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Indications
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Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
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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.
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To assess the presence and extent of
malignant breast disease in adult patients.
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To assess myocardial perfusion (stress,
rest) and late gadolinium enhancement in adult patients with known or
suspected coronary artery disease (CAD).
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Gadavist® is indicated for use in magnetic
resonance angiography (MRA):
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To evaluate known or suspected
supra-aortic or renal artery disease in
adult and pediatric patients including
term neonates.
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Important Safety Information (continued)
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Contraindication and Important Information about Hypersensitivity Reactions:
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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®.
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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.
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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.
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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.
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Overestimation of Extent of Malignant Disease in MRI of the Breast: Gadavist
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MRI of the breast overestimated the histologically confirmed extent of malignancy
in the diseased breast in up to 50% of the patients.
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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.
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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%).
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Please see Full Prescribing
Information for Gadavist® (Vials and Syringes).
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Please see Full Prescribing
Information for Gadavist® (Imaging Bulk Package).
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Please see Full Prescribing
Information for Gadavist® (Pharmacy
Bulk Package).
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References: 1. Consensus Statement on Screening Mammography. The American Society of Breast Surgeons website.
https://www.breastsurgeons.org/docs/statements/Position-Statement-on-Screening- Mammography.pdf. Accessed June 9, 2020. 2.
Breast Cancer Screening in Women at Higher-Than- Average Risk: Recommendations From the ACR. American College of Radiology website.
https://www.jacr.org/article/S1546-1440(17)31524-7/ fulltext. Accessed June 9, 2020.
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