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ELIQUIS®▼(apixaban) 2.5 mg & 5 mg Film-coated Tablets Prescribing Information
Consult summary of product characteristics (SmPC) prior to prescribing PRESENTATION: Film-coated tablets; 2.5mg and 5mg apixaban. INDICATION:
of bleeding. This includes interventions for which the probability of clinically Prevention of stroke and systemic embolism in adult patients with non-valvular significant bleeding cannot be excluded or for which the risk of bleeding would be atrial fibrillation (NVAF) with one or more risk factors, such as prior stroke or unacceptable. Eliquis should be discontinued at least 24 hours prior to elective transient ischaemic attack (TIA), age ≥ 75 years, hypertension, diabetes mel itus surgery or invasive procedures with a low risk of bleeding. This includes or symptomatic heart failure (NYHA Class ≥ II). DOSAGE AND interventions for which any bleeding that occurs is expected to be minimal, non-
ADMINISTRATION: Oral. The recommended dose is 5mg taken twice a day with
critical in its location or easily controlled. If surgery or invasive procedures cannot water, with or without food. Patients who meet at least two of the following be delayed, appropriate caution should be exercised, taking into consideration an criteria:serum creatinine ≥ 1.5 mg/dL (133 micromole/l), age ≥ 80 years, or body increased risk of bleeding. This risk of bleeding should be weighed against the weight ≤ 60 kg should receive the lower dose of Eliquis, 2.5 mg twice daily. All urgency of intervention. Temporary discontinuation: Discontinuing anticoagulants, patients with severe renal impairment (creatinine clearance 15-29 ml/min) should including Eliquis, for active bleeding, elective surgery, or invasive procedures receive the lower dose of Eliquis 2.5 mg twice daily. Therapy should be continued places patients at an increased risk of thrombosis. Lapses in therapy should be long term. If a dose is missed, Eliquis should be taken immediately and then avoided and if anticoagulation with Eliquis must be temporarily discontinued for continue with twice daily dose as before. Switching treatment from parenteral any reason, therapy should be restarted as soon as possible provided the clinical anticoagulants to Eliquis (and vice versa) can be done at the next scheduled situation allows and adequate haemostasis has been established. Spinal/epidural dose. Switching treatment from VKA therapy to Eliquis, discontinue warfarin or anaesthesia or puncture: Special care should be taken when neuraxial other VKA therapy and start Eliquis when the international normalized ratio (INR) anaesthesia or spinal/epidural puncture is employed due to risk of epidural or is < 2.0. Switching treatment from Eliquis to VKA therapy, continue administration spinal haematoma with potential neurologic complications. The risk of these of Eliquis for at least 2 days after beginning VKA therapy. After 2 days of co- events may be increased by the post-operative use of indwelling epidural administration of Eliquis with VKA therapy, obtain an INR prior to next scheduled catheters or the concomitant use of medicinal products affecting haemostasis. dose of Eliquis. Continue co-administration of Eliquis and VKA therapy until the Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior INR is ≥2.0. Eliquis is not recommended in children and adolescents below the to the first dose of Eliquis. The risk may also be increased by traumatic or age of 18. See contraindications, and special warnings and precautions section repeated epidural or spinal puncture. Patients are to be frequently monitored for for information on use in patients with hepatic and renal impairment. signs and symptoms of neurological impairment. Prior to neuraxial intervention the CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the
physician should consider the potential benefit versus the risk in anticoagulated excipients listed in SmPC, active clinically significant bleeding, hepatic disease patients or in patients to be anticoagulated for thromboprophylaxis. There is no associated with coagulopathy and clinically relevant bleeding risk, lesion or clinical experience with the use of Eliquis with indwelling intrathecal or epidural condition if considered a significant risk factor for major bleeding (refer to SmPC). catheters. Please refer to SmPC for further information in case there is such a Concomitant treatment with any other anticoagulant except under the need. Extreme caution is recommended when using Eliquis in the presence of circumstances of switching therapy to or from Eliquis or when unfractionated neuraxial blockade.Laboratory parameters: Clotting tests (PT, INR, and aPTT) are heparin is given at doses necessary to maintain an open central venous or arterial not recommended to assess the pharmacodynamic effects of Eliquis. Information catheter (refer to SmPC). SPECIAL WARNINGS AND PRECAUTIONS: about excipients: Eliquis contains lactose. Patients with galactose intolerance, the
Haemorrhage risk: Carefully observe for signs of bleeding. Use with caution in Lapp lactase deficiency or glucose-galactose malabsorption should not take conditions with increased risk of haemorrhage. Discontinue administration if Eliquis. DRUG INTERACTIONS: Agents associated with serious bleeding are not
severe haemorrhage occurs. Interaction with other medicinal products affecting recommended concomitantly with Eliquis, such as: thrombolytic agents, GPIIb/IIIa haemostasis: Concomitant treatment with any other anticoagulant is receptor antagonists, thienopyridines (e.g., clopidogrel), dipyridamole, dextran and contraindicated (see contraindications). The concomitant use of Eliquis with sulfinpyrazone. Administration of activated charcoal reduces Eliquis exposure. antiplatelet agents increases the risk of bleeding. Care is to be taken if patients Also see contraindications, and special warnings and precautions section; Consult are treated concomitantly with non-steroidal anti-inflammatory drugs (NSAIDs), SmPC (contraindications, special warnings and precautions, and drug including acetylsalicylic acid. Following surgery, other platelet aggregation interactions) for full details on interactions. PREGNANCY AND LACTATION:
inhibitors are not recommended concomitantly with Eliquis. In patients with atrial Pregnancy: Not recommended during pregnancy. Breastfeeding: Discontinue fibril ation and conditions that warrant mono or dual antiplatelet therapy, a careful breastfeeding or discontinue Eliquis therapy. UNDESIRABLE EFFECTS:
assessment of the potential benefits against the potential risks should be made Common (≥ 1/100 to < 1/10): Eye haemorrhage (including conjunctival before combining this therapy with Eliquis. Renal impairment: No dose adjustment haemorrhage), other haemorrhage, haematoma, epistaxis, gastrointestinal in mild or moderate renal impairment. Lower dose of 2.5mg twice daily in severe haemorrhage (including haematemesis and melaena), rectal haemorrhage, renal impairment. Not recommended in patients with creatinine clearance gingival bleeding, haematuria, contusion. Uncommon (≥ 1/1,000 to < 1/100): < 15ml/min or in patients undergoing dialysis. Patients with serum creatinine ≥ 1.5 hypersensitivity (including skin rash, anaphylactic reaction and allergic oedema), mg/dL (133 micromole/l) associated with age ≥ 80 years or body weight ≤ 60 kg brain haemorrhage, other intracranial or intraspinal haemorrhage (including should receive the lower dose of Eliquis, 2.5 mg twice daily. Elderly Patients; The subdural haematoma, subarachnoid haemorrhage, and spinal haematoma), intra- co-administration of Eliquis with acetylsalicylic acid in elderly patients should be used cautiously because of a potentially higher bleeding risk. Hepatic impairment: haematochezia, mouth haemorrhage, abnormal vaginal haemorrhage, urogenital Eliquis is contraindicated in patients with hepatic disease associated with haemorrhage, application site bleeding, occult blood positive, traumatic coagulopathy and clinically relevant bleeding risk. Not recommended in severe haemorrhage, post procedural haemorrhage, incision site haemorrhage. Rare hepatic impairment. Use with caution in mild or moderate hepatic impairment. No (≥ 1/10,000 to < 1/1,000): Respiratory tract haemorrhage (including pulmonary dose adjustment is required in patients with mild or moderate hepatic impairment. alveolar haemorrhage, laryngeal haemorrhage and pharyngeal haemorrhage), Eliquis should be used with caution in patients with elevated liver enzymes retroperitoneal haemorrhage. LEGAL CATEGORY: POM. PACKAGE
ALT/AST >2 x ULN or total bilirubin ≥ 1.5 X ULN. Prior to initiating Eliquis, liver QUANTITIES AND BASIC NHS PRICE: Carton of 10 film-coated tablets 2.5mg
function testing should be performed. Interaction with inhibitors of CYP3A4 and £10.98, 20 film-coated tablets 2.5mg £21.96, 60 film-coated tablets 2.5mg £65.90, P-gp: Eliquis is not recommended in patients receiving concomitant strong 56 film-coated tablets 5mg £61.50. MARKETING AUTHORISATION NUMBERS:
inhibitors of both CYP3A4 and P-gp. Interaction with inducers of CYP3A4 and EU/1/11/691/001 - EU/1/11/691/003 and EU/1/11/691/008. MARKETING
P-gp: Strong inducers of both CYP3A4 and P-gp should be co-administered with AUTHORISATION HOLDER: Bristol-Myers Squibb/Pfizer EEIG, BMS House,
caution. Patients with prosthetic heart valves: Safety and efficacy of Eliquis have Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex. UB8 1DH. not been studied in patients with prosthetic heart valves, with or without atrial fibril ation. Therefore, the use of Eliquis is not recommended in this setting. DATE OF PI PREPARATION: September 2013
Surgery and invasive procedures: Eliquis should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk Adverse events should be reported. Reporting forms and information can be found at
www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bristol-Myers Squibb
Pharmaceuticals Ltd Medical Information on 0800 731 1736 or medical.information@bms.com

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