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Frequently Asked Questions
About KYZATREX®

KYZATREX is designed to simplify testosterone replacement therapy. Find answers to some of the most common questions and navigate your treatment with confidence.

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What is KYZATREX?

KYZATREX is an FDA-approved oral testosterone for men who have low or no testosterone levels due to certain medical conditions.

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

How does KYZATREX work?

KYZATREX is an immediate-release oral testosterone undecanoate. It is absorbed through the lymphatic system, where the body then uses it to replace testosterone that has been lost as a result of various medical conditions.

Who can take KYZATREX?

KYZATREX is used to treat men who have low or no testosterone due to certain medical conditions.

It is not known if KYZATREX is safe or effective in children younger than 18 years old. Improper use of KYZATREX may affect bone growth in children.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients.

How is low testosterone diagnosed?

Diagnosing Low T involves simple lab tests to measure your Total Testosterone (Total T) and Free Testosterone (Free T), along with Sex Hormone Binding Globulin (SHBG), which affects Free T availability. Total T gives an overall level, while Free T shows the testosterone available for your body’s use. High SHBG can lower Free T, impacting its availability. Your doctor may suggest these tests and follow-up labs to monitor your testosterone levels over time, ensuring your treatment is accurately tailored to your needs.

How do I take KYZATREX?

KYZATREX is taken orally, with two doses a day alongside food. Your healthcare provider will provide specific instructions based on your treatment plan.

Is KYZATREX safe?

KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

In the phase 3 clinical trial for KYZATREX (n=155), 4 patients (2.6%) reported high blood pressure. A total of 5 patients (3.2%) began taking new antihypertensive medications after study start. No patient increased their dose of antihypertensive medication.

Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX. If your blood pressure increases, you may need to start medication to control your blood pressure. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added. If your blood pressure cannot be controlled, KYZATREX may need to be stopped.

See additional Important Safety Information, including boxed warning, for KYZATREX below.

Is KYZATREX bad for my liver?

No. KYZATREX was specifically designed to be absorbed lymphatically. This means it bypasses your liver altogether, helping to avoid the liver toxicity often associated with previous generations of oral testosterone.1

How do I get KYZATREX?

KYZATREX is available by prescription. Consult with a healthcare provider knowledgeable in Low T management to discuss if KYZATREX is right for you and how you can obtain it.

Is KYZATREX covered by my insurance?

KYZATREX is a cash-pay medication, removing the complications of insurance. Your doctor will provide you with instructions on how to fill your KYZATREX prescription.

References:

  1. Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024;16:17562872241241864. Published 2024 Apr 10. doi:10.1177/17562872241241864

Important Safety Information for KYZATREX (testosterone undecanoate)

KYZATREX® (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX® is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX® is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children.

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