BRIDGEWATER, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT® (Epoetin alfa), following guidance from the U.S. Food and Drug Administration (FDA) to revise labeling for all drugs within the erythropoiesis-stimulating agent (ESA) class.
The modifications to the label are based on previously reported data and include recommendations from the May 10th FDA Oncologic Drugs Advisory Committee meeting, and the September 11th joint Cardiovascular and Renal Drugs Advisory Committee/Drug Safety & Risk Management Advisory Committee meeting.
“We remain confident in the safety and efficacy of PROCRIT when used according to its FDA-approved label,” said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. “This label supports physicians’ abilities to customize treatment to individual patients’ needs by directing them to utilize the lowest dose needed to avoid transfusions and not to exceed an upper hemoglobin safety limit of 12 grams per deciliter (g/dL).”
Label Change Details
The modifications to the label include a hemoglobin target range of 10-12 g/dL of blood for chronic renal failure patients with anemia; a hemoglobin upper limit of 12 g/dL of blood for oncology patients with anemia due to chemotherapy; and additional data regarding 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 greater than or equal to 12 g/dL. In addition, recommendations have been added for managing chronic renal failure patients who respond poorly to ESA therapy.
The boxed warnings have been modified to now read:
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.
Cancer: * 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 cell transfusions. * Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy. * 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.
(See WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, WARNINGS: Increased Mortality and/or Tumor Progression, and DOSAGE AND ADMINISTRATION.)
Additional changes were made in the Warnings, Dosage and Administration, and Indications and Usage sections of the label, as well as in the patient package insert to reflect the latest FDA guidance.
The Company has worked closely with the FDA to ensure that the updated 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 modified prescribing information through a “Dear Health Care Provider” letter, its product Web site and its product specialists.
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.
Cancer: * 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 cell transfusions. * Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy. * 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.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.
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 ADMINSTRATION 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 contraception evaluated. * 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 www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
Source: Ortho Biotech
