Jatenzo® (testosterone undecanoate; Clarus Therapeutics), an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.
Specifically, Jatenzo is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
- Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone, luteinizing hormone above the normal range.
- Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Jatenzo is not intended for use in males with age-related hypogonadism and its safety and efficacy have not been established in males <18 years old.
The treatment carries a Boxed Warning related to blood pressure (BP) increases that could potentially increase the risk of major adverse cardiovascular events. In a clinical trial, Jatenzo increased systolic BP during 4 months of treatment by an average of 4.9 mmHg based on ambulatory BP monitoring and by an average of 2.8 mmHg from baseline based on BP cuff measurements. For this reason, baseline cardiovascular risk should be considered before initiating therapy and BP should be adequately controlled. Among study patients treated with Jatenzo, 7% were started on antihypertensive medications or required intensification of their antihypertensive medication regimen during the 4-month trial.
Jatenzo, a Schedule III controlled substance, is available in 158mg, 198mg, and 237mg softgels. Dosage should be individualized based on serum testosterone concentrations.
“Jatenzo offers patients a convenient softgel formulation, and eliminates the worry of gel transference, skin irritation from patches, or pain from injections that other testosterone treatments carry,” said Dr Ronald S. Swerdloff, lead investigator of the inTUne trial, the pivotal study that established the safety and efficacy of the treatment.
For more information visit jatenzo.com.