Usual Adult Dose for Prostate Cancer

In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Comments:

• Therapy with this drug should be started at the same time as therapy with an LHRH analog.
• If a dose is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Caution recommended.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Females
• Pregnancy

Dialysis

This drug is highly protein bound; therefore, it is not removed by dialysis.

Other Comments

Administration advice:

• This drug may be taken with or without food.
• Take this drug at the same time each day.

• Store tablets at controlled room temperature, 20C to 25C (68F to 77F).

• This drug is not approved for use alone or with other therapies at 150 mg daily.

• Read the approved patient labeling each time you fill this medication.
• This drug and the LHRH analog should be started at the same time and not interrupted or stopped without consulting your healthcare provider.
• Your healthcare provider should monitor your liver function regularly during therapy to detect signs of hepatitis.
• Notify your healthcare provider of any bleeding or spontaneous bruising while taking this drug with anticoagulants.
• This drug can cause drowsiness. See how it affects you before driving or operating machinery.
• This drug can cause photosensitivity. Avoid direct exposure to excessive sunlight or UV-light exposure. Consider using sunscreen.