The first and only FDA-approved gadolinium-based contrast agent presentation for multi-patient dosing with an FDA-cleared Transfer Spike in the MR suite.
Gadavist® (gadobutrol) injection is a
gadolinium-based contrast agent indicated
for use with magnetic resonance
imaging (MRI):
•
To detect and visualize areas with
disrupted blood brain barrier and/or
abnormal vascularity of the central
nervous system in adult and pediatric
patients including term neonates.
•
To assess the presence and extent of
malignant breast disease in
adult patients.
•
To assess myocardial perfusion (stress,
rest) and late gadolinium enhancement
in adult patients with known or
suspected coronary artery
disease (CAD).
Gadavist® is indicated for use in magnetic
resonance angiography (MRA):
•
To evaluate known or suspected
supra-aortic or renal artery disease in
adult and pediatric patients including
term neonates.
Important Safety
Information
WARNING: NEPHROGENIC
SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast
agents (GBCAs) increase the
risk for NSF among patients
with impaired elimination of
the drugs. Avoid use of
GBCAs in these patients
unless the diagnostic
information is essential and
not available with noncontrasted
MRI or other
modalities. NSF may result in
fatal or debilitating fibrosis
affecting the skin, muscle and
internal organs.
•
The risk of NSF appears
highest among patients
with:
-
Chronic, severe
kidney disease
(GFR <30 mL/min/
1.73m²), or
-
Acute kidney injury
•
Screen patients for acute
kidney injury and other
conditions that may
reduce renal function.
For patients at risk for
chronically reduced renal
function (for example,
age >60 years,
hypertension or
diabetes), estimate the
glomerular filtration
rate (GFR) through
laboratory testing.
•
For patients at highest
risk for NSF, do not
exceed the
recommended
GADAVIST dose and
allow a sufficient period
of time for elimination of
the drug from the body
prior to any
re-administration.
Contraindication and Important Information about Hypersensitivity Reactions:
Gadavist® is contraindicated in patients with history of severe hypersensitivity
reactions to Gadavist®. Anaphylactic and other hypersensitivity reactions with
cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to
severe, including death, have uncommonly occurred following Gadavist® administration. Before Gadavist® administration, assess all patients for any history
of a reaction to contrast media, bronchial asthma and/or allergic disorders. These
patients may have an increased risk for a hypersensitivity reaction to Gadavist®.
Gadolinium Retention: Gadolinium is retained for months or years in several
organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At
equivalent doses, retention varies among the linear agents. Retention is lowest and
similar among the macrocyclic GBCAs. Consequences of gadolinium retention in
the brain have not been established, but they have been established in the skin and
other organs in patients with impaired renal function. While clinical consequences
of gadolinium retention have not been established in patients with normal renal
function, certain patients might be at higher risk. These include patients requiring
multiple lifetime doses, pregnant and pediatric patients, and patients with
inflammatory conditions. Consider the retention characteristics of the agent and
minimize repetitive GBCA studies, when possible.
Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury
sometimes requiring dialysis has been observed with the use of GBCAs. Do not
exceed the recommended dose; the risk of acute kidney injury may increase with
higher than recommended doses.
Extravasation and Injection Site Reactions: Ensure catheter and venous patency
before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation.
Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist® MRI of the breast overestimated the histologically confirmed extent of malignancy
in the diseased breast in up to 50% of the patients.
Low Sensitivity for Significant Arterial Stenosis: The performance of Gadavist® MRA for detecting arterial segments with significant stenosis (>50% renal, >70%
supra-aortic) has not been shown to exceed 55%. Therefore, a negative MRA
study alone should not be used to rule out significant stenosis.
Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with
Gadavist® in clinical studies were headache (1.7%), nausea (1.2%)
and dizziness (0.5%).
You are encouraged to report negative side effects or quality complaints of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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