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:5/1/2015)... , May 1, 2015 The breakthrough ... its high price but manufacturer Gilead Sciences overcame initial ... pricing, and effective public relations campaigns. Sovaldi,s ... less severe side effects propelled the drug to $2.3 ... the therapy,s first quarter on the market. But Sovaldi,s ...
(Date:5/1/2015)... 1, 2015 CANTEL MEDICAL CORP. (NYSE: CMN ... Executive Officer, will be presenting at the Bank of America ... Wynn in Las Vegas, NV. The ... 10:00 AM PT/1:00 PM ET. In addition, management will be ... An audio webcast will be available via the investor ...
(Date:5/1/2015)... 2015 Research and Markets ( http://www.researchandmarkets.com/research/pjbxjd/us_aco_it ... ACO IT Spending Outlook 2018" report to their ... lives covered by ACO would grow at a CAGR ... ACO IT spending has been studied on three main ... spending on services. Our research provides current market estimation ...
Breaking Medicine Technology:New Study Examines Success Lessons of Sovaldi's and Harvoni's Blockbuster Launches 2United States ACO IT Spending Outlook 2014-2018 2
(Date:5/2/2015)... (PRWEB) May 02, 2015 Ticket Down has ... for the long awaited event today, Saturday, May 2nd ... Diehard boxing fans will be able to secure tickets for ... The fight that boxing fans have wanted for more than ... ago. Floyd “Money” Mayweather will step inside the ring to ...
(Date:5/2/2015)... (PRWEB) May 02, 2015 “ ActOn ” ... which takes a look at the latest and coolest applications ... the host of AppWatch and technology expert, conducted the app ... to get connected with organizations to make a difference. , ... are very few things that aren’t about money, which is ...
(Date:5/2/2015)... York, NY (PRWEB) May 02, 2015 ... when a deadly natural disaster strikes anywhere on this ... to leverage human sympathy and compassion for their own ... (United States Computer Emergency Readiness Team) issued an ... users “of potential email scams citing the earthquake in ...
(Date:5/2/2015)... 2015 “ Peachtree Audio ” was ... Report, which features the latest and coolest technology products ... special reporter for NewsWatch, conducted the review and shared ... , Music is an important part of people’s ... and given the royal treatment. Peachtree Audio does just ...
(Date:5/2/2015)... 2015 Kare Visits LLC. launched in Chicago ... caregivers. Kare Visits offers relief for caregivers by visiting ... According to the Caregiver Action Network, eight in ... 20 hours a week caring for an elderly or disabled ... hire a nurse, a caregiver is now empowered to schedule ...
Breaking Medicine News(10 mins):Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 2Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 3Health News:An Application to Help People Make a Difference Was Featured on NewsWatch Television 2Health News:Cyber Aftershocks from Nepal’s Earthquake Can Cripple Businesses Right Here at Home 2Health News:Cyber Aftershocks from Nepal’s Earthquake Can Cripple Businesses Right Here at Home 3Health News:Cyber Aftershocks from Nepal’s Earthquake Can Cripple Businesses Right Here at Home 4Health News:Affordable High-End Audio Equipment was Featured on NewsWatch Television 2Health News:Chicagoan Seeks to Transform Industry by Launching an Innovative Elderly Care Solution 2
... come across, feel residents of the west Garfield County, near ... everyday, in the search of natural gas. Indeed this area ... the lure of big bucks blinds them to the repercussions ... skin irritation, nausea and dizziness from breathing noxious fumes that ...
... can influence a persons diet. Those who dont get enough ... instead, opt to eat fast food. It is the lack ... cause health problems for these people in the long-run. ... York, surveyed nine females and 12 males, all undergraduates who ...
... presented Monday at SLEEP 2007, a sleep-related breathing disorder ... than expected in this population, and at higher rates ... by Hawley E. Montgomery-Downs, PhD, of West Virginia University, ... attending a neonatal follow-up clinic to a research questionnaire. ...
... -of -its-kind case, a teenager died due to an overdose ... Arielle Newman, 17, from Staten Island, New York was examined ... the active ingredient found in such creams, was discovered in ... and Johnson produce such creams meant to ease muscle strain ...
... now they are out to prove to doubting scientists that the ... pain. ,A team of yoga teachers, practitioners and ... scientifically determine whether or not it can help alleviate back pain. ... assess moves from the two most popular types of yoga - ...
... Researchers have found that functional brain scans and tests of ... children will have ongoing reading problems. ,The study ... by Fumiko Hoeft at Stanford University School of Medicine. ... Pittsburgh-area children of ages 8 to 12, who were identified ...
Cached Medicine News:Health News:Residents Of Gas Patch In Colorado Suffering In Silence 2Health News:Residents Of Gas Patch In Colorado Suffering In Silence 3Health News:American Sports Star Teenager Dies Due To Overdose Of Muscle Cream 2Health News:Yoga to Be Scientifically Tested as Therapy for Chronic Low Back Pain 2Health News:Combination of Brain Scans, Reading Skill Tests can Predict Kids Reading Problems 2
... management software for eyecare professionals- ... multi-tasking, multi-office practice management system, ... technology- Winx Pro is a ... you in effectively managing the ...
... over 2,500 ophthalmologists nationwide, ... serve one of the ... in the country. With ... we are setting new ...
... EMR Ophthalmology is a comprehensive electronic ... for ophthalmology practices. Intuition EMR Ophthalmology ... provides the tools to evaluate your ... to make better decisions and to ...
... the latest in advanced cartridge mixing and ... mixes and mechanically injects all types of ... ,The Revolution&trade line-up includes a large selection ... even in difficult to access areas. A ...
Medicine Products: