Zuellig Pharma
Concise Prescribing Info
DVT & pulmonary embolism (PE). Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation (NVAF), w/ ≥1 risk factors [eg, prior stroke or transient ischaemic attack, age ≥75 yr, HTN, DM, symptomatic heart failure (NYHA class ≥II)]. Prevention of VTE in adults who have undergone elective hip or knee replacement surgery. Prevention of recurrent DVT & PE in haemodynamically unstable PE adults.
Dosage/Direction for Use
Acute DVT & PE 10 mg bd for 1st 7 days followed by 5 mg bd. Prevention of stroke & systemic embolism in patient w/ NVAF 5 mg bd. In patient w/ at least 2 of the following characteristics: Age ≥80 yr, ≤60 kg or serum creatinine ≥1.5 mg/dL Dose may be reduced to 2.5 mg bd. Prevention of VTE 2.5 mg bd. Initial dose should be taken 12-24 hr post-op. Recommended duration of treatment: Hip replacement surgery 32-38 days. Knee replacement surgery 10-14 days. Prevention of recurrent DVT & PE Initially 2.5 mg bd, following 6-mth treatment completion w/ 5 mg bd or w/ another anticoagulant. Severe renal impairment (CrCl 15-29 mL/min) 2.5 mg bd.
May be taken with or without food: May be crushed & suspended in water/D5W/apple juice or mixed w/ apple puree. Take mixt immediately or w/in 4 hr.
Hypersensitivity. Clinically significant active bleeding. Lesion or condition at significant risk of major bleeding eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain/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 abnormalities. Concomitant treatment w/ any other anticoagulant eg, unfractionated heparin (UFH), LMWH, heparin derivatives, oral anticoagulants except under the circumstances of switching therapy to or from apixaban, or when UFH is given at doses necessary to maintain an open central venous or arterial catheter or given during catheter ablation for atrial fibrillation. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.
Special Precautions
Discontinue use if severe haemorrhage occurs. Not recommended in patients w/ prosthetic heart valves, undergoing hip fracture surgery & patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome; as alternative to UFH in haemodynamically unstable PE patients or who require thrombolysis or pulmonary embolectomy. Active cancer; spinal/epidural anaesth or puncture. Frequently monitor signs & symptoms of neurological impairment. Not to interrupt treatment in patients undergoing catheter ablation for atrial fibrillation. 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. Temporary discontinuation may increase risk of thrombosis. Remove indwelling epidural or intrathecal catheters at least 5 hr prior to 1st dose. Low body wt <60 kg. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in concomitant use w/ strong CYP3A4 & P-gp inhibitors eg, azole antimycotics & HIV PIs. Concomitant use w/ antiplatelets, SSRIs/SNRIs, NSAIDs including ASA, other platelet aggregation inhibitors (following surgery) or thrombolytic agents for acute ischemic stroke; CYP3A4 & P-gp inducers. Not recommended in patients w/ CrCl <15 mL/min or undergoing dialysis; severe hepatic impairment. Mild or moderate (Child-Pugh A or B) hepatic impairment; elevated liver enzymes ALT/AST >2 x ULN or total bilirubin ≥1.5 x ULN; severe renal impairment (CrCl 15-29 mL/min). Avoid use during pregnancy. Lactation. Childn & adolescent <18 yr. Elderly (co-administration w/ ASA).
Adverse Reactions
Anaemia; haemorrhage, haematoma; nausea; contusion. NVAF & VTEt: Epistaxis, GI & rectal haemorrhage, gingival bleeding; increased γ-glutamyltransferase; haematuria. NVAF: Eye haemorrhage; hypotension. VTEt: Thrombocytopenia; mouth haemorrhage; increased ALT; skin rash; abnormal vag & urogenital haemorrhage.
Drug Interactions
Increased mean AUC & Cmax w/ azole antimycotics (eg, ketoconazole, itraconazole, voriconazole, posaconazole), HIV PIs (eg, ritonavir). Increased plasma conc w/ amiodarone, clarithromycin, diltiazem, fluconazole, naproxen, quinidine, verapamil. Decreased mean AUC & Cmax w/ rifampicin. Reduced plasma conc w/ strong CYP3A4 & P-gp inducers eg, phenytoin, carbamazepine, phenobarb or St. John's wort. Increased bleeding risk w/ other anticoagulants, SSRIs/SNRIs, NSAIDs including ASA, clopidogrel, P2Y12 inhibitors, other platelet aggregation inhibitors (eg, GPIIb/IIIa receptor antagonists, dipyridamole, dextran, sulfinpyrazone), thrombolytic agents. Additive effect on anti-Factor Xa activity w/ enoxaparin. Reduced exposure w/ activated charcoal.
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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