Lucrin Depot for Injection PDS 3.75mg

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** _**General**_ Leuprorelin acetate for depot suspension must be administered under the supervision of a physician. As with other drugs administered by injection, the injection site should be varied periodically. Since the product does not contain a preservative, the suspension should be discarded if not used immediately. _**Prostate cancer, Endometriosis, Endometriosis with Add-back, Uterine Fibroids, Breast Cancer**_ The recommended dose of leuprorelin acetate for depot suspension (3.75 mg) is 3.75 mg administered monthly as a single intramuscular or subcutaneous injection. _**Prostate Cancer**_ 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. _**Central Precocious Puberty**_ The dose of leuprorelin acetate for depot suspension must be individualized for each child. The dose is based on a mg/kg ratio of drug 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, 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. Discontinuation of leuprorelin acetate for depot suspension should be considered before age 11 for females and age 12 for males. _**Administration Guidelines**_ _Initial Dose_ There can be different dosing regimens for CPP but dosing should start at the lowest possible dose. The recommended starting dose of leuprorelin acetate for depot suspension is 0.3 mg/kg/4 weeks (minimum 7.5 mg), administered intramuscularly or subcutaneously. The starting dose will be dictated by the child’s weight as follows:  _Maintenance Dose_ The first dose found to result in adequate hormonal suppression 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 hormonal suppression be verified in such patients whose weight has increased significantly while on therapy. If adequate hormonal and clinical suppression is not achieved, the dose should be increased to 11.25 mg or 15 mg at the next monthly injection until adequate suppression is achieved. An effective dose will be considered the maintenance dose. _**Preparation for Administration**_ For optimal performance of the Prefilled Dual Chamber Syringe (PDS), read the following instructions: 1. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn.  2. Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first stopper is at the blue line in the middle of the barrel.  3. Keep the syringe UPRIGHT. Gently mix the microspheres (particles) thoroughly to form a uniform suspension. The suspension will appear milky.  4. Hold the syringe UPRIGHT. With the opposite hand, pull the needle cap upward without twisting. 5. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe.  6. Inject the entire contents of the syringe at the time of the reconstitution. The suspension settles very quickly following reconstitution; therefore, leuprorelin acetate should be mixed and used immediately. Re-shake the suspension if settling occurs.  Note: Aspirated blood would be visible just below the luer lock connection if a blood vessel is accidentally penetrated. If present, blood can be seen through the transparent hub of the needle.