<s>
Gadobutrol	B-Algorithm
(	O
INN	O
)	O
(	O
Gd-DO3A-butrol	O
)	O
is	O
a	O
gadolinium-based	O
MRI	O
contrast	O
agent	O
(	O
GBCA	O
)	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
is	O
marketed	O
by	O
Bayer	O
AG	O
as	O
Gadovist	B-Algorithm
,	O
and	O
by	O
Bayer	O
HealthCare	O
Pharmaceuticals	O
as	O
Gadavist	B-Algorithm
.	O
</s>
<s>
Gadobutrol	B-Algorithm
is	O
a	O
medicinal	O
product	O
used	O
in	O
diagnostic	O
magnetic	O
resonance	O
imaging	O
(	O
MRI	O
)	O
in	O
adults	O
and	O
children	O
.	O
</s>
<s>
In	O
the	O
central	O
nervous	O
system	O
,	O
Gadobutrol	B-Algorithm
works	O
by	O
highlighting	O
any	O
areas	O
with	O
disrupted	O
blood	O
brain	O
barrier	O
(	O
BBB	O
)	O
and/or	O
abnormal	O
vascularity	O
.	O
</s>
<s>
In	O
breast	O
tissue	O
,	O
Gadobutrol	B-Algorithm
exposes	O
the	O
presence	O
and	O
extent	O
of	O
malignant	O
breast	O
disease	O
.	O
</s>
<s>
Similarly	O
,	O
gadobutrol	B-Algorithm
is	O
also	O
used	O
in	O
contrast-enhanced	O
magnetic	O
resonance	O
angiography	O
(	O
CE-MRA	O
)	O
for	O
the	O
diagnosis	O
of	O
stroke	O
,	O
detection	O
of	O
tumor	O
perfusion	O
,	O
and	O
presence	O
of	O
focal	O
cerebral	O
ischemia	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
should	O
be	O
administered	O
intravenously	O
by	O
medical	O
professionals	O
only	O
.	O
</s>
<s>
When	O
compared	O
to	O
other	O
GBCAs	O
,	O
Gadobutrol	B-Algorithm
is	O
available	O
in	O
a	O
more	O
concentrated	O
form	O
(	O
1mmol/mL	O
)	O
to	O
alleviate	O
a	O
high	O
volume	O
of	O
administration	O
.	O
</s>
<s>
The	O
safety	O
of	O
gadobutrol	B-Algorithm
was	O
assessed	O
throughout	O
clinical	O
trials	O
and	O
post-marketing	O
,	O
for	O
multiple	O
applications	O
,	O
in	O
diverse	O
populations	O
and	O
at	O
multiple	O
doses	O
.	O
</s>
<s>
The	O
most	O
severe	O
reaction	O
to	O
gadobutrol	B-Algorithm
is	O
nephrogenic	O
system	O
fibrosis	O
(	O
NSF	O
)	O
among	O
patients	O
with	O
impaired	O
elimination	O
of	O
the	O
drug	O
.	O
</s>
<s>
Patients	O
who	O
have	O
experienced	O
a	O
previous	O
adverse	O
reaction	O
to	O
another	O
contrast	O
agent	O
,	O
have	O
bronchial	O
asthma	O
,	O
and/or	O
allergic	O
disorders	O
have	O
an	O
increased	O
risk	O
of	O
a	O
hypersensitivity	O
reaction	O
to	O
gadobutrol	B-Algorithm
.	O
</s>
<s>
These	O
reactions	O
are	O
uncommon	O
,	O
however	O
,	O
monitoring	O
of	O
the	O
patient	O
for	O
signs	O
and	O
symptoms	O
during	O
and	O
after	O
administration	O
of	O
gadobutrol	B-Algorithm
is	O
necessary	O
.	O
</s>
<s>
The	O
FDA	O
has	O
labeled	O
gadobutrol	B-Algorithm
as	O
pregnancy	O
category	O
C	O
.	O
Sufficient	O
studies	O
of	O
gadobutrol	B-Algorithm
in	O
pregnant	O
human	O
females	O
have	O
not	O
been	O
conducted	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
should	O
only	O
be	O
administered	O
in	O
pregnant	O
females	O
if	O
the	O
potential	O
benefit	O
outweighs	O
the	O
risk	O
to	O
the	O
fetus	O
.	O
</s>
<s>
It	O
is	O
unknown	O
the	O
amount	O
of	O
Gadobutrol	B-Algorithm
transferred	O
to	O
milk	O
in	O
humans	O
.	O
</s>
<s>
For	O
the	O
highest	O
level	O
of	O
safety	O
,	O
breastfeeding	O
should	O
be	O
discontinued	O
for	O
24	O
hours	O
upon	O
administration	O
of	O
gadobutrol	B-Algorithm
and	O
any	O
milk	O
properly	O
disposed	O
of	O
.	O
</s>
<s>
Clinical	O
data	O
has	O
shown	O
that	O
there	O
is	O
no	O
difference	O
in	O
the	O
safety	O
or	O
efficacy	O
of	O
gadobutrol	B-Algorithm
in	O
subjects	O
of	O
65	O
years	O
and	O
older	O
when	O
compared	O
with	O
those	O
under	O
the	O
age	O
of	O
65	O
years	O
.	O
</s>
<s>
It	O
is	O
recommended	O
that	O
renal	O
impairment	O
be	O
assessed	O
for	O
all	O
patients	O
prior	O
to	O
administration	O
of	O
gadobutrol	B-Algorithm
.	O
</s>
<s>
It	O
is	O
not	O
necessary	O
to	O
adjust	O
the	O
dose	O
in	O
these	O
populations	O
,	O
however	O
,	O
gadobutrol	B-Algorithm
will	O
need	O
to	O
be	O
removed	O
from	O
the	O
body	O
using	O
hemodialysis	O
.	O
</s>
<s>
There	O
are	O
no	O
known	O
drug	O
interactions	O
with	O
gadobutrol	B-Algorithm
.	O
</s>
<s>
Gadobutrol	B-Algorithm
is	O
a	O
paramagnetic	O
macrocyclic	O
contrast	O
agent	O
administered	O
intravenously	O
for	O
use	O
in	O
magnetic	O
resonance	O
imaging	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
was	O
first	O
approved	O
in	O
Switzerland	O
in	O
1998	O
for	O
use	O
in	O
contrast-enhanced	O
MRI	O
scans	O
of	O
the	O
brain	O
and	O
spinal	O
cord	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
was	O
first	O
approved	O
for	O
use	O
in	O
MRIs	O
of	O
the	O
central	O
nervous	O
system	O
in	O
the	O
United	O
States	O
in	O
2011	O
.	O
</s>
<s>
It	O
is	O
currently	O
manufactured	O
by	O
Bayer	O
Healthcare	O
Pharmaceuticals	O
Inc	O
.	O
and	O
marketed	O
under	O
the	O
brand	O
name	O
Gadavist	B-Algorithm
.	O
</s>
<s>
In	O
2015	O
,	O
Gadavist	B-Algorithm
was	O
approved	O
by	O
the	O
FDA	O
as	O
the	O
first	O
contrast	O
agent	O
safe	O
for	O
use	O
in	O
children	O
under	O
the	O
age	O
of	O
2	O
years	O
old	O
.	O
</s>
<s>
Most	O
recently	O
,	O
in	O
early	O
2016	O
,	O
Gadavist	B-Algorithm
was	O
approved	O
in	O
the	O
United	O
States	O
for	O
use	O
in	O
contrast-enhanced	O
magnetic	O
resonance	O
angiography	O
.	O
</s>
<s>
Gadavist	B-Algorithm
was	O
approved	O
in	O
the	O
United	O
States	O
in	O
2011	O
after	O
presenting	O
findings	O
from	O
43	O
clinical	O
studies	O
that	O
had	O
primarily	O
taken	O
place	O
in	O
Asia	O
and	O
the	O
European	O
Union	O
,	O
in	O
addition	O
to	O
one	O
phase	O
2	O
and	O
two	O
phase	O
3	O
clinical	O
trials	O
conducted	O
in	O
the	O
United	O
States	O
.	O
</s>
<s>
Each	O
patient	O
received	O
a	O
single	O
dose	O
of	O
gadobutrol	B-Algorithm
(	O
0.1mmol/kg	O
body	O
weight	O
)	O
via	O
intravenous	O
injection	O
,	O
followed	O
by	O
a	O
single	O
dose	O
of	O
gadoteridol	O
(	O
ProHance	O
)	O
at	O
the	O
approved	O
dose	O
(	O
0.1mmol/kg	O
body	O
weight	O
)	O
via	O
intravenous	O
injection	O
,	O
or	O
vice	O
versa	O
.	O
</s>
<s>
The	O
study	O
evaluated	O
safety	O
and	O
efficacy	O
of	O
gadobutrol	B-Algorithm
.	O
</s>
<s>
Combined	O
gadobutrol-enhanced	O
plus	O
unenhanced	O
images	O
compared	O
to	O
unenhanced	O
images	O
are	O
:	O
</s>
<s>
The	O
open-label	O
,	O
multi-center	O
,	O
pharmacokinetic	O
and	O
safety	O
test	O
studied	O
the	O
way	O
gadobutrol	B-Algorithm
was	O
taken	O
into	O
,	O
moved	O
around	O
,	O
and	O
was	O
eliminated	O
from	O
the	O
body	O
of	O
the	O
infants	O
.	O
</s>
<s>
The	O
study	O
also	O
evaluated	O
safety	O
,	O
tolerability	O
and	O
efficacy	O
of	O
the	O
standard	O
dose	O
of	O
gadobutrol	B-Algorithm
,	O
0.1mmol/kg	O
(	O
0.1	O
mL/kg	O
)	O
of	O
body	O
weight	O
.	O
</s>
<s>
The	O
open-label	O
,	O
muti-center	O
,	O
blinded	O
reading	O
safety	O
and	O
efficacy	O
study	O
compared	O
diagnostic	O
results	O
of	O
gadobutrol	B-Algorithm
enhanced	O
MRA	O
images	O
with	O
no-contrast	O
MRA	O
images	O
.	O
</s>
<s>
Patients	O
received	O
a	O
single	O
intravenous	O
injection	O
of	O
0.1mmol/kg	O
gadobutrol	B-Algorithm
prior	O
to	O
scanning	O
.	O
</s>
<s>
The	O
only	O
US	O
patent	O
for	O
Gadobutrol	B-Algorithm
is	O
US5980864A	O
,	O
granted	O
on	O
November	O
9	O
,	O
1999	O
,	O
to	O
Schering	O
AG	O
.	O
</s>
<s>
The	O
patent	O
is	O
for	O
the	O
process	O
using	O
1	O
,	O
4	O
,	O
7	O
,	O
10-tetraazacyclododecane	O
butyltriols	O
to	O
produce	O
the	O
gadolinium	O
(	O
III	O
)	O
complex	O
of	O
10-(1-hydroxymethyl-2,3-dihydroxypropyl )	O
-1	O
,	O
4	O
,	O
7-triscarboxymethyl-1	O
,	O
4	O
,	O
7	O
,	O
10-tetraazacyclododecane	O
(	O
gadobutrol	B-Algorithm
)	O
.	O
</s>
<s>
After	O
FDA	O
approval	O
in	O
2011	O
,	O
the	O
patent	O
was	O
granted	O
an	O
extension	O
of	O
1,470	O
days	O
and	O
the	O
trade	O
name	O
Gadavist	B-Algorithm
became	O
associated	O
with	O
the	O
patent	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
contrast	O
media	O
is	O
a	O
clear	O
,	O
colorless-to-pale	O
yellow	O
solution	O
of	O
1mmol/mL	O
formulation	O
,	O
available	O
in	O
single	O
dose	O
vials	O
(	O
2	O
mL	O
,	O
7.5	O
mL	O
,	O
10mL	O
,	O
and	O
15	O
mL	O
)	O
,	O
single	O
dose	O
pre-filled	O
injections	O
(	O
7.5	O
mL	O
,	O
10	O
mL	O
,	O
15	O
mL	O
)	O
,	O
and	O
pharmacy	O
bulk	O
packages	O
(	O
30	O
mL	O
and	O
65	O
mL	O
)	O
containing	O
multiple	O
vials	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
is	O
currently	O
marketed	O
in	O
the	O
United	O
States	O
under	O
the	O
name	O
Gadavist	B-Algorithm
,	O
and	O
in	O
most	O
other	O
countries	O
under	O
the	O
name	O
Gadovist	B-Algorithm
or	O
Gadovist	B-Algorithm
1.0	O
.	O
</s>
<s>
Gadobutrol	B-Algorithm
is	O
not	O
available	O
for	O
prescription	O
and	O
can	O
only	O
be	O
administered	O
by	O
trained	O
personnel	O
.	O
</s>
