Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidn... (itional benefit. Use caution in pa...)

Janssen Products, LP Modifies Prescribing Information for PROCRIT® (Epoetin alfa) in Chronic Kidney Disease

Date:6/24/2011

itional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.

In controlled clinical trials of patients with cancer, PROCRIT and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.

In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.

Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer

ESAs resulted in decreased locoregional control/progression-free survival and/or overall survival. These findings were observed in studies of patients with advanced head and neck cancer receiving radiation therapy, in patients receiving chemotherapy for metastatic breast cancer or lymphoid malignancy, and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy.

Hypertension

PROCRIT is contraindicated in patients with uncontrolled hypertension. Following initiation and titration of PROCRIT, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving PROCRIT.
Appropriately control hypertension prior to initiation of and during treatment with PROCRIT. Reduce or withhold PROCRIT if
'/>"/>

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

0

GOOD

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:

(Date:5/22/2013)... May 22, 2013 Hemoglobin A1C levels ... with Type 2 diabetes, while modest improvements in ... outcomes and can lead to substantial healthcare cost ... International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ... studies, sponsored by Valeritas, makers of the V-Go ...

(Date:5/22/2013)... Life Line Screening (LLS), a leading ... creation of a unique partnership with MCM Solutions ... is a population health management organization. LLS will provide ... These important expanded services will help MCM and its ... reduces cost of care when individuals are able to ...

(Date:5/22/2013)... May 22, 2013 Avanir Pharmaceuticals, Inc. (NASDAQ: ... overview of the company at the following conferences. ... Presentation date: Wednesday May 29, 2013 , Presentation time: ... Healthcare Conference , Presentation date: Wednesday June 5, 2013 ... A live webcast and 30-day archive of ...

Breaking Medicine Technology:Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance 2 Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance 3 Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance 4 Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance 5 Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance 6 Life Line Screening and MCM Solutions for Better Health Announce New Partnership 2 Avanir Pharmaceuticals to Participate in Two Upcoming Investor Conferences 2

[0] Type 2 Diabetes Control Worsening, According To Study Of Patients On Commercial Insurance [0] Life Line Screening and MCM Solutions for Better Health Announce New Partnership [0] Avanir Pharmaceuticals to Participate in Two Upcoming Investor Conferences

... Columbia Laboratories, Inc. (Nasdaq: CBRX ) and Watson ... the U.S. Food and Drug Administration (FDA) has accepted for ... (progesterone gel) for the reduction of risk of preterm birth ... of pregnancy. The acceptance of the NDA for filing means ...

... Calif., June 27, 2011 Advanced Sterilization ... an innovative infection prevention technology – GLOSAIR™ Healthcare ... thorough disinfection of hospital rooms and operating suites ... infection-causing pathogens. There is a growing scientific consensus ...

Cached Medicine Technology:Columbia Laboratories' NDA for PROCHIEVE® Vaginal Progesterone Gel Accepted for Filing by FDA 2 Columbia Laboratories' NDA for PROCHIEVE® Vaginal Progesterone Gel Accepted for Filing by FDA 3 Columbia Laboratories' NDA for PROCHIEVE® Vaginal Progesterone Gel Accepted for Filing by FDA 4 ASP Launches GLOSAIR™ Healthcare Environmental Decontamination at the 2011 APIC Conference to Protect Against the Risk of Deadly Infections in Healthcare Facilities 2 ASP Launches GLOSAIR™ Healthcare Environmental Decontamination at the 2011 APIC Conference to Protect Against the Risk of Deadly Infections in Healthcare Facilities 3 ASP Launches GLOSAIR™ Healthcare Environmental Decontamination at the 2011 APIC Conference to Protect Against the Risk of Deadly Infections in Healthcare Facilities 4 ASP Launches GLOSAIR™ Healthcare Environmental Decontamination at the 2011 APIC Conference to Protect Against the Risk of Deadly Infections in Healthcare Facilities 5

Columbia Laboratories' NDA for PROCHIEVE® Vaginal Progesterone Gel Accepted for Filing by FDA ASP Launches GLOSAIR™ Healthcare Environmental Decontamination at the 2011 APIC Conference to Protect Against the Risk of Deadly Infections in Healthcare Facilities

(Date:5/23/2013)... 23, 2013 Kitchen on Fire ... classes, the most advanced culinary technique series currently offered ... with the knowledge of how to purchase, butcher and ... health benefits of organic, local ingredients. The new Intermediate ... six hours each. The next series begins on Sunday, ...

(Date:5/23/2013)... Get ready to sweat. , Automatic Body ... conjunction with the Nutrié California Kick Off ... will get the chance to work out with celebrity ... Dr. Oz Show, and The Dr. Phil Weight Loss ... undefeated UFC heavy-weight contender Daniel Cormier at Chukchansi Park ...

(Date:5/23/2013)... Daimer Industries, Inc.®, the undisputed leader ... , including outstanding car wash equipment and ... other popular cleaning machines with many satisfied customers ... offering the Super Max™ 7000, an electric-powered, tri-mode ... of cleaning applications, such as maintaining wheelchairs. ...

(Date:5/22/2013)... Pleasant Prairie, WI (PRWEB) May 23, 2013 ... company , introduced a new feature to its ... example from the agency’s client portfolio through an immersive, ... gives clients and prospective customers the ability to virtually ... Medical, a developer of medical technologies and services. Users ...

(Date:5/22/2013)... of Lady Niguma was created by a female yogi (‘yogini’) from ... oldest yoga found in written form (in a book made from ... Indian master and yogi Naropa, and the yoga she created is ... , Lady Niguma taught the practice to her student Kyungpo ... to the second Dalai Lama, Gendun Gyatso. While researching rare texts ...

Breaking Medicine News(10 mins):Health News:Kitchen on Fire Launches Intermediate Cooking Series, Advancing the Culinary Skills of Experienced Home Chefs 2 Health News:Kitchen on Fire Launches Intermediate Cooking Series, Advancing the Culinary Skills of Experienced Home Chefs 3 Health News:Kim Lyons, Gunter Schlierkamp, & Daniel Cormier To Host Fresno Charity Workout 2 Health News:Kim Lyons, Gunter Schlierkamp, & Daniel Cormier To Host Fresno Charity Workout 3 Health News:Commercial Pressure Washer Debuted By Daimer Industries For Wheelchair Cleaning 2 Health News:Commercial Pressure Washer Debuted By Daimer Industries For Wheelchair Cleaning 3 Health News:Commercial Pressure Washer Debuted By Daimer Industries For Wheelchair Cleaning 4 Health News:Catalyst Exhibits Debuts 360 Degree Virtual Tour of St. Jude Medical Trade Show Booth 2 Health News:Popular Yoga DVD, Lady Niguma Yoga Released for Sale Online 2 Health News:Popular Yoga DVD, Lady Niguma Yoga Released for Sale Online 3

[0] Kitchen on Fire Launches Intermediate Cooking Series, Advancing the Culinary Skills of Experienced Home Chefs [0] Kim Lyons, Gunter Schlierkamp, & Daniel Cormier To Host Fresno Charity Workout [0] Commercial Pressure Washer Debuted By Daimer Industries For Wheelchair Cleaning [0] Catalyst Exhibits Debuts 360 Degree Virtual Tour of St. Jude Medical Trade Show Booth [0] Popular Yoga DVD, Lady Niguma Yoga Released for Sale Online

... Absence of Verification Safeguards Allow Thieves to Steal, ... millions of Americans,are the victims of identity theft, ... companies, identity theft victim Eric Drew claims that ... to maximize,profits by fully automating their identity verification ...

... Utilizing a new, innovative,twist on the popular Christmas ... Four Points by Sheraton Denver Southeast and give,back to ... staff and the community may donate new costumes for ... National Jewish,Medical and Research Center., "The Glendale Raptors ...

... 22 Sarah C. Albert has been named,Public ... where she provides,leadership and management of the organization,s ... analysis, and,grassroots advocacy efforts. Previously, she served as ... and as Executive Director of the,General Federation of ...

... higher risk for asthma, other respiratory problems, CDC report says ... American kids with food allergies has soared 18 percent in ... and teens now affected with the condition, a new federal ... the age of 18 were reported to have had a ...

... the Staying Sharp session on October 25 at Peter Norton ... highly recognized series, the program emphasizes successful aging, including how ... cognitive function; and the importance of clinical trials and how ... sponsored by The Dana Alliance for Brain Initiatives, in partnership ...

... quarter of 2008 -- Medical membership grew by 63,000 members during the quarter and ... September 30, 2008 -- Benefit expense ratio declined by 80 basis points from the second ... quarter 2008, ... ...

Credit Card Companies Accomplices in Millions of Identity Theft Cases Alleges Eric Drew Glendale Raptors Join Four Points by Sheraton Denver Southeast and Animal Planet's Dr. Kevin Fitzgerald for Second Annual Halloween Costume Drive & Halloween Party for Kunsberg School at National Jewish Medical and Research Center Sarah Albert Joins YWCA USA Senior Executive Staff Food Allergies Up 18% Among U.S. Children Staying Sharp in New York City WellPoint Reports Third Quarter 2008 Results

... design allows "Four gels in one tank" electrophoresis. ... run 200 samples or more in one compact ... gels. To ensure even migration, the electrode height ... being run. Ideal for high throughput procedures, an ...

... tanks come with turn and cast gel ... pouring as simple as possible. , ... your application. Avaialble in a variety of ... gel size right up to the 20 ...

... UniPhor units can be used for: ... and non denaturing SDS-PAGE gels IEF ... Z64,075 1) Preparative Protein and Peptide ... gels IEF in Agarose Ampholyte Gels ...

... Horizontal Gel System provides a compact format ... DNA fragments, PCR products and synthetic oligonucleotides, ... The Mini Horizontal Unit has gel bed ... The gel bed is UV transparent. Adjustable ...

Medicine Products:

Electro-4 Gel System Classic Series Gel Uniphor electrophoresis units Mini Horizontal Gel System