よむ、つかう、まなぶ。
資料１－２ 調査結果報告書 (26 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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2.
EU 添付文書の記載状況
GENOTROPIN/GENOTONORM (somatropin),
NORDITROPIN FlexPro (somatropin) 5 mg/1.5 ml ,
HUMATROPE (somatropin) 6 mg, 12mg, or
1.3 mg, 5.0 mg, 5.3 mg, or 12 mg, powder and
10 mg/1.5 ml, or 15 mg/1.5 ml, solution for
24mg, powder and solvent for solution for
solvent for solution for injection
injection in pre-filled pen
injection
2021 年 10 月版
2021 年 5 月版
2021 年 7 月版
Special warnings and precautions for use
Special warnings and precautions for use
Special warnings and precautions for use
Insulin sensitivity
Blood glucose and insulin
Because somatropin may reduce insulin
Somatropin may reduce insulin sensitivity. For
In Turner syndrome and SGA children it is
sensitivity, patients should be monitored for
patients with diabetes mellitus, the insulin dose
recommended to measure fasting insulin and
evidence of glucose intolerance. For patients with
may require adjustment after somatropin therapy
blood glucose before start of treatment and
diabetes mellitus, the insulin dose may require
is instituted. Patients with diabetes, glucose
annually thereafter. In patients with increased risk
adjustment after somatropin therapy is instituted.
intolerance, or additional risk factors for diabetes
of diabetes mellitus (e.g. familial history of
Patients with diabetes or glucose intolerance
should be monitored closely during somatropin
diabetes, obesity, severe insulin resistance,
should be monitored closely during somatropin
therapy.
acanthosis nigricans), oral glucose tolerance
therapy.
Small for gestational age
testing (OGTT) should be performed. If overt
In SGA children it is recommended to measure
diabetes occurs, somatropin should not be
In children born SGA it is recommended to
fasting insulin and blood glucose before start of
administered.
measure fasting plasma insulin and blood glucose
treatment and annually thereafter. In patients with
Somatropin has been found to influence
before start of treatment and annually thereafter.
increased risk for diabetes mellitus (e.g. familial
carbohydrate metabolism, therefore, patients
In patients with increased risk for diabetes
history of diabetes, obesity, severe insulin
should be observed for evidence of glucose
mellitus (e.g. familial history of diabetes, obesity,
resistance, acanthosis nigricans) oral glucose
intolerance.
severe insulin resistance, acanthosis nigricans)
tolerance testing (OGTT) should be performed. If
Insulin sensitivity
oral glucose tolerance testing (OGTT) should be
overt diabetes occurs, growth hormone should not
Because somatropin may reduce insulin
performed. If overt diabetes occurs, growth
26
EU 添付文書の記載状況
GENOTROPIN/GENOTONORM (somatropin),
NORDITROPIN FlexPro (somatropin) 5 mg/1.5 ml ,
HUMATROPE (somatropin) 6 mg, 12mg, or
1.3 mg, 5.0 mg, 5.3 mg, or 12 mg, powder and
10 mg/1.5 ml, or 15 mg/1.5 ml, solution for
24mg, powder and solvent for solution for
solvent for solution for injection
injection in pre-filled pen
injection
2021 年 10 月版
2021 年 5 月版
2021 年 7 月版
Special warnings and precautions for use
Special warnings and precautions for use
Special warnings and precautions for use
Insulin sensitivity
Blood glucose and insulin
Because somatropin may reduce insulin
Somatropin may reduce insulin sensitivity. For
In Turner syndrome and SGA children it is
sensitivity, patients should be monitored for
patients with diabetes mellitus, the insulin dose
recommended to measure fasting insulin and
evidence of glucose intolerance. For patients with
may require adjustment after somatropin therapy
blood glucose before start of treatment and
diabetes mellitus, the insulin dose may require
is instituted. Patients with diabetes, glucose
annually thereafter. In patients with increased risk
adjustment after somatropin therapy is instituted.
intolerance, or additional risk factors for diabetes
of diabetes mellitus (e.g. familial history of
Patients with diabetes or glucose intolerance
should be monitored closely during somatropin
diabetes, obesity, severe insulin resistance,
should be monitored closely during somatropin
therapy.
acanthosis nigricans), oral glucose tolerance
therapy.
Small for gestational age
testing (OGTT) should be performed. If overt
In SGA children it is recommended to measure
diabetes occurs, somatropin should not be
In children born SGA it is recommended to
fasting insulin and blood glucose before start of
administered.
measure fasting plasma insulin and blood glucose
treatment and annually thereafter. In patients with
Somatropin has been found to influence
before start of treatment and annually thereafter.
increased risk for diabetes mellitus (e.g. familial
carbohydrate metabolism, therefore, patients
In patients with increased risk for diabetes
history of diabetes, obesity, severe insulin
should be observed for evidence of glucose
mellitus (e.g. familial history of diabetes, obesity,
resistance, acanthosis nigricans) oral glucose
intolerance.
severe insulin resistance, acanthosis nigricans)
tolerance testing (OGTT) should be performed. If
Insulin sensitivity
oral glucose tolerance testing (OGTT) should be
overt diabetes occurs, growth hormone should not
Because somatropin may reduce insulin
performed. If overt diabetes occurs, growth
26