Xtandi

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  • XTANDI

Xtandi

Facts of XTANDI (Enzalutamide) Capsules ?

  • Medicine Name: XTANDI
  • Generic Name: ENZALUTAMIDE
  • Date of Approval: 31.08.2012
  • Company Name: ASTELLAS.
Category:

Product Description

WHAT IS XTANDI?

Enzalutamide is an androgen receptor inhibitor. The chemical name is 4-{3-[4-cyano-3-(trifluoromethyl) phenyl]-5, 5dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide.

The molecular weight is 464.44 and molecular formula is C21H16F4N4O2S.

xtandia

Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water.

XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.

WHAT ARE THE INDICATIONS OF XTANDI?

XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

WHAT IS THE DOSAGE AND HOW IS IT ADMINISTERED?

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. 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.

HOW SUPPLIED/STORAGE AND HANDLING ?

How Supplied

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)

Storage and Handling:

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).

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