KYZATREX is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. 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.
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); or are allergic to KYZATREX® or any of its ingredients.
The most common side effect of KYZATREX is high blood pressure. 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 antihypertensive medication dose.
KYZATREX can cause serious side effects. Tell your healthcare provider if you have high blood pressure, a history of diabetes, heart problems, high red blood cell count (hematocrit), high hemoglobin laboratory value, urinary problems due to an enlarged prostate, liver or kidney problems, sleep apnea, which can increase risk of side effects.
See additional Important Safety Information, including boxed warning, for KYZATREX below.
KYZATREX is an FDA-approved oral testosterone for men who have low or no testosterone levels due to certain medical conditions. It is taken twice daily with a fat-containing meal and is available by prescription only. KYZATREX is a controlled substance (CIII) because it contains testosterone.