Testosterone Capsule Gets FDA Green Light

Jatenzo is the first oral testosterone medication approved in decades

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new oral form of testosterone.

Jatenzo (testosterone undecanoate) is a newly approved capsule used to treat hypogonadism. Hypogonadism occurs when organs in the body do not produce the right amount of testosterone. Jatenzo is only for low testosterone caused by certain conditions, including Klinefelter syndrome and tumors that damage the pituitary gland.

An oral form of testosterone provides a new treatment approach. Patients who currently use testosterone often must inject it or apply it to the skin. Jatenzo is to be taken with food.

As with all medications, testosterone is tied to potentially serious side effects, such as a risk of increased blood pressure.

As a result, some patients who take testosterone may face a raised risk of a heart attack, stroke or cardiac death. Jatenzo carries a boxed warning that notes all of these potential events.

Other possible side effects of Jatenzo include a headache and nausea.

Patients can also see an increase in hematocrit (red blood cell count) or a decrease in HDL (“good”) cholesterol. Your health care provider will monitor you while you are taking this medication.

In trials, the initial medication dose was 237 mg twice a day, but the dose was adjusted based on testosterone levels.

This medication is not for everyone. Men with breast cancer or known or suspected prostate cancer should not use Jatenzo. Like other testosterone treatments, Jatenzo is not to be used to treat age-related hypogonadism. The benefits of testosterone treatments, including Jatenzo, have not been established for this use.

Depending on what is causing your hypogonadism, Jatenzo may or may not be right for you. Speaking with your health care provider can help you be sure. For more information on this condition, check out "Low Testosterone."

The FDA granted approval of this medication to Clarus Therapeutics.

Written by Digital Pharmacist Staff

Review Date: 
April 1, 2019