Generic Name and Formulations:
Degarelix 80mg/vial, 120mg/vial; pwd for SC inj after reconstitution.

Company:
Ferring Pharmaceuticals, Inc.

Indications for FIRMAGON:
Advanced prostate cancer.

Adult Dose for FIRMAGON:
Give by SC inj in abdomen once every 28 days; avoid waist and rib areas. Two 120mg injections once, then one 80mg inj once every 28 days.

Children's Dose for FIRMAGON:
Not established.

Pharmacological Class:
GnRH receptor antagonist.

Contraindications:
Pregnancy (Cat.X).

Warnings/Precautions:
Severe renal or hepatic impairment. Congenital long QT syndrome. Electrolyte imbalances. CHF. Monitor serum PSA. Discontinue if serious hypersensitivity reaction occurs; do not rechallenge. Nursing mothers: not recommended.

Interactions:
Caution with Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmics.

Adverse Reactions:
Inj site reactions (eg, pain, erythema, swelling, induration), hot flashes, increased weight, fatigue, increased transaminases, increased gamma-glutamyltransferase; QT prolongation.

How Supplied:
Treatment Initiation pack (120mg/vial)—2 (w. supplies)
Treatment Maintenance pack (80mg/vial)—1 (w. supplies)