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Gadavist® Imaging Bulk Package is the first and only FDA-approved gadolinium-based contrast presentation for multi-patient dosing* with an FDA-cleared Transfer Spike in the MR suite.

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Since receiving FDA approval in 2011, Gadavist® has received 3 additional indications. Click on the Indications tab above to learn more.

 

Relaxivity of Gadavist® is 5.2 L•mmol–1•s–1 at 1.5 Tesla (r1 in plasma at 37°C).

*When used with the FDA-cleared transfer spike

 

 

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Indication

Over 33 million vials of Gadavist have been sold in the U.S. since launch

 

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Cardiac

Gadavist® is approved for Cardiac Magnetic Resonance Imaging (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

 

MRA Indication

The first and only gadolinium-based contrast agent approved for magnetic resonance angiography (MRA) of the supra-aortic vasculature, Gadavist® is approved for use in MRA to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

 

Breast Indication

Gadavist is the first GBCA specifically researched and developed for breast MRI in adult patients in 2 well-controlled clinical trials.

 

CNS

Gadavist® is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist received its indication in CNS for adults and pediatric patients 2 years of age and older in 2011 and in 2014 this was expanded to include patients less than 2 years of age, including term neonates.

 

Pediatric Expansion

CNS approval was expanded in 2014 to include patients less than 2 years of age. Gadavist® is approved for use with magnetic resonance imaging (MRI) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in pediatric patients less than 2 years of age including term neonates.

Bayer Sales Data based on number of vials sold 3/2011 though 8/20221

Reference: 1. Data on file. Bayer HealthCare

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    A High Relaxivity Macrocyclic

    Strong Signal.

    • Signal enhancement is based on multiple factors, including relaxivity and concentration 1
    • High relaxivity could result in:
      • Increased signal on T1-weighted images2,3
      • Improved tissue visualization1
      • Enhanced image quality3

     

    Strong Bond.

    • Macrocyclic structure imparts added strength compared with a linear structure4
    • At pH 7.4, the dissociation half-life of Gadavist is estimated to be >1,000years5
    Group-93

     

    *Relaxivity of Gadavist® is 5.2 L•mmol–1•s–1 at 1.5 Tesla (r1 in plasma at 37°C)

     

    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.

    References: 1. Gadavist [prescribing information]. 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. American Journal of Neuroradiology. 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. European Journal of Radiology. 2008;66(2):175–179. 5. Schmitt-Willich H. Stability of linear and macrocyclic gadolinium based contrast agents. British Journal of Radiology. 2007;80(955):581–583. 

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      Safety Across Clinical Trials

      Safety Profile Established in Clinical Trials of 7,713 Patients Worldwide  

      Adverse reactions associated with the use of Gadavist® are usually mild to moderate in severity and transient in nature. The adverse reactions that occurred in 0.1% of subjects who received Gadavist® were:

      Gadavsit_Safety_Chart

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        A High Concentration GBCA

        For adult and pediatric patients (including term neonates), the Recommended Dose of Gadavist® is 0.1 mL/kg body weight (0.1 mmol/kg).

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          See Gadavist in action with the case studies below. Or go to the Resources section to see all videos.
           

          CNS: A 29-year-old woman with multiple sclerosis

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          YYMMDD Author/Uploaded by

          Breast: A 62-year-old woman with a palpable mass

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          Video title

          YYMMDD Author/Uploaded by

          Accordion header

            Gadavist® is a clear, colorless-to-pale yellow solution containing 1 mmol gadobutrol per milliliter (equivalent to 604.72 mg gadobutrol per mL).

             

            Gadavist® is supplied in the following sizes:

            Gadavist%20Vials_1

            Ordering Information

            Gadavist® is available through all suppliers currently providing our other imaging products. To establish an account, call Bayer HealthCare LLC’s master distributor, McKesson Specialty Distribution, at 1-877-259-4624 (option #1), or contact your local distributor.

            For more information on reimbursement and purchasing options, click here

            *Please see Instructions for Use (IFU) for MEDRAD® Imaging Bulk Package Transfer Spike which is to be used with Gadavist®.

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