Benefits of growth hormone therapy

Decreased body fat and increased lean body mass

In a study of Adult Onset growth hormone deficient patients, those who received Humatrope therapy for six months showed a significant reduction of body fat compared with patients who received placebo injections. Humatrope-treated patients lost an average of 3.27 kg (7.2 lbs) body fat, while placebo-treated patients gained an average of 0.56 kg (1.2 lbs) body fat. The same study showed that Humatrope-treated patients gained an average of 2.59 kg (5.7 lbs) lean body mass, while placebo-treated patients lost an average of 0.22 kg (0.5 lbs) lean body mass. Similar changes were seen in Child Onset growth hormone deficient patients. However, there was no significant change in total body weight in either group of patients. The loss of body fat did not persist for AO patients.

Increased aerobic exercise capacity or performance

In patients with AO GHD, six months of Humatrope therapy resulted in a significant increase in maximal oxygen consumption (a measure of aerobic fitness). Patients who received placebo injections showed no significant increase from baseline.

Increased HDL cholesterol concentrations

Before Humatrope therapy, HDL cholesterol concentrations were low in the majority of patients with either CO or AO GHD. At completion of 18 months of Humatrope therapy, the HDL concentrations had increased into the normal range. Total cholesterol decreased in the first three months, although the changes did not persist.

Important things you need to know about Humatrope

Patients with a known sensitivity to either metacresol or glycerin should not receive Humatrope reconstituted with the supplied diluent for Humatrope.

Somatropin is contraindicated in pediatric patients with closed epiphyses, in patients with proliferative or preproliferative diabetic retinopathy or if there is any evidence of active malignancy. Any pre-existing skin lesions should be monitored carefully for malignant transformation.

Growth hormone deficiency may be an early sign of a pituitary tumor or other intracranial tumor; the presence of such a tumor should be excluded before initiation of somatropin treatment.

Somatropin should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. Fatalities have been reported in such cases.

Blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes, pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance.

Patients with pre-existing tumors or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease.

In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.

Fundoscopic examination is recommended at the initiation of and periodically during therapy as intracranial hypertension with associated side effects has been reported.

Careful monitoring is advisable when growth hormone is administered in combination with insulin, other drugs metabolized by CP450 liver enzymes (e.g., hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporin), or other hormone replacement therapy.

Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone.

Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk.

Because growth hormone is a protein, allergic reactions may occur. Prompt medical attention should be sought if allergic reactions occur.

The safety and effectiveness of somatropin in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin and may be more prone to adverse reactions.

The most commonly reported adverse events include edema, pain (e.g., injection site, muscle, joint, head), and rhinitis.