Usual Adult Dose for Prostate Cancer

14 mg/kg/day orally in 3 or 4 divided doses

Duration of Therapy: Continue therapy as long as there is a favorable patient response; some patients have been maintained on therapy for more than 3 years.

Comments:

• Patients should receive this drug for 30 to 90 days before the treating physician determines the possible benefits of continued therapy.
• Most patients have been treated at 10 to 16 mg/kg/day.

Renal Dose Adjustments

Use with caution.

Liver Dose Adjustments

Use with caution.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:

• Take this drug 1 hour before or 2 hours after meals.
• Swallow this drug with water.
• Avoid simultaneous administration of milk, milk products, and food or drugs containing calcium, magnesium, or aluminum (e.g., antacids) during treatment with this drug.

• Store under refrigeration at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).

• This drug causes little or no bone marrow depression at usual therapeutic dosage.
• This drug has shown effectiveness in patients who have not previously received drug therapy, as well as in those who have shown no response to conventional hormone treatment.

• Blood pressure (periodically during treatment)
• Serum calcium levels (regular intervals during treatment)
• Endocrine and liver function (regular intervals during therapy and after the drug has been withdrawn for 2 months)