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
IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS ( cont ’ d )
DRUG INTERACTIONS
The next dose of ELIQUIS should not be administered earlier
• Strong Dual Inhibitors of CYP3A4 and P-gp : Inhibitors of than 5 hours after the removal of the catheter . The risk cytochrome P450 3A4 ( CYP3A4 ) and P-glycoprotein ( P-gp ) may also be increased by traumatic or repeated epidural increase exposure to apixaban and increase the risk of or spinal puncture . If traumatic puncture occurs , delay the bleeding . For patients receiving ELIQUIS doses of 5 mg or administration of ELIQUIS for 48 hours .
10 mg twice daily , reduce the dose of ELIQUIS by 50 % when Print-only
Monitor patients frequently and if neurological compromise is
ELIQUIS content is coadministered with drugs that are strong dual noted , urgent diagnosis and treatment is necessary . Physicians inhibitors of CYP3A4 and P-gp ( e . g ., ketoconazole , itraconazole , should consider the potential benefit versus the risk of ritonavir , or clarithromycin ). In patients already taking 2.5 mg neuraxial intervention in ELIQUIS patients . twice daily , avoid coadministration of ELIQUIS with strong dual
• Prosthetic Heart Valves : The safety and efficacy of ELIQUIS inhibitors of CYP3A4 and P-gp . have not been studied in patients with prosthetic heart valves • Strong Dual Inducers of CYP3A4 and P-gp : Avoid and is not recommended in these patients . concomitant use of ELIQUIS with strong dual inducers of
• Acute PE in Hemodynamically Unstable Patients or CYP3A4 and P-gp ( e . g ., rifampin , carbamazepine , phenytoin ,
Patients who Require Thrombolysis or Pulmonary
St . John ’ s wort ) because such drugs will decrease exposure
Embolectomy : Initiation of ELIQUIS is not recommended as an to apixaban and increase the risk of stroke and other alternative to unfractionated heparin for the initial treatment thromboembolic events . of patients with PE who present with hemodynamic instability • Anticoagulants and Antiplatelet Agents : Coadministration or who may receive thrombolysis or pulmonary embolectomy . of antiplatelet agents , fibrinolytics , heparin , aspirin , and chronic NSAID use increases the risk of bleeding . APPRAISE-2 ,
ADVERSE REACTIONS a placebo-controlled clinical trial of apixaban in high-risk
• The most common and most serious adverse reactions post-acute coronary syndrome patients treated with aspirin reported with ELIQUIS were related to bleeding . or the combination of aspirin and clopidogrel , was terminated early due to a higher rate of bleeding with apixaban compared to placebo . 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 .
To learn more about ELIQUIS , visit hcp . eliquis . com
* 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 .
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