Enhance Your Imaging Experience Gadavist® (gadabutrol) injection 1mmol/mL | FDA-approved

  BAYER
Gadavist® (gadabutrol)injection 1mmol/ml
The Highest Relaxivity* Macrocyclic
Strong Signal.
Gadavist® (gadabutrol)injection 1mmol/ml   Signal enhancement is based on
multiple factors, including relaxivity
and concentration1
Gadavist® (gadabutrol)injection 1mmol/ml   High relaxivity could result in:
  -   Increased signal on
T1-weighted images2,3
  -   Improved tissue visualization1
  -   Enhanced image quality3
Srong Bond.
Gadavist® (gadabutrol)injection 1mmol/ml   Macrocyclic structure imparts added strength compared with a linear structure4
Gadavist® (gadabutrol)injection 1mmol/ml   At pH 7.4, the dissociation half-life of Gadavist is estimated to be >1,000 years5
*Relaxivities of
 Macrocyclic GBCAs6
Gadavist® (gadabutrol)injection 1mmol/ml
 
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.
Indications
Gadavist® (gadobutrol) injection is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI):
Gadavist® (gadabutrol)injection 1mmol/ml   To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates.
Gadavist® (gadabutrol)injection 1mmol/ml   To assess the presence and extent of malignant breast disease in adult patients.
Gadavist® (gadabutrol)injection 1mmol/ml   To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
Gadavist® is indicated for use in magnetic resonance angiography (MRA):
Gadavist® (gadabutrol)injection 1mmol/ml   To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.
Make an Informed Decision
FDA-approved Indications for Various Gadolinium-based
Contrast Agents (GBCAs)1,7-11
Gadavist® (gadabutrol)injection 1mmol/ml
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.
Connected Solutions from a Leader in MR
Gadavist is part of the Bayer MR portfolio of connected solutions
Gadavist® (gadabutrol)injection 1mmol/ml   Contrast
  Gadavist® (gadabutrol)injection 1mmol/ml   Gadavist is used in 3,200+ institutions across the United States, with over 27 million vials sold in the U.S. since launch
Gadavist® (gadabutrol)injection 1mmol/ml   Devices
  Gadavist® (gadabutrol)injection 1mmol/ml   Over 9,800 Bayer MR power injectors are in use across the
United States§
Gadavist® (gadabutrol)injection 1mmol/ml   Syringes & Disposables
  Gadavist® (gadabutrol)injection 1mmol/ml   Backed by 50+ years of combined manufacturing experience
 
Gadavist® (gadabutrol)injection 1mmol/ml   Informatics
  Gadavist® (gadabutrol)injection 1mmol/ml   Contrast Dose Management software provides clinical insights to help you optimize radiology workflows from the point of care through to post-procedure
Gadavist® (gadabutrol)injection 1mmol/ml   Services
  Gadavist® (gadabutrol)injection 1mmol/ml   Supporting you with a trusted team of more than 200 Solution Delivery Experts, including over 100 Bayer-certified Service Engineers and over 20 Clinical Performance Specialists
Note: The Bayer Radiology contrast and device products should be used in accordance with the Prescribing Information and Instructions for Use, respectively.
Important Safety Information (continued)
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 (1.7%), 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).
Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).
Bayer Sales Data based on active institution accounts as of 5/2021.12
Bayer Sales Data based on number of vials sold 3/2011 through 5/2021.12
§Bayer Sales Data based on number of active service agreements as of 7/2020.12
References:  1. Gadavist [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2011.  2. Kanal E, Maravilla K, Rowley H. Gadolinium Contrast Agents for CNS Imaging: Current Concepts and Clinical Evidence. Am J Neuroradiol. 2014;35(12):2215–2226.  3. Anzalone N, Essig M, Lee S-K, et al. Optimizing Contrast-Enhanced Magnetic Resonance Imaging Characterization of Brain Metastases. Neurosurgery. 2013;72(5):691–701.  4. Morcos S. Extracellular gadolinium contrast agents: Differences in stability. Eur J Radiol. 2008;66(2):175–179.  5. Schmitt-Willich H. Stability of linear and macrocyclic gadolinium based contrast agents. Br J Radiol. 2007;80(955):581–583.  6. Rohrer M, Bauer H, Mintorovitch J, Requardt M, Weinmann H-J. Comparison of Magnetic Properties of MRI Contrast Media Solutions at Different Magnetic Field Strengths. Invest Radiol. 2005;40(11):715–724.  7. Dotarem [prescribing information]. Bloomington, IN: Guerbet; 2018.  8. ProHance [prescribing information]. Monroe Township, NJ: Bracco Diagnostics Inc; 2020.  9. MultiHance [prescribing information]. Monroe Township, NJ: Bracco Diagnostics Inc; 2018.  10. Clariscan [prescribing information]. Princeton, NJ: GE Healthcare; 2020.  11. Omniscan [prescribing information]. Princeton, NJ: GE Healthcare; 2018.  
12. Data on File. Bayer HealthCare.
Bayer, the Bayer Cross, and Gadavist are trademarks owned by
and/or registered to Bayer in the U.S. and/or other countries.

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Gadavist® (gadabutrol)injection 1mmol/ml
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