Navigation Links
Bayer to Present New Data Across Oncology Portfolio at ASCO 2013
Date:5/15/2013

tion For Stivarga® (regorafenib) Tablets

WARNING: HEPATOTOXICITY

  • Severe and sometimes fatal hepatotoxicity has been observed in clinical trials.
  • Monitor hepatic function prior to and during treatment.
  • Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.

Severe drug-induced liver injury with fatal outcome occurred in 0.3% of 1200 Stivarga-treated patients across all clinical trials. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the Stivarga arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the Stivarga arm. 

Obtain liver function tests (ALT, AST, and bilirubin) before initiation of Stivarga and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue Stivarga, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

Stivarga caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with Stivarga vs 8% and 3% with placebo in mCRC and GIST patients, respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%) Stivarga-treated patients and involved the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue Stivarga in patients with severe or life-threat
'/>"/>

SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related medicine technology :

1. Bayer Employee Named Rising Star by Healthcare Businesswomens Association
2. Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution (BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
3. Bayers Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
4. Zacks Bull and Bear of the Day Highlights: Fortune Brands Home & Security, Wal-Mart Stores, Regeneron Pharmaceuticals, Bayer and Array Biopharma
5. U.S. FDA Grants Priority Review to Bayers Radium Ra 223 Dichloride NDA for Castration-Resistant Prostate Cancer with Bone Metastases
6. Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
7. Bayer Consumer Care Voluntarily Recalls 56 Lots of BRONKAID Caplets Dual Action Formula due to Product Labeling Error
8. Bayers Second Annual Virtual Walk for Hemophilia Raises Funds, Generates Excitement in the Hemophilia Community
9. MediSapiens to Provide Bayer HealthCare Pharmaceuticals With a New Cloud Computing Application to Analyze and Visualize Multi-Dimensional Genomics Data
10. MediSapiens liefert neue Cloud-Computing-App zur Analyse und Visualisierung multidimensionaler Genomdaten an Bayer HealthCare Pharmaceuticals
11. MediSapiens sapprête à fournir à Bayer HealthCare Pharmaceuticals une nouvelle application informatique en nuage pour analyser et visualiser les données génomiques multidimensionnelles
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/4/2015)... 4, 2015 Oramed Pharmaceuticals Inc. ... pharmaceutical company focused on the development of oral drug ... in the upcoming Rodman & Renshaw 17 th ... in New York City .  Dr. ... a corporate overview on September 9, 2015. ...
(Date:9/4/2015)... Future Prospects for Companies in Antihistamines, Corticosteroids, ... - new study showing you trends, partnerships, and ... allergic rhinitis drugs heading? What are the commercial prospects ... you potential revenues and other trends to 2025, discussing ... report provides 273 tables, charts, and graphs. Discover the ...
(Date:9/4/2015)... Sep. 04, 2015 ... the addition of the "Pharmacovigilance (London, UK ... offering. Understanding PhV today - the ... working in Drug safety. This course ... with pharmacovigilance. New entrants as well as experienced ...
Breaking Medicine Technology:Oramed to Present at the Rodman & Renshaw Global Investment Conference 2Oramed to Present at the Rodman & Renshaw Global Investment Conference 3Allergic Rhinitis Drugs Market Forecast 2015-2025 2Allergic Rhinitis Drugs Market Forecast 2015-2025 3Allergic Rhinitis Drugs Market Forecast 2015-2025 4Allergic Rhinitis Drugs Market Forecast 2015-2025 5Allergic Rhinitis Drugs Market Forecast 2015-2025 6Allergic Rhinitis Drugs Market Forecast 2015-2025 7Pharmacovigilance Course: The Principles and Practice of Global PhV for those Working in Drug Safety (London, UK - December 7-9, 2015) 2
... N.J., March 17 Hereditary angioedema (HAE) is ... States each year. Patients with HAE suffer from ... skin, airway, and visceral organs. Left untreated, most ... per month. Chronic therapy with attenuated androgens or ...
... Surgeons to Lead Pivotal TrialANN ARBOR, Mich., March 17 ... appointed David Seth Feldman, MD/PhD, FACC, FAHA to be ... United States, studying the new, third generation DuraHeart(TM) Left ... Francis Pagani, Director of the Heart Transplant and Center ...
Cached Medicine Technology:Changing Paradigms in Hereditary Angioedema: A Focus on Prompt Diagnosis and New Therapies 2David Feldman, M.D. Appointed Co-Principal Investigator of DuraHeart(TM) Left Ventricular Assist System U.S. Clinical Trial 2David Feldman, M.D. Appointed Co-Principal Investigator of DuraHeart(TM) Left Ventricular Assist System U.S. Clinical Trial 3
(Date:9/4/2015)... , ... September 04, 2015 , ... According to an ... developed that changes color when subjected to an impact force that is great enough ... implemented in helmets or other sporting equipment so that coaches or officials would instantly ...
(Date:9/4/2015)... ... ... The Schmidt National Law Group filed an Essure® lawsuit against Bayer and ... Group, a leading firm in mass-tort litigation, has filed a lawsuit in the federal ... other Bayer affiliates for injuries alleged to have been caused by her Essure® contraceptive ...
(Date:9/4/2015)... ... September 04, 2015 , ... ... Products Association (CHPA) joint meeting of its Product, Quality and Manufacturers, Dietary Supplements ... handling rules constantly evolving in the consumer goods industry, it can be difficult ...
(Date:9/4/2015)... Maui HI (PRWEB) , ... September 04, 2015 , ... ... the best ways for couples to explore, revitalize and strengthen their ‘couple-ness,’” says ... and his team at Four Seasons Resort Maui, the island’s only Forbes Five Star ...
(Date:9/4/2015)... Portland, ME (PRWEB) , ... September 04, 2015 ... ... Symposium focus on: the microbiome taking place in Hollywood, Florida October 9-10, 2015 ... ihsymposium.com/focus-event. , Speakers at the 2015 symposium are doctors and researchers at the ...
Breaking Medicine News(10 mins):Health News:New Article on Head Injury Detection Technology Highlights Implications for Head Injury Detection in Sports, says The Law Offices of Burg & Brock 2Health News:Schmidt National Law Group Files First Bayer Essure® Lawsuit in California 2Health News:Inmar Experts To Address OTC Manufacturers’ Session on Hazardous Waste and Handling at CHPA Meeting 2Health News:Inmar Experts To Address OTC Manufacturers’ Session on Hazardous Waste and Handling at CHPA Meeting 3Health News:Couples Season at Four Seasons Resort Maui Begins This Week With Best Hotel Rates of the Year through November 2Health News:Couples Season at Four Seasons Resort Maui Begins This Week With Best Hotel Rates of the Year through November 3Health News:Integrative Healthcare Symposium Focus On: The Microbiome Conference Program Announced 2
... BASEL, Switzerland, Feb. 19 Roche (SWX:,ROG.VX; ... (Nasdaq: VMSI ),today announced that Roche has ... Ventana. As of the expiration of the subsequent,offering ... had purchased a total of approximately 34,545,323 shares ...
... that uses millions of identical antibodies to boost the ... patients whose tumors recede in response to the treatment ... and rashes. In a new study, a team ... periodic infusions of such "monoclonal" antibodies to patients who ...
... shows , , MONDAY, Feb. 18 (HealthDay News) -- Statins ... to lower cholesterol levels may also cut the risk ... odds of a stroke, French researchers report. , An ... participants showed that those patients who received statins had ...
... Organizations Develop Action Plan, Announce Feline Life-Stage Guidelines ... ... Western Veterinary Conference -- The,American Association of Feline Practitioners (AAFP) today ... in Palm,Springs, Calif., with initial underwriting from Pfizer Animal Health.,Attendees were led ...
... them to kids to try to prevent fluid buildup, analysis ... significantly reduce fluid buildup in young children with inner ear ... in this regard has been a matter of conjecture, with ... and under. So, Dutch researchers did a meta-analysis of several ...
... year ago today, the,American people first learned about ... treating wounded soldiers returning,from Iraq and Afghanistan. Amid ... saw an opportunity to bolster his presidential,campaign. Days ... on former,Secretary of Defense Don Rumsfeld, saying "the ...
Cached Medicine News:Health News:Roche Completes Tender Offer for Ventana Shares 2Health News:Roche Completes Tender Offer for Ventana Shares 3Health News:Roche Completes Tender Offer for Ventana Shares 4Health News:Vaccine/antibody therapy effective, milder side effects in melanoma and ovarian cancer 2Health News:Vaccine/antibody therapy effective, milder side effects in melanoma and ovarian cancer 3Health News:Cholesterol-Lowering Drugs May Ease Irregular Heartbeat 2Health News:Cholesterol-Lowering Drugs May Ease Irregular Heartbeat 3Health News:CATalyst Summit Declared a Success: It's All About the Cat! 2Health News:CATalyst Summit Declared a Success: It's All About the Cat! 3Health News:Antibiotics Do Little for Inner Ear Infections 2Health News:Walter Reed Anniversary Exposes More McCain Double Talk 2Health News:Walter Reed Anniversary Exposes More McCain Double Talk 3
The new PERIMOUNT Magna heart valve (bioprosthesis), with its true supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve disease....
... background in high performance ultrasound design ... of echocardiography. Echocardiography imaging requires superior ... sensitive Doppler performance. The Terason Echo ... Teratech Architecture, delivers a compact imaging ...
... In-office. Information. In real time. The FemExam pH ... elevated vaginal fluid pH (pH >= 4.7) and ... is easy to use and delivers accurate results ... a swab containing unprocessed vaginal fluid across each ...
For the quantitative determination of human MMP-9/NGAL Complex concentrations in cell culture supernates, serum,plasma, urine and saliva....
Medicine Products: