"The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.
The FDA initially appr"...
XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
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 coadministered a strong CYP2C8 inhibitor, reduce the XTANDI dose to 80 mg once daily. If coadministration 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 ENZ.
Storage And Handling
- XTANDI (enzalutamide) 40 mg capsules are supplied as white to off-white oblong soft gelatin capsules imprinted in black ink with ENZ. 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. Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Medivation Inc., San Francisco, CA 94105. Revised: September 2014
Last reviewed on RxList: 9/17/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Xtandi Information
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.
Get the latest treatment options.