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資料１－２ 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》 |
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GENOTROPIN GoQuick (somatropin)
NORDITROPIN NordiFlex (somatropin)
HUMATROPE (somatropin) 6 mg, 12 mg, or
24 mg powder and solvent for solution for injection
risk of diabetes mellitus (e.g. familial history of
diabetes, obesity, severe insulin resistance,
acanthosis nigricans) oral glucose tolerance
testing (OGTT) should be performed. If overt
diabetes occurs, somatropin should not be
administered.
Drug Interactions
Drug Interactions
Drug Interactions
Insulin and/or Oral/Injectable Hypoglycemic
Drug-Drug Interactions
Drug-Drug Interactions
Agents
Insulin and/or Oral Hypoglycemic Agents
Insulin and Anti-hyperglycemic Agents
In patients with diabetes mellitus requiring drug
Effects：May decrease effectiveness of insulin
Effects：Patients with diabetes mellitus who
therapy, the dose of insulin and/or oral/injectable
and/or hypoglycemic agents
receive concomitant somatropin may require
agent may require adjustment when somatropin
Clinical comments：Dose of insulin and/or oral
adjustment of their doses of insulin and/or other
therapy is initiated (see WARNINGS AND
agent may require adjustment when somatropin
antihyperglycemic agents.
PRECAUTIONS).
therapy is initiated.
Clinical comments：Because somatropin may
induce a state of insulin resistance, patients who
receive somatropin should be monitored for
evidence of abnormal glucose metabolism and/or
diabetes mellitus. New-onset type 2 diabetes
mellitus has been reported in children and adults
receiving somatropin.
30
NORDITROPIN NordiFlex (somatropin)
HUMATROPE (somatropin) 6 mg, 12 mg, or
24 mg powder and solvent for solution for injection
risk of diabetes mellitus (e.g. familial history of
diabetes, obesity, severe insulin resistance,
acanthosis nigricans) oral glucose tolerance
testing (OGTT) should be performed. If overt
diabetes occurs, somatropin should not be
administered.
Drug Interactions
Drug Interactions
Drug Interactions
Insulin and/or Oral/Injectable Hypoglycemic
Drug-Drug Interactions
Drug-Drug Interactions
Agents
Insulin and/or Oral Hypoglycemic Agents
Insulin and Anti-hyperglycemic Agents
In patients with diabetes mellitus requiring drug
Effects：May decrease effectiveness of insulin
Effects：Patients with diabetes mellitus who
therapy, the dose of insulin and/or oral/injectable
and/or hypoglycemic agents
receive concomitant somatropin may require
agent may require adjustment when somatropin
Clinical comments：Dose of insulin and/or oral
adjustment of their doses of insulin and/or other
therapy is initiated (see WARNINGS AND
agent may require adjustment when somatropin
antihyperglycemic agents.
PRECAUTIONS).
therapy is initiated.
Clinical comments：Because somatropin may
induce a state of insulin resistance, patients who
receive somatropin should be monitored for
evidence of abnormal glucose metabolism and/or
diabetes mellitus. New-onset type 2 diabetes
mellitus has been reported in children and adults
receiving somatropin.
30