Jatenzo's label will be marketed with a boxed warning stating it can cause risen blood pressure, thereby increasing heart attack, stroke, and cardiovascular death risks.
The US Food and Drug Administration (FDA) has approved testosterone undecanoate (Jatenzo) for the treatment of men with hypogonadism. The oral capsule therapy is designated for men with low testosterone levels due to specific genetic disorders or pituitary gland-damaging tumors.
However, the FDA approval does not designate undecanoate for age-related hypogonadism—in which men’s testosterone levels are in decline due to aging—due to the therapy’s benefits not outweighing its risks in that use.
The efficacy of Jatenzo, from Clarus Therapeutics, was demonstrated in a four-month clinical trial in which a 237 mg oral drug was administered twice daily to 166 men with hypogonadism. Patient doses were adjusted either downward or upward to a maximum of 396 mg twice daily based on current testosterone levels.
Investigators reported that 87% of therapy-treated men achieved the primary endpoint of an average normal-range testosterone level. Common adverse effects, which occurred in at least 2% of patients in the trial included headache, red blood cell count increases, decreases in high-density lipoprotein cholesterol, high blood pressure, and nausea.
Testosterone undecanoate’s label will be marketed with a boxed warning stating it can cause risen blood pressure, thereby increasing heart attack, stroke, and cardiovascular death risks. Physicians are advised to periodically monitor their patients’ blood pressure during treatment.
With the approval, testosterone undecanoate becomes the second testosterone product to carry that warning. The FDA requires all testosterone product manufacturers to perform post-marketing blood pressure trials to better address the products’ risks.
Hylton V. Joffe, MD, MMSc, director of the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said that testosterone undecanoate’s oral administration makes it an “important addition to current treatment options available” for the patient population. Up until now, most testosterone products are administered subcutaneously or intravenously.
“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’,” Joffe said in a statement. “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.”