Adults and Elderly100 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 populationThe safety and efficacy of gonadorelin in children under one year have not been established. No data are available.
Route of administrationFor subcutaneous and intravenous administration.For instructions on reconstitution before administration, see section 6.6.
Test MethodologyTo 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.
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 disordersUncommon: painRare: headache, dizziness
Reproductive system and breast disorders:Frequency unknown: menorrhagia
Respiratory, thoracic and mediastinal disorders:Rare: bronchospasm
Skin and subcutaneous disorders:Uncommon: swelling, pruritisRare: urticaria, erythema, erythema of eyelidFrequency unknown: rash
Vascular disorders:Rare: flushingFrequency 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
30 August 2022