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Eliquis® (apixaban)

Risk Minimisation Information for Healthcare Professionals

Populations potentially at higher risk of bleeding1,2

Several subgroups of patients are at increased risk of bleeding and should be carefully monitored for signs and symptoms of bleeding complications. Apixaban should be used with caution in conditions with an increased haemorrhagic risk. Apixaban administration should be discontinued if severe haemorrhage occurs.

Lesion or condition if considered a significant risk factor for major bleeding and where use is contraindicated

This includes:

  • Active clinically significant bleeding
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
  • Current or recent gastrointestinal ulceration
  • Presence of malignant neoplasms at high risk of bleeding
  • Recent brain or spinal injury
  • Recent brain, spinal or ophthalmic surgery
  • Recent intracranial haemorrhage
  • Known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities

Interactions with other medicinal products affecting haemostasis

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  • Unfractionated heparin (UFH), low molecular weight heparins (e.g. enoxaparin, dalteparin), heparin derivatives (e.g. fondaparinux)
  • Oral anticoagulants (e.g. warfarin, rivaroxaban, dabigatran)

Due to an increased bleeding risk, concomitant treatment with apixaban and any other anticoagulant agent is contraindicated, 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 when UFH is given during catheter ablation for atrial fibrillation.

Factors which may increase apixaban exposure/increase apixaban plasma levels

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See sections on patients with renal impairment under dosing recommendations for each separate indication

  • Use is not recommended in patients with CrCl <15 ml/min or patients undergoing dialysis
  • No dose adjustment is required in patients with mild or moderate renal impairment

Patients with NVAF

  • Patients with severe renal impairment (CrCl 15–29 ml/min) should receive the lower dose of apixaban 2.5 mg twice daily
  • Patients with serum creatinine ≥1.5 mg/dL (133 µmol/L) associated with age ≥80 years or body weight ≤60 kg should receive the lower dose of apixaban 2.5 mg twice daily

Factors which may reduce apixaban exposure/reduce apixaban plasma levels

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This Prescriber Guide is not a substitute for the apixaban Summary of Product Characteristics (SmPC). Please consult the SmPC for full prescribing information.