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Eliquis® (apixaban)
Risk Minimisation Information for Healthcare Professionals
Risk Minimisation Information for Healthcare Professionals
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.
This includes:
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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.
The concomitant use of apixaban with antiplatelet agents increases the risk of bleeding.
Apixaban should be used with caution when coadministered with selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs), non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA) and/or P2Y12 inhibitors (e.g. clopidogrel).
There is limited experience of co-administration with other platelet aggregation inhibitors (such as GPIIb/ IIIa receptor antagonists, dipyridamole, dextran or sulfinpyrazone) or thrombolytic agents. As such agents increase the bleeding risk, co-administration of these medicinal products with apixaban is not recommended.
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See sections on patients with renal impairment under dosing recommendations for each separate indication
No dose adjustment required
No dose adjustment required except in combination with other factors
No dose adjustment required
No dose adjustment required except in combination with other factors
Apixaban is not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g. ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g. ritonavir).
No dose adjustment for apixaban is required when coadministered with, for example, amiodarone, clarithromycin, diltiazem, fluconazole, naproxen, quinidine and verapamil.
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The concomitant use of apixaban with strong inducers of both CYP3A4 and P-gp (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or
Apixaban is not recommended
This Prescriber Guide is not a substitute for the apixaban Summary of Product Characteristics (SmPC). Please consult the SmPC for full prescribing information.