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

s undergoing cardiac or vascular surgery.
  • As a substitute for RBC transfusions in patients who require immediate correction of anemia.

  • IMPORTANT SAFETY INFORMATION

    WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

    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) transfusions.

    Cancer:

    • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
    • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology program to prescribe and/or dispense PROCRIT to patients with cancer.  To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
    • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid red blood cell (RBC) transfusions.
    • Use ESAs only for anemia from myelosuppressive chemotherapy.
    • ESAs are not indicated for patients receiving myelosuppressive chemother
      '/>"/>

    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:9/23/2014)... , Sept. 23, 2014 ... of the "Physician Office Laboratory Markets, 3rd ... This report, Physician Office Laboratory Markets is ... the IVD industry. Physician office laboratories are diverse ... simply perform reimbursable, in-office pregnancy and glucose tests. ...
    (Date:9/23/2014)... The Pennsylvania State Police will accept unwanted, expired ... of National Prescription Drug Take-Back Day. The service is ... Day is a national initiative, conducted in partnership with ... the public to dispose of expired, unused or unwanted ... From 10 a.m. to 2 p.m., unwanted ...
    (Date:9/23/2014)... , Sept. 23, 2014 Research and ... "Biopharmaceutical and Vaccine Production Markets" report to their ... new therapies and vaccines - including products to treat ... still huge challenges during the final stages of clinical ... and how to risk production capital to upscale while ...
    Breaking Medicine Technology:Physician Office Laboratory Markets, 3rd Edition 2Physician Office Laboratory Markets, 3rd Edition 3Biopharmaceutical and Vaccine Production Markets 2Biopharmaceutical and Vaccine Production Markets 3
    ... Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), ... and commercialization of its proprietary stent platform technology, ... summary of  three years collective data will be ... Transcatheter Cardiovascular Therapeutics (TCT) conference. The conference is ...
    ... Express Scripts, Inc., one of the largest ... Rexam as its 2011 Supplier of the Year. ... This award recognizes suppliers who have a ... continuous improvement in supplier relationship management, quality, service, ...
    Cached Medicine Technology:InspireMD to Sponsor Satellite Symposium Breakfast Meeting Chaired by Dr. Gregg W. Stone November 9th at TCT 2011 2InspireMD to Sponsor Satellite Symposium Breakfast Meeting Chaired by Dr. Gregg W. Stone November 9th at TCT 2011 3InspireMD to Sponsor Satellite Symposium Breakfast Meeting Chaired by Dr. Gregg W. Stone November 9th at TCT 2011 4Rexam Chosen as Express Scripts' Supplier of the Year 2
    (Date:9/23/2014)... 24, 2014 Menopause can cause ... roughly half of women, menopause can trigger debilitating ... commonly associated with major depressive disorder. These ... disturbances, memory loss, and fatigue. While hormone ... effects and high cost make them an unsuitable ...
    (Date:9/23/2014)... NY (PRWEB) September 23, 2014 The ... moderate rate over the past five years. Growth in ... consciousness has encouraged Canadians to consume more fish and ... encouraged food retailers and food-service establishments to increase their ... industry revenue. Additionally, strong economic growth in much of ...
    (Date:9/23/2014)... Mo. Infants, vocalizations throughout the first year ... and cooing to forming syllables and first words. ... amount of vocalizations may differ between hearing and ... that infant vocalizations are primarily motivated by infants, ... with profound hearing loss who received cochlear implants ...
    (Date:9/23/2014)... NIH TO CONVENE PATHWAYS TO PREVENTION WORKSHOP: ROLE OF ... WHAT: , The National Institutes of Health is ... available scientific evidence on the long-term effectiveness and potential ... be among the nation,s top experts in the field ... as well as key NIH scientists who focus on ...
    (Date:9/23/2014)... Diego, CA (PRWEB) September 23, 2014 ... daily regarding all the latest information from the FDA ... on September 5, that its Private Label Jalapeno Bagels ... and small stones. Publix Jalapeno Bagels were ... the bakery department. , Taking into consideration the ...
    Breaking Medicine News(10 mins):Health News:Pristiq Discounts Now Available from MedicationDiscountCard.com To Help Ease Menopause Symptoms 2Health News:Fish and Seafood Wholesaling in Canada Industry Market Research Report Now Available from IBISWorld 2Health News:Fish and Seafood Wholesaling in Canada Industry Market Research Report Now Available from IBISWorld 3Health News:Infant cooing, babbling linked to hearing ability, MU researcher finds 2Health News:NIH Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain 2Health News:NIH Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain 3Health News:Publix Private Label Jalapeno Bagels Recalled: AttorneyOne Monitors and Keeps Consumers Informed 2
    ... , , , ROCHESTER, Minn., Sept. ... is the focus of a Perspectives article in ... 23, 2009, and in the print issue on Oct. 1, 2009. , ... , "We must hold physicians and other providers accountable for ...
    ... from the dried venom secreted by the skin glands of ... those normally administered, and may slow disease progression in some ... D. Anderson Cancer Center. The results from ... M. D. Anderson and Fudan University Cancer Hospital in Shanghai, ...
    ... The Weill Cornell Institute of Geriatric Psychiatry at ... the largest grant in its 20-year history. One ... million, five-year "Center Grant" from the National Institute ... investigators to advance their pioneering work in understanding ...
    ... registered in the past 30 years, cardiovascular disease (CVD) remains the ... In the EU, experts reveal that striking disparities still exist ... with regard to national prevention policies. In view of this, there ... tackle heart disease and stroke. The message coincides with ...
    ... ... ... -- Whether in a quest for beauty or out of necessity, millions of Americans will ... technologies, and research will be presented at Plastic Surgery 2009, the annual scientific meeting of ...
    ... flu not effective , THURSDAY, Sept. 24 (HealthDay News) ... give the wrong dose of Tamiflu to their children ... dosing instructions don,t always coincide with the measurement markings ... , The warning letter, penned by scientists from Northwestern ...
    Cached Medicine News:Health News:Mayo Clinic Offers Perspective on Health Care Reform in New England Journal of Medicine 2Health News:M. D. Anderson examines use of toad venom in cancer treatment 2Health News:M. D. Anderson examines use of toad venom in cancer treatment 3Health News:Weill Cornell Institute for Geriatric Psychiatry awarded $10 million grant 2Health News:Weill Cornell Institute for Geriatric Psychiatry awarded $10 million grant 3Health News:Weill Cornell Institute for Geriatric Psychiatry awarded $10 million grant 4Health News:World Heart Day resonates with recent experts' findings on CVD and EU institutions' determination to promote heart health 2Health News:World Heart Day resonates with recent experts' findings on CVD and EU institutions' determination to promote heart health 3Health News:American Society Of Plastic Surgeons Hosts 78th Annual Meeting 2Health News:American Society Of Plastic Surgeons Hosts 78th Annual Meeting 3Health News:American Society Of Plastic Surgeons Hosts 78th Annual Meeting 4Health News:Letter Warns About Tricky Dosing With Liquid Tamiflu for Kids 2Health News:Letter Warns About Tricky Dosing With Liquid Tamiflu for Kids 3
    ... Bio-Rad isotopic anemia ... and minimal ,pipetting steps ... information about the processes ... and the benefit to ...
    ... Bio-Rad isotopic anemia assays ... minimal ,pipetting steps for ... about the processes ,involved ... the benefit to your ...
    ... The ImmunoDOT Autoimmunity Screening Panel ... test for screening and detection,of autoantibodies ... DNA, SS-A/SS-B, RNP/Sm) in serum, and ... diagnosis of systemic lupus erythematosus (SLE), ...
    The MESACUP ANA Test Kit is a semi-quantitative enzyme-linked immunosorbent assay,(ELISA) for the detection of specific anti-nuclear antibodies in human serum as an aid in,the determination of autoim...
    Medicine Products: