Apixaban Teva

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). Treatment of DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults.

Prevention of stroke & systemic embolism in NVAF 5 mg bd. Reduce dose to 2.5 mg bd in case of at least 2 of the following characteristics: age ≥80 yr, body wt ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromol/L). Patient w/ severe renal impairment (CrCl 15-29 mL/min) 2.5 mg bd. Patient undergoing cardioversion For patients initiating treatment w/ apixaban: 5 mg bd for at least 2.5 days (5 single doses) before cardioversion to ensure adequate anticoagulation. Reduce to 2.5 mg bd for at least 2.5 days (5 single doses) if criteria for dose reduction is met. If cardioversion is required before 5 doses of apixaban can be administered: 10 mg loading dose, followed by 5 mg bd. Reduce to 5 mg loading dose, followed by 2.5 mg bd if criteria for dose reduction is met. Administer loading dose at least 2 hr before cardioversion. Treatment of DVT & PE 10 mg bd for the 1st 7 days, followed by 5 mg bd. Prevention of recurrent DVT & PE Initiate 2.5 mg bd following completion of 6 mth of treatment w/ apixaban 5 mg bd or w/ another anticoagulant.

May be taken with or without food: Swallow whole w/ water. If unable to swallow whole tab, crush tab & suspend in water, or 5% glucose in water (G5W), or apple juice or mix w/ apple puree & immediately administer orally; alternatively, crush tab & suspend in 60 mL of water or G5W & immediately deliver through a nasogastric tube.

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. Concomitant treatment w/ any other anticoagulant agent 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.

Carefully observe for signs of bleeding. Caution in conditions w/ increased risk of haemorrhage. Discontinue if severe haemorrhage occurs. Discontinue at least 48 hr prior to elective surgery or invasive procedures w/ moderate or high risk of bleeding. Discontinue at least 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding. Restart apixaban after invasive procedure or surgical intervention as soon as possible provided the clinical situation allows & adequate haemostasis has been established. Increased risk of thrombosis when discontinuing anticoagulants, including apixaban, for active bleeding, elective surgery, or invasive procedures. Not recommended as alternative to UFH in patients w/ PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Carefully assess benefits against risks when apixaban is considered for DVT or PE treatment in cancer patients. Perform liver function testing prior to initiating treatment. Interaction w/ other medicinal products affecting haemostasis. Very limited experience w/ use of thrombolytic agents for the treatment of acute ischemic stroke in patients administered apixaban. Not recommended in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inhibitors. Use w/ caution in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inducers for the prevention of stroke & systemic embolism in NVAF patients & prevention of recurrent DVT & PE. Do not use in patients receiving concomitant systemic treatment w/ strong CYP3A4 & P-gp inducers for the treatment of DVT & PE. Clotting tests (eg, prothrombin time, INR, & aPTT) are affected as expected by the mechanism of action of apixaban. Limited experience of apixaban treatment at the recommended dose for NVAF patients when used in combination w/ antiplatelet agents in patients w/ acute coronary syndrome &/or undergoing percutaneous coronary intervention after haemostasis is achieved. Caution in patients w/ severe renal impairment for the treatment of DVT & PE & prevention of recurrent DVT & PE; patients w/ mild or moderate hepatic impairment; patients w/ elevated ALT/AST >2 x ULN or total bilirubin ≥1.5 x ULN. Not recommended in patients w/ CrCl <15 mL/min or in patients undergoing dialysis; patients w/ severe hepatic impairment; patients w/ prosthetic heart valves, w/ or w/o atrial fibrillation; patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Preferable to avoid use during pregnancy. Discontinue breastfeeding or discontinue/abstain from apixaban therapy. Safety & efficacy in childn & adolescents <18 yr have not been established. Increasing age may increase haemorrhagic risk. Low body wt (<60 kg) may increase haemorrhagic risk.

Haemorrhage, contusion, epistaxis, haematoma.

Increased AUC & C_max w/ ketoconazole (strong CYP3A4 & P-gp inhibitor); diltiazem (moderate CYP3A4 & weak P-gp inhibitor); naproxen (P-gp inhibitor); clarithromycin (P-gp inhibitor & strong CYP3A4 inhibitor). Reduced plasma conc w/ strong CYP3A4 & P-gp inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). Increased bleeding risk w/ other anticoagulants; SSRIs/SNRIs, NSAIDs, ASA &/or P2Y12 inhibitors; other platelet aggregation inhibitors (eg, GPIIb/IIIa receptor antagonists, dipyridamole, dextran, sulfinpyrazone) or thrombolytic agents. Reduced exposure w/ activated charcoal.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AF02 - apixaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

P₁S₁S₃