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.
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
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.
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 (BBB) 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
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 (continued)
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 in these patients.
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
Adverse Reactions: The most frequent (≥0.5%) adverse reactions associated with Gadavist®
in clinical studies were headache (1.5%), nausea (1.1%) and dizziness (0.5%).
References: 1. Gadavist [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc;
2011. 2. Frenzel T, Lengsfeld P, Schirmer H, et al. Stability of gadolinium-based magnetic resonance
imaging contrast agents in human serum at 37 degrees C. Invest Radiol. 2008;43(12):817-828. 3. Morcos SK. Extracellular gadolinium contrast agents: differences in stability. Eur J Radiol.
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to discontinue any product or service identified in this publication at any time without
prior notice or obligation. Please contact your authorized Bayer representative for the
most current information.
Bayer, the Bayer Cross, and Gadavist are trademarks owned by
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