Apiraban®

Contraindications:

Active pathological bleeding, Severe hypersensitivity reaction to Apixaban.

Interactions:

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to apixaban and increase the risk of stroke. The dose of Apixaban should be decreased to 2.5 mg twice daily when it is co-administered with drugs that are strong dual inhibitors of CYP3A4 and P-gp, (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). Avoid concomitant use of Apixaban with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban. Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding.

Pregnancy and Lactation:

Pregnancy Category B
It is unknown whether apixaban or its metabolites are excreted in human milk. Rats excrete apixaban in milk (12% of the maternal dose). Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Warning and Precaution:

Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant. Apixaban increases the risk of bleeding and can cause serious, potentially fatal, bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitor, and nonsteroidal anti-inflammatory drugs (NSAIDs). The safety and efficacy of Apixaban has not been studied in patients with prosthetic heart valves. Therefore, use of Apixaban is not recommended in these patients.

Adverse Reactions:

Increased gamma-glutamyl transferase, gingival hemorrhage, nausea, hematuria, hypermenorrhea, anemia, bruise, hematoma, rectal hemorrhage, postprocedural hemorrhage, increased serum transaminases, epistaxis, hemoptysis.

Storage:

Store below 30 and protect from light and moisture.