.
May be taken with or without food.
Hypersensitivity. Clinically significant active bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition if considered at significant risk factor for major bleeding. Concomitant treatment w/ other anticoagulant agent.
Special Precautions
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. Discontinue in the event of hemorrhagic complications & consider initiation of appropriate treatment (eg, surgical hemostasis or fresh frozen plasma transfusion). Renal impairment (CrCl <15 mL/min). Contraindicated in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Not recommended in patients w/ severe hepatic impairment. Patients w/ mild or moderate hepatic impairment (Child Pugh A or B). Low body wt (<60 kg). Patients receiving concomitant systemic treatment w/ strong inhibitors of both CYP3A4 & P-gp 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). Patients receiving concomitant systemic treatment w/ strong inducers of both CYP3A4 & P-gp for the prevention of VTE in elective hip or knee replacement surgery, stroke in patients w/ NVAF. Patients treated concomitantly w/ medicinal products affecting haemostasis eg, NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents. Spinal/epidural anaesth or puncture. Hip fracture surgery. Patients w/ prosthetic heart valves w/ or w/o atrial fibrillation. Patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Anaemia; thrombocytopenia; hypersensitivity; allergic edema & anaphylaxis; brain, eye (eg, conjunctival), intra-abdominal, resp tract, GI, haemorrhoidal, mouth, rectal, gingival, retroperitoneal, muscle, vag, urogenital & post-procedural haemorrhage; haematoma; epistaxis, nausea; haemoptysis; haematochezia; increased transaminase, increased AST, increased γ-glutamyltransferase, abnormal liver function test, increase blood alkaline phosphatase, increased blood bilirubin; skin rash; haematuria; application site bleeding; occult blood positive.
Drug Interactions
Increased apixaban exposure by 2-fold w/ strong inhibitors of CYP3A4 & P-gp (eg, azole antimycotics). Reduced plasma conc w/ strong CYP3A4 & P-gp inducers eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort. Additive effect on anti-factor Xa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs, acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents. Serious bleeding risk w/ thrombolytic agents, GPIIb/IIIa receptor antagonists, thienopyridines (eg, clopidogrel), dipyridamole, dextran & sulfinpyrazone. Reduced exposure w/ activated charcoal. Apixaban did not meaningfully alter the pharmacokinetics of digoxin, naproxen, atenolol.
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
20's (Rp450,855/boks)
Eliquis FC tab 5 mg
20's (Rp450,855/pak)
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