よむ、つかう、まなぶ。
資料２－２ 調査結果報告書 (29 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_24579.html |
| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会安全対策調査会（令和3年度第31回 3／22）《厚生労働省》 |
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le risque d’avortement spontané, mais à ce jour, ces données ne suggèrent pas d’augmentation de ce risque.
Si l’état clinique le nécessite, l’utilisation de Betaferon peut être envisagée pendant la grossesse.
カナダ添付文書
CONTRAINDICATIONS
（2021 年 8 月版）
（関連記載なし）
Special Populations
Pregnant women.There are no controlled clinical studies of BETASERON in pregnant women. The administration of
BETASERON during confirmed pregnancy should be avoided, unless clearly needed.
A European registry study collected data on 778 prospective pregnancies in women with MS who were treated with one of
five interferon beta medications. The rates of aggregated adverse pregnancy outcomes were in line with reference ranges
published in the literature.
Data from a retrospective register-based study in Sweden and Finland have likewise not indicated an increased risk of major
congenital anomalies after early pregnancy exposure. However, the duration of exposure during the first trimester was
uncertain since data were collected when interferon beta use was contraindicated during pregnancy, and treatment was
interrupted when the pregnancy was detected and/or confirmed. Experience with exposure during the second and third
trimester was too limited to determine whether exposure affects maternal or fetal health.
BETASERON was not teratogenic at doses up to 0.42 mg (13.3 MIU)/kg/day in rhesus monkeys, but demonstrated doserelated abortifacient activity when administered at doses ranging from 0.028 mg (0.89 MIU)/kg/day (2.8 times the
recommended human dose based on body surface area comparison) to 0.42 mg (13.3 MIU)/kg/day (40 times the
recommended human dose based on body surface area comparison). It is not known if animal doses can be extrapolated to
29
Si l’état clinique le nécessite, l’utilisation de Betaferon peut être envisagée pendant la grossesse.
カナダ添付文書
CONTRAINDICATIONS
（2021 年 8 月版）
（関連記載なし）
Special Populations
Pregnant women.There are no controlled clinical studies of BETASERON in pregnant women. The administration of
BETASERON during confirmed pregnancy should be avoided, unless clearly needed.
A European registry study collected data on 778 prospective pregnancies in women with MS who were treated with one of
five interferon beta medications. The rates of aggregated adverse pregnancy outcomes were in line with reference ranges
published in the literature.
Data from a retrospective register-based study in Sweden and Finland have likewise not indicated an increased risk of major
congenital anomalies after early pregnancy exposure. However, the duration of exposure during the first trimester was
uncertain since data were collected when interferon beta use was contraindicated during pregnancy, and treatment was
interrupted when the pregnancy was detected and/or confirmed. Experience with exposure during the second and third
trimester was too limited to determine whether exposure affects maternal or fetal health.
BETASERON was not teratogenic at doses up to 0.42 mg (13.3 MIU)/kg/day in rhesus monkeys, but demonstrated doserelated abortifacient activity when administered at doses ranging from 0.028 mg (0.89 MIU)/kg/day (2.8 times the
recommended human dose based on body surface area comparison) to 0.42 mg (13.3 MIU)/kg/day (40 times the
recommended human dose based on body surface area comparison). It is not known if animal doses can be extrapolated to
29