The long-term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]). Other causes of short stature should be excluded
Small for gestational age (SGA): The treatment of growth failure (current height standard deviation score [SDS] less than -2) in short children born SGA (birth weight and/or length below -2 SD) and who fail to achieve catch-up growth (height velocity SDS <0 during the last year) by 2 to 4 years or later
Turner syndrome (TS): The treatment of short stature associated with TS in patients whose epiphyses are not closed
Idiopathic short stature (ISS): The long-term treatment of ISS, also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) less than -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. OMNITROPE® treatment for ISS should be prescribed only for those patients whose epiphyses are not closed
OMNITROPE® is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
a) Adult onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy or trauma; or
b) Childhood onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults.
According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate
growth hormone provocative test with two exceptions:
1. patients with multiple other pituitary hormone deficiencies due to organic disease; and
2. patients with congenital/genetic growth hormone deficiency.
Any evidence of neoplastic activity
Pediatric patients with closed epiphyses or patients who have reached satisfactory adult height
Acute critical illness due to complications following cardiac or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure
Patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment
Current antitumour therapy; antitumour therapy should be completed before growth hormone therapy with OMNITROPE® is initiated Intracranial lesions and/or tumour must be inactive; anti-tumor or anti-malignancy treatment must be completed with evidence of remission prior to the institution of somatropin therapy
Proliferative or preproliferative diabetic retinopathy
Newborns or in patients with a known sensitivity to benzyl alcohol
In patients who are hypersensitive to somatotropin or to any ingredient in the formulations
Most serious warnings and precautions:
Product use: only use OMNITROPE® if, once reconstituted, the resulting solution is water-clear and devoid of particulate matter.
Toxicity in newborns: Benzyl alcohol, used as a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in newborns. When administering OMNITROPE® to newborns, reconstitute with sterile water for injection USP. Only use one reconstituted dose per growth hormone vial and discard the unused portion.
Treating physician requirements: Treatment with somatropin should be directed by specialists experienced in the diagnosis and management of growth disorders.
Brand change: Any change in brand of somatropin products should be made cautiously and only under medical supervision.
There have been reports of fatalities associated with the use of growth hormone in pediatric patients with Prader-Willi syndrome who have one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea or unidentified [i.e., previously undiagnosed/ mildly symptomatic] respiratory infections.
A significant increase in mortality was reported among somatropin treated patients with acute critical illness in intensive care units due to complications following open-heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure compared with those receiving placebo.
Other relevant warnings and precautions:
Patients and caregivers who will administer Omnitrope in medically unsupervised situations should receive appropriate training and instruction.
If injected subcutaneously, rotate the injection site to minimize the risk of lipoatrophy occurring.
To avoid transmission of disease, cartridge and prefilled syringe shall not be used by more than one person.
Concomitant glucocorticoid therapy may inhibit the response to growth hormone and should not exceed 10-15 mg hydrocortisone equivalent/m2 body surface area during somatropin therapy.
Increased risk of developing neoplasm.
In childhood cancer survivors, an increased risk of a second neoplasm (benign and malignant) has been reported.
Interrupt somatropin treatment if signs of upper airway obstruction (including onset of or increased snoring), and/or new onset of sleep apnea appear. Patients should be treated for upper airway obstruction and/or sleep apnea.
Patients with Turner syndrome may be at increased risk for development of intracranial hypertension and cardiovascular disorders. Otitis media and other ear disorders before and during treatment should be carefully evaluated in these patients.
Inappropriate use of somatropin by individuals who do not have indications for which growth hormone is approved, may result in clinically significant negative health consequences.
Patients with diabetes mellitus or glucose intolerance should be monitored closely during therapy with somatropin as an adjustment of their antidiabetic therapy may be required.
In patients with hypopituitarism (multiple hormonal deficiencies) standard hormonal replacement therapy should be monitored closely when treatment with Omnitrope is administered.
Fluid retention during somatropin replacement therapy in adults may occur frequently. Clinical manifestations of fluid retention are usually transient and dose dependent.
Serum levels of inorganic phosphorous, alkaline phosphatase and Insulin-like Growth Factor 1 (IGF-1) may increase.
Local or systemic allergic reactions.
A small percentage of patients may develop antibodies during treatment.
Increased tissue turgor (non-edematous swelling, particularly in the hands and feet) and musculoskeletal discomfort.
Slipped capital femoral epiphysis.
Girls and women receiving oral estrogen replacement may require greater somatropin dosage
Cases of pancreatitis have been reported.
Patients with growth hormone deficiency secondary to an intracranial lesion should be examined frequently for progression or recurrence of the underlying disease process.