RIDGEFIELD, Conn., April 17, 2018 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration
"In the rare event of an emergency situation requiring reversal, treatment decisions must be made quickly and confidently," said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe that the wide availability of Praxbind—and the robust data on its use—can provide patients and healthcare providers with greater assurance in their anticoagulation treatment decisions."
The FDA granted accelerated approval to Praxbind in October 2015, with continued approval contingent upon results from the phase III RE-VERSE AD™ trial, the largest study to investigate a reversal agent for a NOAC. The final results of RE-VERSE AD were published in the New England Journal of Medicine in July 2017, and showed that Praxbind immediately reversed the anticoagulant effect of Pradaxa. The majority of patients had complete reversal of anticoagulation within four hours as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%).
In the RE-VERSE AD study, no adverse safety signals were observed and there was a low rate of thrombotic events. In clinical studies, Praxbind has not shown a procoagulant effect. Healthcare providers should consider resuming anticoagulant therapy as soon as medically appropriate due to the risk of thrombosis associated with patients' underlying conditions.
Praxbind is stocked in more than 3,000 hospitals in all 50 states nationwide. Healthcare providers and patients can quickly search for institutions in the U.S. where Praxbind is stocked by using a zip code locator tool available at Praxbind.com.
Praxbind is distributed by U.S. hospital pharmacy distributors ASD, Cardinal Health, MPB, HD Smith and Morris Dickson. Orders can generally be filled or restocked within 24 hours. Additional information about stocking Praxbind, as well as the zip code locator tool, is available at Praxbind.com or by calling 1?800?542?6257 (Opt 1).
About RE-VERSE AD™ RE-VERSE AD (NCT02104947) is a phase III global study of patients taking dabigatran who require urgent procedures or have uncontrolled bleeding. The final analysis from RE-VERSE AD included data from patients requiring urgent procedures/emergency surgery, e.g. surgery for an open fracture after a fall, or patients with either uncontrolled or life-threatening bleeding complications, e.g. intracranial hemorrhage or severe trauma after a car accident. The primary endpoint, the degree of reversal of the anticoagulant effect of dabigatran (Pradaxa) achieved by idarucizumab within four hours, was measured by dTT and ECT.
The study, which began in May 2014, is the largest study to investigate a reversal agent for a novel oral anticoagulant (NOAC) in real-world emergency settings. It enrolled a total of 503 patients at 173 sites in 39 countries, which were included in one of two groups:
About Praxbind® (idarucizumab)
INDICATIONS AND USAGEPraxbind® (idarucizumab) is indicated in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:
IMPORTANT SAFETY INFORMATION ABOUT PRAXBINDWARNINGS AND PRECAUTIONSThromboembolic Risk
Re-elevation of Coagulation Parameters
Risk in Patients With Hereditary Fructose Intolerance
USE IN SPECIFIC POPULATIONSPregnancy and Lactation
About Pradaxa® (dabigatran etexilate mesylate)
Indications and UsagePradaxa® (dabigatran etexilate mesylate) capsules is indicated:
IMPORTANT SAFETY INFORMATION ABOUT PRADAXAWARNING: (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 EVENTSPremature 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 HEMATOMAEpidural 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.
CONTRAINDICATIONSPradaxa is contraindicated in patients with:- active pathological bleeding;- known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to Pradaxa;- mechanical prosthetic heart valve
WARNINGS & PRECAUTIONS
Increased Risk of Thrombotic Events after Premature DiscontinuationPremature 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
Hemodialysis can remove dabigatran; however clinical experience for hemodialysis as a treatment for bleeding is limited. Prothrombin complex concentrates or recombinant Factor VIIa may be considered but their use has not been evaluated. Protamine sulfate and vitamin K are not expected to affect dabigatran anticoagulant activity. Consider administration of platelet concentrates where thrombocytopenia is present or long-acting antiplatelet drugs have been used.
Thromboembolic and Bleeding Events in Patients with Prosthetic Heart ValvesThe 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 ExposureConcomitant 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
ADVERSE REACTIONSThe most serious adverse reactions reported with Pradaxa were related to bleeding.
Other Measures EvaluatedIn 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 POPULATIONSPregnancy: 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.
About Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.
In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.
For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, Praxbind® and RE-VERSE AD™ under license.
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SOURCE Boehringer Ingelheim
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