HRF

Posology Adults and Elderly 100 micrograms, subcutaneously or intravenously. In females for whom the phase of the menstrual cycle can be established, the test should be performed in the early follicular phase (days 1-7). Paediatric population The safety and efficacy of gonadorelin in children under one year have not been established.

No data are available. Route of administration For subcutaneous and intravenous administration. 6. Test Methodology To determine the status of the gonadotropin secretory capacity of the anterior pituitary, a test procedure requiring seven venous blood samples for LH is recommended.

Procedure: 1. Venous blood samples should be drawn at -15 minutes and immediately prior to gonadorelin administration. The LH baseline is obtained by averaging the LH values of the two samples. 2. Administer a bolus of gonadorelin subcutaneously or intravenously.

3. Draw venous blood samples at 15, 30, 45, 60 and 120 minutes after administration. 4. Blood samples should be handled as recommended by the laboratory that will determine the LH content. It must be emphasised that the reliability of the test is directly related to the inter-assay and intra-assay reliability of the laboratory performing the assay.

Interpretation of test results:

Interpretation of the LH response requires an understanding of the hypothalamic-pituitary physiology, knowledge of the clinical status of the individual patient, and familiarity with the normal ranges and the standards used in the laboratory performing the LH assays.

Figures 1 - 4 represent the LH response curves after gonadorelin administration in normal subjects. The normal LH response curves were established between the 10th percentile (B line) and 90th percentile (A line) of all LH responses in normal subjects analysed from the results of clinical studies.

Individual patient responses should be plotted on the appropriate curve. A subnormal response in patients is defined as three or more LH values which fall below the B line of the normal LH response curve. In cases where there is a blunted or borderline response, the gonadorelin test should be repeated.

The gonadorellin test complements the clinical assessment of patients with a variety of endocrine disorders involving the hypothalamic-pituitary axis. In cases where there is a normal response, it indicates the presence of functional pituitary gonadotropes.

The following adverse drug reactions have been identified or suspected in clinical trials and through post-marketing use. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).

Frequency categories are defined according to the following convention:

Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Cardiac disorders:

Rare: tachycardia Gastrointestinal disorders: Rare: nausea, abdominal discomfort General disorders and administration site conditions: Rare: induration at injection site Immune system disorders: Rare: hypersensitivity reactions Infections and infestations: Frequency unknown: sepsis Investigations: Rare: antibody test - positive for antibody formation Nervous system disorders Uncommon: pain Rare: headache, dizziness Reproductive system and breast disorders: Frequency unknown: menorrhagia Respiratory, thoracic and mediastinal disorders: Rare: bronchospasm Skin and subcutaneous disorders: Uncommon: swelling, pruritis Rare: urticaria, erythema, erythema of eyelid Frequency unknown: rash Vascular disorders: Rare: flushing Frequency unknown: thrombophlebitis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Although allergic and hypersensitivity reactions have been observed with other polypeptide hormones, to date no such reactions have been encountered following the administration of a single 100 micrograms dose of gonadorelin used for diagnostic purposes.

Rare instances of hypersensitivity reactions have been reported. Therefore, patients in whom re-administration is considered, particularly by the intravenous route, should be carefully observed. 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 for use in patients with pituitary adenoma as haemorrhagic infarction (pituitary apoplexy) may occur.

1. Known or suspected pregnancy.