BRIDGEWATER, N.J., May 16 NJ-Ortho-ASCO-Present
BRIDGEWATER, N.J., May 16 /PRNewswire/ -- Data from three studies
evaluating associations between lower mean baseline hemoglobin (Hb) levels and
the rate of blood transfusions, as well as the possible effect of restrictions
on reimbursement for erythropoiesis-stimulating agents (ESAs) in Medicare
patients on the nation's blood supply, will be presented at the American
Society of Clinical Oncology (ASCO) Annual Meeting later this month. The
meeting will take place in Chicago from May 30 to June 3, 2008.
Data from the following studies will be presented:
Transfusion Outcomes in Erythropoiesis-Stimulating Agent (ESA)-Treated
Cancer Chemotherapy Patients Based on Achieved Hemoglobin (Hb) Levels
Kay Larholt, Sc.D., Abt Associates, Lexington, MA
Presentation: Health Svcs Research, Sunday, June 1, 2008; 8:00am - 12:00pm
CST, S Hall A1
Abstract Number: 6637
Last year, the Centers for Medicare and Medicaid Services (CMS)
implemented a National Coverage Determination (NCD) largely eliminating
coverage for non-renal ESA administration when patients have hemoglobin
concentrations above 10 grams per deciliter of blood (g/dL). This study
assessed the potential clinical implications of these policy changes by
evaluating data from an ongoing prospective registry of ESA-treated patients
in 55 U.S. oncology clinics between December 2003 and November 2007. Data were
analyzed from 330 adult chemotherapy-treated oncology patients who had
hemoglobin concentrations less than 10 g/dL prior to ESA administration and
received two or more ESA doses. Transfusion-related outcomes were categorized
based on mean Hb values achieved during ESA treatment into three cohorts: mean
achieved Hb between 9.1 g/dL and 10 g/dL, between 10.1 g/dL and 11 g/dL, or
between 11.1 g/dL and 12 g/dL.
Hematologic and Transfusion Outcomes Following Implementation of the
Erythropoiesis-Stimulating Agent (ESA) National Coverage Determination (NCD)
in Medicare Cancer Patients Receiving Chemotherapy
James Gilmore, PharmD, Georgia Cancer Associates, Atlanta, GA
Presentation: Health Svcs Research, Sunday, June 1, 2008, 8:00am - 12:00pm
CST, S Hall A1
Abstract Number: 6548
The purpose of this study was to describe the association between the CMS
NCD and clinical outcomes for patients with chemotherapy-induced anemia
requiring ESA therapy, as determined by the treating physician. A total of
285 Medicare patients receiving two or more ESA doses with concurrent
chemotherapy and a cancer diagnosis were included in this retrospective
observational study of an electronic medical record database.
Transfusion Outcomes Among Oncology Patients Initiated with
Erythropoiesis-Stimulating Agents (ESAs) at Baseline (BL) Hemoglobin (Hb) of <
10 v. 10-11g/dL: Observational Data from the Dosing and Outcomes Study of
Erythropoiesis-Stimulating Therapies (DOSE) Registry
Tanya Burton, Ph.D., Abt Associates, Lexington, MA
Publication Number: 20637
Limited real-world data exist on transfusion patterns in patients
initiated with ESAs at different baseline Hb levels. Observational data from
an ongoing, prospective registry of 1,059 ESA-treated patients in 59 U.S.
oncology clinics from December 2003 to November 2007 were analyzed to
investigate transfusion outcomes in chemotherapy-treated oncology patients
initiated on ESAs at baseline Hb of <10 g/dL vs. 10-11 g/dL. Hospital- and
community-based outpatient practices were included in the analysis.
About PROCRIT (Epoetin alfa)
PROCRIT(R) (Epoetin alfa) is an ESA 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.
Note: Data in this release correspond to ASCO abstracts 6637 and 6548 and
publication number 20637
SOURCE Ortho Biotech Products, L.P.
