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資料１－２ 調査結果報告書 (29 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 GoQuick (somatropin)
NORDITROPIN NordiFlex (somatropin)
HUMATROPE (somatropin) 6 mg, 12 mg, or
24 mg powder and solvent for solution for injection
therapy with somatropin, as an adjustment of their
treated with somatropin, especially in those with
obesity, Turner syndrome, or a family history of
antidiabetic therapy may be required.
risk factors for diabetes mellitus, such as obesity,
diabetes mellitus, those receiving high dose
Treatment with somatropin may decrease insulin
Turner syndrome, or a family history of diabetes
corticosteroid therapy, and patients with impaired
sensitivity, particularly at higher doses in patients
mellitus. Patients with pre-existing type 1 or
glucose tolerance or pre-existing diabetes
with risk factors for diabetes mellitus, such as
type 2 diabetes mellitus or impaired glucose
mellitus. As a result, previously undiagnosed
obesity, Turner syndrome, or a family history of
tolerance should be monitored closely during
impaired glucose tolerance and overt diabetes
diabetes mellitus, those receiving high dose
somatropin therapy. The doses of
mellitus may be unmasked during somatropin
corticosteroid therapy, and patients with impaired
antihyperglycemic drugs (i.e., insulin or
treatment. Therefore, patients who receive
glucose tolerance or pre-existing diabetes
oral/injectable agents) may require adjustment
somatropin should be monitored for evidence of
mellitus. As a result, previously undiagnosed
when somatropin therapy is instituted in these
abnormal glucose metabolism and/or diabetes
impaired glucose tolerance and overt diabetes
patients.
mellitus. New-onset type 2 diabetes mellitus has
mellitus may be unmasked during somatropin
Monitoring and Laboratory Tests
been reported in children and adults receiving
treatment. Therefore, patients who receive
Because human growth hormone may induce a
somatropin.
somatropin should be monitored for evidence of
state of insulin resistance, patients should be
abnormal glucose metabolism and/or diabetes
observed for evidence of glucose intolerance.
mellitus. New-onset type 2 diabetes mellitus has
Patients with diabetes or glucose intolerance
been reported in children and adults receiving
should be monitored closely during therapy with
somatropin.
growth hormone. In Turner syndrome and SGA
children it is recommended to measure fasting
insulin and blood glucose before start of treatment
and annually thereafter. In patients with increased
29
NORDITROPIN NordiFlex (somatropin)
HUMATROPE (somatropin) 6 mg, 12 mg, or
24 mg powder and solvent for solution for injection
therapy with somatropin, as an adjustment of their
treated with somatropin, especially in those with
obesity, Turner syndrome, or a family history of
antidiabetic therapy may be required.
risk factors for diabetes mellitus, such as obesity,
diabetes mellitus, those receiving high dose
Treatment with somatropin may decrease insulin
Turner syndrome, or a family history of diabetes
corticosteroid therapy, and patients with impaired
sensitivity, particularly at higher doses in patients
mellitus. Patients with pre-existing type 1 or
glucose tolerance or pre-existing diabetes
with risk factors for diabetes mellitus, such as
type 2 diabetes mellitus or impaired glucose
mellitus. As a result, previously undiagnosed
obesity, Turner syndrome, or a family history of
tolerance should be monitored closely during
impaired glucose tolerance and overt diabetes
diabetes mellitus, those receiving high dose
somatropin therapy. The doses of
mellitus may be unmasked during somatropin
corticosteroid therapy, and patients with impaired
antihyperglycemic drugs (i.e., insulin or
treatment. Therefore, patients who receive
glucose tolerance or pre-existing diabetes
oral/injectable agents) may require adjustment
somatropin should be monitored for evidence of
mellitus. As a result, previously undiagnosed
when somatropin therapy is instituted in these
abnormal glucose metabolism and/or diabetes
impaired glucose tolerance and overt diabetes
patients.
mellitus. New-onset type 2 diabetes mellitus has
mellitus may be unmasked during somatropin
Monitoring and Laboratory Tests
been reported in children and adults receiving
treatment. Therefore, patients who receive
Because human growth hormone may induce a
somatropin.
somatropin should be monitored for evidence of
state of insulin resistance, patients should be
abnormal glucose metabolism and/or diabetes
observed for evidence of glucose intolerance.
mellitus. New-onset type 2 diabetes mellitus has
Patients with diabetes or glucose intolerance
been reported in children and adults receiving
should be monitored closely during therapy with
somatropin.
growth hormone. In Turner syndrome and SGA
children it is recommended to measure fasting
insulin and blood glucose before start of treatment
and annually thereafter. In patients with increased
29