よむ、つかう、まなぶ。
資料２－２ 調査結果報告書 (30 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
human doses. Lower doses were not studied in monkeys. BETASERON given to rhesus monkeys on gestation days 20 to
70 did not cause teratogenic effects; however, it is not known if teratogenic effects exist in humans. 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 4 月版）
（関連記載なし）
4.6 FERTILITY, PREGNANCY AND LACTATION
Use in pregnancy – Pregnancy Category D
BETAFERON was not teratogenic in rhesus monkeys at doses up to 13.3 million IU/kg/day SC, but demonstrated an
abortifacient activity when administered at doses ranging from 0.89 to 24 million IU/kg/day. It is not known whether
interferon beta-1b can cause foetal harm when administered to a pregnant woman or can affect human reproductive capacity.
Data from pregnancy registries and post-marketing experience on the use of BETAFERON in pregnant women (exposures
mostly during the first trimester) suggest that frequencies of miscarriage and congenital abnormalities were comparable
with the estimated background risk in the general population. Miscarriages have been reported in subjects with MS in
controlled clinical trials with incidence rates not exceeding those in the general population. Therefore, women of childbearing potential should take appropriate contraceptive measures. If the patient becomes pregnant or plans to become
pregnant while taking interferon beta-1b, she should be informed of the potential hazards and discontinuation of therapy
should be considered; the benefits and possible risks of continuing BETAFERON therapy are recommended to be weighed.
The individual disease severity and the potential detrimental effects that could occur if medication is stopped should be
discussed with the patient.
30
70 did not cause teratogenic effects; however, it is not known if teratogenic effects exist in humans. 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 4 月版）
（関連記載なし）
4.6 FERTILITY, PREGNANCY AND LACTATION
Use in pregnancy – Pregnancy Category D
BETAFERON was not teratogenic in rhesus monkeys at doses up to 13.3 million IU/kg/day SC, but demonstrated an
abortifacient activity when administered at doses ranging from 0.89 to 24 million IU/kg/day. It is not known whether
interferon beta-1b can cause foetal harm when administered to a pregnant woman or can affect human reproductive capacity.
Data from pregnancy registries and post-marketing experience on the use of BETAFERON in pregnant women (exposures
mostly during the first trimester) suggest that frequencies of miscarriage and congenital abnormalities were comparable
with the estimated background risk in the general population. Miscarriages have been reported in subjects with MS in
controlled clinical trials with incidence rates not exceeding those in the general population. Therefore, women of childbearing potential should take appropriate contraceptive measures. If the patient becomes pregnant or plans to become
pregnant while taking interferon beta-1b, she should be informed of the potential hazards and discontinuation of therapy
should be considered; the benefits and possible risks of continuing BETAFERON therapy are recommended to be weighed.
The individual disease severity and the potential detrimental effects that could occur if medication is stopped should be
discussed with the patient.
30