"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
DOSAGE AND ADMINISTRATION
The recommended dose of XTANDI is 160 mg (four 40 mg capsules) administered orally once daily. XTANDI can be taken with or without food [see CLINICAL PHARMACOLOGY]. Swallow capsules whole. Do not chew, dissolve, or open the capsules.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable side effect, withhold dosing for one week or until symptoms improve to ≤ Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg), if warranted.
Concomitant Strong CYP2C8 Inhibitors
The concomitant use of strong CYP2C8 inhibitors should be avoided if possible. If patients must be co-administered a strong CYP2C8 inhibitor, reduce the XTANDI dose to 80 mg once daily. If co-administration of the strong inhibitor is discontinued, the XTANDI dose should be returned to the dose used prior to initiation of the strong CYP2C8 inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
XTANDI 40 mg capsules are white to off-white oblong soft gelatin capsules imprinted in black ink with MDV.
Storage And Handling
XTANDI (enzalutamide) 40 mg capsules are supplied as white to off-white oblong soft gelatin capsules imprinted in black ink with MDV. XTANDI capsules are available in the following package sizes:
Bottles of 120 capsules (NDC 0469-0125-99)
Recommended storage: Store XTANDI capsules at 20°C to 25°C (68°F to 77°F) in a dry place and keep the container tightly closed. Excursions permitted from 15°C to 30°C (59°F to 86°F).
Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716. Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062. Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Medivation, Inc., San Francisco, CA 94105. Issued: August 2012
Last reviewed on RxList: 9/18/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Xtandi Information
- Xtandi Drug Interactions Center: enzalutamide oral
- Xtandi Side Effects Center
- Xtandi FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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