Flutamide

Treatment of advanced prostate cancer in which suppression of testosterone effects is indicated: as initial treatment in combination with an LHRH-agonist; as adjunctive therapy in patients already receiving LHRH-agonist therapy; in surgically castrated patients; in the treatment of patients who have not responded to other forms of hormonal manipulation or in patients who cannot tolerate such treatment.

INDICATIONS AND USAGE

Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy.

Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression.

FLUTAMIDE (flutamide) is indicated:  For use in combination with LHRH agonistic analogues (such as leuprolide acetate) for the treatment of metastatic prostatic carcinoma (stage D2). To achieve the benefit of the adjunctive therapy with FLUTAMIDE, treatment must be started simultaneously using both drugs.

 As an adjunctive therapy to orchiectomy, in order to achieve complete androgen blockade.  FLUTAMIDE in combination with LHRH agonists are also indicated prior to and during definitive external beam radiotherapy for patients with bulky locally advanced Stage B2 and Stage C prostatic carcinoma.

See 4 DOSAGE AND ADMINISTRATION. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.