Prescribing Information |
Proven Safety and Efficacy of PRADAXA as Shown in the Pivotal Trial
The safety and efficacy profile of PRADAXA vs warfarin was established in the pivotal trial known as RE-LY®.1 PRADAXA demonstrated a 35% superior dual reduction in stroke and systemic embolism among patients with nonvalvular atrial fibrillation compared to warfarin (1.12%/yr [135 events] vs 1.72%/yr [203 events], HR: 0.65, 95% CI [0.52, 0.81], P=0.0001).2 The rates of major bleeding were similar in PRADAXA-treated vs warfarin-treated patients (3.47%/yr [350 events] vs 3.58%/yr [374 events], HR: 0.97, 95% CI [0.84, 1.12]).2,3
The rate of intracranial hemorrhage was lower for patients administered PRADAXA 150 mg than for those given warfarin; the rate of fatal bleeding was similar between these two groups; while the rate of major gastrointestinal bleeding was higher with PRADAXA than warfarin intake across the evaluated age groups.1,3
Bleeding Events in the Pivotal RE-LY Trial3
*Patients during treatment or within 2 days of stopping study treatment. Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories.
Pivotal RE-LY® Trial: PRADAXA vs warfarin1,2
||Total number of strokes in the RE-LY Trial: 123 for PRADAXA vs 187 for warfarin (HR: 0.64, 95% CI [0.51, 0.81], P=0.001).2
View study design and bleeding definitions at https://www.pradaxapro.com/safety/nonvalvular-atrial-fibrillation.
See key findings from real-world data for PRADAXA
BID=twice daily; CI=confidence interval; HR=hazard ratio; NOAC=novel oral anticoagulant; NVAF=non-valvular atrial fibrillation; RE-LY=Randomized Evaluation of Long-term anticoagulant therapY; SE=systemic embolism.
References: 1. Connolly SJ, Ezekowitz MD, Yusuf S, et al.; and the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151. 2. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. 3. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; revised 03/2018. http://docs.boehringer-ingelheim.com/PrescribingInformation/PIs/Pradaxa/Pradaxa.pdf. 4. Connolly SJ, Wallentin L, Ezekowitz MD, et al. The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study. Circulation. 2013;128(3):237-243.
Copyright ©2019. Boehringer Ingelheim Pharmaceuticals, Inc.
All rights reserved. (06/19) PC-US-110119
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant
(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated.
Indications and Usage
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:
PRADAXA is contraindicated in patients with:
-active pathological bleeding;
-known serious hypersensitivity reaction to PRADAXA (e.g., anaphylactic reaction or anaphylactic shock);
-mechanical prosthetic heart valve
WARNINGS & PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation
Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate.
Risk of Bleeding
Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
The use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
Concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.
Reduction of Risk of Stroke/Systemic Embolism in NVAF
Treatment and Reduction in the Risk of Recurrence of DVT/PE & Prophylaxis of DVT/PE Following Hip Replacement Surgery
The most common adverse reactions reported with PRADAXA were related to gastritis-like symptoms and bleeding.
Other Measures Evaluated
In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).
USE IN SPECIFIC POPULATIONS
Pregnancy: The limited available data on PRADAXA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.
Lactation: Breastfeeding is not recommended.
Geriatric: Risk of bleeding increases with age.
Please see full Prescribing Information, including boxed WARNING and Medication Guide.
CL-PX-100018 August 2018
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