Eliquis

Eliquis

apixaban

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Apixaban
Indications/Uses
DVT & pulmonary embolism (PE); prevention of recurrent DVT & PE in adults. Prevention of stroke & systemic embolism in adult patients 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)]. 2.5 mg FC tab Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery.
Dosage/Direction for Use
DVT or PE 10 mg bd for the 1st 7 days (max daily dose: 20 mg) followed by 5 mg bd (max daily dose: 10 mg). Prevention of recurrent DVT &/or PE following completion of 6 mth of treatment for DVT or PE 2.5 mg bd (max daily dose: 5 mg). Prevention of stroke & systemic embolism Patient w/ NVAF 5 mg bd. Patient w/ NVAF & at least 2 of the following characteristics: ≥80 yr, ≤60 kg or serum creatinine ≥1.5 mg/dL 2.5 mg bd, should be continued as long-term therapy. Severe renal impairment (CrCl 15-29 mL/min) in patient w/ NVAF 2.5 mg bd. 2.5 mg FC tab Prevention of VTE: Elective hip or knee replacement surgery 2.5 mg bd, initially taken 12-24 hr post-op. Duration of treatment: 32-38 days (hip replacement surgery); 10-14 days (knee replacement surgery).
Administration
May be taken with or without food: Swallow tab w/ water. For patients who are unable to swallow, tab may be crushed & suspended in water, or 5% dextrose in water (D5W) or apple juice or mixed w/ apple puree. Drink immediately. Soln stable for up to 4 hr. Alternatively, crush & suspend in 60 mL water or D5W & administer via nasogastric tube.
Contraindications
Hypersensitivity. Active clinically significant bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition if 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/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 anticoagulants eg, unfractionated heparin (UFH), LMWH (eg, enoxaparin, dalteparin), heparin derivatives (eg, fondaparinux), oral anticoagulants (eg, warfarin, rivaroxaban, dabigatran) except under specific circumstances of switching anticoagulant therapy, when UFH is given at doses necessary to maintain an open central venous or arterial catheter or when UFH is given during catheter ablation for atrial fibrillation.
Special Precautions
Carefully observe for signs of bleeding; conditions w/ increased risk of haemorrhage; discontinue if severe haemorrhage occurs. Concomitant use w/ antiplatelets, SSRIs or SNRIs, NSAIDs including ASA. Not recommended to be used w/ other platelet aggregation inhibitors following surgery. Patients w/ atrial fibrillation & conditions that warrant mono or dual antiplatelet therapy. Patients w/ NVAF & acute coronary syndrome &/or percutaneous coronary intervention. Concomitant use w/ thrombolytics for acute ischaemic stroke. Not recommended in patients w/ prosthetic heart valves w/ or w/o atrial fibrillation; w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. 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. Bridging anticoagulation during 24-48 hr after stopping apixaban & prior to intervention is not generally required in patients w/ NVAF. Discontinue use in active bleeding, elective surgery, or invasive procedures which places patients at an increased risk of thrombosis. Not recommended as an alternative to unfractionated heparin in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Patients w/ active cancer. Low body wt (<60 kg) may increase haemorrhagic risk. Not recommended in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole) & HIV PIs (eg, ritonavir). Concomitant use w/ strong CYP3A4 & P-gp inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb or St. John's Wort). Clotting tests (eg, prothrombin time, INR & aPTT) are affected. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains Na <1 mmol. Severe renal impairment in patients treated for DVT, PE & prevention of recurrent DVT & PE, & for the prevention of VTE in elective hip or knee replacement surgery; not recommended in patients w/ CrCl <15 mL/min or undergoing dialysis. Not recommended in patients w/ severe hepatic impairment. Patients w/ mild or moderate hepatic impairment (Child-Pugh A or B); elevated ALT/AST >2 x ULN or total bilirubin ≥1.5 x ULN. Avoid use during pregnancy. Lactation. Childn & adolescent <18 yr. Elderly; potential higher bleeding risk during co-administration w/ ASA. 2.5 mg FC tab Frequently monitor for signs & symptoms of neurological impairment (eg, numbness or weakness of the legs, bowel or bladder dysfunction). Extreme caution is recommended when used in the presence of neuraxial blockade. Not recommended in patients undergoing hip fracture surgery.
Adverse Reactions
Anaemia; haemorrhage, haematoma; nausea; contusion. Epistaxis; GI & rectal haemorrhage, gingival bleeding; increased γ-glutamyltransferase; haematuria. Eye haemorrhage (including conjunctival haemorrhage); hypotension (including procedural hypotension). Thrombocytopenia; mouth haemorrhage; increased ALT; skin rash; abnormal vag & urogenital haemorrhage.
Drug Interactions
Mean AUC & Cmax may be increased w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole, posaconazole) & HIV PIs (eg, ritonavir). Plasma conc may be increased to a lesser extent w/ amiodarone, clarithromycin, diltiazem, fluconazole, naproxen, quinidine, verapamil. Mean AUC & Cmax may be decreased w/ rifampicin. Plasma conc may be reduced w/ strong CYP3A4 & P-gp inducers (eg, phenytoin, carbamazepine, phenobarb, St. John's wort). Increased bleeding risk w/ other anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs, NSAIDs, ASA &/or P2Y12 inhibitors. Additive effect on anti-Factor Xa activity w/ enoxaparin. Not recommended to co-administer w/ other platelet aggregation inhibitors (eg, GPIIb/IIIa receptor antagonists, dipyridamole, dextran, sulfinpyrazone) or thrombolytics. Reduced exposure by 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.
Presentation/Packing
Form
Eliquis FC tab 2.5 mg
Packing/Price
60's
Form
Eliquis FC tab 5 mg
Packing/Price
60's
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