Category
Gonadotropin Releasing Hormone (GnRH) Agonist
Generic Name
Leuprorelin acetate
Formulation
Each pre-filled syringe in a kit contains:
|
7.5 mg |
22.5 mg |
45mg |
|
|
Powder (syringe B): |
7.5 mg leuprorelin acetate, equivalent to 6.96 mg leuprorelin |
22.5 mg leuprorelin acetate, equivalent to 20.87 mg leuprorelin |
45 mg leuprorelin acetate, equivalent to 41.7 mg leuprorelin |
|
Solvent (syringe A): |
82.5 mg Poly (DL-lactic-co-glycolic-acid) (50:50), 160 mg N-Methylpyrrolidone |
158.6 mg Poly(DL-lactic-co-glycolic-acid) (75:25), 193.9 mg N-Methylpyrrolidone |
165 mg Poly(DL-lactic-co-glycolic-acid) (85:15), 165 mg N-Methylpyrrolidone |
Indication
Leuprorelin (ELIGARD®) is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
Dosage
Leuprorelin (ELIGARD®) should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment.
Leuprorelin (ELIGARD®) 7.5 mg is administered as a single subcutaneous injection every month. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate for one month.
Leuprorelin (ELIGARD®) 22.5 mg is administered as a single subcutaneous injection every three months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a three-month period.
Leuprorelin (ELIGARD®) 45 mg is administered as a single subcutaneous injection every six months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate over a six-month period.
Contraindication
Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of its excipients.
Packaging
Single dose kit (1M, 3M, 6M)