ELIQUIS for initial DVT / PE treatment *—
And for appropriate patients , continue on a low dose † to reduce the risk of recurrent DVT / PE following initial therapy 1
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* Initial therapy : 10 mg , orally twice daily for the first 7 days . After 7 days , 5 mg orally twice daily .
†
Extended therapy : 2.5 mg , orally twice daily . Please see full dosing information in the Prescribing Information .
IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS ( cont ’ d ) The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter . The risk may also be increased by traumatic or repeated epidural or spinal puncture . If traumatic puncture occurs , delay the administration of ELIQUIS for 48 hours . Monitor patients frequently and if neurological compromise is noted , urgent diagnosis and treatment is necessary . Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients .
• Prosthetic Heart Valves : The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients .
• Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy : Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy .
ADVERSE REACTIONS
• The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding .
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS
• ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding . ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled . Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required . ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established .
DRUG INTERACTIONS
• Strong Dual Inhibitors of CYP3A4 and P-gp : Inhibitors of cytochrome P450 3A4 ( CYP3A4 ) and P-glycoprotein ( P-gp ) increase exposure to apixaban and increase the risk of bleeding . For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily , reduce the dose of ELIQUIS by 50 % when ELIQUIS is coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp ( e . g ., ketoconazole , itraconazole , ritonavir , or clarithromycin ). In patients already taking 2.5 mg twice daily , avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp .
• Strong Dual Inducers of CYP3A4 and P-gp : Avoid concomitant use of ELIQUIS 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 and increase the risk of stroke and other thromboembolic events .
• Anticoagulants and Antiplatelet Agents : Coadministration of antiplatelet agents , fibrinolytics , heparin , aspirin , and chronic NSAID use increases the risk of bleeding . APPRAISE-2 , a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel , was terminated early due to a higher rate of bleeding with apixaban compared to placebo .
PREGNANCY CATEGORY B
• There are no adequate and well-controlled studies of ELIQUIS in pregnant women . Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery . ELIQUIS should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus .
Reference : 1 . ELIQUIS ® Package Insert . Bristol-Myers Squibb Company , Princeton , NJ , and Pfizer Inc , New York , NY .
Please see Brief Summary of Full Prescribing Information , including Boxed WARNINGS , on adjacent pages .
ELIQUIS ® and the ELIQUIS logo are trademarks of Bristol-Myers Squibb Company . © 2017 Bristol-Myers Squibb . All rights reserved . 432US1702247-02-01 07 / 17