Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**DOSAGE AND ADMINISTRATION** Leuprorelin acetate for depot suspension must be administered under the supervision of a physician. Lucrin Depot for Injection PDS 30mg is administered as a single subcutaneous injection **every six months.** _**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. For optimal performance of the prefilled dual-chamber syringe (PDS), read and follow 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 subcutaneously 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 the blood vessel is accidentally penetrated. If present, blood can be seen through the transparent hub of the needle. Although the solution has been shown to be stable for 24 hours following reconstitution, the suspension should be discarded if not used immediately, as the product does not contain a preservative. As with other drugs administered by injection, the injection site should be varied periodically. Product contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.
SUBCUTANEOUS
Medical Information
**INDICATIONS** Lucrin Depot for Injection PDS 30mg is indicated in the palliative treatment of advanced prostatic cancer.
**CONTRAINDICATIONS** Lucrin Depot for Injection PDS is contraindicated in patients with known hypersensitivity to leuprorelin acetate or similar nonapeptides or any of the excipients. Isolated cases of anaphylaxis have been reported with the monthly formulation of leuprorelin acetate. Although not relevant to the approved indication, leuprorelin acetate is contraindicated in pregnancy due to its embryotoxic effects. (See PRECAUTIONS – Use in Pregnancy – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Although not relevant to the approved indication, leuprorelin acetate should not be administered to a nursing mother, as it is not known whether leuprorelin acetate is excreted into human milk. (See PRECAUTIONS – Use in Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Although not relevant to the approved indication, leuprorelin acetate should not be administered to women with undiagnosed vaginal bleeding.
L02AE02
leuprorelin
Manufacturer Information
ABBVIE PTE. LTD.
Takeda Pharmaceutical Company Limited (Osaka Plant)
Takeda Pharmaceutical Company Limited (Hikari Plant)
Active Ingredients
Documents
Package Inserts
Lucrin Depot for Injection PI.pdf
Approved: September 23, 2020