Eliquis

Eliquis

apixaban

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Apixaban
Indications/Uses
Prevention of VTE in adults who have undergone elective hip or knee replacement surgery. Reduced the risk of stroke, systemic embolism, & death in patients w/ nonvalvular atrial fibrillation (NVAF) w/ ≥1 risk factors, including patients unsuitable for warfarin. Treatment & prevention (recurrent) of DVT & pulmonary embolism (PE).
Dosage/Direction for Use
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 of treatment: 32-38 days for hip replacement surgery & 10-14 days for knee replacement surgery. Prevention of stroke & systemic embolism 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 mmol/L) 2.5 mg bid. 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. Surgery & invasive procedures Patient not previously treated w/ anticoagulants At least 5 doses of 5 mg bid (2.5 mg bid in patient who qualify for dose reduction) should be given before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of Eliquis: 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. Loading dose should be given at least 2 hr before cardioversion.
Administration
May be taken with or without food: For patients w/ swallowing difficulties, crush tab & suspend in water, 5% dextrose in water (D5W), apple juice or mixed w/ applesauce. Drink immediately. Soln stable for 4 hr. Alternatively, crush & suspend in 60 mL water or D5W & administer via nasogastric tube.
Contraindications
Hypersensitivity. Clinically significant active bleeding.
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 ophth surgery. Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk; undergoing hip fracture surgery; prosthetic heart valves w/ or w/o atrial fibrillation. Discontinue if severe hemorrhage occurs. 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. 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. 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. 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; other platelet aggregation inhibitors or other antithrombotic agents. 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.
Adverse Reactions
Contusion. Post-surgery orthopedic patients: Anemia (including post-op & hemorrhagic anemia, & respective lab parameters); hemorrhage (including hematoma, & vag & urethral hemorrhage); nausea. NVAF patients: Eye hemorrhage (including conjunctival hemorrhage); other hemorrhage, hematoma; epistaxis; GI (including hematemesis & melena) & rectal hemorrhage, gingival bleeding; hematuria. VTE patients: Hematoma; epistaxis; gingival bleeding; hematuria; menorrhagia.
Drug Interactions
Increased mean AUC & Cmax w/ strong CYP3A4 & P-pg inhibitors (eg, ketoconazole). Increased plasma conc w/ diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine. Decreased mean AUC & Cmax 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-FXa activity w/ enoxaparin. Increased bleeding risk w/ NSAIDs, ASA or P2Y12 inhibitors. 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.
Presentation/Packing
Form
Eliquis FC tab 2.5 mg
Packing/Price
10's
Form
Eliquis FC tab 5 mg
Packing/Price
10's
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