Usual Adult Dose for Prostate Cancer

160 mg (four 40 mg capsules) orally once a day

Comments:

• This drug can be taken with or without food.
• Swallow capsules whole. Do not chew, dissolve, or open the capsules.
• Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Renal Dose Adjustments

Mild or moderate renal impairment: No adjustment recommended.
Severe renal impairment or end-stage renal disease: Caution recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Grade 3 or more toxicity or intolerable side effect:

• Withhold dosing for one week or until symptoms improve to Grade 2 or less, then resume at usual dose or reduce dose to 120 mg or 80 mg once daily if necessary.

• Avoid concomitant use. If concomitant use is necessary, reduce dose to 80 mg once daily and return to the prior dose if the strong CYP450 2C8 inhibitor is discontinued.

• The concomitant use of strong CYP450 3A4 inducers should be avoided if possible. If coadministration is necessary, increase the dose to 160 to 240 mg once daily. If the strong CYP450 3A4 is discontinued, the dose should be returned to the dose used prior to initiation of the strong CYP450 3A4 inducer.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• Take with or without food.
• Swallow capsules whole with water. Do not chew, dissolve, or open the capsules.

• This drug is not indicated for use in women. Fetal harm may occur with this drug; avoid pregnancy during therapy. If pregnancy occurs, contact your doctor immediately.
• If your sexual partner is pregnant, you must use a condom during and for 3 months after treatment with this drug. If your sexual partner has the possibility of becoming pregnant, you must use a condom and another form of birth control during and for 3 months after treatment with this drug. Talk with your doctor if you have questions about birth control.
• Due to risk of seizure associated with this drug, tell your doctor if you have a history of seizures or any other predisposing factors, including but not limited to brain injury, stroke, or brain tumors.
• Due to risk of seizure associated with this drug, avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others.
• This drug may cause side effects including but not limited to fatigue, back pain, diarrhea, infections, dizziness, falls, and problems thinking clearly. Tell your doctor if you have any side effect that bothers you or does not go away.

Frequently asked questions

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