Navigation Links
Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa)
Date:3/7/2008

upport the most appropriate use of the product.

About PREPARE and GOG-191

PREPARE was a study in patients receiving neo-adjuvant breast cancer treatment in which darbepoetin alfa was administered to prevent anemia at target hemoglobin levels of 12.5-13 g/dL. After a median follow up of approximately three years, relapse-free survival (72% versus 78%), and overall survival (86% versus 90%), were lower in darbepoetin alfa-treated patients.

GOG-191 evaluated the efficacy of maintaining hemoglobin levels between 12-14 g/dL in patients with advanced cervical cancer undergoing chemotherapy or radiotherapy. Progression-free survival (59% versus 62%) at three years, and overall survival (61% versus 71%), were lower in Epoetin alfa-treated patients.

The Boxed Warnings have been modified to now read:

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

-- ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with breast, non-small cell lung, head and

neck, lymphoid, and cervical cancers when dosed to target a hemoglobin

of greater than or equal to 12 g/dL.

-- The risks of shortened survival and tumor progression have not been

excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

-- To minimize these risks, as well as the risk of serious cardio- and

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusions.

-- Use only for treatment of anemia due to c
'/>"/>

SOURCE Ortho Biotech Products, L.P.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Osteotech to Present at the Canaccord Adams Small-Cap Orthopedics Conference in San Francisco
2. ROBODOC(R) Emerges as a Curexo Technology Company at Upcoming Orthopaedic Surgeons Conference in San Francisco
3. NuVasive to Present at Canaccord Adams Small-Cap Orthopedics Conference
4. SyntheMed to Present at Canaccord Adams Small-Cap Orthopedics Conference
5. Ortho Biotech Statement On JAMA Publication Regarding Erythropoiesis-Stimulating Agents
6. Symmetry Medical to Present at Canaccord Adams Small-Cap Orthopedics Conference
7. Kensey Nash to Present at the Canaccord Adams Small-Cap Orthopedics Conference
8. Barr and Ortho Womens Health & Urology in Discussions to Settle ORTHO TRI-CYCLEN(R) LO Patent Litigation
9. Progentix Orthobiology B.V. Closes Series A Financing Round
10. Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings
11. Collagen Matrix, Inc. Launches OssiMend(TM) Bone Graft Matrix for Orthopedic and Spine Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... Capital, a firm specializing in acquiring and managing food ... the Slim-Fast brand from Unilever. Unilever will retain a ... were not disclosed. Slim-Fast is a branded ... shakes, powders, bars and snacks to retail customers throughout ... United Kingdom and Ireland.  The ...
(Date:7/10/2014)... 15, 2014 -- According to the International Atomic ... security comes from terrorists acquiring sufficient quantities of ... a crude nuclear explosive device. The IAEA also ... have involved gram-level quantities, which can be challenging ... to a new study appearing this week in ...
(Date:7/10/2014)... Understanding the basis of psychiatric disorders has been extremely ... increase risk but are insufficient to cause disease. Now ... Cell Press journal Cell Stem Cell describe ... genetic risks interact with other risk factors or environmental ... Their research pinpoints a genetic variant that may predispose ...
(Date:7/10/2014)... shelled out for crude 3-D glasses, polarized glasses, ... These basic devices, used to trick the brain ... be rendered obsolete with the introduction of new ... , TAU doctoral students Yuval Yifat, Michal Eitan, ... based on nanoantennas that could be used for ...
Breaking Biology Technology:Kainos Capital Acquires Slim-Fast From Unilever 2Sensitive detection method may help impede illicit nuclear trafficking 2New strategy could uncover genes at the root of psychiatric illnesses 2Projecting a 3-dimensional future 2Projecting a 3-dimensional future 3
... Neurognostics, Inc ., a Wisconsin company specializing in functional ... that the Food and Drug Administration (FDA) issued a ... MindState fDAD. MindState fDAD had previously received clearance ... The Special 510(k) allows Neurognostics to enhance fDAD by ...
... eMed , a Merge Healthcare company and a ... the release of Cedara I-ReadMammo digital mammography workstation ... product is designed to help organizations streamline breast ... mammography. , ,I-ReadMammo was designed to help ...
... a country that invented take out food, that is in love ... in motion, it was inevitable that work and indeed the workplace ... the place where knowledge work happens has shifted from primarily office ... a subway car, walking down the street or of course, hanging ...
Cached Biology Technology:Who moved the workplace? 2Who moved the workplace? 3Who moved the workplace? 4
(Date:7/11/2014)... of Entiat on Tuesday, July 8, 2014. Despite the ... over 1,000 acres by evening. Three outbuildings were damaged. ... the Washington Department of Natural Resources. The fire ... fire control strategies and tactics. Other cooperators include the ... Resources, (WA DNR), Bureau of Land Management, Chelan County ...
(Date:7/11/2014)... in German . ... uses the refraction of X-rays through a specimen instead ... this method are often of much higher quality than ... of Prof. Franz Pfeiffer are particularly interested in developing ... including X-ray phase-contrast imaging. One main goal is to ...
(Date:7/11/2014)... July 10, 2014---A team of researchers from The Chinese ... identified a gene of wild soybean linked to salt ... grow in saline soil. This study published online in ... unveil novel genomic information for crop improvement. , Soybean ... domestication and human selection, cultivated soybeans have less genetic ...
Breaking Biology News(10 mins):New simple setup for X-ray phase contrast 2BGI reports a novel gene for salt tolerance found in wild soybean 2
... COLD SPRING HARBOR, N.Y. (Thurs., Oct. 1, 2009) ... choice for understanding where and when genes are expressed in ... physiological or environmental conditions. Recent discoveries have revolutionized our ... active in a much wider set of biological processes than ...
... Spatial Integrated Systems, Inc. ("SIS"), a leader in ... digital 3D data capture and processing technologies, announced ... been published for "system and method for generating ... No. US2009/0169095A1. , "We are pleased that our ...
... BATON ROUGE For Sophie Warny, LSU assistant professor of ... Natural Science, years of patience in analyzing Antarctic samples with ... and colleagues from around the world now have proof of ... 15.7 million years ago and lasted for a few thousand ...
Cached Biology News:Cold Spring Harbor Protocols features RNA analysis methods 2Spatial Integrated Systems, Inc. Files Patent Application 2Algae and pollen grains provide evidence of remarkably warm period in Antarctica's history 2Algae and pollen grains provide evidence of remarkably warm period in Antarctica's history 3Algae and pollen grains provide evidence of remarkably warm period in Antarctica's history 4
... G bind specifically to Fc regions of ... G conjugates are commonly used as affinity ... subtypes from serum, hybridoma ascites fluids, tissue ... reagents are also commonly used to capture ...
... Dermal Fibroblasts (Mouse/BalbC) and media. This cell ... and is guaranteed to provide an additional ... date supplied, when used with the recommended ... 18.5 ,Applications: ,Cultivation: Plate at ...
... A and Protein G bind specifically to ... A and Protein G conjugates are commonly ... (antibodies) and immunoglobulin subtypes from serum, hybridoma ... biological fluids. These reagents are also commonly ...
... statistical software package for scientists and engineers ... without being a statistical expert.Just answer a ... and SigmaStat suggests the appropriate test. It ... assumptions and suggests another test if your ...
Biology Products: