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INDICATIONS AND USAGE
- Pediatric Patients - Humatropin is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
- Humatropin is indicated for the treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
- Adult Patients -Humatropin is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet both of the following two criteria:
- Adult Onset: Patients who have growth hormone deficiency either alone or with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma;
- Childhood Onset: Patients who were growth hormone-deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatropin is started. Biochemical diagnosis of growth hormone deficiency, by means of a negative response to a standard growth hormone stimulation test [maximum peak < 5 ng/mL when measured by RIA (polyclonal antibody) or < 2.5 ng/mL when measured by IRMA (monoclonal antibody)].
- Humatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
- Humatropin should not be used or should be discontinued when there is any evidence of active malignancy. Anti-malignancy treatment must be complete with evidence of remission prior to the institution of therapy.
- Humatropin should not be reconstituted with the supplied Diluent for Humatropin for use by patients with a known sensitivity to either Melacresol or glycerin.
- 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 (see WARNINGS ).
WARNING : If sensitivity to the diluent should occur the vials may be reconstituted with Bacteriostatic Water for Injection, USP or, Sterile Water for Injection, USP. When Humatropin is used with Bacteriostatic Water (Benzyl Alcohol preserved), the solution should be kept refrigerated at 2° to 8°C (36° to 46°F) and used within 14 days. Benzyl alcohol as a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in newborns. When administering Humatropin to newborns, use the Humatropin diluent provided or if the patient is sensitive to the diluent, use Sterile Water for Injection, USP. When Humatropin is reconstituted with Sterile Water for Injection, USP in this manner, use only one dose per Humatropin vial and discard the unused portion. If the solution is not used immediately, it must be refrigerated (2° to 8°C [36° to 46°F]) and used within 24 hours.
Cartridges should be reconstituted only with the supplied diluent. Cartridges should not be reconstituted with the Diluent for Humatropin provided with Humatropin Vials, or with any other solution. Cartridges should not be used if the patient is allergic to Metacresol or glycerin.
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma or with acute respiratory failure. 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.
- General --Therapy with Humatropin should be directed by physicians who are experienced in the diagnosis and management of patients with growth hormone deficiency, Turner syndrome or adult patients with either childhood-onset or adult-onset growth hormone deficiency.
- Patients with preexisting tumors or with growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease process. In pediatric patients, clinical literature has demonstrated no relationship between somatropin replacement therapy and CNS tumor recurrence. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence.
- Patients should be monitored carefully for any malignant transformation of skin lesions.
- For patients with diabetes mellitus, the insulin dose may require adjustment when somatropin therapy is instituted. Because human growth hormone may induce a state of insulin resistance, patients should be observed for evidence of glucose intolerance. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy.
- In patients with hypopituitarism (multiple hormonal deficiencies) standard hormonal replacement therapy should be monitored closely when somatropin therapy is administered. Hypothyroidism may develop during treatment with somatropin, and inadequate treatment of hypothyroidism may prevent optimal response to somatropin.
- Pediatric Patients ( see General Precautions) --Pediatric patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital epiphyses more frequently. Any pediatric patient with the onset of a limp during growth hormone therapy should be evaluated.
- Growth hormone has not been shown to increase the incidence of scoliosis. Progression of scoliosis can occur in children who experience rapid growth. Because growth hormone increases growth rate, patients with a history of scoliosis who are treated with growth hormone should be monitored for progression of scoliosis. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients.
- Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear or hearing disorders (see Adverse Reactions). Patients with Turner syndrome are at risk for cardiovascular disorders (e.g. stroke, aortic aneurysm, hypertension) and these conditions should be monitored closely.
- Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease. Therefore, patients should have periodic thyroid function tests and be treated as indicated ( see General Precautions ).
- Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of pediatric patients treated with growth hormone products. Symptoms usually occurred within the first eight (8) weeks of the initiation of growth hormone therapy. In all reported cases, IH-associated signs and symptoms resolved after termination of therapy or a reduction of the growth hormone dose. Funduscopic examination of patients is recommended at the initiation and periodically during the course of growth hormone therapy. Patients with Turner syndrome may be at increased risk for development of IH.
- Adult Patients (see General Precautions )--Patients with epiphyseal closure who were treated with growth hormone replacement therapy in childhood should be re-evaluated according to the criteria in INDICATIONS AND USAGE before continuation of somatropin therapy at the reduced dose level recommended for growth hormone-deficient adults.
- Experience in patients above 60 years is lacking.
- Experience with prolonged treatment in adults is limited.
- Drug Interactions --Excessive glucocorticoid therapy may prevent optimal response to somatropin. If glucocorticoid replacement therapy is required, the glucocorticoid dosage and compliance should be monitored carefully to avoid either adrenal insufficiency or inhibition of growth promoting effects.
- Limited published data indicate that growth hormone (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.
- Carcinogenesis, Mutagenesis, Impairment of Fertility --Long-term animal studies for carcinogenicity and impairment of fertility with this human growth hormone (Humatropin) have not been performed. There has been no evidence to date of Humatropin-induced mutagenicity.
- Pregnancy--Pregnancy Category C --Animal reproduction studies have not been conducted with Humatropin. It is not known whether Humatropin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Humatropin should be given to a pregnant woman only if clearly needed.
- Nursing Mothers --There have been no studies conducted with Humatropin in nursing mothers. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humatropin is administered to a nursing woman.
- Information for Patients --Patients being treated with growth hormone and/or their parents should be informed of the potential risks and benefits associated with treatment. Instructions on appropriate use should be given, including a review of the contents of the patient information insert. This information is intended to aid in the safe and effective administration of the medication. It is not a disclosure of all possible adverse or intended effects.
Patients and/or parents should be thoroughly instructed in the importance of proper needle disposal. A puncture resistant container should be used for the disposal of used needles and/or syringes (consistent with applicable state requirements). Needles and syringes must not be reused ( see Information for Patient insert).
ADVERSE REACTIONS: Growth-Hormone Deficient Pediatric Patients- - As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. During the first six months of Humatropin therapy in 314 naive patients, only 1.6% developed specific antibodies to Humatropin (binding capacity >/= 0.02 mg/L). None had antibody concentrations which exceeded 2 mg/L. Throughout 8 years of this same study, 2 patients (0.6%) had binding capacity >2 mg/L. Neither patient demonstrated a decrease in growth velocity at or near the time of increased antibody production. It has been reported that growth attenuation from pituitary-derived growth hormone may occur when antibody concentrations are >1.5 mg/L.
In addition to an evaluation of compliance with the treatment program and of thyroid status, testing for antibodies to human growth hormone should be carried out in any patient who fails to respond to therapy.
In studies with growth hormone-deficient pediatric patients, injection site pain was reported infrequently. A mild and transient edema, which appeared in 2.5% of patients, was observed early during the course of treatment.
Leukemia has been reported in a small number of pediatric patients who have been treated with growth hormone, including growth hormone of pituitary origin as well as of recombinant DNA origin (somatrem and somatropin). The relationship, if any, between leukemia and growth hormone therapy is uncertain.