The FDA has announced its decision to remove the Black Boxed Warning related to an increase in adverse cardiovascular outcomes. Read the full announcement here.
We appreciate your interest in bringing KYZATREX to your practice. Our dedicated sales representatives are here to help. They will reach out to schedule a time to meet with you, where they’ll provide detailed information about KYZATREX, its benefits, and how it can fit into your treatment offerings.
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What is KYZATREX®
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.
It is not known if KYZATREX® is safe or effective in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”).
KYZATREX® is not meant for use by women.
Important Safety Information for KYZATREX
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.
Before you take KYZATREX®, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX® with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.
Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).
KYZATREX may cause other serious side effects including:
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effect of KYZATREX® is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.
These are not all the possible side effects of KYZATREX®. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius [by visiting www.mariuspharma.com].
Keep KYZATREX and all medicines out of the reach of children.
See Full Prescribing Information and Medication Guide for KYZATREX.
Important Safety Information for KYZATREX (testosterone undecanoate)
KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke.
Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.
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