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General: Sermorelin acetate therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of growth hormone deficiencies.

In clinical studies, the incidence of hypothyroidism during Sermorelin therapy was 6.5%. In the largest clinical study, 8 of 110 enrolled patients were on thyroid replacement therapy prior to Sermorelin therapy and an additional 5 after initiating therapy. Untreated hypothyroidism can jeopardize the response to Sermorelin . Therefore, thyroid hormone determinations should be performed before the initiation and throughout the duration of Sermorelin therapy. Thyroid hormone replacement therapy should be initiated when indicated.

Patients with growth hormone deficiency secondary to an intracranial lesion were not studied in clinical trials. It is not recommended that such patients be treated with Sermorelin .

As with the administration of any peptide, local or systemic allergic reactions may occur. P atients should be informed that such reactions are possible and that prompt medical attention should be sought if allergic reactions occur.

Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, GH and IGF-1 may increase with Sermorelin therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenicity and impairment of fertility have not been performed with Sermorelin . There has been no evidence from studies to date of Sermorelin -induced genetic toxicity.

Pregnancy: Pregnancy Category C. During teratology studies Sermorelin produced minor variations in fetuses of rats and rabbits when given at a dose of 0.5 mg/kg/day. This dose is approximately 3 and 6 times the daily human dose calculated on a body surface area (mg/m 2 ) basis, for rats and rabbits, respectively. There are no adequate and well controlled studies in pregnant women. Sermorelin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Women: It is not known whether Sermorelin is excreted in human milk. Because many drugs are excreted in human milk, cautions should be exercised when Sermorelin is administered to a nursing women.

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