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資料１－２ 調査結果報告書 (25 ページ)
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| 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 (somatropin) for injection, for
NORDITROPIN (somatropin) for injection, for
HUMATROPE (somatropin) for injection, for
subcutaneous use
subcutaneous use
subcutaneous use
those with risk factors for diabetes mellitus, such
Patients with preexisting type 1 or type 2 diabetes
diabetes mellitus. Patients with preexisting type 1
as obesity, Turner syndrome, or a family history of
mellitus or impaired glucose tolerance should be
or type 2 diabetes mellitus or impaired glucose
diabetes mellitus. Patients with preexisting type 1
monitored closely. The doses of antidiabetic
tolerance should be monitored closely.
or type 2 diabetes mellitus or impaired glucose
agents may require adjustment when Norditropin
The doses of antidiabetic agents may require
tolerance should be monitored closely during
is initiated.
adjustment when HUMATROPE is initiated.
Drug Interactions
Drug Interactions
Drug Interactions
Insulin and/or Oral/Injectable Hypoglycemic
Insulin and/or Other Hypoglycemic Agents
Insulin and/or Other Hypoglycemic Agents
Agents
Clinical Impact：Treatment with
Clinical Impact：Treatment with HUMATROPE
In patients with diabetes mellitus requiring drug
NORDITROPIN may decrease insulin sensitivity,
may decrease insulin sensitivity, particularly at
therapy, the dose of insulin and/or oral/injectable
particularly at higher doses.
higher doses.
agent may require adjustment when somatropin
Intervention：Patients with diabetes mellitus may
Intervention：Patients with diabetes mellitus may
therapy is initiated [see Warnings and
require adjustment of their doses of insulin and/or
require adjustment of their doses of insulin and/or
Precautions].
other hypoglycemic agents [see Warnings and
other hypoglycemic agents [see Warnings and
Precautions].
Precautions].
somatropin therapy. The doses of
antihyperglycemic drugs (i.e., insulin or
oral/injectable agents) may require adjustment
when somatropin therapy is instituted in these
patients.
25
NORDITROPIN (somatropin) for injection, for
HUMATROPE (somatropin) for injection, for
subcutaneous use
subcutaneous use
subcutaneous use
those with risk factors for diabetes mellitus, such
Patients with preexisting type 1 or type 2 diabetes
diabetes mellitus. Patients with preexisting type 1
as obesity, Turner syndrome, or a family history of
mellitus or impaired glucose tolerance should be
or type 2 diabetes mellitus or impaired glucose
diabetes mellitus. Patients with preexisting type 1
monitored closely. The doses of antidiabetic
tolerance should be monitored closely.
or type 2 diabetes mellitus or impaired glucose
agents may require adjustment when Norditropin
The doses of antidiabetic agents may require
tolerance should be monitored closely during
is initiated.
adjustment when HUMATROPE is initiated.
Drug Interactions
Drug Interactions
Drug Interactions
Insulin and/or Oral/Injectable Hypoglycemic
Insulin and/or Other Hypoglycemic Agents
Insulin and/or Other Hypoglycemic Agents
Agents
Clinical Impact：Treatment with
Clinical Impact：Treatment with HUMATROPE
In patients with diabetes mellitus requiring drug
NORDITROPIN may decrease insulin sensitivity,
may decrease insulin sensitivity, particularly at
therapy, the dose of insulin and/or oral/injectable
particularly at higher doses.
higher doses.
agent may require adjustment when somatropin
Intervention：Patients with diabetes mellitus may
Intervention：Patients with diabetes mellitus may
therapy is initiated [see Warnings and
require adjustment of their doses of insulin and/or
require adjustment of their doses of insulin and/or
Precautions].
other hypoglycemic agents [see Warnings and
other hypoglycemic agents [see Warnings and
Precautions].
Precautions].
somatropin therapy. The doses of
antihyperglycemic drugs (i.e., insulin or
oral/injectable agents) may require adjustment
when somatropin therapy is instituted in these
patients.
25