Apixaban Sandoz

Apixaban

DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE. Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery. Reduce the risk of stroke, systemic embolism, & death in patients w/ non-valvular atrial fibrillation (NVAF) w/ ≥1 risk factors, including patients unsuitable for warfarin.

Acute DVT or PE 10 mg bid for 1st 7 days. Max: 20 mg daily; followed by 5 mg bid. Max: 10 mg daily. Prevention of recurrent DVT &/or PE following completion of 6 mth of treatment for DVT or PE 2.5 mg bid. Max: 5 mg daily. Prevention of VTE (elective hip or knee replacement surgery) 2.5 mg bid. Take initial dose 12-24 hr after surgery. Recommended duration of treatment: Patients undergoing hip replacement surgery 32-38 days; knee replacement surgery 10-14 days. Prevention of stroke & systemic embolism in patients w/ NVAF 5 mg bid. NVAF patients, either age ≥80 years, body wt ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L) Reduce dose to 2.5 mg bid.

May be taken with or without food: Swallow w/ water. For patients w/ difficulty swallowing, crush tab & suspend in water/5% dextrose in water (D5W)/apple juice, or mix w/ applesauce & take immediately. Alternatively, crush tab & suspend in 60 mL water/D5W & administer immediately via nasogastric tube.

Hypersensitivity. Active clinically significant bleeding. Current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury/brain, spinal or ophth surgery/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, LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran). Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.

Discontinue use if severe haemorrhage occurs; at least 48 hr prior to elective surgery or invasive procedures w/ moderate or high risk of bleeding; 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding. Not recommended as an alternative to unfractionated heparin in patients w/ PE who are haemodynamically unstable. Not recommended in patients w/ prosthetic heart valves, w/ or w/o atrial fibrillation; history of thrombosis who are diagnosed w/ antiphospholipid syndrome; undergoing hip fracture surgery. Not to interrupt treatment for patients undergoing catheter ablation for atrial fibrillation. Risk of developing an epidural or spinal haematoma. Presence of neuraxial blockade. Patients w/ atrial fibrillation; active cancer. Frequently monitor for signs & symptoms of neurological impairment (eg, numbness or weakness of legs, bowel, or bladder dysfunction). Affected prothrombin time, INR, & aPTT. Consider urgency of intervention if surgery or invasive procedures cannot be delayed. Indwelling epidural or intrathecal catheters must be removed at least 5 hr prior to 1st dose treatment. Perform LFTs prior to initiation of treatment. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid lapses in therapy. Concomitant treatment w/ any other anticoagulants; antiplatelet agents; SSRIs, SNRIs, or NSAIDs; ASA. Not recommended concomitantly w/ other platelet aggregation inhibitors following surgery; in patients receiving concomitant systemic treatment w/ strong inhibitors of both CYP3A4 & P-gp, eg, azole-antimycotics (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). Severe renal impairment (CrCl 15-29 mL/min). Not recommended in patients w/ CrCl <15 mL/min, or undergoing dialysis. Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Discontinue lactation or discontinue/abstain from treatment during lactation. Childn & adolescents <18 yr. Increased haemorrhagic risk in low body wt & elderly patients.

Haemorrhage, contusion, epistaxis, & haematoma.

Increased mean AUC & C_max w/ ketoconazole, diltiazem, naproxen, & clarithromycin. Decreased mean AUC & C_max w/ rifampicin. Reduced plasma conc w/ other strong CYP3A4 & P-gp inducers (eg, phenytoin, carbamazepine, phenobarb or St. John's Wort). Reduced exposure w/ activated charcoal. Concomitant use w/ strong inhibitors of both CYP3A4 & P-gp, eg, azole-antimycotics (ketoconazole, itraconazole, voriconazole & posaconazole) & HIV PIs (ritonavir); strong inducers of both CYP3A4 & P-gp; anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs & NSAIDs; other platelet aggregation inhibitors (eg, glycoprotein IIb/IIIa receptor antagonists, dipyridamole, dextran or sulfinpyrazone) or thrombolytic agents.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

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