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

HORSHAM, Pa., June 24, 2011 /PRNewswire/ -- Janssen Products, LP, formerly Centocor Ortho Biotech Products, L.P., today announced updated prescribing information for PROCRIT® (Epoetin alfa) when used to treat anemia associated with chronic kidney disease (CKD) as part of a U.S. Food and Drug Administration (FDA)-approved class-wide update for erythropoiesis-stimulating agents (ESAs).

The updates include modifications to the Boxed Warning, Warnings and Precautions, Indications and Usage, and Dosage and Administration sections for CKD, which have been revised to clarify important new information based on the totality of clinical data when ESAs are used to increase hemoglobin (Hb) levels beyond labeled guidance.

The updates to the Boxed Warning include language noting the increased risk for death, serious adverse cardiovascular reactions, and stroke when ESAs are administered to target an Hb level of greater than 11 grams per deciliter (g/dL), and that the lowest dose should be used to reduce the need for red blood cell (RBC) transfusions.  Additionally, the Dosage and Administration section for patients with CKD-associated anemia who are not on dialysis has been updated to provide indication-specific guidance to prescribers considering ESA treatment.  

The updated label states that for patients with CKD who are not on dialysis, physicians should consider initiating treatment with PROCRIT only when the patient's Hb level is less than 10 g/dL, the rate of Hb decline indicates the likelihood of the patient requiring an RBC transfusion, and the goal is reducing the risk of an immune response to donor antigens or other RBC transfusion-related risks. Additional guidance has been provided to reduce or interrupt the PROCRIT dose if the patient's Hb level exceeds 10 g/dL and to individualize dosing, using the lowest dose of PROCRIT sufficient to reduce the need for RBC transfusions.

"Anemia is a frequent complicati
'/>"/>

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:1/23/2015)... Jan. 23, 2015  Pete Rose, baseball,s all-time hits leader, is ... pain reliever Myoflex, Ducere Pharma has announced. "Pete,s ... excited to have him on board with Myoflex," said Ducere ... a legendary player who is known across all generations. The ...
(Date:1/23/2015)... 2015 Cord Blood America, Inc. ( www.cordblood-america.com ) (OTC ...  filed a Preliminary Proxy Statement, Schedule 14A, with the U.S. ... an update for shareholders detailing why a "YES" vote to ... Dear Shareholders, As we reflect upon the 2014 ...
(Date:1/23/2015)... and BOSTON , January 23, 2015 ... discovery and development company, is delighted to announce that the ... awarded to Miles Congreve (Vice President of Chemistry), ... Malcolm Weir (Chief Executive Officer and co-founder) for ...
Breaking Medicine Technology:Pete Rose bets on Myoflex to relieve aches and pains 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4
... Dec. 14, 2010 The Dr. Paul Janssen ... call for nominations. This prestigious award recognizes individuals ... potential to make, significant transformational contributions toward the ... www.pauljanssenaward.com and will be accepted until ...
... The DNA Medicine Institute (DMI) successfully completed reduced-gravity experiments ... to the Space Environment for Technology (FAST) program, at ... Texas, at the end of September.  The rHEALTH sensor ... from a single drop of blood.  Although designed for ...
Cached Medicine Technology:Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations 2Dr. Paul Janssen Award for Biomedical Research Issues Call for Nominations 3DNA Medicine Institute Completes Reduced-Gravity Experiments on its NASA-Funded rHEALTH Sensor 2
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy ... its highest annual revenues in the past three years. Today, ... wedding dresses. , According to the sales manager of the ... for them in 2015. This point can be reflected on ...
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... JJsHouse.com is a famous dress online store for wedding dresses ... latest collection of wedding dresses , and launches a site-wide ... wedding dress on your big day; the wedding gown is ... wants to find the most suitable wedding dress. Now, we ...
(Date:1/22/2015)... Richmond, VA (PRWEB) January 22, 2015 ... the power at the Science Museum of Virginia. Wicked ... 24. , Wicked Plants unearths 75 poisonous, carnivorous and ... traverse through each room to uncover the biochemical, physical ...
(Date:12/26/2014)... 2014 It is said that nothing makes ... UWDress.com, the famous wedding dress supplier, shows its new ... cocktail gown promotion. , UWDress.com’s navy cocktail gowns are ... come in high fashion styles. Simple dresses in bright neon ...
Breaking Medicine News(10 mins):Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2Health News:Wicked Plants are taking over the Science Museum of Virginia 2Health News:UWDress.com Shows Its New Navy Cocktail Dresses For 2015 2
... significantly increased life expectancy in early tests of patients ... aggressive form of brain cancer in adults − is ... Clinic in Jacksonville. , The vaccine represents a fresh ... neurosurgeon Kent New, M.D., Ph.D., who will be leading ...
... Looks toward Year of Continued Rapid Growth For Retail ... ... Web Golinkin, president and CEO,of RediClinic, LLC, has been elected president ... Care,Industry (CCI). A founder of the association and its first treasurer, ...
... to Break Ground, TAMPA, Fla., Oct. 22 The ... of Tampa Bay will break ground in January of,2008, and ... Center of Tampa Bay, developed and operated by Tampa Bay,Radiosurgical ... be used by a large number of physicians from various ...
... Medicine, will appear at Sixth & I for a ... sciences and their potential to transform medical treatment. ... scientist in the United Kingdom, where he was born. ... (CDK) as the key regulator molecule controlling the process ...
... in the fight against HIV and they must be ... to a new commentary published today in the journal ... London, who are evaluating multiple candidate vaccines designed to ... must commit to sharing technology and expertise with those ...
... October 22, 2007 Today, The National Institutes of ... Science Editors global theme issue on poverty and human ... by more than 230 journals worldwide. , Many ... Science Editors campaign to encourage science journals to focus ...
Cached Medicine News:Health News:Mayo Clinic tests novel vaccine for aggressive brain tumors 2Health News:RediClinic's Web Golinkin to Lead Convenient Care Association 2Health News:Fight against HIV needs local scientists, say researchers 2Health News:Elsevier journals participate widely in global theme issue on poverty and human development 2
... Corneal Topographer has applications in ... procedures including Radial Keratotomy, Astigmatic ... Lens Fitting. Based on an ... E300 analyses an accurate ring ...
... System provides an automated scalable system capable ... SNP genotypes per day. Combined with multiplexing ... enables you to process a wide range ... designed to deliver your intended results faster ...
... including fourSight 4D ultrasound imaging technology for ... wide variety of imaging and workflow enhancements ... combine to expand the clinical capabilities for ... was built on four foundations that mark ...
... The BeStent2, a laser-cut stent, is the ... stent systems for use after coronary arteries ... a therapy known as percutaneous transluminal coronary ... a number of features designed to optimize ...
Medicine Products: