madubois63
01-24-2008, 10:11 PM
<tt><tt>I received this from a leukemia site I subscribe to, but I've taken leukine a few times for bc so I thought I'd post it for anyone interested...
Bayer Withdraws Liquid Formulation of Leukine (sargramostim) in US Due
to Adverse Reactions
LEVERKUSEN, GERMANY -- January 23, 2008 -- Bayer HealthCare
announced today, following consultation with the United States Food and
Drug Administration (FDA), that it will withdraw the current liquid
formulation of Leukine(R) (sargramostim) marketed in the US.
This decision was made in light of an upward trend in spontaneous
reports of adverse reactions, including syncope, which are temporally
correlated with the liquid Leukine 500 mcg vial which currently contains
EDTA (edetate disodium).
While Bayer works to increase supplies of lyophilized Leukine and
reformulate the liquid Leukine (to eliminate EDTA), Bayer will establish
a special access program for the currently marketed lyophilized Leukine
250 mcg vial which does not contain EDTA. The upward trend in the
adverse event reporting rates is only associated with the Leukine liquid
500 mcg vial containing EDTA. Bayer has not observed an upward trend in
reporting rates of these adverse events in the marketed Leukine 250 mcg
lyophilized vial which does not contain EDTA. These adverse reactions
are listed in the Leukine prescribing information.
The special access program is designed to prioritize the supply
of the lyophilized Leukine for patients with Acute Myelogenous Leukemia
(AML) and those who are experiencing bone marrow transplantation graft
failure or engraftment delay. Leukine is the only myeloid growth factor
approved to reduce the incidence of infections resulting in early death
following induction chemotherapy in older adults with AML and to prolong
survival of patients with bone marrow graft failure or engraftment
delay, as compared to historical experience. The special access program
also will be used to provide continued Leukine therapy to patients
currently participating in ongoing clinical studies.
Bayer informed the FDA of an increase in reporting rates of
syncope, with or without documented hypotension; these adverse reactions
are listed in the Leukine prescribing information. The timing of
increased reporting of these adverse events coincides with a change in
the formulation of liquid Leukine to include EDTA.
Bayer has posted a Dear Health Care Provider letter, along with
its enclosures, on its websites today at www.pharma.bayer.com (http://www.pharma.bayer.com/),
www.bayeroncology.com (http://www.bayeroncology.com/) and www.leukine.com (http://www.leukine.com/) and will be mailing it to US
oncologists and hematologists who prescribe and use Leukine for their
patients.
In the coming days, Bayer will provide hematologists and
oncologists who prescribe and use Leukine for their patients with
instructions for accessing priority supplies of lyophilized Leukine 250
mcg vial. Bayer will work to increase supplies of lyophilized Leukine
and reformulate the liquid Leukine (to eliminate EDTA) as quickly as
possible.
About Leukine®
Leukine® (sargramostim) is a growth factor that helps fight
infection and disease in appropriate patients by enhancing immune cell
function. Leukine was approved in the United States in 1991, and is
marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth
factor approved in the US for use following induction chemotherapy in
older adults with acute myelogenous leukemia to shorten the time to
neutrophil recovery and reduce the incidence of severe and
life-threatening infections and infections resulting in death. Leukine
also has been approved in the US for use in four additional indications:
myeloid reconstitution following allogeneic and autologous bone marrow
transplantation, peripheral blood stem cell (PBSC) mobilization and
subsequent myeloid reconstitution in patients undergoing PBSC
transplantation, and bone marrow transplantation failure or engraftment
delay.
SOURCE: Bayer Schering Pharma</tt></tt>
Bayer Withdraws Liquid Formulation of Leukine (sargramostim) in US Due
to Adverse Reactions
LEVERKUSEN, GERMANY -- January 23, 2008 -- Bayer HealthCare
announced today, following consultation with the United States Food and
Drug Administration (FDA), that it will withdraw the current liquid
formulation of Leukine(R) (sargramostim) marketed in the US.
This decision was made in light of an upward trend in spontaneous
reports of adverse reactions, including syncope, which are temporally
correlated with the liquid Leukine 500 mcg vial which currently contains
EDTA (edetate disodium).
While Bayer works to increase supplies of lyophilized Leukine and
reformulate the liquid Leukine (to eliminate EDTA), Bayer will establish
a special access program for the currently marketed lyophilized Leukine
250 mcg vial which does not contain EDTA. The upward trend in the
adverse event reporting rates is only associated with the Leukine liquid
500 mcg vial containing EDTA. Bayer has not observed an upward trend in
reporting rates of these adverse events in the marketed Leukine 250 mcg
lyophilized vial which does not contain EDTA. These adverse reactions
are listed in the Leukine prescribing information.
The special access program is designed to prioritize the supply
of the lyophilized Leukine for patients with Acute Myelogenous Leukemia
(AML) and those who are experiencing bone marrow transplantation graft
failure or engraftment delay. Leukine is the only myeloid growth factor
approved to reduce the incidence of infections resulting in early death
following induction chemotherapy in older adults with AML and to prolong
survival of patients with bone marrow graft failure or engraftment
delay, as compared to historical experience. The special access program
also will be used to provide continued Leukine therapy to patients
currently participating in ongoing clinical studies.
Bayer informed the FDA of an increase in reporting rates of
syncope, with or without documented hypotension; these adverse reactions
are listed in the Leukine prescribing information. The timing of
increased reporting of these adverse events coincides with a change in
the formulation of liquid Leukine to include EDTA.
Bayer has posted a Dear Health Care Provider letter, along with
its enclosures, on its websites today at www.pharma.bayer.com (http://www.pharma.bayer.com/),
www.bayeroncology.com (http://www.bayeroncology.com/) and www.leukine.com (http://www.leukine.com/) and will be mailing it to US
oncologists and hematologists who prescribe and use Leukine for their
patients.
In the coming days, Bayer will provide hematologists and
oncologists who prescribe and use Leukine for their patients with
instructions for accessing priority supplies of lyophilized Leukine 250
mcg vial. Bayer will work to increase supplies of lyophilized Leukine
and reformulate the liquid Leukine (to eliminate EDTA) as quickly as
possible.
About Leukine®
Leukine® (sargramostim) is a growth factor that helps fight
infection and disease in appropriate patients by enhancing immune cell
function. Leukine was approved in the United States in 1991, and is
marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth
factor approved in the US for use following induction chemotherapy in
older adults with acute myelogenous leukemia to shorten the time to
neutrophil recovery and reduce the incidence of severe and
life-threatening infections and infections resulting in death. Leukine
also has been approved in the US for use in four additional indications:
myeloid reconstitution following allogeneic and autologous bone marrow
transplantation, peripheral blood stem cell (PBSC) mobilization and
subsequent myeloid reconstitution in patients undergoing PBSC
transplantation, and bone marrow transplantation failure or engraftment
delay.
SOURCE: Bayer Schering Pharma</tt></tt>