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flutamide 125 mg capsule

Out of Stock Manufacturer ACTAVIS/TEVA 00591246618
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Uses

Prostate Cancer

Flutamide is used in combination with a gonadotropin-releasing hormone (GnRH) analog (e.g., goserelin, leuprolide acetate) in the treatment of prostate cancer that is clinically localized, such as that confined to the prostate but with extensive involvement of one lobe or with involvement of both lobes (stage B2) and that localized to the periprostatic area but extending beyond the capsule and possibly affecting seminal vesicles (stage C). Flutamide also is used in combination with a GnRH analog in the treatment of metastatic prostate cancer that involves distant lymph nodes, bone, or visceral organs (stage D2). For additional information on combined antiandrogenic and GnRH analog therapy, .

Prostate specific antigen (PSA) concentrations should be determined periodically during combined flutamide and GnRH analog therapy to monitor therapeutic response, including successful remission or possible progression of cancer. If PSA concentrations increase substantially and consistently during flutamide therapy, the possibility of clinical progression should be evaluated. Progression noted after gonadal ablation (i.e., pharmacologic treatment with a GnRH analog or orchiectomy) and antiandrogen therapy may represent growth that is not androgen dependent. For patients who have an objective progression of disease together with an elevated PSA, treatment with a GnRH analog without flutamide may be considered. Withdrawal of flutamide in such patients can be associated with a decrease in PSA. The mechanism of this response to flutamide withdrawal has not been determined, but may involve the development of mutations at the androgen receptor.

Flutamide is metabolized in part to 4-nitro-3-fluoro-methylaniline. Toxicities associated with aniline exposure and flutamide therapy include methemoglobinemia, hemolytic anemia, and cholestatic jaundice. Methemoglobin concentrations should be monitored periodically in susceptible patients (e. g., those with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease, smokers).

Dosage and Administration

Patients should be advised of the possibility of facial flushing during flutamide therapy and that alcohol could exacerbate this effect. Patients who experience such intolerance during therapy with the drug should avoid alcohol consumption.

Administration

Flutamide is administered orally without regard to meals.

Dosage

Because of the intended labeled use of flutamide, safety and efficacy of the drug have not been established in women or children. Flutamide is not intended for use in women and should not be used in women, particularly for nonserious or nonlife-threatening conditions.

Prostate Cancer

For use in combination with a gonadotropin-releasing hormone (GnRH) analog in the management of clinically localized (stage B2 or C) or metastatic (stage D2) prostate cancer, the usual dosage of flutamide is 250 mg 3 times daily. In patients with clinically localized (stages B2 and C) prostatic cancer, treatment with flutamide and the GnRH analog should be initiated 8 weeks prior to and continued during radiation therapy. In patients with metastatic (stage D2) prostate cancer, treatment with flutamide and the GnRH analog should be initiated on the same day. The duration of combined therapy with flutamide and a GnRH analog depends on the clinical response of the patient and usually should continue until progression of the disease in patients with metastatic stage D2 prostate cancer.

Periodic monitoring of serum prostate specific antigen (PSA) may be useful for assessing the patient's response to therapy. For patients with objective progression of disease and an elevated serum PSA, temporary withdrawal of flutamide therapy while continuing therapy with the GnRH analog may be considered.

Discontinuance of Therapy for Hepatic Toxicity

Hepatic injury, manifested by elevated serum transaminase concentrations, jaundice, hepatic encephalopathy, and death related to acute hepatic failure, has been reported in patients receiving flutamide. Liver failure associated with flutamide has required hospitalization in some cases and rarely has been fatal. Onset of hepatic injury occurred within the first 3 months of flutamide therapy in about half of the cases reported. Hepatic injury was reversible in some patients following discontinuance of the drug. Serum transaminase should be measured prior to starting flutamide therapy, and the drug is not recommended in patients with baseline serum ALT (SGPT) concentrations exceeding twice the upper limit of normal. Measurement of serum transaminase concentrations should be performed monthly for the first 4 months of flutamide therapy and periodically thereafter. Liver function tests also should be performed at the first sign or symptom of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, unexplained flu-like symptoms). If liver function test results are elevated (i.e., transaminases increase to 2-3 times the upper limit of normal) or if jaundice occurs, flutamide therapy should be discontinued immediately and liver function tests monitored closely until resolution.

Dosage in Hepatic and Renal Impairment

Flutamide is extensively metabolized to at least 6 metabolites.

No information is available concerning use of flutamide in patients with hepatic impairment. The manufacturer states that flutamide should not be used in patients with severe hepatic impairment. Serum transaminase concentrations should be measured prior to initiation of flutamide therapy, at regular intervals during the first 4 months of treatment, and periodically thereafter in all patients receiving flutamide.(See Discontinuance of Therapy for Hepatic Toxicity, in Dosage and Administration: Dosage.)

In individuals with chronic renal insufficiency receiving a single 250-mg dose of flutamide, there was no correlation between creatinine clearance and plasma concentrations of the drug. Renal impairment did not affect peak concentrations or AUCs of the drug and principal active metabolite. In individuals with a creatinine clearance of less than 29 mL/minute, the half-life of the active metabolite is slightly prolonged. Adjustment of flutamide dosage in patients with renal impairment generally is unnecessary.

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