Usual Adult Dose for Prostate Cancer

• Initial dose: 300 mg orally once a day for first 30 days

• Maintenance dose: 150 mg orally once a day after first 30 days

• Comments: For maximum benefit, treatment should begin on the same day or the day after surgical castration.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Severe liver impairment: Contraindicated

Precautions

US BOXED WARNING:

• Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials. A small study in Japanese subjects showed that 17% of patients developed interstitial pneumonitis. There have been rare postmarketing reports of interstitial changes, including pulmonary fibrosis, that led to hospitalization and death. Symptoms included exertional dyspnea, cough, chest pain, and fever. Most cases occurred within the first 3 months of treatment and most reversed with treatment discontinuation. A routine chest X-ray should be performed prior to treatment initiation; baseline pulmonary function tests may be considered. Patients should be instructed to report new or worsening shortness of breath they experience during treatment. If symptoms occur, treatment should be immediately discontinued until it can be determined if the symptoms are drug-related.

Dialysis

Data not available.

Other Comments

Administration Advice:

• Take with or without food.
• Patients should not interrupt dosing or stop treatment without medical consultation.

• In case of overdose, minimize the absorption of the drug (e.g., with oral administration of activated charcoal), induce vomiting (if that does not occur spontaneously and the patient is alert), and provide general supportive care. Dialysis may not be of benefit since this drug is 80% to 84% protein-bound.

• Cardiovascular: QT interval
• Hepatic: Transaminase levels
• Respiratory: Chest X-ray (baseline), pulmonary function testing (baseline)

• This drug may cause alcohol intolerance and vision problems. Avoid drinking alcohol, and doing activities such as driving (especially at night and through tunnels) and operating machinery until you know how this drug affects you.