May 27, 2016
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Xtandi

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Xtandi




Indications
Dosage
How Supplied

INDICATIONS

XTANDI® is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

DOSAGE AND ADMINISTRATION

Dosing Information

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.

Dose Modifications

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].

Concomitant Strong CYP3A4 Inducers

The concomitant use of strong CYP3A4 inducers should be avoided if possible. If patients must be co-administered a strong CYP3A4 inducer, increase the XTANDI dose from 160 mg to 240 mg once daily. If co-administration of the strong CYP3A4 inducer is discontinued, the XTANDI dose should be returned to the dose used prior to initiation of the strong CYP3A4 inducer [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

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: October 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/16/2015

Indications
Dosage
How Supplied

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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