よむ、つかう、まなぶ。
資料２－２ 調査結果報告書 (24 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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effects on fetal development were observed. Abortifacient activity was evident following 3 to 5 doses at this level. These
effects are consistent with the abortifacient effects of other type I interferons.
The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot be evaluated based on the currently
available data.
オーストラリア添付文書
4.3 CONTRAINDICATIONS
（2021 年 2 月版）
AVONEX is contraindicated in patients with current severe depression and/or suicidal ideation and in women who are or
plan to become pregnant while on therapy.
4.6 FERTILITY, PREGNANCY AND LACTATION
Use in pregnancy – Category D
Interferon beta-1a was not teratogenic in rhesus monkeys at doses up to 50 μg (10 million IU)/kg SC. Abortifacient activity
was evident at this dose but not at 1.25 μg (0.25 million IU)/kg. Patients should be advised of the abortifacient potential of
interferon beta observed in animal studies.
There is limited information on the use of AVONEX in pregnancy. In a pregnancy registry, 302 pregnant MS patients
exposed to AVONEX, primarily during the first trimester (mean exposure 5.2 weeks) were followed prospectively. Exposure
to AVONEX did not increase the rate of spontaneous abortion or alter the pattern of defects compared to the general
population. Due to the limitations of the study and absence of comparator MS population data the significance of the
observed spontaneous abortion rate is unclear.
Initiation of treatment is contraindicated during pregnancy (see Section 4.3 - Contraindications). Women of child-bearing
potential should take appropriate contraceptive measures during treatment with AVONEX. If a patient becomes pregnant
or plans to become pregnant while taking AVONEX, the patient should be informed of the potential hazards to the foetus
24
effects are consistent with the abortifacient effects of other type I interferons.
The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot be evaluated based on the currently
available data.
オーストラリア添付文書
4.3 CONTRAINDICATIONS
（2021 年 2 月版）
AVONEX is contraindicated in patients with current severe depression and/or suicidal ideation and in women who are or
plan to become pregnant while on therapy.
4.6 FERTILITY, PREGNANCY AND LACTATION
Use in pregnancy – Category D
Interferon beta-1a was not teratogenic in rhesus monkeys at doses up to 50 μg (10 million IU)/kg SC. Abortifacient activity
was evident at this dose but not at 1.25 μg (0.25 million IU)/kg. Patients should be advised of the abortifacient potential of
interferon beta observed in animal studies.
There is limited information on the use of AVONEX in pregnancy. In a pregnancy registry, 302 pregnant MS patients
exposed to AVONEX, primarily during the first trimester (mean exposure 5.2 weeks) were followed prospectively. Exposure
to AVONEX did not increase the rate of spontaneous abortion or alter the pattern of defects compared to the general
population. Due to the limitations of the study and absence of comparator MS population data the significance of the
observed spontaneous abortion rate is unclear.
Initiation of treatment is contraindicated during pregnancy (see Section 4.3 - Contraindications). Women of child-bearing
potential should take appropriate contraceptive measures during treatment with AVONEX. If a patient becomes pregnant
or plans to become pregnant while taking AVONEX, the patient should be informed of the potential hazards to the foetus
24