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Summary of the safety data for Gadobutrol and Gadofosveset

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European Radiology Supplements

Abstract

Despite the differences in imaging conditions and the range of approved indications for gadolinium-based contrast agents, the similarities in the structures of these substances have so far resulted in largely similar safety profiles. Nevertheless, some safety-related questions have been raised recently, which indicates that the existing differences in the physicochemical and pharmacokinetic properties of these contrast agents may result in differences in some aspects of the safety profile, in particular for special populations under particular circumstances. An analysis of the current data shows that Gadobutrol and Gadofosveset are well tolerated in the investigated patient populations. Both contrast agents have comparable adverse events profiles.

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References

  1. Claussen C, Laniado M, Schörner W et al. (1985) Gadolinium-DTPA in MR imaging of glioblastomas and intracranial metastases. Am J Neuroradiol 6(5):669–674

    CAS  PubMed  Google Scholar 

  2. Niendorf HP, Laniado M, Semmler W, Schorner W, Felix R (1987) Dose administration of gadolinium-DTPA in MR imaging of intracranial tumors. Am J Neuroradiol 8(5):803–815

    CAS  PubMed  Google Scholar 

  3. Rohrer M, Bauer H, Mintorovitch J, Requardt M, Weinmann H-J (2005) Comparison of magnetic properties of MRI contrast media solutions at different magnetic field strengths. Invest Radiol 40:715–724

    Article  PubMed  Google Scholar 

  4. Zhang HL, Ersoy H, Prince MR (2006) Effects of gadopentetate dimeglumine and gadodiamide on serum calcium, magnesium and creatinine measurements. J Magn Res Imaging 23:383–387

    Article  Google Scholar 

  5. Marckmann P, Skov L, Rossen K et al. (2006) Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol 17:2359–2362

    Article  PubMed  Google Scholar 

  6. Maloo M, Abt P, Kashyap R et al (2006) Nephrogenic systemic fibrosis among liver transplant recipients: a single institution experience and topic update. Am J Transplan 6:2212

    Article  CAS  Google Scholar 

  7. Thomsen HS, Morcos SK, Dawson P (2006) Is there a causal relation between the administration of gadolinium-based contrast media and the development of nephrogenic systemic fibrosis (NSF)? Clin Radiol 61:905–906

    Article  CAS  PubMed  Google Scholar 

  8. Multicenter, intra-individually controlled, open-label study of 1 molar gadobutrol in patients with CNS lesions, data on file AI68, Schering AG, Germany (1996)

  9. Deo A, Fogel M, Cowper SE (2007) Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol 2:264–267

    Article  PubMed  Google Scholar 

  10. Staks T, Schuhmann-Giampieri G, Frenzel T, Weinmann HJ, Lange L, Platzek J (1994) Pharmacokinetics, dose proportionality, and tolerability of Gadobutrol after single intravenous injection in healthy volunteers. Invest Radiol 29:709–715

    Article  CAS  PubMed  Google Scholar 

  11. Vogler H, Platzek J, Schuhmann-Giampieri G et al (1995) Pre-clinical evaluation of Gadobutrol: a new, neutral, extracellular contrast agent for magnetic resonance imaging. Eur J Radiol 21:1–10

    Article  CAS  PubMed  Google Scholar 

  12. Balzer JO, Loewe C, Davis K (2003) Safety of contrast-enhanced MR angiography employing Gadobutrol 1.0 M as contrast material. Eur Radiol 13:2067–2074

    Article  PubMed  Google Scholar 

  13. Tombach B, Heindel W (2002) Value of 1.0-M gadolinium chelates: review of preclinical and clinical data on Gadobutrol. Eur Radiol 12:1550–1556

    Article  PubMed  Google Scholar 

  14. Forsting M (2008) Gadovist 1.0-M: tolerance and clinical safety. Eur Radiol 18(Suppl 1):324–325

    Google Scholar 

  15. Tombach B, Bremer C, Reimer P (2000) Pharmacokinetics of 1M Gadobutrol in patients with chronic renal failure. Invest Radiol 35:35

    Article  CAS  PubMed  Google Scholar 

  16. Tombach B, Bremer C, Reimer P et al. (2001) Renal tolerance of a neutral gadolinium chelate (Gadobutrol) in patients with chronic renal failure: results of a randomized study. Radiology 218:651–657

    CAS  PubMed  Google Scholar 

  17. Tombach B, Bremer C, Reimer P et al. (2002) Using highly concentrated Gadobutrol as an MR contrast agent in patients also requiring hemodialysis: safety and dialysability. Am J Roentgenol 178:105–109

    Google Scholar 

  18. Safety, tolerability and pharmacokinetics of gadobutrol 1 molar in a dose range of 0.3–1.5 mmol/kg b.w. in healthy volunteers, data on file B000, Schering AG, Germany (1999)

  19. Huppertz A, Rohrer M (2004) Gadobutrol, a highly concentrated MR-imaging contrast agent: its physicochemical characteristics and the basis for its use in contrast-enhanced MR angiography and perfusion imaging. Eur Radiol 14(Suppl 5):M12–18

    PubMed  Google Scholar 

  20. ClinicalTrails.gov. [online]. Available from URL http://www.clinicaltrials.gov

  21. Goyen M, Edelman M, Perreault P et al. (2005) MR angiography of aortoiliac occlusive disease: a Phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325. Radiology 236:825–833

    Article  PubMed  Google Scholar 

  22. Rapp JH, Wolff SD, Quinn SF et al. (2005) Aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease: safety and efficacy of Gadofosveset-enhanced MR angiography - multicenter comparative Phase III study. Radiology 236:71–78

    Article  PubMed  Google Scholar 

  23. European Medicines Agency. Vasovist: summary of product characteristics. [online]. Available from http://www.emea.eu.int/

  24. Shamsi K, Yucel EK, Chamberlin P (2006) A summary of safety of Gadofosveset (MS-325) at 0.03 mmol Gd/kg body weight dose. Invest Radiol 41:822–830

    Article  CAS  PubMed  Google Scholar 

  25. Cowper SE, Robins HS, Steinberg HM, Su LD, Gupta S, Leboit PE (2000) Scleromyxedema-like cutaneous diseases in renal-dialysis patients. Lancet 356:1000–1001

    Article  CAS  PubMed  Google Scholar 

  26. Grobner T (2006) Gadolinium - a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant 21:1104–1108. Erratum in Nephrol Dial Transplant 2006:21(6):1745. Comment in Nephrol Dial Transplant 2006:21(12):3604–3605 and Nephrol Dial Transplant 2006:21(11):3344

    Article  CAS  PubMed  Google Scholar 

  27. Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA (2007) Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR Am J Roentgenol 188(2):586–592

    Article  PubMed  Google Scholar 

  28. Khurana A, Runge VM, Narayanan M, Greene JF Jr, Nickel AE (2007) Nephrogenic systemic fibrosis: a review of 6 cases temporally related to gadodiamide injection (Omniscan). Invest Radiol 42(2):139–145

    Article  PubMed  Google Scholar 

  29. Idée JM, Port M, Raynal I, Schaefer M, Le Greneur S, Corot C (2006) Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundam Clin Pharmacol 20:563–576 (review). Erratum in Fundam Clin Pharmacol 2007:21:335

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Medical Affairs Europe/Canada, TA Diagnostic Imaging, Bayer Schering Pharma AG, Müllerstraße 178, 13353, Berlin, Germany

    Petra Palkowitsch

  2. Global Medical Affairs Diagnostic Imaging, Bayer Schering Pharma AG, Müllerstraße 178, 13353, Berlin, Germany

    Matthias Voth

Authors
  1. Petra Palkowitsch
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  2. Matthias Voth
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Correspondence to Petra Palkowitsch.

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Palkowitsch, P., Voth, M. Summary of the safety data for Gadobutrol and Gadofosveset. Eur Radiol Suppl 18 (Suppl 5), 47–53 (2008). https://doi.org/10.1007/s10406-009-0245-5

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  • DOI: https://doi.org/10.1007/s10406-009-0245-5

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