- Label change based on data previously reported, communicated in late 2007 -
BRIDGEWATER, N.J., March 7 /PRNewswire/ -- 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.
Modifications to the label were based on an unplanned interim analysis of
Amgen's PREPARE study in women with breast cancer receiving preoperative
chemotherapy, and from GOG-191, a study of advanced cervical cancer patients
conducted by the Gynecologic Oncology Group with support from Ortho Biotech.
Both investigational studies were designed to evaluate the efficacy of
maintaining hemoglobin levels greater than 12 grams per deciliter of blood
(g/dL) and observed lower survival in patients being treated with ESAs.
However, neither study showed a statistically significant effect on survival
or tumor outcomes.
"These studies are consistent with results from previous studies
demonstrating that ESAs should not be used to enhance the response to
chemotherapy or radiotherapy, and should be administered to achieve a
hemoglobin level of less than 12 g/dL," said Craig Tendler, M.D., Vice
President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P.
"We look forward to thoughtful consideration of the totality of available
scientific evidence at next week's FDA Oncologic Drugs Advisory Committee
Meeting (ODAC), including a substantial body of data that has been submitted
to the agency over the past several months."
Ortho Biotech remains confident in the safety and efficacy of PROCRIT when
used at the lowest dose to avoid transfusion in anemic patients receiving
concomitant chemotherapy. The company also remains committed to continuing to
work with the FDA to ensure that physicians have the most up-to-date
information to support the most appropriate use of the product.
About PREPARE and GOG-191
PREPARE was a study in patients receiving neo-adjuvant breast cancer
treatment in which darbepoetin alfa was administered to prevent anemia at
target hemoglobin levels of 12.5-13 g/dL. After a median follow up of
approximately three years, relapse-free survival (72% versus 78%), and overall
survival (86% versus 90%), were lower in darbepoetin alfa-treated patients.
GOG-191 evaluated the efficacy of maintaining hemoglobin levels between
12-14 g/dL in patients with advanced cervical cancer undergoing chemotherapy
or radiotherapy. Progression-free survival (59% versus 62%) at three years,
and overall survival (61% versus 71%), were lower in Epoetin alfa-treated
patients.
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 breast, non-small cell lung, head and
neck, lymphoid, and cervical cancers 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 section of the label to
reflect these two studies.
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 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 breast, non-small cell lung, head and
neck, lymphoid, and cervical cancers 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.
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
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
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.
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 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 the Company's Annual Report on Form 10-K for the fiscal year
ended December 30, 2007. Copies of this Form 10-K, as well as subsequent
filings, are available online at http://www.sec.gov, www.jnj.com 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.
SOURCE Ortho Biotech Products, L.P.
Media, Stephanie Fagan, +1-908-541-4029 - office, +1-201-572-9581 - cell, or
sfagan@obius.jnj.com; Investors, Stan Panasewicz, +1-732-524-2524, or Tina
Pinto, +1-732-524-2034, all for Ortho Biotech Products, L.P.
