Gonadorelin

SOURCE SCOPE: this is the SPC for the 100 microgram gonadorelin injection, which is a DIAGNOSTIC product - it is used to determine the status of the gonadotropin secretory capacity of the anterior pituitary. It does not cover pulsatile gonadorelin therapy for ovulation induction, and no dose for that use is present in the bundle. Interpretation of the LH response requires an understanding of hypothalamic-pituitary physiology, knowledge of the clinical status of the individual patient, and familiarity with the normal ranges and standards used in the laboratory performing the LH assays; the reliability of the test is directly related to the inter-assay and intra-assay reliability of that laboratory. Normal LH response curves were established between the 10th percentile (B line) and the 90th percentile (A line) of all LH responses in normal subjects; a subnormal response is defined as three or more LH values falling below the B line. A normal response indicates the presence of functional pituitary gonadotropes. The single injection test does NOT determine the patho-physiological cause of a subnormal response and does not measure pituitary gonadotropic reserve. The test should be conducted in the absence of other drugs which directly affect the pituitary secretion of gonadotropins. Administration during the follicular phase of a normal cycle may result in premature ovulation, and appropriate measures are advised to prevent an unwanted pregnancy in these circumstances. Gonadorelin and its analogues are not recommended in patients with pituitary adenoma, as haemorrhagic infarction (pituitary apoplexy) may occur. PAEDIATRIC: the SPC gives no separate paediatric dose; the safety and efficacy of gonadorelin in children under one year have not been established and no data are available. Verify any paediatric use against a children's formulary.