The U.S. Food and Drug Administration (FDA) has approved Jatenzo, an oral testosterone capsule manufactured by Clarus Therapeutics, for the treatment of certain forms of hypogonadism in men.
It is considered safe and effective for men with low testosterone caused by specific medical conditions – such as genetic disorders (Klinefelter syndrome) or the pituitary gland tumor.
Please note that Jatenzo is not advised to men with hypogonadism caused by aging, in which testosterone levels are decreased due to advancing age, even though they have symptoms similar to low testosterone.
Dr. Hylton V. Joffe, the director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, said, “Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected.”
“But it’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism.’ The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population,” he added.
Jatenzo comes with a boxed warning on its labeling, which states that the drug can increase blood pressure, thereby increasing the risk of stroke, heart attack, and even cardiovascular death.
Prescribing doctors should consider a patient’s heart disease risk and make sure that blood pressure is adequately controlled before recommending Jatenzo. Also, they should periodically monitor the patient’s blood pressure during the therapy.
Currently, Jatenzo is one of two testosterone products, which have this boxed warning. The agency has advised all testosterone product manufacturers to conduct and monitor blood pressure post-marketing clinical trials so that it can be better understood whether the products increase blood pressure.
According to clinical trials, common side effects of Jatenzo, which may occur in more than 2 percent of patients, include headache, an increase in red blood cell count, a decrease in HDL (good) cholesterol, high blood pressure, and nausea. Patients should have their red blood cell count, cholesterol, and PSA checked regularly during treatment. Men with benign prostate hyperplasia (BPH) should be checked for worsening of symptoms.
