Leuprorelin acetate (Luprodex) 3.75 mg Depot must be administered under the supervision of a physician.
The recommended duration of treatment with Leuprorelin acetate (Depot) as a single subcutaneous or intramuscular injection or in combination with norethindrone acetate every month for a period of 6 months only. The initial dose should be given during the first 5 days of menstrual cycle.
In women, the addition of hormone replacement therapy (estrogen and progestogen) would be useful to reduce bone mineral density loss and vasomotor symptoms.
If the symptoms of endometriosis recur after a course of therapy, retreatment with a six-month course of Leuprorelin acetate monthly and norethindrone acetate daily may be considered. Retreatment beyond this one six-month course cannot be recommended. It is recommended that bone density be assessed before retreatment begins to ensure that value are within normal limits. If norethindrone acetate is contraindicated for the individual patient, then retreatment is not recommended.
Uterine Leiomyomata (Fibroids):
Recommended duration of therapy with Leuprorelin acetate (Depot) is up to 3 months. The symptoms associated with uterine leiomyomata will recur following discontinuation of therapy. If additional treatment with Leuprorelin acetate is contemplated, bone density should be assessed prior to initiation of therapy.
The initial dose should be given during the first 5 days of menstrual cycle. For endometrial preparation prior to intrauterine surgery, 3.75 mg leuprorelin acetate single dose may be given subcutaneous or intramuscular injection 5-6 weeks prior to surgery.
Administered monthly as a single intramuscular injection of 3.75 mg depot every month. Therapy should not be discontinued when remission or improvement occurs. This treatment is usually continued upon development of castrate-resistant prostate cancer.
Central Precocious Puberty (CPP):
Leuprorelin Acetate (Luprodex) 3.76 mg Depot must be administered under the supervision of a paediatrician.
The dose of Leuprorelin acetate must be individualised for each child. The dose is based on a mg/kg ratio of drug to body weight. Younger children may require higher doses on a mg/kg ratio. After 1-2 months of initiating therapy or changing doses, the child must be monitored with a GnRH stimulation test, sex steroids, and Tanner staging to confirm down regulation. Measurements of bone age for advancement should be monitored every 6-12 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 down regulation can probably be maintained for the duration of therapy in most children however, there are insufficient data to guide dosage adjustment as patients move to higher weight categories after beginning therapy at very young ages and low dosages. It is recommended that adequate down regulation be verified in such patient whose weight has increased significantly while on therapy. Discontinuation of leuprorelin acetate should be considered before age 11 for girls and age 12 for boys.
The recommended starting dose is 0.3 mg/kg/4 weeks (minimum 7.5 mg) administered as a single intramuscular injection or subcutaneously. The starting dose will be dictated by the child's weight as follows: See Table 1.
Click on icon to see table/diagram/image
If a total down regulation is not achieved, the dose should be titrated upward in increment of 3.75 mg every 4 weeks. This dose will be considered the maintenance dose.
When two injections are required to achieve the desired total dosage, they should be administered at one site, however more than two injections should be administered at different injection sites.
Reconstitution & Administration for Leuprorelin acetate (Depot):
Use Aseptic precautions throughout.
Do not substitute saline or sterile water for diluent.
1. Ensure that the diluent fluid is at bottom section of the ampoule of diluent. Open the ampoule from the tip.
2. Using a syringe with 22-gauge needle, withdraw 1 ml of diluent from the ampoule. (Extra Diluent is provided, any remaining unused portion should be discarded.)
3. Remove the plastic seal cap from the vial.
4. Inject the Diluent from the syringe into the glass vial.
5. Shake well for thorough dispersion of particles to obtain uniform suspension. (The suspension will appear milky.)
6. Withdraw entire contents from the vial into the syringe.
7. Inject intramuscularly/subcutaneously.
8. Discard the unused product remaining in the vial along with unused diluent remaining in the ampoule.