From: Ortho Biotech
August 13, 2004
Products, LP ("Ortho Biotech"), wishes to advise you of
important changes to the safety information and dosing sections of
the product labeling for PROCRIT epoetin alfa. To ensure consistency
with labeling for other products in this class, changes to hemoglobin
rate of rise and target have been made.
revised prescribing information for PROCRIT in its cancer
chemotherapy indication recommends dosing interruption and
modification if the rate of rise of hemoglobin exceeds 1 gram per
deciliter over a 2-week period. The goal of treatment (hemoglobin
target level) should be individually determined for each patient, and
this target may range form 10 up to 12 grams per deciliter.
Importantly, the new prescribing information recommends that the
target hemoglobin in patients with cancer should not exceed 12 grams
per deciliter in men and women. The dose should be withheld if the
hemoglobin is 13 grams per deciliter, or above. This guideline
applies whether patients are treated with PROCRIT three times weekly
or with the newly approved once weekly dosing regimen (see below).
recommendations result from recent investigational studies, some with
erythropoietin products other than PROCRIT, and conducted outside the
US, where patients with cancer were treated to high hemoglobin target
levels, beyond the correction of anemia. These studies permitted or
required dosing to achieve hemoglobin levels of greater than 12 grams
per deciliter. An increased frequency of adverse patient outcomes,
including increased mortality and thrombotic vascular events was
reported in these studies. Additional details of these studies are
included in the following sections of the revised Prescribing
Information: See WARNINGS-Thrombotic Events and Mortality and
PRECAUTIONS-Tumor Growth Factor Potential.
erythropoietin products share similarities in mechanism of action,
Ortho Biotech deems this information to be relevant for prescribers
and patients to help ensure the safe and effective use of PROCRIT.
Dosage and Administration:
the only dosing regimen specified in PROCRIT labeling for the cancer
chemotherapy indication was 150 IU per kilogram SC TIW. Recently,
another dosing regimen, 40,000 IU SC weekly, has been approved for
use in this patient population. The revised product labeling includes
the following guidance regarding once weekly dosing of PROCRIT:
dose is 40,000 Units SC weekly. If after 4 weeks of therapy, the
hemoglobin has not increased by > 1 g/dL, in the absence of
RBC transfusion, the PROCRIT dose should be increased to 60,000 Units weekly.
have not responded satisfactorily to a PROCRIT dose of 60,000 Units
weekly after 4 weeks, it is unlikely that they will respond to higher
doses of PROCRIT.
is committed to providing you with the most current product
information for PROCRIT. You can report adverse events to Ortho
Biotech at Medical Information at 1-800-325-7504, Prompt #2.
Alternately, this information may be reported to FDA's MedWatch
reporting system by phone (1-800-FDA-1088), facsimile
(1-800-FDA-0178), the MedWatch website at www.fda.gov/medwatch, or
mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD
20852-9787. Both healthcare professionals and consumers should use
Form 3500 (available at the MedWatch website) for reporting adverse events.
A copy of the
revised prescribing information for PROCRIT is enclosed. Should you
have any questions or require further information regarding the use
of PROCRIT, please contact the Ortho Biotech Medical Information at
1-800-325-7504, prompt #2.
Marc Kamin, M.D.
President, Ortho Biotech Clinical Affairs, LLC.