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Gadovist®

Canada’s most used MR Contrast agent

In moments like this it’s good to know that you can rely on Gadovist® to support an accurate diagnosis.3,4 Additionally, its macrocyclic structure contributes to a very good safety profile.5 – 7

Clear Direction > From Diagnosis to Care

Gadovist®

What is Gadovist®?

Gadovist®, as a macrocyclic agent, belongs to the class with high kinetic stability and therefore, low, almost negligible, release of Gadolinium.5 Gadovist® 1.0 has higher gadolinium concentration (1.0 mol/L) than all the other marketed extracellular gadolinium based contrast agents (0.5M).

How does Gadovist® work?

The active ingredient in Gadovist® is gadobutrol. Gadobutrol contains gadolinium (Gd3+) which is firmly bound in a macrocyclic complex. Gadolinium is a rare earth element, which causes contrast enhancement in MRI scans. The mode of action is the same as with all currently marketed extracellular Gd-containing products. High concentration and high relaxivity of Gadovist result in highest T1 shortening per mL, thus resulting in excellent image quality.2

* Gadovist® 1.0 provides diagnostic confidence and is well tolerated.1

Gadovist Product Monograph. Approved date: March 5, 2018

2 Rohrer M, Bauer H, Mintorovitch J, et al. Invest Radiol. 2005;40(11):715–24.

Sardanelli F, Newstead GM, Putz B, et al. Invest Radiol. 2016;51(7):454–61.

4 Gutierrez JE, Rosenberg M, Seemann J, et al. Magn Reson Insights. 2015;8:1–10.

5 Frenzel T, Lengsfeld P, Schirmer H, et al. Invest Radiol. 2008;43(12):817–28.

6 Endrikat J, Vogtlaender K, Dohanish S, et al. Invest Radiol. 2016;51(9):537–43.

7 Prince MR, Lee HG, Lee CH, et al. Eur Radiol. 2017;27(1):286–95.

Application

Gadovist® is offered as a ready-to-use solution in 7.5, 15, 30mL vial/bottles.

How is Gadovist® administered?

Gadovist® is injected intravenously as a bolus, in some indications preferably via an MR power injector.

Indications

Approved Gadovist® indications are:

011_Image-Highlight_Gadovist

1 Gadovist Product Monograph, March 5,2018

2  Gadoteridol Product Monograph. March 9, 2018.

3  Gadoterate meglumine Product Monograph.

April 23, 2018.

 

 

 

Characteristics

Gadovist® is registered at dosages up to 0.3 mmol/kg body weight (b.w.) in adults and at 0.1 mmol/kg b.w. for pediatric use. The standard dose of Gadovist® with 0.1 mmol/kg body weight is suitable from 0 years onwards. The required dose is administered intravenously as a bolus injection.

Pharmacokinetics

The pharmacokinetic distribution and renal clearance of Gadovist® 1.0 is comparable in adults and children, with no dose adjustment from the standard adult dose based on bodyweight (0.1 mmol/kg) necessary in pediatric patients aged 0 to 17 years.1,2 After more than 16 years and over 25 million applications* of routine clinical use, the favorable safety profile demonstrated in clinical studies of Gadovist® 1.0 remains unchanged. No relevant differences have been observed for patients with hepatic or renal impairment, allergic dispositions or hemoglobinopathies, or in children or elderly patients.1,2

Safety

Gadovist® has been investigated at doses of up to 0.5 mmol/kg b.w. in clinical trials. The safety of Gadovist® 1.0 has been demonstrated in clinical studies involving a wide variety of patients, including those with renal insufficiency.3,4

.
    Adverse Drug Reaction Incidence (%)**
    Headache 1.5
    Nausea 1.2
    Injection site reaction (various kinds) 0.6
    Dysgeusia 0.5
    Feeling hot 0.5
    Dizziness 0.4
    Vomiting 0.4
    Rash (includes generalized, macular, papular, pruritic rash) 0.3
    Pruritus (includes generalized pruritus) 0.2
    Erythema 0.2
    Dyspnea 0.2
    Paresthesia 0.1

    Adverse drug reactions occurring in ≥ 0.1% of the patients following the administration of Gadobutrol

    Source: Voth M et al. Invest Radiol 2011;46:663-71.

    Bayer data on file PSUR 2015

    ** Adverse reactions that occurred with a frequency of 0.1% include hypersensitivity/ anaphylactoid reaction, loss of consciousness, convulsion, parosmia, tachycardia, palpitation, dry mouth, malaise, and feeling cold.

     Injection site reactions (various kinds) comprise the following terms: Injection site extravasation, injection site burning, injection site coldness, injection site warmth, injection site erythema or rash, injection site pain, injection site hematoma.

    1 Hahn G, et al. Invest Radiol 2009;44:776-83.

    2 Hahn G et al. RSNA 2014; Abstract SSM20-04.

    3 Tombach B, et al. Eur Radiol 2008;18:2610-9.

    4 Balzer JO, et al. Eur Radiol 2003;13:2067-74

    .

      Gadovist® 1.0 mmol / mL solution for injection.

      Gadovist® 1.0 mmol / mL solution for injection.Composition: GADOVIST 1.0 is a clear, sterile, aqueous solution. Each mL of GADOVIST 1.0 contains 604.72mg (1.0 mmol) of gadobutrol, 1.211 mg trometamol, 0.013 mg sodium (0.00056 mmol), and 0.513 mg calcium sodium butrol in water for injection. The pH of GADOVIST 1.0 is adjusted to between 6.6 and 8.0 with hydrochloric acid.

      Indications: GADOVIST 1.0 (gadobutrol) is a medicinal product for diagnostic use only. GADOVIST 1.0 (gadobutrol) is indicated in adults and children of all ages including term newborns for: contrast enhancement during cranial and spinal MRI investigations and for contrast-enhanced magnetic resonance angiography (CE-MRA); contrast-enhanced MRI of the breast to assess the presence and extent of malignant breast disease, and MRI of the kidney. GADOVIST 1.0 is particularly suited for cases where the exclusion or demonstration of additional pathology may influence the choice of therapy or patient management, for detection of very small lesions and for visualization of tumors that do not readily take up contrast media. GADOVIST 1.0 is also suited for perfusion studies for the diagnosis of stroke, detection of focal cerebral ischemia, and tumor perfusion.

      Contraindications: GADOVIST 1.0 should not be administered to patients who have experienced a life-threatening reaction to GADOVIST 1.0 previously.

      Serious warnings and precautions: Gadolinium-based contrast agents (GBCAs) increase the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with: chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or acute renal failure / acute kidney injury. In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with noncontrast-enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a GBCA, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.

      Adverse reactions: Patients with a history of previous reaction to contrast media, allergic disorders, or bronchial asthma suffer more frequently from hypersensitivity reactions than others. As with other contrast media, delayed allergoid reactions occurring hours or days after administration have been observed, though rarely. Anaphylactoid reactions may occur. Transient sensations of taste or smell perversion may occur during or immediately after injection of GADOVIST 1.0.

      For additional information, please visit the Product Monograph.

      If you want to report a side effect or quality complaint, please contact your healthcare professional (e.g. physician or pharmacist) or your local health authority.
      Side effects can also be reported to Bayer Inc. by clicking here.

      .

        Gadovist®: double the concentration, half the volume and superior relaxivity*

         

        2x greater volume is required by other macrocyclic agents compared to Gadovist®1–3

        011_Image-Highlight_Gadovist

        1.0 mmol/mL Gadovist®

        011_Image-Highlight_Gadovist

        0.5 mmol/mL GBCA

         

         

        Competing macrocyclic agents offer 21–31% lower relaxivity at 1.5T compared to Gadovist®4*

        Benefits shown with Gadovist®

        Higher concentration results in:

        • Lower volume of administration
        • More compact bolus

         

        Higher relaxivity could result in:

        • Enhanced image quality6
        • Improved diagnostic confidence7,8
        011_Image-Highlight_Gadovist
        Adapted from Anzalone N, et al. and Kanal E, et al.6,9

         

         

        Gadovist® demonstrated significantly higher sensitivity and accuracy for detection of malignancy compared to ProHance® without a change in specificity7

        Follow-up evaluation for a glioma diagnosis using contrast-enhanced T1-weighted images

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        Enhancement with sharp delineation of the anatomic involvement, which was diagnosed as residual/recurrent high-grade glial tumour.

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        Less sharp rings of enhancement that were characterized as infection rather than tumour.

            
         GadovistProHance®Nominal p-value
        Sensitivity (n=93)66.7%60.2%p=0.014
        Specificity (n=199)97.5%97.5%p=1.000
        Accuracy (n=292)87.7%85.6%p=0.034

        Sensitivity, specificity and accuracy in determination of malignancy for combined Gadovist® contrast-enhanced vs. combined ProHance®contrast-enhanced imaging (majority reader diagnosis). Full analysis set (n=336).

        Lower quality imaging with other macrocyclic agents can lead to less differentiation of malignant vs. benign lesions, which can have an impact on diagnosis and patient care

        Gadovist® showed better visualization of enhancing brain lesion vs. Dotarem ®10

        011_Image-Highlight_Gadovist
        011_Image-Highlight_Gadovist

        A 69-year-old male patient with butterfly glioma (glioblastoma WHO grade IV). Three consecutive T1-weighted images after a single dose (0.1 mmol/kg body weight) of Gadovist® (1) and DOTAREM® (2).

        In 66% of assessments (131/199), Gadovist® was better than DOTAREM® in terms of overall preference§¶

        Gadovist® provided:

        • Better contrast enhancement of lesions than DOTAREM®
        • Higher lesion-to-brain signal (p<0.001)
        • 9% difference in relative enhancement (p<0.001)

         

         

        Gadovist® provides superior results compared to other GBCAs

        011_Image-Highlight_Gadovist

        Benefits for you and your patients

        • Less contrast agent used1–3
        • Increased signal and contrast on images6,9
        • Enhanced image quality6
        • Higher sensitivity and accuracy for detection of malignancy7
        • Improved diagnostic confidence7,8

         

        Gd=gadolinium; GBCA=gadolinium-based contrast agent.

        * Relaxivity is a marker for the ability of a GBCA to enhance signal intensity on the magnetic resonance image and a prerequisite of technical efficacy of GBCAs.5

        † Other GBCAs include DOTAREM® and ProHance®.

        ‡ At equal contrast dose.

        § Three independent blinded readers assessed off-site their overall diagnostic preference (primary efficacy parameter) based on a matched pairs approach.

        ¶ Assessments in which a preference for either agent was expressed (p<0.001). No preference recorded in a further 175.

        References:

        1. GADOVIST® 1.0 Product Monograph, Bayer Inc., March 5, 2018. 2. ProHance® Product Monograph, Bracco Imaging Canada, March 9, 2018. 3. DOTAREM® Product Monograph, Guerbet, imported by Methapharm Inc., April 23, 2018. 4. Szomolanyi P, et al. Comparison of the relaxivities of macrocyclic gadolinium-based contrast agents in human plasma at 1.5, 3 and 7 T, and blood at 3 T. Invest Radiol 2019 [Epub ahead of print]. 5. Tóth É, Helm L and Merbach A. Relaxivity of gadolinium(III) complexes: Theory and mechanism. In: Merbach A, Helm L, Tóth É, eds. The chemistry of contrast agents in medical magnetic resonance imaging. Second Edition ed: John Wiley & Sons, Ltd; 2013:25–81. 6. Anzalone N, et al. Optimizing contrast-enhanced magnetic resonance imaging characterization of brain metastases: relevance to stereotactic radiosurgery. Neurosurgery 2013;72(5):691–701. 7. Gutierrez JE, et al. Safety and Efficacy of Gadobutrol for Contrast-enhanced Magnetic Resonance Imaging of the Central Nervous System: Results from a Multicenter, Double-blind, Randomized, Comparator Study. Magn Reson Insights 2015;8:1–10. 8. Katakami N, et al. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol 2011;46(7):411–18. 9. Kanal E, Maravilla K and Rowley HA. Gadolinium contrast agents for CNS imaging: current concepts and clinical evidence. AJNR Am J Neuroradiol 2014;35(12):2215–26. 10. Anzalone N, et al. Cerebral neoplastic enhancing lesions: multicenter, randomized, crossover intraindividual comparison between gadobutrol (1.0M) and gadoterate meglumine (0.5M) at 0.1 mmol Gd/kg body weight in a clinical setting. Eur J Radiol 2013;82(1):139–45.

        .

          Gadovist 101

          Gadovist

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          Case Reports

           

           

          Adults

          .

            History: A 69-year-old female, 57 kg, presenting with confusion, expressive aphasia, dysarthria, left upper motor neuron facial weakness, left arm and leg weakness. She does not have any other preexisting medical conditions. She has a skin lesion in the right temple.

            Highlight_Adults-Case1

            1 T1 Flash
            2 T1 Flash + Gadovist
            3 rCBV + Gadovist
            4 Ktrans + Gadovist
            5 CBV + Gadovist

            (Courtesy of Thanh Binh Nguyen, The Ottawa Hospital, Ottawa, Canada)

            MRI: An initially suspected hemorrhagic lesion was detected as neoplasm. Structural (B) and dynamic contrast enhanced MRI (D and E) revealed an underlying enhancing mass in the right frontal lobe, suspicious for metastasis or glioblastoma multiforme (GBM). Dynamic Gadovist® 1.0-enhanced MR perfusion (D and E) is more useful than DSC-MR perfusion (C) in the presence of hemorrhage as it is not limited by susceptibility artifacts.

            Final Diagnosis: Metastatic melanoma in the right frontal lobe

            Patient Outcome: MRI prompted the patient to undergo a full metastatic workup and surgical resection.

            History: 49-year-old asymptomatic female without pathological findings in X-ray mammography (A). Concomitant ultrasound showed a suspicious nodule in the left breast (B).

            Highlight_Adults-Case2

            1 MLO Mammography
            2 Ultrasound
            3 Early Substraction Imaging
            4 Early 1.00 M contrast-enhanced T1w

            (Courtesy of B.-K. Han; Samsung Medical Center/Department of Radiology, Seoul, South Korea.)

            MRI: Early dynamic THRIVE subtraction MRI (C) and early dynamic THRIVE MRI (D) show a 0.9-cm, spiculated, enhancing mass in the upper outer quadrant of the left breast, characterized by fast post-initial washout.

            Gadovist®-MRI improves the sensitivity of breast lesion detection, aiding the diagnosis of invasive ductal carcinoma, even in dense breast tissue.

            Pediatrics

            .

              History: A 3-day-old male infant weighing 3.7 kg with no preexisting conditions presented with paraplegia of the legs. Gadovist® 1.0 contrast-enhanced MRI was ordered to assess the neurological deficit.

              Highlight_Padiatrics-Case1

              (Courtesy of Dr. Gabriele Hahn, Pediatrician and Pediatric Radiologist, Carl Gustav Carus University Hospital Dresden, Germany)

              Findings: Large retroperitoneal mass directly extending into the spinal canal through the neural foramina with resultant spinal cord compression.


              Diagnosis: “Dumbbell” neuroblastoma forming an hourglass shaped mass with strong contrast enhancement.
              Patient Management and Outcome: The tumor was biopsied and pathology was proven. Chemotherapy was administered to reduce the tumor. Surgery was performed to remove the residual tumor.


              Take-Home Messages

              • Imaging of neuroblastoma with transforaminal extension requires contrast administration.
              • The large tumor with strong contrast enhancement was clearly visible retroperitoneally and intraspinally.
              • Gadovist® 1.0 was well tolerated in this neonate without symptoms or side effects.

              History: A 2-month-old male patient with left frontal lobe tumor (Desmoplastic infantile ganglioglioma; (DIG)).

              Highlight_Padiatrics-Case2

              (Courtesy of Bhargava R and Noga M, Magnetic Resonance Insights 2013; 6:1–12)

              MRI: Pre-contrast, transverse T2-weighted (A), T1-weighted (B) and post-gadobutrol T1-weighted MR images show a lobulated left cerebral hemisphere mass. Post-contrast gadobutrol (Gadovist® 1.0) image (C) shows a homogeneous enhancement of the tumor with notable enhancing extension of the tumor to the dura laterally, a distinguishing feature of DIG.

              Studies

              Relaxivity

              How to Investigate the Clinical Effect of Relaxivity?

              Direct comparison studies have been conducted to investigate the effect of the high relaxivity of Gadovist® vs. the other macrocyclic GBCAs gadoteridol and gadoterate meglumine.

              Injected dose and imaging parameters need to be kept identical in intra-individual trials when investigating possible effects of relaxivity differences between two GBCAs.

              What Is Relaxivity?

              Relaxivity is a marker for the ability of a GBCA to enhance signal intensity.

              Learn More

              Why is Relaxivity Important?

              Image quality depends on relaxivity: High relaxivity improves image quality.

              Learn More

              Macrocyclic GBCAs differ in their relaxivity

              While the absolute relaxivity values differ, the order of relaxivity values is consistent. Gadovist® shows consistently high relaxivity values.

              Learn More

              Molecular Structure & Relaxivity

              Molecular properties of Gadovist® are designed to produce high relaxivity.

              Learn More

              CNS: Gadovist® vs. Gadoteridol

              Gadovist® shows significantly higher sensitivity and accuracy in detecting malignant lesions.

              Learn More

              Radiosurgery Planning: Benefits of Gadovist®

              Gadovist® could be effectively used for radiosurgery planning of malignant CNS lesions.

              Learn More

              Brain Tumors: Gadovist® vs. Gadoteridol

              Gadovist® demonstrated significant superiority in lesion-to-brain contrast.

              Learn More

              CNS: Gadovist® vs. Gadoterate Meglumine

              Gadovist® provided better visualization of enhancing brain lesions.

              Learn More

              MS: Gadovist® vs. Gadoterate Meglumine

              Increased Enhancement in Multiple Sclerosis (MS) lesions with Gadovist®.

              Learn More

              Safety Review

              The 2017 intermediate review contained:

              • “Evidence suggests higher risk of gadolinium accumulation after repeat administration of linear than after repeat administration of macrocyclic agents”
              • Advice to use the lowest dose needed and to carefully consider whether repeated doses are required

              The 2018 final review stated: “use of macrocyclic GBCAs may be preferable to linear GBCAs in patients who may need repeated GBCA doses, as well as in children and pregnant women.

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