قرص زابانو 5 میلی گرم

Xabano
A factor Xa Inhibitor (Direct Oral Anticoagulant (DOAC)) with the brand name of Xabano (Apixaban)

Description
Apixaban inhibits platelet activation and fibrin clot formation via direct, selective and reversible inhibition of free and clot-bound factor Xa (FXa), so it decreases thrombin generation and thrombus development. Apixaban indirectly inhibits platelet aggregation induced by thrombin.

Product Information
Xabano with the generic name of apixaban, by selective inhibition of free and clot-bound factor Xa, inhibits the conversion of prothrombin to thrombin. thrombin by activation of platelets and catalyzing the conversion of fibrinogen to fibrin, causes thrombus development. Xabano is indicated:
•    to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). 
•    for the prophylaxis of deep vein thrombosis (DVT), and pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
•    for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.

General Product Information
Product Review
What is the mechanism of action of Xabano?
Apixaban is a Direct Oral Anticoagulant that selectively inhibits free and clot-bound FXa. Apixaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, apixaban decreases thrombin generation and thrombus development.

What are the indications of Xabano?
Apixaban is indicated:
•    to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. 
•    for the prophylaxis of deep vein thrombosis (DVT), and pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
•    for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.

What are the dosage forms of Xabano?
Each Xabano 2.5 tablet contains 2.5 mg of Apixaban.
Each Xabano 5 tablet contains 5 mg of Apixaban.
Does Xabano need dose adjustment in kidney impairment?
Serum creatinine ≥1.5 mg/dL and either ≥80 years of age or body weight ≤60 kg in AF patients: reduce the dose to 2.5 mg twice daily.
No dosage adjustment is recommended for any degree of reduced kidney function in the prophylaxis and treatment of DVT and PE.

Does Xabano need dose adjustment in hepatic impairment?
Moderate hepatic impairment (Child-Pugh class B): because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with apixaban in these patients, dosing recommendations cannot be provided.
Severe hepatic impairment (Child-Pugh class C): apixaban is not recommended in patients with severe hepatic impairment. 

What are the contraindications of Xabano?
Avoid use in case of severe hypersensitivity reaction (ie, anaphylaxis) to apixaban or any component of the formulation or active pathological bleeding.

Who should use Xabano with caution?
Increased Risk of thrombotic events after premature discontinuation: Premature discontinuation of any oral anticoagulant, including apixaban, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

Bleeding: Concomitant use of drugs affecting hemostasis, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of bleeding. Patients should be aware of signs and symptoms of bleeding and report them immediately or go to an emergency room.
Patients with Prosthetic Heart Valves: The safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves. Therefore, use of apixaban is not recommended in these patients.
Spinal/ epidural anesthesia or puncture: Spinal hematoma or epidural intracranial hemorrhage may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture; may result in long-term or permanent paralysis. Patients should be monitored frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, or bowel or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary.
Elective surgery/procedure: The timing of discontinuation of apixaban before elective surgeries depends on kidney function and risk for bleeding complications. In patients with Creatinine Clearance (CrCl) ≥30 mL/minute, discontinue therapy approximately 24 to 48 hours before surgery, depending on risk for bleeding. In patients with CrCl <30 mL/minute, may consider discontinuing therapy ~48 to 72 hours before surgery, depending on risk for bleeding. May reinstitute therapy after ≥24 hours depending on risk for bleeding. 
Acute PE in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy: Initiation of apixaban is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
Antiphospholipid syndrome: Use not recommended for patients with triple-positive antiphospholipid syndrome (positive for all 3 antiphospholipid antibodies [lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I]). 

What are the drug interactions of Xabano?
Alteplase and tenecteplase: May enhance the anticoagulant effect of Anticoagulants. Avoid combination.
Anticoagulants: Apixaban may enhance the anticoagulant effect of Anticoagulants. Avoid combination.
Inducers of CYP3A4 (Strong) and P-glycoprotein like carbamazepine, phenytoin, phenobarbital, primidone and rifampin: May decrease the serum concentration of Apixaban. Avoid combination.
St John's Wort: May decrease the serum concentration of Apixaban. Avoid combination.
Enzalutamide: May decrease the serum concentration of Apixaban. Consider alternatives to this combination when possible. 
Inhibitors of CYP3A4 (Strong) and P-glycoprotein like atazanavir, ceritinib, clarithromycin, darunavir, indinavir, itraconazole, ketoconazole, lopinavir, nelfinavir, posaconazole, ritonavir and tucatinib: May increase the serum concentration of Apixaban. Consider dose adjustment or therapy modification. 
Naproxen: May enhance the adverse/ toxic effect of Apixaban specifically, the risk for bleeding. A comprehensive risk to benefit assessment should be done for all patients before any concurrent use of apixaban and naproxen. If combined, monitor patients closely for signs and symptoms of bleeding. 
Grapefruit juice: may increase levels/ effects of apixaban. Advise patients who consume grapefruit juice during therapy to use caution; monitor for increased effects (bleeding).

Is Xabano recommended during pregnancy and lactation?
Data are insufficient to evaluate the safety of direct-acting oral anticoagulants during pregnancy and use in pregnant patients is not recommended. 
Until safety data are available, direct acting oral anticoagulants are not recommended for use in patients who are breastfeeding; use of an alternative anticoagulant is preferred. 

FAQs
1-    What will happen if Xabano be stopped?
Do not stop taking Xabano without talking to your doctor. If you stop taking Xabano, the rate at which your blood clots will return to what it was before you started taking it, usually within a day or two of stopping. This means that you may be at increased risk of serious problems like stroke, heart attack, DVT or PE.

2-    What should be done in case of a missed dose?
Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

3-    How is Xabano best taken?
Xabano can be taken with or without food.