Active Ingredient: Leuprorelin
Treatment of central precocious puberty (girls under 9 years of age, boys under 10 years of age).
For this indication, competent medicine agencies globally authorize below treatments:
Intramuscular
0.3 mg per kg of body weight
0.3 mg per kg of body weight once every 28 day(s)
Subcutaneous
5.63 - 11.25 mg
From 5.63 To 11.25 mg once every 90 day(s)
1 ml (11.25 mg leuprorelin acetate) suspension of 130.0 mg sustained-release microcapsules in 1 ml vehicle solution are administered every 3 months as a single subcutaneous injection.
In these rare cases the following dosage should be administered according to the clinical activity of the central precocious puberty:
0.5 ml (5.625 mg leuprorelin acetate) suspension of 130.0 mg sustained-release microcapsules in 1 ml vehicle solution are administered every 3 months as a single subcutaneous injection.
The remainder of the suspension should be discarded. The child’s weight gain should be monitored.
Depending on the activity of the central precocious puberty, it may be necessary to increase the dosage in the presence of inadequate suppression (clinical evidence e.g. spotting or inadequate gonadotropin suppression in the LHRH test).
The minimaleffective 3-monthly dose to be administered should then be determined by means of the LHRH test. Sterile abscesses at the injection site often occurred when leuprorelin acetate was administered intramuscularly at higher than the recommended dosages. Therefore, in such cases, the medicinal product should be administered subcutaneously.
It is recommended to use the lowest volumes possible for injections in children in order to decrease the inconvenience which is associated with the intramuscular/subcutaneous injection. The duration of treatment depends on the clinical parameters at the start of treatment or during the course of treatment (final height prognosis, growth velocity, bone age and/or bone age acceleration) and is decided by the treating paediatrician together with the legal guardian and, if appropriate, the treated child. The bone age should be monitored during treatment at 6-12 month intervals.
In girls with bone maturation of older than 12 years and boys with bone maturation of older than 13 years discontinuation of treatment should be considered taking into account the clinical parameters.
In girls, pregnancy should be excluded before the start of treatment. The occurrence of pregnancy during treatment cannot be generally excluded. In such cases, medical advice should be sought.
Note: The administration interval should be 90 ± 2 days in order to prevent the recurrence of precocious puberty symptoms.
Subcutaneous
0.3 mg per kg of body weight
0.3 mg per kg of body weight once every 28 day(s)
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