Vol.21 No.5

Review Article

Acquisition of expanded indications for intravenous cyclophosphamide in the management of childhood rheumatic disease in general

Authors

Masaaki Mori1 , Takuji Murata2 , Syuji Takei3 , Tomoyuki Imagawa4 , Shumpei Yokota4

  • Department of Pediatrics, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan
  • Department of Pediatrics, Osaka Medical College, Takatsuki, Japan
  • School of Health Sciences, Faculty of Medicine, Kagoshima University, Kagoshima, Japan
  • Department of Pediatrics, Yokohama City University, School of Medicine, Yokohama, Japan
Received:

24 February 2011

Accepted:

18 March 2011

Published online:

16 April 2011

Full Text

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Abstract

We created the final bill of “Intravenous cyclophosphamide (IVCY) for the treatment of rheumatic disease of children in general” in order to get approval for the offlabel use of IVCY from the Study Group on Pediatric Drug Therapy. As a result, this study group approved IVCY’s offlabel use in children via public applications. We could create IVCY regimen specific for Japanese children independently of the efficacy, dosage, and administration applied in Germany, which at the time of application was the only country in Europe and the USA where IVCY was approved. Later, its use in adults was given approval through public applications after being fully reviewed by the Study Group on Unapproved and Off-label Drugs of High Medical Need. Consequently, IVCY is now available for the treatment of both childhood and adult rheumatic diseases in general.

Key words

Childhood - Rheumatic disease - Intravenous cyclophosphamide - The Ministry of Health - Labour and Welfare - Expansion of indications