See full prescribing information for complete boxed. Transition of anticoagulants 2019 van hellerslia, pharmd, bcps, cacp, clinical assistant professor of pharmacy practice, temple university school of pharmacy, philadelphia, pa. Pradaxa 220 mg taken as one 110 mg capsule twice a day. Prescribing information spaf uk pradaxa dabigatran etexilate capsules containing 110 mg or 150 mg dabigatran etexilate as mesilate action. There are differences between pradaxa and warfarin. The recommended dose of praxbind is 5 g, provided as 2 separate 50ml vials, each containing 2.
Pradaxa treatment can be initiated 24 hours after administration of praxbind. These highlights do not include all the information needed to use. Us prescribing information for eliquis medication guide for eliquis dhcp letter for a period of 2 years the eliquis rems website is part of the rems and is appended. Pradaxa dabigatran etexilate mesylate capsules for oral use. Please see prescribing information for praxbind, and visit for more information. Pradaxa dabigatran etexilate mesylate capsules for oral use initial u. Please see important safety information for pradaxa on pages 9. Exelon rivastigmine tartrate capsules, for oral use exelon rivastigmine tartrate oral solution initial u. Please see full prescribing information, including boxed warning. Oral anticoagulant rx eliquis apixaban safety info.
Highlights of prescribing information these highlights do. Pradaxa ii31 revised product information european medicines. Pradaxa dabigatran etexilate mesylate capsule boehringer ingelheim pharmaceuticals inc. Guideline for the prescribing of novel oral anticoagulants. For emergency surgeryurgent procedures in lifethreatening or uncontrolled bleeding 2 dosage and administration 2.
Please see important safety information for pradaxa on. Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more of the following. Highlights of prescribing information these highlights do not include all the information needed to use exelon safely and effectively. For more information about pradaxa, including current prescribing information and medication guide, go to. Consider reducing the dose of pradaxa to 75 mg twice daily see drug. Jan 01, 2020 you can ask your pharmacist or doctor for information about pradaxa that is written for health professionals. See how pradaxa compares to warfarin, and find dosing and coverage information.
Learn more about pradaxa and its role in reducing risk of stroke in afib, and treating blood clots for dvt and pe. This product information was approved at the time this auspar was published. Choose pradaxa dabigatran etexilate for afib, dvt or pe. Do not stop taking pradaxa without talking to the doctor who prescribes it for you. Heparin is a heterogenous group of straightchain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties.
Please see important safety information and full prescribing information. Also learn about solutionsplus, and inside rx programs. Guideline for the prescribing of novel oral anticoagulants noacs. A specific reversal agent for pradaxa is available when reversal of the anticoagulant effect is needed, such as for emergency surgery and uncontrolled bleeding. Explore a range of informative materials designed to help you and your patients in using pradaxa. If you have a potentially higher risk for bleeding, your doctor may decide to prescribe a dose of. Highlights of prescribing information these highlights do not include all the information needed to use coumadin safely and effectively. Please read full prescribing information, including boxed warnings for xarelto. Healthcare professionals should use sound clinical judgment and individualize patient care.
Review the comparison chart, then talk to your doctor about whether pradaxa is right for you. For emergency surgeryurgent procedures in lifethreatening or uncontrolled bleeding. In patients with moderate renal impairment and concomitantly treated with dabigatran etexilate and verapamil, a dose reduction of pradaxa to 75. Please see additional important safety information on next page. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose i. See full prescribing information for other components of the formulation exelon. If youve been diagnosed with atrial fibrillation afib not caused by a heart valve problem, then its important to discuss. If you have to stop taking pradaxa, your doctor may prescribe another medicine to help prevent a blood clot from forming. Highlights of prescribing information these highlights do not include all the information needed to use savaysa safely and effectively. Refer to prescribing information for more complete information. You can ask your pharmacist or doctor for information about pradaxa that is written for health professionals. Fdaapproved reversal treatment available in all 50 states. Fda approves pradaxa, marking a major milestone to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.
Pradaxa fda prescribing information, side effects and uses. For additional information, consult the prescribing information for protamine sulfate injection. The recommended dose is 60 mg once daily in patients with. Because fatal reactions often resembling anaphylaxis have been reported with protamine, it should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.
Dec 18, 2017 recently, the american college of cardiology acc released the 2017 acc expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation to provide guidance in this area. Refer to the idarucizumab prescribing information for additional information. Pradaxa dabigatran etexilate mesylate capsules for oral use warning. Most common adverse reactions with xarelto were bleeding complications.
Detailed information on this medicinal product is available on the website of the. Stopping pradaxa increases your risk of hatving a stroke. Please see important safety information and full prescribing information, including boxed warning. Dabigatran etexilate, a new oral direct thrombin inhibitor, for stroke prevention in patients with atrial fibrillation.
Consult the full prescribing information prior to use for potential drug interactions. Each hard capsule contains 150 mg dabigatran etexilate as mesilate. Pradaxa is the only noac with a specific reversal, available in all 50 states. Demonstrated to significantly reduce stroke compared to warfarin, pradaxa is first new oral anticoagulant approved by the fda in more than 50 years. Xarelto rivaroxaban information for healthcare professionals. You are about to leave the boehringer ingelheim site for a site not created, managed or maintained by boehringer ingelheim. Highlights of prescribing information these highlights do not include all the information needed to use biktarvy safely and effectively. Medication guide pradaxa pra dax a dabigatran etexilate mesylate capsules read this medication guide before you start taking pradaxa and each time you get a refill. Bring this doctor discussion guide with you if you are talking to your doctor about dvt or pe and pradaxa. View important safety information and full prescribing information on website. Select safety information about pradaxa for people taking pradaxa for atrial fibrillation.
Information for the patient pradaxa 150 mg hard capsules. Dabigatran pradaxa, rivaroxaban xarelto, apixaban eliquis the contents of this cpg are to be used as a guide. Limited data shows that hemodialysis can remove 4957% of dabigatran over. Highlights of prescribing information these hig hlights do not include all the informatio n nee ded to use pradaxa safely and effectively.
Pradaxa dabigatran etexilate mesylate capsules for oral. Xarelto rivaroxaban tablets, for oral use initial u. Click here for information on sharps medical waste disposal. Pradaxa is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Use a specific reversal agent idarucizumab in case of emergency surgery or urgent procedures when reversal of the anticoagulant effect of dabigatran is needed.
Highlights of prescribing information these highlights do not include all the information needed to use feiba safely and effectively. Product information on treatment with praxbind, the only fdaapproved specific reversal agent for a noac available in all 50 states. Highlights of prescribing information vosevi is not. Annexa4 interim data set, prior to day 30 from the prescribing information. Praxbind idarucizumab is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed. Explore resources just for you to help you on your treatment journey. Boehringer ingelheim hopes that this link will be of interest and use to visitors, but it accepts no liability in relation to the website or its contents and gives no war. For more information, contact your local sanofiaventis u. Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding. Learn how pradaxa can help reduce the risk of stroke in afib not caused by a heart valve problem. Instructions on starting patients on pradaxa, and dosing for multiple indications.
An agent to reverse the antifactor xa activity of rivaroxaban is available. Recently, the american college of cardiology acc released the 2017 acc expert consensus decision pathway for periprocedural management of anticoagulation in patients with nonvalvular atrial fibrillation to provide guidance in this area. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Please see prescribing information for praxbind, and visit pradaxa. Dailymed pradaxa dabigatran etexilate mesylate capsule. Your personalized doctor discussion guide fill out your guide and bring it with you to your next appointment. Full prescribing information 1 indications and usage praxbind is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed. Find easy to use information on the recommended dose and download preparation instructions for praxbind. Pradaxa dabigatran etexilate mesylate capsules, for oral use. Highlights of prescribing information these highlights do not. Please see prescribing information and medication guide, and visit pradaxa. Please see accompanying full prescribing information for pradaxa, including boxed warning and medication guide, as well as full prescribing information for praxbind.
Direct oral anticoagulants in extremely obese patients. Watch videos, access surveys, and download tools and brochures. Oct 04, 2019 use a specific reversal agent idarucizumab in case of emergency surgery or urgent procedures when reversal of the anticoagulant effect of dabigatran is needed. Highlights of prescribing information these highlights do not include all the information needed to use pradaxa safely and effectively. Medication guide pradaxa pra dax a dabigatran etexilate. Pradaxa, inndabigatran etexilate european medicines agency. Since certain patients who take pradaxa are at increased risk of bleeding, a number of precautions were included in the prescribing information. Prophylaxis of dvt following hip or knee replacement surgery. See full prescribing information for complete boxed warning a premature discontinuation of xarelto increases the risk of thrombotic events premature discontinuation of any oral anticoagulant, including xarelto, increases the risk of thrombotic events. An agent to reverse the antifactor xa activity of apixaban is available. Praxbind is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed. Patient brochure pradaxa dabigatran etexilate and its reversal. Help your eligible patients start saving on pradaxa.
288 1081 1522 94 613 87 1176 182 1082 663 9 1125 392 467 177 1342 1469 357 547 653 234 832 141 519 1397 1273 805 334 550 607 898