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Successful Management of Enzyme Replacement Therapy in Related Fabry Disease Patients with Severe Adverse Events by Switching from Agalsidase Beta (Fabrazyme(®)) to Agalsidase Alfa (Replagal (®)).
[fabry disease]
Background
:
Enzyme
replacement
therapy
(
ERT
)
is
the
only
approved
therapy
for
Fabry
disease
.
In
June
2009
,
there
was
a
worldwide
shortage
of
agalsidase
beta
,
necessitating
dose
reductions
or
switching
to
agalsidase
alfa
in
some
patients
.
Case
presentation
:
We
present
two
cases
of
Fabry
disease
(
a
parent
and
a
child
)
who
received
agalsidase
beta
for
27
months
at
the
licensed
dose
and
10
months
at
a
reduced
dose
,
followed
by
a
switch
to
agalsidase
alfa
for
28
months
.
Case
1
,
a
26
-
year
-old
male
had
severe
coughing
and
fatigue
during
ERT
with
agalsidase
beta
requiring
antitussive
and
asthmatic
drug
therapy
.
After
switching
to
agalsidase
alfa
,
the
coughing
gradually
resolved
completely
.
Case
2
,
a
62
-
year
-old
female
had
advanced
cardiac
manifestations
at
the
time
of
diagnosis
.
Despite
receiving
ERT
with
the
approved
dose
of
agalsidase
beta
,
she
experienced
aggravation
of
congestive
heart
failure
and
was
hospitalized
.
After
switching
to
agalsidase
alfa
with
standard
care
in
heart
disease
,
BNP
level
,
echocardiographic
parameters
,
eGFR
rate
and
lyso-
Gb
3
levels
were
improved
or
stabilized
.
Conclusions
:
We
report
on
two
Fabry
disease
patients
who
experienced
severe
adverse
events
while
on
approved
and
/
or
reduced
doses
of
agalsidase
beta
.
Switching
to
agalsidase
alfa
associated
with
standard
care
in
heart
disease
led
to
resolution
or
improvement
in
the
cardiorespiratory
status
.
And
reduction
in
dose
associated
with
standard
care
in
respiratory
disease
was
useful
for
decrease
in
cough
and
fatigue
.
Plasma
BNP
level
was
useful
for
monitoring
heart
failure
and
the
effects
of
ERT
.
Diseases
Validation
Diseases presenting
"heart disease"
symptom
22q11.2 deletion syndrome
achondroplasia
acute rheumatic fever
adrenal incidentaloma
child syndrome
classical phenylketonuria
cohen syndrome
congenital diaphragmatic hernia
dentinogenesis imperfecta
esophageal adenocarcinoma
fabry disease
familial mediterranean fever
heparin-induced thrombocytopenia
hirschsprung disease
holt-oram syndrome
homocystinuria without methylmalonic aciduria
kabuki syndrome
monosomy 21
omenn syndrome
phenylketonuria
sneddon syndrome
systemic capillary leak syndrome
wiskott-aldrich syndrome
wolf-hirschhorn syndrome
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