MRI Is an Important Tool for Breast Cancer Detection Gadavist® (gadabutrol) injection 1mmol/mL | FDA-approved

Gadavist® (gadabutrol)injection 1mmol/ml
October is National Breast Cancer Awareness Month
Magnetic Resonance Imaging (MRI)
is an Important Tool for Breast
Cancer Detection
The American College of Radiology recommends annual screening breast
MRI as a supplement to mammography
for certain women:1
Gadavist® (gadabutrol)injection 1mmol/ml   With ≥20% lifetime risk of breast cancer (beginning at age 30)*
Gadavist® (gadabutrol)injection 1mmol/ml   With personal history of breast cancer
and dense breasts
Gadavist® (gadabutrol)injection 1mmol/ml   Diagnosed with breast cancer under the
age of 50
Gadavist® (gadabutrol)injection 1mmol/ml   With a known BRCA mutation
(beginning at age 30)*
The American Society of Breast Surgeons recommends considering supplemental imaging (breast MRI or ultrasound) in addition to annual mammography in
women with increased breast density
(C and D density; beginning at age 40)2
* Annual MRI (without mammography) is recommended
in these patients starting between ages 25–30
Class C or 3 density = heterogeneously dense;
Class D or 4 density = extremely dense
For your breast MRI patients, Gadavist is the only FDA-approved contrast to assess the presence and extent of malignant
breast disease
Gadavist® (gadabutrol)injection 1mmol/ml   Visit
to learn more
Important Safety Information
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 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.
Please see additional Important Safety Information below.
Indication and Usage
Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI) to assess the presence and extent of malignant breast disease in adult patients.
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; 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.
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%).
Please see Full Prescribing Information for Gadavist® (Vials and Syringes).
Please see Full Prescribing Information for Gadavist® (Imaging Bulk Package).
References:  1. Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR. American College of Radiology website. 31524-7/fulltext. Accessed June 9, 2020.  2. Consensus Statement on Screening Mammography.
The American Society of Breast Surgeons Website.
Position-Statement-on-Screening-Mammography.pdf. Accessed June 9, 2020.
The individuals depicted in this material are actors
and not actual health care providers or patients.

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© 2021 Bayer. This material may not be reproduced, displayed, modified or
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Contact Us | PP-GADA-US-0533-1 | September 2021

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Gadavist® (gadabutrol)injection 1mmol/ml
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