Navigation Links
Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Six Years With Similar Safety Profile Observed in Original Fracture Trial
Date:11/5/2011

n infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Endocarditis was reported more frequently in the Prolia-treated patient group. Epidermal and dermal adverse events such as dermatitis, rashes and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop.

Prolia resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw (ONJ), atypical fractures and delayed fracture healing. ONJ has been reported in patients with Prolia. Patients should be monitored for these adverse outcomes. The most common adverse reactions (> 5 percent and more common than placebo) were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia and cystitis. Pancreatitis has also been reported with Prolia.

Important EU Safety Information

The most common adverse reactions with Prolia were urinary tract infection, upper respiratory tract infection, sciatica, cataracts, constipation, rash and pain in extremity. The most serious adverse reactions were those of skin infections, predominantly cellulitis, reported more commonly in the Prolia group compared with placebo (0.4 percent vs. 0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions of skin infection were similar in the Prolia and placebo groups (0.6 percent vs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial in patients with prostate cancer receiving ADT, an imbalance in cataract adverse events was observed with Prolia compared with placebo (4.7 percent vs. 1.2 perce
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
2. Prolia® (Denosumab) Phase 2 Extension Study Showed Continued Increase in Bone Mineral Density Over Eight Years of Treatment
3. Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate
4. Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
5. XGEVA® (Denosumab) Granted Marketing Authorization in the European Union
6. Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
7. Results Published in The Lancet Demonstrate Superiority of XGEVA™ (Denosumab) in the Prevention of Bone Complications for Men With Bone Metastases From Advanced Prostate Cancer
8. The Journal of Clinical Oncology Publishes Phase 3 XGEVA™ (Denosumab) Results in Advanced Cancer Patients With Solid Tumors or Multiple Myeloma
9. XGEVA™ (Denosumab) Significantly Improved Bone Metastasis-Free Survival in Men With Prostate Cancer
10. Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
11. Prolia™ (denosumab) Receives Best New Drug Honor at Scrip Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Jan. 22, 2015  ResMed Inc. (NYSE: RMD ) ... Revenue for the quarter was $423.0 million, a 10 percent ... 14 percent increase on a constant currency basis). Net income ... the quarter ended December 31, 2013. Diluted earnings per share ...
(Date:1/22/2015)... (NASDAQ: TECH ) announced today that it ... Simple Plex platform through its Proteins Platform division under ... the previously acquired CyPlex instrument platform from CyVek. ... technology which integrates an innovatively designed microfluidic cartridge with ...
(Date:1/22/2015)... Markets ( http://www.researchandmarkets.com/research/3h534b/infectious ) has announced the ... Product, Application, Technology, End User - Global Forecast to ... The infectious disease diagnostics market is expected to grow ... 2019 from $12,422.8 million in 2014. Increase in governmental ...
Breaking Medicine Technology:ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 2ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 3ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 4ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 5ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 6ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 7ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 8ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 9ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 10ResMed Inc. Announces Results for the Second Quarter of Fiscal Year 2015 11Bio-Techne Launches Simple Plex Platform 2Bio-Techne Launches Simple Plex Platform 3Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 2Global Infectious Disease Diagnostics (Instruments, Reagents, Services, Software) Market - Forecast to 2019 3
... Germany, October 6, 2010 ... ... var ... by longUrl, so we need to grab the first one. for (var r in data.results) { first_result ...
... 5 Amgen (Nasdaq: AMGN ) today ... Company,s oncology portfolio will be presented at the 35th ... 2010, in Milan, Italy. "Cancer is ... is exploring numerous biologic pathways to develop novel therapies ...
Cached Medicine Technology:Gerresheimer Reports Strong Earnings and Sales Growth 2Gerresheimer Reports Strong Earnings and Sales Growth 3Gerresheimer Reports Strong Earnings and Sales Growth 4Gerresheimer Reports Strong Earnings and Sales Growth 5Gerresheimer Reports Strong Earnings and Sales Growth 6Gerresheimer Reports Strong Earnings and Sales Growth 7Gerresheimer Reports Strong Earnings and Sales Growth 8Gerresheimer Reports Strong Earnings and Sales Growth 9Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 2Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 3Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 4Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 5Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 6Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 7Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 8Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 9Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 10Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 11Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 12Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 13Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 14Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 15Amgen Highlights Key Clinical Data to be Presented at European Society for Medical Oncology Congress 16
(Date:1/22/2015)... (PRWEB) January 23, 2015 VogueQueen is a ... affordable prices and many designers are thrilled to have it ... business announces its new collection of prom dresses for the ... to drive the strategic vision and he focuses on continuing ...
(Date:1/22/2015)... January 22, 2015 Blue Cross and Blue ... who exemplify what it means to “Live Fearless.” ... people to share their stories about how they or someone ... inspired others by living in the moment. By telling these ...
(Date:1/22/2015)... January 22, 2015 Juvent Sports ( ... the 2015 PGA Merchandise Show to bestow a Juvent ... female amateur golfer, Arlene McKitrick. The award commemorated and ... golf tournament win. She won her first amateur tournament ...
(Date:1/22/2015)... 2015 Autocarinsurancebest.com has released a new blog ... auto insurance policy . , Auto insurance quotes help ... is no longer necessary to call an agent or visit ... online on a single website: http://autocarinsurancebest.com/ . , Every ...
(Date:1/22/2015)... NJ (PRWEB) January 22, 2015 Joan ... and keynote speaker at the upcoming 32nd Annual ... ACCME-accredited Physicians’ Education Resource®, LLC (PER®) , shares ... would have gone undetected if she had not followed ...
Breaking Medicine News(10 mins):Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6
... Tolerated at All Doses ... Tested - ... - Exploratory Analysis of Cytokine Profile Following Treatment Supports ... Calif. and BOSTON, Nov. 5 Peregrine,Pharmaceuticals, Inc. (Nasdaq: PPHM ), a biopharmaceutical ...
... (OTC Bulletin,Board: CRDT), a leading healthcare staffing company, ... Vice President of Operations of Crdentia,s,newly acquired Florida, ... Mr. Jones joins Crdentia from ATS Health Services, ... staffing services with six offices in,Florida, one in ...
... are nation,s healthiest states; ... WASHINGTON, Nov. 5 The overall health of ... made in several key health,indicators, according to a ... Public Health Association (APHA) and Partnership,for Prevention(TM). The ...
... DIEGO, Nov. 5 ADVENTRX Pharmaceuticals,Inc. (Amex: ... on commercializing proprietary product candidates for the treatment,of ... M. Culley,ADVENTRX,s chief business officer, is scheduled to ... November 14th, 2007 at 11:30,a.m. Central European Time ...
... 5 Boston Scientific,Corporation (NYSE: BSX ) today ... of its Cardiac Surgery and Vascular Surgery,businesses to the ... The transaction will be for a cash price of ... 45-90 days, subject to regulatory,approvals and customary conditions. The ...
... TARRYTOWN, N.Y., Nov. 5 EpiCept Corporation,(Nasdaq: ... financial,results for the three and nine months ended September ... a net loss attributable to common,stockholders of $7.7 million, ... million, or $0.22 per basic and diluted share, for ...
Cached Medicine News:Health News:Positive Results From Peregrine Pharmaceuticals' Bavituximab Phase l HCV Trial Presented at AASLD Meeting 2Health News:Positive Results From Peregrine Pharmaceuticals' Bavituximab Phase l HCV Trial Presented at AASLD Meeting 3Health News:Positive Results From Peregrine Pharmaceuticals' Bavituximab Phase l HCV Trial Presented at AASLD Meeting 4Health News:Positive Results From Peregrine Pharmaceuticals' Bavituximab Phase l HCV Trial Presented at AASLD Meeting 5Health News:Crdentia Announces Appointment of Tim Jones to Senior Management Team 2Health News:Crdentia Announces Appointment of Tim Jones to Senior Management Team 3Health News:2007 America's Health Rankings(TM) Show a Decline in the Overall Health of the Nation 2Health News:2007 America's Health Rankings(TM) Show a Decline in the Overall Health of the Nation 3Health News:2007 America's Health Rankings(TM) Show a Decline in the Overall Health of the Nation 4Health News:2007 America's Health Rankings(TM) Show a Decline in the Overall Health of the Nation 5Health News:2007 America's Health Rankings(TM) Show a Decline in the Overall Health of the Nation 6Health News:2007 America's Health Rankings(TM) Show a Decline in the Overall Health of the Nation 7Health News:ADVENTRX Pharmaceuticals to Present at the 13th Annual BIO-Europe Partnering Conference 2Health News:Boston Scientific Announces Sale of Cardiac Surgery and Vascular Surgery Businesses 2Health News:Boston Scientific Announces Sale of Cardiac Surgery and Vascular Surgery Businesses 3Health News:Boston Scientific Announces Sale of Cardiac Surgery and Vascular Surgery Businesses 4Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 2Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 3Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 4Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 5Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 6Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 7Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 8Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 9Health News:EpiCept Corporation Reports Third Quarter 2007 Operating and Financial Results 10
... has greatly enhanced the stabilization ... Biomet Low Profile Tibial Nail ... treatment of unstable fractures, tibial ... pathologic or impending fractures but ...
Arthroscopic instrument system for instability and SLAP fixation....
Arthroscopic instrument system for instability and SLAP fixation....
Suture Cutter, Open Ended, Left Notch...
Medicine Products: