Navigation Links
Boehringer Ingelheim Pharmaceuticals, Inc. Statement on RE-ALIGN Data
Date:8/31/2013

fect of P-gp Inducers & Inhibitors on Dabigatran Exposure
The 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.

  • For patients with moderate renal impairment (CrCl 30-50 mL/min), consider reducing the dose of PRADAXA to 75 mg twice daily when dronedarone or systemic ketoconazole is coadministered with PRADAXA.
  • For patients with severe renal impairment (CrCl 15-30 mL/min), avoid concomitant use of PRADAXA and P-gp inhibitors.

ADVERSE REACTIONS
In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in higher rates of major GI bleeds and any GI bleeds compared to warfarin. In patients >75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin. Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions. These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer). Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.

Other Measures Evaluated
In the pivotal trial, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA (0.7 per 100 patient-years for 150 mg dose) than in those who received warfarin (0.6).

Click

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Boehringer Ingelheim Announces Launch of GLORIA™-AF Registry in Newly-Diagnosed Patients with Non-Valvular Atrial Fibrillation
2. New Data to be Presented at the Annual American Thoracic Society International Conference Demonstrates Depth of Boehringer Ingelheim Respiratory Research Pipeline
3. Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012
4. Results of Phase II Study of Boehringer Ingelheims Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
5. Boehringer Ingelheim Presents First Data for Tiotropium in Adolescents with Moderate Persistent Asthma
6. Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine
7. Boehringer Ingelheim and Lilly introduce the My Well Planner Lifestyle Improvement Program for Adults with Type 2 Diabetes
8. Boehringer Ingelheim announces afatinib expanded access program (EAP) for patients with EGFR mutation-positive advanced NSCLC
9. Whistleblowers extraordinary efforts helped win $95 million settlement with Boehringer Ingelheim
10. Phase 2b Data of Boehringer Ingelheims Interferon-Free Hepatitis C Treatment Show Viral Cure Achieved in Up to 85% of Treatment-Naive Patients
11. Boehringer Ingelheim Announces Equine Research Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/21/2014)... , Nov. 20, 2014 /CNW Telbec/ - KLOX ... announce the following appointments: Todd ... in the newly created role of Chief Commercial Officer, ... system using topical photoconverter gel for the treatment of ... and traumatic wounds, recently approved in Europe ...
(Date:11/21/2014)... Michael DeMarco (42) erinnert sich ... Februar 2014 zugetragen hat. Seine Tochter Aly Demarco (13) ... Video - http://youtu.be/5cVoMCe0uiE „Man ... Training zu machen", erzählt Michael DeMarco . „Meine ... begeisterte Anhänger der CrossFit-Trainingsmethode. Ich war auf dem Fahrrad, ...
(Date:11/21/2014)... , Nov. 20, 2014   Coqui RadioPharmaceuticals Corp. ... first U.S. commercial producer of Molybdenum-99 (Mo-99), is proud ... INVAP to design its Medical Isotope Production ... Mo-99 is the parent isotope of Technetium-99, which is ... In 2012, Congress passed legislation making it a national ...
Breaking Medicine Technology:KLOX Technologies announces executive appointments 2KLOX Technologies announces executive appointments 3KLOX Technologies announces executive appointments 4Tochter rettet Vater durch Herz-Lungen-Wiederbelebung vor plötzlichem Herztod 2Tochter rettet Vater durch Herz-Lungen-Wiederbelebung vor plötzlichem Herztod 3Coqui RadioPharmaceuticals Inks Deal With INVAP 2
... BETHESDA, Md., May 25, 2011 Northwest Biotherapeutics (OTC.BB: ... of clinical trial sites, exceeding its projections for the ... quarter, for enrollment of new patients into the Company,s ... of DCVax® immune therapy for Glioblastoma multiforme (GBM), the ...
... 25, 2011 Executives from Medco Health Solutions, Inc. (NYSE: ... investor conferences: Timothy Wentworth, Group President, Employer and ... Strategic Decisions Conference on Wednesday, June 1 at 10 a.m. ... New York.  Richard J. Rubino, Medco,s chief financial officer, is ...
Cached Medicine Technology:Northwest Biotherapeutics Further Expands Ongoing Brain Cancer Trial 2Northwest Biotherapeutics Further Expands Ongoing Brain Cancer Trial 3Medco Executives to Present at Upcoming Investor Conferences 2
(Date:11/22/2014)... November 22, 2014 Lipitor lawsuits ( ... patients who allegedly developed Type 2 diabetes due to ... multidistrict litigation now underway in U.S. District Court, District ... court documents, the litigation will convene its next Status ... has directed Lead Counsel for Plaintiffs and Defendants to ...
(Date:11/22/2014)... Recently, UWDress.com is gratified to introduce ... . In addition, the company has also offered an ... a leading online supplier of wedding dresses, UWDress.com is ... unusual best wedding guest gowns are provided over 20 ... this new selection is famous for high quality. Therefore, ...
(Date:11/22/2014)... Sandbridge Capital, a private equity firm ... brand sector, acquired a minority stake in BackJoy ... help fund BackJoy’s global growth and accelerate the ... apparel and footwear lines. Sandbridge Capital Managing Partner ... , BackJoy is a high-growth health and wellness ...
(Date:11/22/2014)... 2014 “Greenfield Naturals” was featured on ... , which features the latest and coolest technology products ... reporter for NewsWatch, conducted the product review and shared ... of your water. , From pollution to hazardous substances ... everything is done to remove these chemicals, especially in ...
(Date:11/22/2014)... 21, 2014 (HealthDay News) -- A clinical trial of ... been halted a year early because the results show ... the disease and reduce the risk of stroke. ... 25 medical centers in the United States and Canada, ... Lung, and Blood Institute (NHLBI). Researchers compared monthly ...
Breaking Medicine News(10 mins):Health News:Lipitor Lawsuit Conference Scheduled for December, Bernstein Liebhard LLP Reports 2Health News:Lipitor Lawsuit Conference Scheduled for December, Bernstein Liebhard LLP Reports 3Health News:Best Wedding Guest dresses Introduced by UWDress.com 2Health News:Sandbridge Capital Acquires a Minority Stake in BackJoy 2Health News:Sandbridge Capital Acquires a Minority Stake in BackJoy 3Health News:An Easy Home Solution to Get Better Tasting Water was Featured on NewsWatch Television on October 30, 2014 2Health News:Sickle Cell Anemia Treatment So Successful in Kids That Trial Is Halted 2
... 4, 2008 Bayada Nurses will hold,a news conference ... and the,public about the importance of raising the Medicaid ... health care, and allow more,individuals to benefit from the ... 190,000 Pennsylvanians use home health care services each,week -- ...
... Receives National Award for Arming Oncologists, Families and ... 2008 When the,critically acclaimed A LION IN ... the film galvanized public attention for childhood cancer ... their families. Now,LION,s producers are being honored in ...
... ARBOR, Mich.---Having a husband creates an extra seven hours a ... Michigan study of a nationally representative sample of U.S. families. ... saves men from about an hour of housework a week. ... housework trends, based on 2005 time-diary data from the federally-funded ...
... Study by New York,s premier dermatologist, Dr. David J. ... first ... 4, 2008 Aesthetic Technologies,announced during the 28th Annual ... Kissimmee, Fla., the introduction of its,Parisian Peel(R) Suffusion System. ...
... Donation Will Be Made to Middle Island Man, 32, Injured ... 4, 2008 The,following was released by The SCOOTER Store:, ... New York,City patrolman and Suffolk County parks policeman, John ... Tim Bishop (NY - 1st District), Suffolk County Legislator ...
... Ohio) More than 600,000 children participate in school-sponsored ... Yet gymnastics continues to be overlooked in terms of ... injury rates of all girls sports. , A study, ... and Policy (CIRP) at The Research Institute at Nationwide ...
Cached Medicine News:Health News:Acclaimed A LION IN THE HOUSE Team Honored in Washington for Pioneering Work on Pediatric Cancer 2Health News:Acclaimed A LION IN THE HOUSE Team Honored in Washington for Pioneering Work on Pediatric Cancer 3Health News:Exactly how much housework does a husband create? 2Health News:Parisian Peel(R) Introduces Anti-Aging Suffusion System 2Health News:Parisian Peel(R) Introduces Anti-Aging Suffusion System 3
Dissecting Forceps, straight, with RF-cable, 7" (18 cm). For use with all electrosurgical generators with standard three-prong sockets....
... the art in inverted microscopy from Zeiss. ... range of ICS objectives, with innovative condensers ... an unusual scope of sophisticated documentation and ... designed. And Axiovert 200 M, fully motorized, ...
... optics and workmanship are the hallmark of ... sensitivity in mind. The top (incident) circular ... eliminating shadows while remaining cool to the ... available with 10x to 44x zoom magnification ...
... system designed for scientific microscope imaging ... cameras provides high-resolution, full-color images and ... PC via its Firewire (IEEE 1394) ... is accompanied by automatic white balance ...
Medicine Products: