Usual Adult Dose for Prostate Cancer

250 mg orally every 8 hours

Comments:

• This drug may be taken with or without food.
• Stage B2-C Prostatic Carcinoma: Treatment with this drug and the goserelin acetate implant starting 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
• Stage D2 Metastatic Carcinoma: This drug should be initiated with the LHRH-agonist and continued until progression.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild or moderate hepatic impairment: Data not available
Severe hepatic impairment: Contraindicated

Precautions

US BOXED WARNINGS:
Hepatic Injury:

• Liver failure has been reported. Symptoms include elevated serum transaminase levels, jaundice, hepatic encephalopathy, and death related to acute hepatic failure. Hepatic injury was reversible after discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of therapy.
• Measure serum transaminase levels prior to initiating therapy, monthly for the first 4 months of therapy, and periodically thereafter.
• This drug is not recommended in patients whose ALT values exceed 2 times the upper limit of normal.
• Assess liver function tests at the first sign of liver dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "influenza-like" symptoms, hyperbilirubinuria, jaundice, right upper quadrant tenderness).
• If a patient develops jaundice or their ALT rises above 2 times the upper limit of normal, discontinue therapy and follow-up with liver function tests until resolution.

• Hypersensitivity to the active component or any of the ingredients
• Severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to therapy)

Dialysis

This drug is highly protein bound and not dialyzable to a significant degree.

Other Comments

Storage requirements:

• Store at 20C to 25C (68F to 77F).

• Dispense in a tight, light-resistant container.

• Liver function tests

• Inform patients that this drug and the drug used for medical castration should be administered concomitantly, and that they should not interrupt their dosing or stop taking these medications without consulting the physician.
• This drug can damage the liver; therefore, it is important to avoid excessive consumption of alcohol.

Frequently asked questions

• How does flutamide work in prostate cancer?