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Medication Guide
Gadavist

  • Gadavist®

Gadavist® is Now 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).

Since receiving FDA approval in 2011, Gadavist® has received 4 additional indications. Click on the Indications tab above to learn more.

IndicationApprovalTimeline

 

Cardiac

Gadavist® is Now 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.

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

    Relaxivities-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
macyclic
*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 [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.

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).

gad_table5.png

 

gad_molecule1.png
1.0 Molar Gadavist®
gad_molecule2.png

0.5 Molar GBCA

Due to its 1.0 Molar concentration, Gadavist® is approved at a dose half the volume of 0.5 Molar GBCAs and with a more compact bolus.

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_Packaging_Table@2x.jpg

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.

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Note: The Bayer in Radiology contrast and device products should be used in accordance with the Prescribing Information and Instructions For Use, respectively.

Optimize workflows with Contrast Dose Management

 

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MEDRAD® MRXperion MR Injection System: A Smart Addition

IMPORTANT SAFETY INFORMATION AND INDICATIONS
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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.

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.

 

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%).

 

INDICATIONS 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 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 in adult patients.
  • 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):

  • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates.

Please see Full Prescribing Information for Gadavist® (Vials and Syringes).

Please see Full Prescribing Information for Gadavist® (Pharmacy Bulk Package).