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High Relaxivity.* Macrocyclic Bond. Enhancing Breast Imaging When It Matters.
October Is National Breast Cancer Awareness Month
Remember that for women with greater than or equal to 20% lifetime risk for development of breast cancer, the American College of Radiology recommends annual breast magnetic resonance imaging (MRI) screening in addition to mammography.1
For your breast MRI patients, Gadavist is the only FDA‑approved contrast to assess the presence and extent of malignant breast disease
Learn more at gadavistmoments.com
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.
  • 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
Please see Full Prescribing Information for Gadavist® (Vials & Syringes).
Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).
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
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. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (for example, brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium 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. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function. There are rare reports of pathologic skin changes in patients with normal renal function. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.

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 when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies particularly closely spaced 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 some 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 (1.5%), nausea (1.1%) and dizziness (0.5%).
Please see Full Prescribing Information for Gadavist® (Vials & Syringes).
Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).
References: 1. American College of Radiology. ACR Practice Parameter for the Performance of Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast. https://www.acr.org/-/media/ACR/Files/Practice-Parameters/mr-contrast-breast.pdf. Accessed August 28, 2018.
Bayer reserves the right to modify the specifications and features described herein or 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 and/or registered to Bayer in the U.S. and/or other countries.

© 2018 Bayer. This material may not be reproduced, displayed, modified or
distributed without the express prior written consent of Bayer.
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