Xagulant 2.5/Xagulant 5

Apixaban

Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation (NVAF), w/ ≥1 risk factors, eg, prior stroke or transient ischaemic attack (TIA); ≥75 yr; HTN; DM; symptomatic heart failure (NYHA Class ≥II). Treatment of DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults. Xagulant 2.5 Prevention of VTE in adults who have undergone elective hip or knee replacement surgery.

Prevention of stroke & systemic embolism in patient w/ NVAF 5 mg bid. Patient w/ at least 2 of the following characteristics: Age ≥80 yr, wt ≤60 kg, or serum creatinine ≥1.5 mg/dL 2.5 mg bid. Patient w/ renal impairment 2.5 mg bid. DVT, PE 10 mg bid for the 1st 7 days followed by 5 mg bid. Prevention of recurrent DVT & PE 2.5 mg bid. Should be initiated following completion of 6 mth of treatment w/ apixaban 5 mg bid or w/ another anticoagulant. Patient undergoing cardioversion 5 mg bid for at least 2.5 days (5 single doses) before cardioversion to ensure adequate anticoagulation. If cardioversion is required before 5 doses of apixaban: 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 criteria for dose reduction. Loading dose should be given at least 2 hr before cardioversion. Xagulant 2.5 Prevention of VTE (VTEp): elective hip or knee replacement surgery 2.5 mg bid. Initial dose should be taken 12-24 hr after surgery. Recommended duration of treatment: Hip replacement surgery: 32-38 days. Knee replacement surgery: 10-14 days.

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/ apple puree. Alternatively, crush tab & suspend in 60 mL water/D5W & administer immediately via nasogastric tube.

Hypersensitivity. Active clinically significant bleeding. Lesion or condition if considered a significant risk factor for major bleeding including current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or 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 agent eg, unfractionated heparin (UFH), LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, rivaroxaban, dabigatran) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk.

Conditions w/ increased risk of haemorrhage. Discontinue if severe haemorrhage occurs. Concomitant use w/ antiplatelet agents; SSRIs, SNRIs, NSAIDs including ASA. Acute ischemic stroke. Not recommended in patients w/ prosthetic heart valves, w/ or w/o atrial fibrillation; history of thrombosis w/ diagnosed antiphospholipid syndrome. Discontinue at least 48 hr prior to elective surgery or invasive procedures w/ a moderate or high risk of bleeding; at least 24 hr prior to elective surgery or invasive procedures w/ a low risk of bleeding. Temporarily discontinue for active bleeding, elective surgery, or invasive procedures; avoid lapses in therapy & restart as soon as possible. Not recommended as alternative to unfractionated heparin in patients w/ pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Frequently monitor for signs & symptoms of neurological impairment (eg, numbness or weakness of the legs, bowel or bladder dysfunction). Active cancer. Increased haemorrhagic risk in low body wt (<60 kg). Concomitant use w/ CYP3A4, P-gp inducers or HIV PI inhibitors is not recommended; CYP3A4 & P-gp inducers. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Not recommended in patients w/ renal impairment (CrCl <15 mL/min) & those undergoing dialysis. Mild to severe (not recommended) hepatic impairment. Concomitant use w/ strong CYP3A4 & P-gp inhibitors [eg, azole-antimycotics (ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (ritonavir)] or inducers (eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort), antiplatelet agents, NSAIDs. Not recommended during pregnancy. Lactation. Elderly. Childn & adolescent <18 yr. Xagulant 2.5 Risk of developing spinal or epidural hematoma during spinal/epidural anesth or puncture which can result in long-term or permanent paralysis. Remove at least 5 hr prior to the 1st dose of apixaban indwelling epidural or intrathecal catheters. Not recommended in patients undergoing hip fracture surgery.

Anaemia, haemorrhage, haematoma; epistaxis; nausea; rectal haemorrhage, gingival bleeding; increased γ-glutamyltransferase; haematuria; contusion. Prevention of stroke & systemic embolism in adults w/ NVAF, w/ ≥1 risk factors (NVAF): Eye haemorrhage including conjunctival haemorrhage; hypotension. Treatment of DVT & PE, & prevention of recurrent DVT & PE (VTEt): Thrombocytopenia; mouth haemorrhage; increased ALT; skin rash; abnormal vag haemorrhage, urogenital haemorrhage.

Increased mean AUC & mean C_max w/ strong CYP3A4 & P-gp inhibitors (eg, ketoconazole, itraconazole, voriconazole & posaconazole) & HIV PIs (eg, ritonarvir). 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). Increased risk of bleeding w/ other anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs & NSAIDs including ASA. Additive effect on anti-Factor Xa activity w/ enoxaparin. Co-administration w/ other platelet aggregation inhibitors (eg, GPIIb/IIIa receptor antagonists, dipyridamole, dextran or sulfinpyrazone) or thrombolytic agents are not recommended. 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.

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