Xtandi (enzalutamide) Price, Approval, Prescribing Information, and Side Effects | Samar Borhani, PharmD | RxEconsult
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Xtandi (enzalutamide) Price, Dosage, Prescribing Information, and Side Effects Category: Cancer by - June 18, 2014 | Views: 26393 | Likes: 1 | Comment: 0  

Brand Name: Xtandi Xtandi Prescribing Information
Generic Name: enzalutamide

Drug Class: Antiandrogen 
Manufacturer: Catalent Pharma Solutions, LLC
FDA Approval Date: August 2012

What is Xtandi and its mechanism of action?

Xtandi is an androgen receptor inhibitor and it is FDA approved for treating prostate cancer. It affects the androgen receptor signaling pathway. Androgen is a steroid hormone responsible for male characteristics. In prostate cancer, androgens cause an increase in production of prostate cells. Xtandi inhibits the binding of androgen to prostate cells, resulting in decrease in production of prostate cancer cells.

What does Xtandi Treat?

Xtandi is used for metastatic castration-resistant prostate cancer in patients who were previously treated with docetaxel. Metastatic castration-resistant prostate cancer is a prostate cancer that does not respond to any treatments that decreases testosterone and the cancer has spread to other parts of the body.

Who should not use Xtandi?

  • Female patients
  • Xtandi may cause fetal damage when used during pregnancy, therefore it is contraindicated in patients who are pregnant or planning to become pregnant.
  • Xtandi should be used with cautious in patients with history of seizure disorders because it causes seizures.

How effective is Xtandi?

In a clinical study trial 1199 patients who had previously received docetaxel were given Xtandi 160 mg once daily or a daily dose of placebo. 48% of the Xtandi group and 46% of the placebo group were also placed on a glucocorticoid treatment. After 18 months the reported deaths in the Xtandi group were 38.5% of patients compared to 53.1% in the placebo group.

Interesting facts about Xtandi

Males with female sexual partners of child bearing age must use a condom and female partners must use an effective form of birth control during treatment and for 3 months after treatment with Xtandi.

What is the dosing of Xtandi?

The recommended dose of Xtandi is 160 mg by mouth once daily. Xtandi is supplied as a 40 mg capsule, therefore patients  are required to take 4 capsules once every day. It can be taken with or without food and it should be swallowed whole, not chewed, crushed or dissolved in water. 

What are the side effects of Xtandi?

Xtandi can cause fatigue, back pain, diarrhea, joint pain, swelling in feet, headache, upper and lower respiratory infection, dizziness, insomnia, anxiety, hot flashes, high blood pressure, blood in the urine, seizures, and low white blood cells (neutropenia).

What are Xtandi drug interactions?

Avoid combining Xtandi with the following drugs:

  • Rifampin because it may decrease the concentration of Xtandi
  • Gemfibrozil and trimethoprim may increase the concentration of Xtandi
  • Anticonvulsants, barbiturates, and St. John’s Wort may decrease the concentration of Xtandi
  • Xtandi may decrease blood levels of midazolam, warfarin, and omeprazole

What is the price of Xtandi?

The wholesale price of a bottle of Xtandi 40 mg containing 120 capsules is $9467.46

How to obtain prescription cost assistance for Xtandi

To receive patient assistant on your Xtandi prescription visit Astellas Patients Assistance.

References

Xtandi Prescribing Information. Catalent Pharma Solutions, LLC. St. Petersburg: August 2012

RED BOOK Online. XTANDI. Truven Health Analytics, Inc.; 2014 



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