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October is National Breast Cancer Awareness Month |
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Magnetic Resonance Imaging (MRI)
is an Important Tool for Breast
Cancer Detection
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The American College of Radiology recommends annual screening breast
MRI as a supplement to mammography
for certain women:1 |
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With ≥20% lifetime risk of breast cancer (beginning at age 30)* |
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With personal history of breast cancer and dense breasts |
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Diagnosed with breast cancer under the
age of 50 |
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With a known BRCA mutation
(beginning at age 30)* |
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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 |
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Annual MRI (without mammography) is recommended
in these patients starting between ages 25–30 |
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Class C or 3 density = heterogeneously dense;
Class D or 4 density = extremely dense |
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For your breast MRI patients, Gadavist is the only FDA-approved contrast to assess the presence and extent of malignant
breast disease |
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| 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
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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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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| 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. |
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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®. |
| 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). |
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Please see Full Prescribing
Information for Gadavist® (Imaging Bulk Package). |
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References: 1. 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. 2. 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. |
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The individuals depicted in this material are actors
and not actual health care providers or patients.
Bayer, the Bayer Cross, and Gadavist are trademarks owned by
and/or registered to Bayer in the U.S. and/or other countries.
© 2021 Bayer. This material may not be reproduced, displayed, modified or
distributed without the express prior written consent of Bayer.
100 Bayer Boulevard, P.O. Box 915, Whippany, NJ 07981.
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.
Contact Us | PP-GADA-US-0533-1 | September 2021
This promotional content is brought to you by the Pharmaceutical Division at Bayer. |
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+1 520-298-1000
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