July 9, 2019 -- A High Relaxivity* Macrocyclic Contrast Agent with a Wide Range of Indications

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Gadavist.* (gadobutrol) injection 1 mmol/mL
 
Strong Signal.
Strong Bond.
 
     
Learn more at Gadavist.com
 
 
     
Gadavist Is a
High Relaxivity*
Contrast Agent
 
 
    Signal enhancement is based on multiple factors, including relaxivity and concentration¹  
Stronger signal enhancement may improve tissue visualization in contrast-enhanced images¹
   
  * Relaxivity of Gadavist is 5.2 L •
mmol-1 • s-1 at 1.5 Tesla
(r1 in plasma at 37°C)
 
     
Gadavist Is a
Macrocyclic
Contrast Agent
 
 
    There are two structural classes of gadolinium-based contrast agents: macrocyclic and linear2  
Gadavist is a macrocyclic GBCA with the gadolinium ion caged in a rigid cavity of the ligand³
Macrocyclic structure imparts added strength compared with a linear structure3
 
     
Gadavist also has a
wide range of indications
 
     
Learn more at Gadavist.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 below.
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 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 significant stenosis.
 
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. 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.
2008;66(2):175-179.
 
     
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.

© 2019 Bayer. This material may not be reproduced, displayed, modified or distributed without the express prior written consent of Bayer.
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