Two new analyses of observational
data presented at Community Oncology Conference reported a
significantly lower proportion of patients receiving transfusions when
erythropoiesis- stimulating agents (ESAs) treatment was initiated at
hemoglobin (Hb) levels between 10 to 11 grams per deciliter (g/dL) of blood
compared with patients having Hb levels less than 10 g/dL prior to ESA
treatment. In addition, wide variability in hemoglobin levels prior to
transfusion was reported.
These analyses were conducted using data from the ongoing prospective,
observational Dosing and Outcomes Study of Erythropoiesis-Stimulating
Therapies (DOSE) Registry, sponsored by Centocor Ortho Biotech Services,
L.L.C.
"Observational data reflect real-world clinical practice and therefore
these findings are important in helping to understand transfusion
patterns," said Kay Larholt, Sc.D., Vice President, Biometrics at Abt
Associates, a biopharmaceutical research and consulting firm, and lead
author of both analyses presented today. "The analyses indicate that the
presence of a lower hemoglobin when ESA therapy was initiated was
associated with a higher need for transfusion, and suggest initiation at a
hemoglobin between 10 to 11 g/dL may reduce the need for transfusion."
Methodology and Results
For both analyses, real-world data on ESA-treated patients in 48 U.S.
oncology clinics were analyzed from the DOSE Registry. Data were collected
from participating hospital- and community-based outpatient practices
between December 2003 and July 2007.
In the first analysis of 969 patients, transfusion data were analyzed
from adult chemotherapy-treated oncology patients that received at least
two ESA doses. Results of the analysis were as follows:
-- A significantly greater proportion of chemotherapy-treated patients
received transfusions when ESA treatment was initiated at Hb levels
below 10 g/dL compared with patients having Hb levels of 10 to 11 g/dL
prior to ESA administration: 31% vs. 14%, respectively, p
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
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.
-- 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 procrit 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 orthobiotech.
Ortho Biotech Products, L.P.
orthobiotech