Luprolex Dosage/Direction for Use

Leuprorelin (Luprolex) must be administered under the supervision of a physician.
Leuprorelin (Luprolex) 1.88 mg or 3.75 mg is to be given ONCE A MONTH and 3-Month 11.25 mg is to be given ONCE EVERY THREE MONTHS.
Incorporated in a depot formulation, the lyophilized microspheres are to be reconstituted and administered as a single intramuscular/subcutaneous injection, in accordance with the following directions: 1. Using a syringe with a 23 gauge needle, withdraw 2 mL of diluent from the ampule, and inject it into the vial.
2. Shake well to thoroughly disperse particles to obtain a uniform suspension. The suspension will appear milky.
3. Withdraw the entire contents of the vial into the syringe and inject it at the time of reconstitution.
The suspension settles very quickly following reconstitutions, therefore, it is preferable that Leuprorelin (Luprolex) be mixed and used immediately. Reshake suspension if settling occurs.
Although the potency of the reconstituted suspension has been shown to be stable for 24-hours, since the product does not contain a preservative, the suspension should be discarded if not used immediately.
As with other drugs administered by injection, the injection site should be varied periodically.
For Uterine fibroids/endometriosis: For patients weighing less than 50 kg, 1.88 mg is administered as single intramuscular or subcutaneous injection.
For patients weighing more than 50 kg, or with a markedly large uterus, 3.75 mg is administered (e.g. as Leuprorelin (Luprolex) 3.75 mg powder for injection).
Pediatric Population: The treatment of children with leuprorelin acetate should be under the overall supervision of the pediatric endocrinologist.
The dosing scheme needs to be adapted individually.
The recommended starting dose is dependent on the body weight.
Children with a body weight ≥20 kg: 3.75 mg is administered [e.g. as Leuprorelin (Luprolex) 3.75 mg powder for injection], or 2 mL [11.25 mg Leuprorelin (Luprolex)] suspension of 130.0 mg sustained-release microcapsules in 2 mL vehicle solution are administered every 3 months as a single subcutaneous injection.
Children with a body weight <20 kg: In these rare cases the following dosage should be administered according to the clinical activity of the central precocious puberty: 2 mL [1.88 mg Leuprorelin (Luprolex)] or 1 mL [3.75 mg Leuprorelin (Luprolex)] is administered once a month as a single subcutaneous injection, or 1 mL [5.625 mg Leuprorelin (Luprolex)] is administered every 3 months as a single subcutaneous injection.
The remainder of the 3.75 mg and 11.25 mg 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 minimal effective monthly (for 1.88 mg and 3.75 mg) or 3-monthly (for 11.25 mg) 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 volume 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 pediatrician together with the legal guardian and, if appropriate, the treated child. The bone age should be monitored during treatment with 6-12 months intervals.
In girls with bone maturation of older than 12 years and boys with 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 30±2 (for 1.88 mg and 3.75 mg) or 90± 2 (for 11.25 mg) days in order to prevent the recurrence of precocious puberty.