Company: Bristol-Myers Squibb/Pfizer EEIG
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Apixaban 5mg.
Description: Pink, oval film-coated tablets marked 894 on one side and 5 on reverse.
Presentation: 5mg-56, €65.80.
Indications: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), and ≥1 risk factors, e.g. prior stroke or TIA, age ≥ 75 years, hypertension, diabetes mellitus, symptomatic heart failure.
Pharmacology: Apixaban is a potent, oral, reversible, direct and highly selective active site inhibitor of factor Xa. It does not require antithrombin III for antithrombotic activity. Apixaban inhibits free and clot-bound factor Xa, and prothrombinase activity.
Dosage: Adult: 5mg twice daily swallowed with water; 2.5mg twice daily in severe renal impairment (creatinine clearance 15-29ml/min) or if two of following present: ≥ 80 years, ≤ 60kg, serum creatinine ≥133mcmole/l. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active clinically significant bleeding, hepatic disease associated with coagulopathy and bleeding risk, lesion or condition if considered a significant risk factor for major bleeding.
Special precautions: Not recommended: Patients with cc<15ml/min or undergoing dialysis, severe hepatic impairment, pregnancy, lactation. Caution: Severe renal impairment (cc 15-29ml/min), mild or moderate hepatic impairment (Child Pugh A or B), elevated liver enzymes (ALT/AST>2 x ULN) or total bilirubin 1.5 x ULN (measure ALT in pre-operative evaluation. Carefully observe for signs of bleeding; caution with conditions with increased risk of haemorrhage (discontinue if severe haemorrhage occurs). Neuraxial blockade (use with extreme caution). Remove indwelling epidural or intrathecal catheters at least 5 hours prior to first dose. Spinal/epidural anaesthesia; monitor frequently for signs of neurological impairment (see SPC). Elective surgery or invasive procedure: Discontinue 48 hours before if the bleeding risk is moderate/ high, or 24 hours before if it is low. This risk of bleeding should be weighed against the urgency of intervention. Lapses in therapy should be avoided and if anticoagulation with Eliquis must be temporarily discontinued for any reason, therapy should be restarted as soon as possible provided the clinical situation allows and adequate haemostasis has been established. Contains lactose. Patients with galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Eliquis.
Drug interactions: Contraindicated: Other anticoagulants (except when switching, or with unfractionated heparin at doses necessary to maintain an open central venous or arterial catheter). Not recommended: Strong inhibitors of both CYP3A4 and P-glycoprotein (P-gp) (such as azole-antimycotics (e.g. ketoconazole, itraconazole, voriconazole, posaconazole) and HIV protease inhibitors (e.g. ritonavir)), platelet aggregation inhibitors or other antithrombotic agents (other than NSAIDs), thrombolytics, GPIIb/IIIa receptor antagonists, thienopyridines (eg. clopidogrel), dipyridamole, dextran, sulfinpyrazone. Caution: Strong inducers of both CYP3A4 and P-gp (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, St. John’s Wort), NSAIDs including acetylsalicylic acid (especially severe renal impairment, elderly).
Adverse drug reactions: Eye haemorrhage (including conjunctival), other haemorrhage including gastrointestinal haemorrhage (such as haematemesis and melaena), rectal haemorrhage, gingival bleeding. Epistaxis, haematuria, contusion.
Full prescribing information and references available from Pfizer Healthcare Ireland. Telephone: (01) 4676500.