FIRMAGON 80 MG 1 VIAL + SOLVENT

** FIRMAGON (degarelix) 80 mg Powder and solvent for solution for injection.

** Subcutaneous use only.

** Each vial contains 80 mg degarelix (as acetate).

After reconstitution each ml of the solution contains 20 mg degarelix.

Mannitol (E421), water for injections

Powder and solvent for solution for injection

1 vial with 80 mg degarelix (powder)

1 vial with 6 ml solvent

1 syringe

2 vial adaptors

1 injection needle

** Pharmacotherapeutic group:

Endocrine therapy, Other hormone antagonists and related agents, ATC code: L02BX02

** Mechanism of Action:

Degarelix is a selective gonadotrophin releasing-hormone (GnRH) receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone.

** Indications:

FIRMAGON is a gonadotrophin releasing hormone (GnRH) receptor antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.

** Posology and method of administration:

THE VIALS SHOULD NOT BE SHAKEN.

INJECT SLOWLY.

Starting dose:

240 mg administered as two subcutaneous injections of 120 mg each

Maintenance dose – monthly administration:

80 mg administered as one subcutaneous injection

To be used within 2 hours from reconstitution time.

** Read the package leaflet before use.

** Keep out of the reach and sight of children.

** Medicinal product subject to medical prescription.

** Store below 25 degrees C.

** Manufacturer: Rentschler Biotechnologie GmbH, Laupheim, Germany

Marketing Authorization Holder: Ferring GmbH, Kiel, Germany (FERRING PHARMACEUTICALS)