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Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings
Date:11/8/2007

BRIDGEWATER, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Ortho Biotech Products, L.P. today modified prescribing information for PROCRIT(R) (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(R) 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 http://www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.


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SOURCE Ortho Biotech
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