Diagnosis of growth hormone deficiency (GHD)

Active Ingredient: Macimorelin

Indication for Macimorelin

Population group: only adults (18 years old or older)
Therapeutic intent: Diagnostic

For this indication, competent medicine agencies globally authorize below treatments:

500 ug/kg once

Route of admnistration

Oral

Defined daily dose

500 - 500 ug per kg of body weight

Dosage regimen

From 500 To 500 ug per kg of body weight once every day

Detailed description

The dose is calculated based on the patient’s body weight. The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.

The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product.

Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin

Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin. These substances could lead to unreliable GH stimulation results.

Dosage considerations

Macimorelin granules are to be reconstituted with water and must be used within 30 minutes after preparation. Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels.

During the test, the patient needs to stay fasted until the end of the blood sampling. Fluid intake of no more than 100 mL of non-carbonated water is allowed each within 1 hour pre-dose, as well as within 1 hour post-dose.

Active ingredient

Macimorelin

Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin. Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus.

Read more about Macimorelin

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