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Japanese Journal of Radiology

, Volume 36, Issue 11, pp 676–685 | Cite as

Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan

  • Yoshito TsushimaEmail author
  • Kazuo Awai
  • Gen Shinoda
  • Hiroyuki Miyoshi
  • Masayuki Chosa
  • Toshiyuki Sunaya
  • Jan Endrikat
Special Report

Abstract

Purpose

To evaluate the safety of gadobutrol for magnetic resonance imaging in a prospective, non-interventional, post-marketing surveillance in Japan.

Materials and methods

Gadobutrol was administered in accordance with Japanese prescribing information over a 2-year enrollment period, using a standardized questionnaire to collect information. The primary outcome was the incidence of adverse reactions (ARs) following gadobutrol injection.

Results

Questionnaire data were analyzed for 3337 patients (age, 58.1 ± 17.4 years [mean±SD]). Gadobutrol was administered at a dose of 0.10 ± 0.02 mL/kg body weight. Thirty-three patients were observed to have 42 ARs suspected to be due to gadobutrol, an incidence proportion of 0.99%; 29 ARs were acute (<1 h post-injection)—including one case of severe acute AR (0.03%). Patient subpopulations (with hepatic, renal, cardiovascular diseases) did not differ markedly in AR proportions categorized by age, sex, presence of comorbidity, or imaging indication. No cases of nephrogenic systemic fibrosis were reported. Investigators rated images as improved or profoundly improved following gadobutrol injection in 91.1% of examinations.

Conclusion

Gadobutrol was well tolerated with a good safety profile in this post-marketing surveillance of a large patient population in Japan.

Keywords

Gadobutrol Gadolinium-based contrast agents Magnetic resonance imaging (MRI) Post-marketing surveillance 

Notes

Acknowledgements

This surveillance was funded by Bayer Yakuhin, Ltd. Editorial assistance was provided by Bill Wolvey of PAREXEL, which was funded by Bayer Yakuhin, Ltd.

Compliance with ethical standards

Conflict of interest

YT has no conflict of interest. KA received lecture fees and honoraria for chairman from Bayer Yakuhin, Ltd. GS is an employee of Bayer Yakuhin, Ltd. HM is an employee of Bayer Yakuhin, Ltd. MC is an employee of Bayer Yakuhin, Ltd. TS is an employee of Bayer Yakuhin, Ltd. JE is an employee of Bayer AG.

Ethical standards and informed consent

This surveillance was conducted in compliance with the GPSP and GVP of the Ministry of Health, Labor and Welfare in Japan. Approval by the ethics committee of each institution was not mandatory, since GPSP and GVP do not require such approval for a PMS. Informed consent from each patient was waived

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Copyright information

© Japan Radiological Society 2018

Authors and Affiliations

  • Yoshito Tsushima
    • 1
    Email author
  • Kazuo Awai
    • 2
  • Gen Shinoda
    • 3
  • Hiroyuki Miyoshi
    • 3
  • Masayuki Chosa
    • 4
  • Toshiyuki Sunaya
    • 5
  • Jan Endrikat
    • 6
    • 7
  1. 1.Department of Diagnostic Radiology and Nuclear MedicineGunma University Graduate School of MedicineMaebashiJapan
  2. 2.Department of Diagnostic Radiology, Graduate School of Biomedical and Health SciencesHiroshima UniversityHiroshimaJapan
  3. 3.Medical Affairs Radiology, Bayer Yakuhin, LtdOsakaJapan
  4. 4.Pharmacovigilance PMS, Bayer Yakuhin, LtdOsakaJapan
  5. 5.Product Development, Clinical StatisticsBayer Yakuhin, LtdOsakaJapan
  6. 6.RadiologyBayer AGBerlinGermany
  7. 7.Department of Gynecology, Obstetrics and Reproductive MedicineUniversity Medical School of SaarlandHomburg/SaarGermany

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