Navigation Links
Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidney Disease
Date:6/24/2011

on of CKD in patients not yet on dialysis as well as in patients on dialysis, and untreated may lead to the requirement for blood transfusions.  As CKD severity progresses in patients not on dialysis, anemia becomes more frequent and severe, and is almost universal among patients requiring dialysis," said Thomas Schaible, Ph.D., Vice President, Medical Affairs, Janssen Products, LP.  "PROCRIT is an important treatment option for patients with CKD-associated anemia who are not on dialysis and are likely to require transfusion.  The revised label provides additional clarification to prescribers on how to use PROCRIT in this patient segment."

Additional modifications have been made to the label to conform to the guidance of the Physician's Labeling Rule (PLR) and to the Medication Guide, which is part of the full prescribing information.  The Medication Guide is a component of the ESA Risk Evaluation and Mitigation Strategy (REMS).

As part of the class-wide update for ESAs, the company is notifying health care providers about the updated prescribing information through a joint Dear Health Care Provider letter with Amgen, and will post the letter along with the updated prescribing information on the PROCRIT website, www.PROCRIT.com.

Additional Label Update Details

The CKD section of the updated Boxed Warning of the PROCRIT label now reads:

Chronic Kidney Disease:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
  • Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC) transfus
    '/>"/>

SOURCE Janssen Products, LP
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Related medicine technology :

1. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets
2. Record Breaking $327 Million Verdict Announced in Janssen Case
3. MHPA Center for Best Practices Receives Sponsorship from Ortho-McNeil Janssen Pharmaceuticals, Inc. to Improve Medicaid Quality, Care Coordination for Serious Mental Illness
4. Lilly Makes an Irrevocable Offer to Acquire Janssen Animal Health
5. Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations
6. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Announces Oncology Research Collaboration Agreement with the Koch Institute for Integrative Cancer Research at MIT
7. The Pittsburgh Life Sciences Greenhouse Congratulates Diamyd Medical on Its Agreement with Ortho-McNeil-Janssen Pharmaceuticals to Develop Diabetes Therapy
8. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resolves Investigation of Past TOPAMAX(R) Marketing and Promotional Activities
9. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Agrees to $75 Million Settlement for Topamax(R) False Claims Lawsuit
10. WuXi PharmaTech Enters into Collaboration with J&JPRD, a division of Janssen Pharmaceutica for Preclinical Services and Training
11. Nominations Open for the 2010 Dr. Paul Janssen Award for Biomedical Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)... N.C. , May 1, 2015  An ... that can provide non-binding but informed guidance to ... the return on investment, it is important for ... invest optimal resources. Research and ... study to assist pharmaceutical and medical device executives ...
(Date:5/1/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/vzcw2v/americas_clinical ) has announced ... by Product, by End-Users - Forecast to 2019" report ... market is estimated to grow at a CAGR of 5.2% ... Canada , Mexico , ... covered in this report. The Americas is the ...
(Date:5/1/2015)... 2015 Following yesterday,s release of Center for Medicaid ... five things you need to know: ... unique among government programs. ... than other parts of Medicare and other government programs because ... to offer prescription drug benefits to enrollees. , Competition ...
Breaking Medicine Technology:New Study Presents Insights to Advisory Board Effectiveness in the Pharmaceutical Sector 2Americas Clinical Chemistry Analyzer (Semi-Automated Clinical Chemistry and Fully-Automated Clinical Chemistry) Market - Forecast to 2019 25 Things to Know About the CMS Part D Data Release 25 Things to Know About the CMS Part D Data Release 3
... 1, 2012 The FDA and representatives from the ... on proposed recommendations for the third reauthorization of a ... http://photos.prnewswire.com/prnh/20090824/FDALOGO ) The recommendations would authorize the ... five years, plus adjustments for inflation. Details of the ...
... Corporation (NYSE: BSX ) announces first ... PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent ... the new device was performed by Professor Antonio ... at Columbus Hospital and San Raffaele Hospital in ...
Cached Medicine Technology:FDA and Industry Reach Agreement in Principle on Medical Device User Fees 2FDA and Industry Reach Agreement in Principle on Medical Device User Fees 3Boston Scientific Announces First Implant and Market Launch of PROMUS Element™ Plus Stent System in Europe 2Boston Scientific Announces First Implant and Market Launch of PROMUS Element™ Plus Stent System in Europe 3Boston Scientific Announces First Implant and Market Launch of PROMUS Element™ Plus Stent System in Europe 4
(Date:5/3/2015)... “ BolehVPN ” was featured on NewsWatch as ... and coolest technology products available to consumers. Scott Steinberg, a ... and shared with viewers how to protect their private information. ... on computers and even more so online. It helps everyone ... over the world. In terms of work, the internet makes ...
(Date:5/3/2015)... May 03, 2015 SpineFrontier, a Less ... the FDA to produce and market their new sacroiliac ... be used in outpatient settings and is compatible with ... posterior approach has been extensively researched and refined by ... to use this approach in conjunction with a sacroiliac ...
(Date:5/2/2015)... As one of only 30 Illinois companies to be ... and Recognition Program (SHARP) certification, Essentra Specialty Tapes ... Department of Labor to host this special event. ... the Occupational Safety and Health Administration’s (“OSHA”) Onsite Consultation ... or exceed all of the necessary regulations and standards, ...
(Date:5/2/2015)... “ ActOn ” was featured on NewsWatch ... at the latest and coolest applications on the market for ... and technology expert, conducted the app review and shared with ... organizations to make a difference. , In this material world, ... that aren’t about money, which is why those things should ...
(Date:5/2/2015)... We are pleased to announce the Sun ... one of the Top Workplaces of 2015. , The ... field for their ethics and standards of excellence. The ... their educational efforts. The Delray Recovery Center prides itself ... purpose – to help individuals heal from the disease ...
Breaking Medicine News(10 mins):Health News:A Method to Keep Private Information Secure was Featured on NewsWatch Television 2Health News:Essentra Specialty Tapes is Selected to Host Gov. Rauner and the Workers' Memorial Day Celebration 2Health News:Essentra Specialty Tapes is Selected to Host Gov. Rauner and the Workers' Memorial Day Celebration 3Health News:An Application to Help People Make a Difference Was Featured on NewsWatch Television 2Health News:The Delray Recovery Center Named 2015 Top Workplace 2
... factors for spontaneous or unexpected preterm birth any birth ... without a known cause is already having had one. ... this scenario in their second pregnancy, focusing on weight gain ... new study reported at the Society for Maternal-Fetal Medicine,s annual ...
... HealthDay Reporter , THURSDAY, Feb. 9 (HealthDay News) -- A ... had chemotherapy while pregnant aren,t at higher risk for a ... be safe for the fetus in most instances. There,s ... were more likely to be born prematurely, potentially putting them ...
... Annual Meeting of the American Academy of Orthopaedic Surgeons ... living with a total knee replacement (TKR), as the ... the past decade, with the sharpest rise among younger ... TKR., Investigators used a computer model; U.S. Census data; ...
... (February 10, 2012) In a study to be ... meeting, The Pregnancy Meeting , in Dallas, Texas, researchers ... can be used to diagnose fetal aneuploidies, including Down ... Because of the importance of the clinical data, the ...
... obstructive sleep apnea had substantial improvements in attention, anxiety ... pressure (PAP)a nighttime therapy in which a machine delivers ... nose. "The benefits occurred even when children ... Carole L. Marcus, M.D., a sleep specialist and director ...
... , THURSDAY, Feb. 9 (HealthDay News) -- Small, premature ... higher risk for serious breathing problems than those delivered ... syndrome, which mostly affects premature newborns and can lead ... more common in the babies born by cesarean, or ...
Cached Medicine News:Health News:To avoid early labor and delivery, weight and diet changes not the answer 2Health News:Chemo During Pregnancy Doesn't Seem to Harm Baby 2Health News:Chemo During Pregnancy Doesn't Seem to Harm Baby 3Health News:4.5 million Americans living with total knee replacement 2Health News:Study finds massively parallel sequencing can detect fetal aneuploidies, including Down syndrome 2Health News:Sleep breathing machine shows clear benefits in children with sleep apnea 2Health News: C-Sections Might Put Preemies at Risk for Breathing Problems 2Health News: C-Sections Might Put Preemies at Risk for Breathing Problems 3
... Many special order products are offered as ... long lengths. The modular instruments may be ... options such as ratchets, insulation and flush ... Mediflex stock. Customer specifications may affect delivery ...
... Many special order products are offered as ... long lengths. The modular instruments may be ... options such as ratchets, insulation and flush ... Mediflex stock. Customer specifications may affect delivery ...
... are offered as 1-piece or modular, in ... instruments may be customized with handles of ... insulation and flush ports. Many standard patterns ... may affect delivery times. , Please ...
... offered as 1-piece or modular, in regular ... may be customized with handles of choice ... and flush ports. Many standard patterns are ... affect delivery times. , Please Note: ...
Medicine Products: