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Now FDA-Approved! Gadavist® Imaging Bulk Package

Gadavist® is the first and only gadolinium-based contrast agent with an FDA-approved Imaging Bulk Package presentation for multi-patient dosing with an FDA-cleared transfer spike in a room designated for radiological procedures with IV contrast.

 

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).

 

 

Over 19 million vials of Gadavist have been sold in the U.S. since launch

 

IndicationApprovalTimeline

 

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

The first and only contrast agent Indicated for breast MRI (BMR), Gadavist® is approved for use with magnetic resonance imaging (MRI) to assess the presence and extent of malignant breast disease in adult patients.

 

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 through 5/2019.1

 

Reference: 1. Data on file. Bayer HealthCare

Strong Signal, Strong Bond

A High Relaxivity Gadolinium-based Contrast Agent

  • Strong enhancement is based on multiple factors, including relaxivity and concentration1  
  • Stronger signal enhancement may improve tissue visualization in contrast-enhanced images1

    Gadavist Chart

 

A Macrocyclic Gadolinium-based Contrast Agent

  • There are 2 structural classes of Gd-chelate complexes: linear and macrocyclic2
  • Macrocyclic structure imparts added strength compared with a linear structure3
  • At pH 5.3 and 25°C, the dissociation half-life of Gadavist® is 65 years, and at pH 7.4 the dissociation half-life is estimated to be >1,000 years2,4
*Relaxivity of Gadavist® is 5.2 L•mmol–1•s–1 at 1.5 Tesla (r1 in plasma at 37°C)

Group-93

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 [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2019. 2. Frenzel T, Lengsfeld P, Schirmer H, et al. Stability of gadolinium-based magnetic resonance imaging contrast agents in human serum at 37°C. Invest Radiol. 2008;43(12):817-828. 3. Morcos SK. Extracellular gadolinium contrast agents: differences in stability. Eur J Radiol. 2008;66:175-179. 4. Schmitt-Willich H. Stability of linear and macrocyclic gadolinium based contrast agents. Br J Radiol. 2007;80(955):581-583. 5. 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

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:

Gadavist Safety Chart

Double the Concentration, Half the Volume

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

chart 2

volume detail

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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

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

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 Vials

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

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