PROFESSIONAL LINKS
Amgen Professional Sites
Amgen (www.amgen.com)
Amgen is a leading human therapeutics company in the biotechnology industry.
Aranesp® (darbepoetin alfa) Prescribing Information (www.aranesp.com)
An Amgen product site with information about Aranesp®.
Medical Information Connection™ (www.amgenmedinfo.com)
This site provides healthcare professionals access to scientific and clinical data pertaining to Amgen Products.
Reimbursement Connection® (www.reimbursementconnection.com)
This site provides reimbursement information on Amgen products.
Sensipar® (cinacalcet HCl) (www.sensipar.com)
An Amgen product site with information about Sensipar®.
General Nephrology Resources
National Kidney Foundation (www.kidney.org)
The NKF supports the prevention of kidney and urinary tract diseases, fosters improvement of the health and well-being of affected individuals and their families, and increases the availability of organs for transplantation.
Kidney School (www.kidneyschool.org)
Life Options free, interactive, online kidney learning center (the only CKD [stage 3-5] curriculum available nationally, 24/7).
Life Options Rehabilitation Program (www.lifeoptions.org)
To make rehabilitation a reality for more people on dialysis, the Life Options Rehabilitation Program, supported by an unrestricted educational grant from Amgen Renal Advances, develops resources and programs based on encouragement, education, exercise, employment, and evaluation.
The Nephron Information Center (www.nephron.com)
The Nephron Information Center is a non-profit organization. Its primary focus is to support the generation and dissemination of valid health information relevant to the kidney community, as well as to the public.
RenalWeb (www.renalweb.com)
Announcement board for news, useful information, new products, services, and educational resources designed for healthcare professionals.
Kidney Learning System (www.kidney.org)
In April 2003, the NKF launched its Kidney Learning System (KLS), which is focused on education, early patient identification, prevention, and clinical applications that improve outcomes.
Societies, Associations, and Foundations
American Society of Nephrology (www.asn-online.org)
The American Society of Nephrology (ASN) was founded in 1967 as a nonprofit corporation to enhance and assist the study and practice of nephrology, to provide a forum for the promulgation of research, and to meet the professional and continuing education needs of its members.
American Nephrology Nurses' Association (www.annanurse.org)
The mission of the American Nephrology Nurses' Association (ANNA) is to advance nephrology nursing practice and positively influence outcomes for patients with kidney or other disease processes requiring replacement therapies through advocacy, scholarship, and excellence.
National Renal Administrators Association (www.nraa.org)
The National Renal Administrators Association (NRAA) is a nonprofit organization representing professional managers of dialysis facilities and centers throughout the United States.
Community Bulletin Boards
Forum of ESRD Networks (www.esrdnetworks.org)
18 ESRD Networks are members of the Forum, which facilitates the flow of information and advances a national quality agenda with CMS and other renal organizations.
RenalWeb (www.renalweb.com)
Announcement board for news, useful information, new products, services, and educational resources designed for healthcare professionals.
Government Agencies
National Institutes of Health (www.nih.gov)
Health information, news and events, grants and funding opportunities, scientific resources, institutes, and offices.
Centers for Medicare & Medicaid Services (cms.hhs.gov)
The Centers for Medicare & Medicaid Services (CMS) is a Federal agency within the US Department of Health and Human Services which administers Medicare, Medicaid, and the State Children's Health Insurance Program.
Food and Drug Administration (www.fda.gov)
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Indication
EPOGEN® (Epoetin alfa) is indicated for the treatment of anemia in patients with chronic renal failure (CRF) on dialysis. EPOGEN® is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE
and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Chronic Renal Failure:
- In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
- Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense EPOGEN®
(Epoetin alfa) 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.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: EPOGEN ® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
- EPOGEN® is contraindicated in patients with uncontrolled hypertension.
- Patients with chronic renal failure (CRF) participating in clinical studies experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
- Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients.
- These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis.
- A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
- This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration.
- PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.
- A sudden loss of response to EPOGEN®, accompanied by severe anemia and low reticulocyte count, should be evaluated.
- If anti-erythropoietin antibody-associated anemia is suspected, withhold EPOGEN® and other ESAs. EPOGEN® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
- Seizures have occurred in patients with CRF participating in EPOGEN® clinical trials.
- The most commonly reported side effects in clinical trials were hypertension, headache, arthralgias, and nausea.
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