LUCRIN Depot Solution for injection Ref.[50336] Active ingredients: Leuprorelin

LUCRIN DEPOT 3,75 must be administered under the supervision of a medical practitioner.

Endometriosis

The recommended dose of LUCRIN DEPOT 3,75 in the treatment of endometriosis is 3,75 mg.

Prostate Cancer

The recommended dose of LUCRIN DEPOT 3,75 in the palliative treatment of advanced prostatic carcinoma is 3,75 mg administered subcutaneously once a month.

In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of castration-resistant prostate cancer. Reference should be made to relevant guidelines.

Breast Cancer

The recommended dose of LUCRIN DEPOT 3,75 as adjuvant therapy to surgery in breast cancer is 3,75 mg administered 4-weekly as a single intramuscular or subcutaneous injection.

Central Precocious Puberty

The recommended dose for the treatment of children with central precocious puberty must be individualised for each child based on a mg/kg ratio of medicine to body weight. Younger children require higher doses on a mg/kg ratio.

For each dosage form, after one to two months of initiating therapy or changing doses, the child must be monitored with a GnRH stimulation test, determination of sex steroids and Tanner staging to confirm downregulation. Measurements of bone age for advancement should be monitored every 6 to 12 months. The dose should be titrated upward until no progression of the condition is noted either clinically and/or by laboratory parameters.

The first dose found to result in adequate downregulation can probably be maintained for the duration of therapy in most children. However, there are insufficient data to guide dosage adjustment as patients move into higher weight categories after beginning therapy at very young ages and low dosages. It is recommended that adequate downregulation be verified in such patients whose weight has increased significantly while on therapy.

Discontinuation of LUCRIN DEPOT 3,75 should be considered before age 11 for females and age 12 for males.

Administration Guidelines for Central Precocious Puberty

Initial Dose

The recommended starting dose of LUCRIN DEPOT 3,75 is 0,3 mg/kg for four weeks (minimum 7,5 mg), administered intramuscularly or subcutaneously.

The following physiologic effects have been noted with the chronic administration of leuprolide acetate in this patient population:

1. Skeletal Growth: A measurable increase in body length can be noted, since the epiphyseal plates will not close prematurely.
2. Organ Growth: Reproductive organs will return to a prepubertal state.
3. Menses: Menses, if present, will cease.

The starting dose will be dictated by the child’s weight as follows:

Note: When two injections are required to achieve the desired total dosage, they should be administered at the same time.

Maintenance Dose

If total downregulation is not achieved, the dose should be titrated upward in increments of 3,75 mg every four weeks. This dose will be considered the maintenance dose.

In overdose, side effects would be exacerbated and exaggerated (see section 4.4 and section 4.8). Treatment is symptomatic and supportive.

36 months.

Store at room temperature (below 25°C).

LUCRIN DEPOT 3,75 is available in a single dose administration kit containing one vial of sterile lyophilised microspheres of leuprolide acetate (3,75 mg); one ampoule of diluent, one syringe with two 22-gauge needles and one alcohol swab.

LUCRIN DEPOT 3,75 is a white powder. The sterile liquid for reconstitution is a clear, colourless liquid. After reconstitution the suspension should appear milky.

Reconstitution

The lyophilised microspheres are to be reconstituted and administered monthly as a single intramuscular or subcutaneous injection in accordance with the following directions:

1. Using a syringe with a 22-gauge needle, withdraw 1 mL of diluent from the ampoule, and inject it into the vial. (Extra diluent is provided and any remaining diluent should be discarded).
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 injection sites should be varied, periodically.

Although the solution has been shown to be stable for 24 hours following reconstitution, since the product does not contain preservatives, the suspension should be discarded if not used immediately.