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Now Approved for Cardiac Magnetic Resonance (MR) Imaging
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Gadavist is the first gadolinium-based contrast agent approved 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® (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 (BBB) 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
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WARNING: NEPHROGENIC
SYSTEMIC FIBROSIS (NSF)
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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 non-contrasted
MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
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The risk of NSF appears highest among patients with:
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Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
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Acute kidney injury
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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.
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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.
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Please see additional Important Safety Information below.
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Please see Full Prescribing Information for Gadavist® (Vials & Syringes).
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Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).
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Important Safety Information (continued)
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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®.
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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 in these patients.
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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®
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 & Syringes).
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Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).
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Bayer, the Bayer Cross, and Gadavist are trademarks owned by
and/or registered to Bayer in the U.S. and/or other countries.
© 2019 Bayer. This material may not be reproduced, displayed, modiļ¬ed or
distributed without the express prior written consent of Bayer.
100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981.
This message is brought to you by the Pharmaceutical Division of Bayer.
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PP-GADA-US-0199-1 July 2019
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