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)