Medically reviewed on September 4, 2018.
Applies to the following strengths: 40 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Prostate Cancer
160 mg (four 40 mg capsules) orally once a day
-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.
Use: Metastatic and non-metastatic castration-resistant prostate cancer
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.
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.
Strong CYP450 2C8 inhibitors:
-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.
Strong CYP450 3A4 inducers:
-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.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: antiandrogens
Other brands: Xtandi