In adults with GHD, the FDA-approved labeling states that the starting dosage of GH should be very low ( to mg/day). The product labeling further states that this dose should be increased gradually on the basis of clinical and biochemical responses assessed at monthly intervals. The biochemical marker generally relied upon for GH is the IGF-I level in serum. Values of IGF-I should be maintained in the normal age- and sex-adjusted range. The literature indicates that the dose may be increased, on the basis of individual patient requirements, to a maximum of mg daily in patients younger than 35 years of age, and to a maximum of mg daily in patients older than 35 years of age. Of note, this dose is substantially less than GH replacement doses in children and adolescents, in whom the dose is based on weight.
AB - Seventy girls with Turner syndrome, 4 to 12 years of age, were randomly assigned to receive either no treatment (control) or methionyl human growth hormone ( mg/kg three times per week), oxandrolone ( mg/kg/day), or combination hGH plus oxandrolone therapy. Baseline growth rates averaged cm/yr, and all were within 2 SD of mean growth velocity for age in giris with Turner syndrome. Sixty-seven giris remained in the study for a minimum of 1 year. Growth rates and growth velocity (in standard deviations for age in girls with Turner syndrome) were control cm/yr (- SD), hGH cm/yr (+ SD), oxandrolone cm/yr (+ SD), and combination therapy cm/yr (+ SD). Mean bone ages advanced years (hGH), years (oxandrolone), and years (combination). However, median increments in height age/bone age (ΔHA/ΔBA) ratios ranged from to for treatment groups, compared with for the controls. Predicted adult height by the method of Bayley-Pinneau increased cm for hGH or oxandrolone alone, and cm for combination treatment. These data indicate that both hGH and oxandrolone can significantly stimulate short-term skeletal growth in patients with Turner syndrome, and potentially increase final adult height.
In expanded post-trial extension studies, diabetes mellitus developed in 12 of 3,031 patients (%) during treatment with GENOTROPIN. All 12 patients had predisposing factors, ., elevated glycated hemoglobin levels and/or marked obesity, prior to receiving GENOTROPIN. Of the 3,031 patients receiving GENOTROPIN, 61 (2%) developed symptoms of carpal tunnel syndrome , which lessened after dosage reduction or treatment interruption (52) or surgery (9). Other adverse events that have been reported include generalized edema and hypoesthesia.