内容紹介
Results of a Drug Use Survey of Filgrastim Biosimilar 1(Filgrastim BS Syringe for Inj.“MOCHIDA”and“F”)
Summary
With the aim of evaluating the safety and efficacy of filgrastim biosimilar 1(Filgrastim BS syringe for Inj.“MOCHIDA”and“F”), we conducted a drug use results survey of this product for its indications, including mobilization of hematopoietic stem cells into peripheral blood and chemotherapy-induced neutropenia. Of the 518 cases enrolled between August 2013 and July 2015, 495 were selected to be subjects of our safety and efficacy evaluations. 37 cases(7.47%)experienced side effects, which were mainly lower back pain(19, 3.84%), fever(8, 1.62%)and bone pain(3, 0.61%). As for serious side effects, interstitial pneumonia was reported in 2 cases, but this disorder has already been recognized as being associated with the use of filgrastim originator, and there were no reports of unknown side effects calling for immediate attention. In addition, we investigated hypersensitivity reactions(such as nettle rash and anaphylactic shock)and diminished drug effects, both of which are considered to be attributable to immunogenicity, and found that non-serious nettle rash was reported in 2 cases. However, there have been no reports of anaphylactic shock or diminished drug effects. The efficacy rate based on physicians' clinical observations was 97.98%. This study confirmed that there are no problems with the clinical use of filgrastim biosimilar 1.
要旨
フィルグラスチム後続1(フィルグラスチムBS注シリンジ「モチダ」,同「F」)の安全性および有効性を検討する目的で,本剤の適応症である造血幹細胞の末梢血中への動員およびがん化学療法による好中球減少症などを対象とした使用成績調査を実施した。2013年8月～2015年7月までに518例が登録され,うち495例を安全性および有効性評価症例とした。副作用は37例(7.47%)に認められ,主な副作用は腰痛19例(3.84%),発熱8例(1.62%),骨痛3例(0.61%)であった。重篤な副作用として間質性肺炎2例が発現したが,すでに知られている副作用であり,新たに注意を喚起すべき副作用は認められなかった。また,免疫原性に起因する過敏性反応(蕁麻疹,ショックなど)および薬効低下を調査し,非重篤な蕁麻疹2例が認められたが,ショックや薬効低下は報告されなかった。医師の総合判定による有効率は97.98%であった。本調査結果より,フィルグラスチム後続1の臨床使用に問題がないことが確認された。
目次
Summary
With the aim of evaluating the safety and efficacy of filgrastim biosimilar 1(Filgrastim BS syringe for Inj.“MOCHIDA”and“F”), we conducted a drug use results survey of this product for its indications, including mobilization of hematopoietic stem cells into peripheral blood and chemotherapy-induced neutropenia. Of the 518 cases enrolled between August 2013 and July 2015, 495 were selected to be subjects of our safety and efficacy evaluations. 37 cases(7.47%)experienced side effects, which were mainly lower back pain(19, 3.84%), fever(8, 1.62%)and bone pain(3, 0.61%). As for serious side effects, interstitial pneumonia was reported in 2 cases, but this disorder has already been recognized as being associated with the use of filgrastim originator, and there were no reports of unknown side effects calling for immediate attention. In addition, we investigated hypersensitivity reactions(such as nettle rash and anaphylactic shock)and diminished drug effects, both of which are considered to be attributable to immunogenicity, and found that non-serious nettle rash was reported in 2 cases. However, there have been no reports of anaphylactic shock or diminished drug effects. The efficacy rate based on physicians' clinical observations was 97.98%. This study confirmed that there are no problems with the clinical use of filgrastim biosimilar 1.
要旨
フィルグラスチム後続1(フィルグラスチムBS注シリンジ「モチダ」,同「F」)の安全性および有効性を検討する目的で,本剤の適応症である造血幹細胞の末梢血中への動員およびがん化学療法による好中球減少症などを対象とした使用成績調査を実施した。2013年8月～2015年7月までに518例が登録され,うち495例を安全性および有効性評価症例とした。副作用は37例(7.47%)に認められ,主な副作用は腰痛19例(3.84%),発熱8例(1.62%),骨痛3例(0.61%)であった。重篤な副作用として間質性肺炎2例が発現したが,すでに知られている副作用であり,新たに注意を喚起すべき副作用は認められなかった。また,免疫原性に起因する過敏性反応(蕁麻疹,ショックなど)および薬効低下を調査し,非重篤な蕁麻疹2例が認められたが,ショックや薬効低下は報告されなかった。医師の総合判定による有効率は97.98%であった。本調査結果より,フィルグラスチム後続1の臨床使用に問題がないことが確認された。