No

Diagnostic Agent

For the evaluation of short children whose height is at least 2 standard deviations below the mean height for their chronological age and sex, presenting with low basal serum levels of IGF-1 and IGF-1-BP3. A single intravenous injection of sermorelin is indicated for evaluating the ability of the somatotroph of the pituitary gland to secrete growth hormone (GH). A normal plasma GH response demonstrates that the somatotroph is intact.

C

Clinical effects on the fetus: Sermorelin has been shown to produce minor variations in fetuses of rats and rabbits when given in S.C. doses of 50, 150, and 500 mcg/kg. In the rat teratology study, external malformations (thin tail) were observed in the higher dose groups, and there was an increase in minor skeletal variants at the high dose. Some visceral malformations (hydroureter) were observed in all treatment groups, with the incidence greatest in the high-dose group. In rabbits, minor skeletal anomalies were significantly greater in the treated animals than in the controls. There are no adequate and well-controlled studies in pregnant women.

Known hypersensitivity to sermorelin acetate, mannitol, or albumin

Not used for the diagnosis of acromegaly; subnormal GH response may cause obesity, hyperglycemia, and elevated plasma fatty acids

1% to 10%:

Central nervous system: Headache

Dermatologic: Transient flushing of the face

Gastrointestinal: Nausea, vomiting

Local: Pain, redness, and/or swelling at the injection site

Changes of heart rate and blood pressure have been reported with sermorelin in I.V. doses exceeding 10 mcg/kg. Cardiovascular collapse is a conceivable, but as of yet, unreported, complication of overdosage with sermorelin.

The test should not be conducted in the presence of drugs that directly affect the pituitary secretion of somatotropin. These include preparations that contain or release somatostatin, insulin, glucocorticoids, or cyclo-oxygenase inhibitors such as ASA or indomethacin. Somatotropin levels may be transiently elevated by clonidine, levodopa, and insulin-induced hypoglycemia. Response to sermorelin may be blunted in patients who are receiving muscarinic antagonists (atropine) or who are hypothyroid or being treated with antithyroid medications such as propylthiouracil. Obesity, hyperglycemia, and elevated plasma fatty acids generally are associated with subnormal GH responses to sermorelin. Exogenous growth hormone therapy should be discontinued at least 1 week before administering the test.

Lyophilized preparation must be stored in the refrigerator; use immediately after reconstitution; each ampul should be reconstituted with a minimum of 0.5 mL of the accompanying sterile diluent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the reconstituted solution if it appears cloudy, lumpy, or discolored.

In a study of 71 children, the growth hormone peak plasma response to a bolus injection of sermorelin occurred at 30 ± 27 minutes; however, the response following subsequent injections is smaller and gradually diminishes; continuous infusion does not lead to sustained increases in growth hormone secretion

I.V.: As a single dose in the morning following an overnight fast:

<50 kg: Draw venous blood samples for GH determinations 15 minutes before and immediately prior to administration, then administer 1 mcg/kg followed by a 3 mL normal saline flush, draw blood samples again for GH determinations

>50 kg: Determine the number of ampuls needed based on a dose of 1 mcg/kg, draw venous blood samples for GH determinations 15 minutes before and immediately prior to administration, then administer 1 mcg/kg followed by a 3 mL normal saline flush, draw blood samples again for GH determinations

Administer as an I.V. bolus over 1-3 minutes at a final concentration not to exceed 100 mcg/mL followed by a 3 mL normal saline flush

Peak growth hormone levels of >7-10 mcg/L are rarely achieved upon provocation in patients with classic growth hormone deficiency; a marked growth hormone response in these patients (>10-12 mcg/L) is strongly suggestive of hypothalamic dysfunction, as opposed to pituitary dysfunction

See Drug Interactions

No information available to require special precautions

No effects or complications reported

Powder for injection, lyophilized: 50 mcg