BRIDGEWATER, N.J., Dec. 4 /PRNewswire/ -- An updated analysis from a 2001 study conducted by the Gynecologic Oncology Group evaluating Epoetin alfa in 109 patients with cervical cancer has been posted online (http://dx.doi.org/10.1016/j.ygyno.2007.10.011). The study (GOG-191) was terminated in 2003 due to potential concerns of thromboembolic events (TE) in the group treated with Epoetin alfa. The U.S. Food and Drug Administration (FDA) was notified at that time.
GOG-191 was a randomized phase III trial designed to evaluate the efficacy of maintaining hemoglobin levels above 12 grams per deciliter of blood (g/dL) with Epoetin alfa in subjects with advanced cervical cancer undergoing chemoradiotherapy. The updated analysis, expected to be published in the journal, Gynecologic Oncology, found a statistically non-significant trend toward decreased progression-free and overall survival in the patients treated with Epoetin alfa.
The updated analysis provides further evidence supporting the recent ESA class label change to utilize the lowest dose needed to avoid transfusions and not to exceed an upper hemoglobin safety limit of 12 g/dL.
Ortho Biotech has informed FDA of this updated analysis, and will continue to work with the agency and the GOG to ensure that these data are shared expeditiously with the medical community.
The safety and effectiveness of Epoetin alfa in its approved uses has been established in well-controlled studies and substantiated clinically over the past 20 years in more than four million patients worldwide for approved indications.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those 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. Depending on the country in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression
Renal failure: Patients experienced greater risks for death and serious
cardiovascular events when administered erythropoiesis-stimulating agents
(ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL;
14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve
and maintain hemoglobin levels within the range of 10 to 12 g/dL.
-- ESAs shortened overall survival and/or time-to-tumor progression in
clinical studies in patients with advanced breast, head and neck,
lymphoid, and non-small cell lung malignancies when dosed to target a
hemoglobin of greater than or equal to 12 g/dL.
-- The risks of shortened survival and tumor progression have not been
excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
-- To minimize these risks, as well as the risk of serious cardio- and
thrombovascular events, use the lowest dose needed to avoid red blood
-- Use only for treatment of anemia due to concomitant myelosuppressive
-- Discontinue following the completion of a chemotherapy course.
Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
PROCRIT is contraindicated in patients with uncontrolled hypertension
or with known hypersensitivity to albumin (human) or mammalian cell-derived
Additional Important Safety Information
-- The dose of PROCRIT should be titrated for each patient to achieve and
maintain the following hemoglobin levels:
-- Chronic renal failure patients - hemoglobin levels between 10 to 12
g/dL. If a patient does not attain hemoglobin levels of 10 to 12
g/dL despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and
ADMINISTRATION in the PROCRIT Prescribing Information.
-- Cancer or HIV patients - the lowest hemoglobin level sufficient to
avoid transfusion and not to exceed 12 g/dL.
-- Monitor hemoglobin regularly during therapy, more frequently following
a dosage adjustment or until hemoglobin becomes stable.
-- 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 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 other
erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-
888-227-5624) to perform assays for binding and neutralizing
antibodies. If erythropoietin antibody-mediated anemia is confirmed,
PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins.
-- The safety and efficacy of PROCRIT therapy have not been established in
patients with a known history of a seizure disorder or underlying
hematologic disease (e.g., sickle cell anemia, myelodysplastic
syndromes, or hypercoagulable disorders).
-- In some female patients, menses have resumed following PROCRIT therapy;
the possibility of pregnancy should be discussed and the need for
-- Prior to and regularly during PROCRIT therapy monitor iron status;
transferrin saturation should be greater than or equal to 20% and
ferritin should be greater than or equal to 100 ng/mL. During therapy
absolute or functional iron deficiency may develop and all patients
will eventually require supplemental iron to adequately support
erythropoiesis stimulated by PROCRIT.
-- During PROCRIT therapy, blood pressure should be monitored carefully
and aggressively managed, particularly in patients with an underlying
history of hypertension or cardiovascular disease.
-- In studies, the most common side effects included fever (pyrexia),
diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or
loss of strength or weakness (asthenia, fatigue), shortness of breath,
high blood pressure, headache, joint pain (arthralgias), abnormal skin
sensations (as tingling or tickling or itching or burning;
paresthesia), rash, constipation, and upper respiratory infection.
Please visit http://www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
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.
|SOURCE Ortho Biotech Products, L.P.|
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