Ortho Biotech Revises Prescribing Information for Procrit (Epoetin alfa)
Revised PROCRIT Label Reflects FDA Update for All Products Within the Erythropoiesis-stimulating Agent ClassBRIDGEWATER, N.J., March 09, 2007 /PRNewswire/ -- Ortho Biotech Products, L.P. today revised the label for PROCRIT(R) (Epoetin alfa), acting upon guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.
The action is being taken in response to reports from several investigational studies evaluating ESAs. The label for all ESAs, including PROCRIT, now includes a boxed warning containing the following information:
* Use the lowest dose of PROCRIT that will gradually increase the
hemoglobin concentration to the lowest level sufficient to avoid the
need for red blood cell transfusion.
* PROCRIT and other erythropoiesis-stimulating agents (ESAs) increased the
risk for death and for serious cardiovascular events when administered
to target a hemoglobin of greater than 12 grams per deciliter of blood
(g/dL).
* Cancer Patients: Use of ESAs:
-- shortened the time to tumor progression in patients with advanced
head and neck cancer receiving radiation therapy when administered to
target a hemoglobin of greater than 12 g/dL;
-- shortened overall survival and increased deaths attributed to disease
progression at 4 months in patients with metastatic breast cancer
receiving chemotherapy when administered to target a hemoglobin of
greater than 12 g/dL;
-- increased the risk of death when administered to target a hemoglobin
of 12 g/dL in patients with active malignant disease receiving
neither chemotherapy nor radiation therapy. ESAs are not indicated
for this population.
* Patients receiving ESAs pre-operatively for reduction of allogeneic
blood transfusions: A higher incidence of deep venous thrombosis was
documented in patients receiving PROCRIT who were not receiving
prophylactic anticoagulation. Antithrombotic prophylaxis should be
strongly considered when PROCRIT is used to reduce allogeneic red blood
cell transfusions.
The Company has worked closely with the FDA to ensure that the PROCRIT label provides physicians and patients with the information they need to make the most appropriate and informed treatment decisions. To that end, Ortho Biotech is committed to broadly disseminating this important new prescribing information about the safety of PROCRIT through a "Dear Health Care Provider" letter and its field-based employees.
"We remain confident in the safety and efficacy of PROCRIT when used according to its label. The benefits and risks of PROCRIT have been established in well-controlled studies and substantiated clinically over the past 18 years in more than four million patients worldwide for approved indications," said Craig Tendler, M.D., Vice President, Ortho Biotech Clinical Affairs, L.L.C. "We look forward to the May 10 meeting of the Oncologic Drugs Advisory Committee, at which there will be important discussions of data pertaining to the safe use of erythropoietins."
About PROCRIT (Epoetin alfa)
PROCRIT is approved for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic kidney disease who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. PROCRIT is not indicated in patients with active malignant disease not receiving chemotherapy.
Important Safety Information
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
PROCRIT and other erythropoiesis-stimulating agents (ESAs) in controlled clinical trials increased the risk for:
* Death and for serious cardiovascular events (including arterial and
venous thromboembolic events, myocardial infarction, stroke, congestive
heart failure and hemodialysis graft occlusion); and
* Shortened time to tumor progression in patients with advanced head and
neck cancer receiving radiation therapy. ESAs also shortened survival
in patients with metastatic breast cancer receiving chemotherapy.
* To help reduce these risks:
-- Use the lowest dose of PROCRIT that will gradually increase the
hemoglobin (Hb) concentration to the lowest level sufficient to avoid
the need for RBC transfusion.
-- Hemoglobin levels should not exceed 12 g/dL, and the rate of Hb
increase should not exceed 1 g/dL in any two-week period. (For more
details see Dosage and Administration section of the Prescribing
Information)
-- During therapy, the Hb should be monitored regularly.
Antithrombotic prophylaxis should be strongly considered when PROCRIT is used to reduce allogeneic red blood cell transfusions in anemic patients who are scheduled for elective noncardiac, nonvascular surgery.
Cases of pure red cell aplasia (PRCA) and of severe anemia have been reported in patients with chronic renal failure receiving PROCRIT by subcutaneous administration. If any patient develops a sudden loss of response to PROCRIT, accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT and evaluate for the presence of antibodies to erythropoietin. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be switched to other erythropoietic proteins.
In studies, the most common side effects included fever, diarrhea, nausea, vomiting, edema, shortness of breath, high blood pressure, headache, joint pain, tingling, and upper respiratory infection.
Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed Warning.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit http://www.orthobiotech.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.
CONTACT: Media: Stephanie Fagan, office: +1-908-541-4029, cell:+1-201-572-9581, , or Investors: Louise Mehrotra,+1-732-524-6491, or Stan Panasewicz, +1-732-524-2524, or Lesley Fishman,+1-732-524-9322, all for Ortho Biotech Products, L.P. sfagan@obius.jnj.com
Web site: http://www.orthobiotech.com/http://www.procrit.com/
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