Active Ingredient: Somatropin
Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.
All other patients will require IGF-I assay and one growth hormone stimulation test.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≤ 60
Subcutaneous, between 0.15 milligrams somatropin and 0.3 milligrams somatropin, once daily.
Regimen B, in case that patient age in years is > 60
Subcutaneous, between 0.1 milligrams somatropin and 0.2 milligrams somatropin, once daily.
In adults with adult-onset GHD, therapy should start with a low dose, 0.15-0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
Treatment goal should be insulin-like growth factor (IGF-I) concentrations within 2 SDS from the age corrected mean. Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS. Clinical response and side effects may also be used as guidance for dose titration. It is recognized that there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and thus do not require dose escalation. The maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. The accuracy of the growth hormone dose should therefore be controlled every 6 months. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.
In patients above 60 years, therapy should start with a dose of 0.1-0.2 mg per day and should be slowly increased according to individual patient requirements. The minimum effective dose should be used. The maintenance dose in these patients seldom exceeds 0.5 mg per day.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
For:
Subcutaneous, between 0.1 milligrams somatropin and 0.2 milligrams somatropin, once daily.
Therapy should start with a dose of 0.1-0.2 mg per day and should be slowly increased according to individual patient requirements. The minimum effective dose should be used. The maintenance dose in these patients seldom exceeds 0.5 mg per day.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
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