Navigation Links
Ortho Biotech Statement On JAMA Publication Regarding Erythropoiesis-Stimulating Agents
Date:2/26/2008

ed for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed 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 advanced breast, head and neck,

lymphoid, and non-small cell lung malignancies 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 concomitant myelosuppressive

chemotherapy.

-- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

Additional Important Safety Information

-- The dose of PROCRIT should
'/>"/>

SOURCE Ortho Biotech
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Ortho Biotech Supports FDA Advisory Committees Recommendations on Use of ESAs in Chronic Renal Failure Patients
2. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
3. New Orthopedic Surgical Robotics Company Opens Its Doors; Files with the FDA for Clearance of Its Flagship Product
4. Innovative Neurotronics, a Subsidiary of Hanger Orthopedic Group, Earns the 2007 da Vinci Award for the WalkAide System
5. Bone-growing nanomaterial could improve orthopaedic implants
6. Advancements in Population Age and Technology Drive Future of Orthopedic Materials Market
7. Collagen Matrix, Inc. Launches OssiMend(TM) Bone Graft Matrix for Orthopedic and Spine Applications
8. Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings
9. Progentix Orthobiology B.V. Closes Series A Financing Round
10. Barr and Ortho Womens Health & Urology in Discussions to Settle ORTHO TRI-CYCLEN(R) LO Patent Litigation
11. Kensey Nash to Present at the Canaccord Adams Small-Cap Orthopedics Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/26/2014)... SonaCare Medical, a leading manufacturer ... recently participated in the American Urology Association’s (AUA) ... Key opinion leaders in urology presented on the ... renal masses while attendees had the opportunity to ... hands-on labs. Attendees at the Los Angeles, CA ...
(Date:11/26/2014)... PA (PRWEB) November 25, 2014 The ... of its official conference and exposition mobile app, ... for free download in the App Store for iOS ... a valuable resource tool before, during and after the ... containing details on exhibiting companies, technical sessions, Conferee Networking ...
(Date:11/26/2014)... Boston, MA (PRWEB) November 26, 2014 ... and collaboration company is proud to announce that Darren ... Development and Sales. Darren will drive the ... and positive customer experience. , Darren brings ... He has held key roles in channel operations, from ...
(Date:11/26/2014)... TOKYO , 25 novembre 2014 Theravalues ... Super sur le marché européen au salon Hi ... Amsterdam ). Curcumine la ... une technologie amorphe (non-cristalline) à des ingrédients approuvés ... est un pigment jaune présent dans la racine ...
Breaking Biology Technology:SonaCare Medical Supports American Urology Association’s Small Renal Mass 360° Summit 2SonaCare Medical Supports American Urology Association’s Small Renal Mass 360° Summit 3Pittcon Releases 2015 Mobile App 2SoundConnect Appoints Director of Channel Development & Sales 2La curcumine présentant la plus haute biodisponibilité bientôt en vente en Europe 2La curcumine présentant la plus haute biodisponibilité bientôt en vente en Europe 3
... CAMBRIDGE, Mass., Oct. 26 Verenium Corporation (Nasdaq: ... commercialization of high-performance enzyme solutions, today announced that it ... Alfa Laval, a leading global provider of heat transfer, ... 2009 Verenium and Alfa Laval signed an agreement to ...
... (IDC), a privately held biotechnology company developing novel vaccines ... that it has entered into a license and development ... IDC’s proprietary Glucopyranosyl Lipid Adjuvant (GLA) as a component ... are pleased to enter into this license with MedImmune ...
... Oct. 26 aTyr Pharma, the physiocrine therapeutics ... equity financing led by Domain Associates.  Domain joins ... Polaris Ventures, who also participated in the financing. ... of aTyr,s preclinical pipeline and advance physiocrine drug ...
Cached Biology Technology:Verenium and Alfa Laval Announce Extension of Purifine® PLC Enzyme Agreement 2Verenium and Alfa Laval Announce Extension of Purifine® PLC Enzyme Agreement 3Verenium and Alfa Laval Announce Extension of Purifine® PLC Enzyme Agreement 4Immune Design Grants Adjuvant License to MedImmune 2aTyr Pharma Secures $23M Financing From Top Tier Venture Investor 2
(Date:11/4/2014)... nature, the right amount of death at the right ... according to new research that could help in understanding ... stocks. , In a paper in the journal ... researcher and European colleagues conclude that the kind of ... loss of individuals, or mortality, depends on the size ...
(Date:11/4/2014)... newly published research study examining only marketing directed ... fast food restaurants has found that the majority ... exposed to such marketing tactics. , Authored by ... colleagues, the study is the first to examine ... and exterior of fast food restaurants and its ...
(Date:11/4/2014)...   Neurotechnology , a provider of high-precision ... version of its fingerprint matching algorithm has achieved ... evaluation organized by NIST. The MINEX test measures ... 378 fingerprint standard template format. MINEX compliance is ... the United States and ...
Breaking Biology News(10 mins):When less is more: Death in moderation boosts population density in nature 2Fast food marketing for children disproportionately affects certain communities 2Fast food marketing for children disproportionately affects certain communities 3Neurotechnology Places Second in Ongoing MINEX Ranking for Fingerprint Matching Algorithms 2Neurotechnology Places Second in Ongoing MINEX Ranking for Fingerprint Matching Algorithms 3
... PHILADELPHIA Young mice that experienced the psychosocial stress ... incidence and faster onset of breast tumors compared with ... event. Specifically, neonatal mice separated from their mothers for ... as fast as mice that experienced short or no ...
... of an insect birth control program helps to get ... that combines the planting of pest-resistant cotton and releasing ... the world,s most destructive cotton pests from Arizona. ... advance online publication of the journal Nature Biotechnology ...
... a key step in metabolic pathways linked to diabetes and ... 2 was published online in the journal Current Biology ... Akt, which plays a crucial role in how cells respond ... College of Biological Sciences at UC Davis and senior author ...
Cached Biology News:Prolonged maternal separation increased breast cancer risk in neonatal mice 2Prolonged maternal separation increased breast cancer risk in neonatal mice 3New insect birth control strategy zaps cotton pests 2New insect birth control strategy zaps cotton pests 3New insect birth control strategy zaps cotton pests 4Understanding diabetes at the molecular level 2