Growth Hormone (rDNA)
Growth Hormone is a peptide hormone that boosts protein production, promotes the utilization of fat, raises levels of insulin-like growth factor-1 (IGF-1), and interferes with the action of insulin
Some people may experience a negative reaction to metacresol in the form of redness and soreness at the injection site. To minimize the appearance of such reactions, we recommend using the drug intramuscularly.
The absolute bioavailability of recombinant human growth hormone (rhGH) after subcutaneous administration in healthy adult males has been determined to be 81±20%. The mean terminal t1/2 after subcutaneous administration is significantly longer than that seen after intravenous administration (2.1±0.43 hours vs. 19.5±3.1 minutes) indicating that the subcutaneous absorption of the compound is slow and rate-limiting. The volume of distribution at steady state for rhGH in healthy adult males is about 50 mL/kg body weight, approximating the serum volume. The mean terminal t1/2 after intravenous administration of rhGH in healthy adult males is estimated to be 19.5±3.1 minutes.
Indications and Usage
Growth Hormone(rDNA) is indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.
Growth Hormone(rDNA) is indicated for the replacement of endogenous GH in patients with adult GH deficiency.
Dosage and Administration
Pediatric Growth Hormone Deficiency (GHD). A weekly dosage of up to 0.3 mg/kg of body weight divided into daily subcutaneous injection is recommended. In pubertal patients, a weekly dosage of up to 0.7 mg/kg divided daily may be used.
Adult Growth Hormone Deficiency (GHD) The recommended dosage at the start of therapy is not more than 0.006 mg/kg given as a daily subcutaneous injection. The dose may be increased according to individual patient requirements to a maximum of 0.025 mg/kg daily in patients under 35 years and to a maximum of 0.0125 mg/kg daily in patients over 35 years.
Possibility of injection site induration and redness.
The safety of continuing growth hormone treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with growth hormone in patients having acute critical illnesses should be weighed against the potential risk.
Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or to patients having acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone-deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin-treated patients (doses 5.3−8 mg/day) compared to those receiving placebo.
Growth Hormone(rDNA) should not be used in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops.
Excessive glucocorticoid therapy will inhibit the growth-promoting effect of human GH. Patients with ACTH deficiency should have their glucocorticoid-replacement dose carefully adjusted to avoid an inhibitory effect on growth. The use of Growth Hormone(rDNA) in patients with CRI receiving glucocorticoid therapy has not been evaluated. Concomitant glucocorticoid therapy may inhibit the growth-promoting effect of Growth Hormone(rDNA). If glucocorticoid replacement is required, the glucocorticoid dose should be carefully adjusted. There was no evidence in the controlled studies of GH’s interaction with drugs commonly used in chronic renal insufficiency patients. Limited published data indicate that GH treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in man. These data suggest that GH administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporin). Careful monitoring is advisable when GH is administered in combination with other drugs known to be metabolized by CP450 liver enzymes.
As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. GH antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed.
Other adverse drug reactions that have been reported in GH-treated patients include the following:
1) Metabolic: mild, transient peripheral edema. In GHD adults, edema or peripheral edema was reported in 41% of GH-treated patients and 25% of placebo-treated patients;
2) Musculoskeletal: arthralgias; carpal tunnel syndrome. In GHD adults, arthralgias and other joint disorders were reported in 27% of GH-treated patients and 15% of placebotreated patients;
3) Skin: rare increased growth of pre-existing nevi; patients should be monitored for malignant transformation; and
4) Endocrine: gynecomastia. Rare pancreatitis.
Store the vial at 2−8°C/36−46°F in a dark place when it is not in use. Avoid freezing the vial.
1x10ml glass vial