Hemapix

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 (TIA); age ≥75 yr; HTN; DM; symptomatic heart failure (NYHA class ≥II). Treatment of DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults. 2.5 mg: Prevention of VTE in adult patients who have undergone elective hip or knee replacement surgery.

Prevention of stroke & systemic embolism Patient w/ NVAF 5 mg bid. Dose reduction: 2.5 mg bid in patient w/ NVAF & at least 2 of the following characteristics: age ≥80 yr, body wt ≤60 kg, or serum creatinine ≥1.5 mg/dL (133 micromole/L). Therapy should be continued long-term. Treatment of DVT or PE 10 mg bid for 1st 7 days (max daily dose: 20 mg) followed by 5 mg bid (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 bid (max daily dose: 5 mg). 2.5 mg FC tab Prevention of VTE 2.5 mg bid. Initial dose should be taken 12-24 hr after surgery. Recommended duration of treatment: Patient undergoing hip replacement surgery 32-38 days, knee replacement surgery 10-14 days.

May be taken with or without food: Swallow tab w/ water. Patient who is unable to swallow whole tab: Tab may be crushed & suspended in water, or 5% glucose in water (G5W), or apple juice or mixed w/ apple puree & immediately administered orally. Alternatively, may be crushed & suspended in 60 mL water or G5W & immediately delivered through a nasogastric tube. Crushed tab are stable in water, G5W, apple juice & puree for up to 4 hr.

Hypersensitivity. Active clinically significant bleeding. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Lesion or condition if considered a significant risk 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, when UFH is given at doses necessary to maintain an open central venous or arterial catheter or during catheter ablation for atrial fibrillation.

Discontinue use if severe haemorrhage occurs; 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. Exercise appropriate caution if surgery or invasive procedures cannot be delayed. Restart apixaban after invasive procedure or surgical intervention as soon as possible provided the clinical situation allows & adequate haemostasis has been established. Not recommended in patients w/ prosthetic heart valves, w/ or w/o atrial fibrillation; in patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome; as an alternative to unfractionated heparin in patients w/ pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy; in patients receiving concomitant systemic treatment w/ strong inhibitors of both CYP3A4 & P-gp eg, azole antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole) & HIV PIs (eg, ritonavir). Not to be used for treatment of DVT & PE in patients receiving concomitant systemic treatment w/ strong inducers of both CYP3A4 & P-gp. Patients w/ active cancer can be at high risk of both VTE & bleeding events. Changes in clotting tests (eg, prothrombin time, INR, & aPTT). Caution when concomitantly used w/ antiplatelet agents; SSRIs, SNRIs, or NSAIDs, including ASA; strong inducers of both CYP3A4 & P-gp. Not recommended w/ other platelet aggregation inhibitors following surgery. Very limited experience w/ use of thrombolytic agents for treatment of acute ischemic stroke in patients administered w/ apixaban. Not recommended in patients w/ severe hepatic impairment. Caution in patients w/ mild or moderate hepatic impairment (Child-Pugh A or B); elevated liver enzymes ALT/AST >2 times ULN or total bilirubin ≥1.5 times ULN; severe renal impairment (CrCl 15-29 mL/min); serum creatinine ≥1.5 mg/dL (133 micromole/L); low body wt (<60 kg); elderly. Preferable to avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from therapy. 2.5 mg: Risk of developing epidural or spinal haematoma when neuraxial anaesth (spinal/epidural anaesth) or spinal/epidural puncture is employed; frequently monitor for signs & symptoms of neurological impairment (eg, leg numbness or weakness, bowel or bladder dysfunction). No clinical experience of use w/ indwelling intrathecal or epidural catheters. Extreme caution is recommended when using in the presence of neuraxial blockade. Not recommended in patients w/ CrCl <15 mL/min or undergoing dialysis. Not recommended in patients undergoing hip fracture surgery.

Anaemia, thrombocytopenia; eye haemorrhage (including conjunctival haemorrhage); haemorrhage, haematoma; hypotension (including procedural hypotension); epistaxis; nausea, GI, mouth, & rectal haemorrhage, gingival bleeding; increased γ-glutamyltransferase & ALT; skin rash; haematuria; abnormal vag & urogenital haemorrhage; contusion.

Increased plasma conc w/ strong inhibitors of both CYP3A4 & P-gp (eg, ketoconazole, itraconazole, voriconazole & posaconazole) & HIV PIs (eg, ritonavir). Increased plasma conc to a lesser extent w/ active substances which are not considered strong inhibitors of both CYP3A4 & P-gp (eg, amiodarone, clarithromycin, diltiazem, fluconazole, naproxen, quinidine, verapamil). Decreased mean AUC & C_max w/ rifampicin (strong inducer of both CYP3A4 & P-gp). Reduced plasma conc w/ other strong CYP3A4 & P-gp inducers (eg, phenytoin, carbamazepine, phenobarb or St. John's Wort). Increased bleeding risk w/ other anticoagulants, SSRIs/SNRIs, NSAIDs, ASA, P2Y12 inhibitors, other platelet aggregation inhibitors (eg, GPIIb/IIIa receptor antagonists, dipyridamole, dextran or 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.

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