The Food and Drug Administration (FDA) has approved Jatenzo (testosterone undecanoate; Clarus Therapeutics) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.

Jatenzo is not intended for use in males with age-related hypogonadism and its safety and efficacy have not been established in males aged <18 years.

Its efficacy was evaluated in a 4-month trial (NCT02722278) that assigned 166 patients to Jatenzo 237 mg twice daily, and was adjusted up or down based on testosterone levels (max 396 mg twice daily); the study included a Screening Phase, a Treatment Titration Phase, and a Treatment Maintenance Phase. The data showed that 87% (145/166) of men who received Jatenzo achieved an average testosterone level within normal range (primary endpoint).

“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,” said Hylton V. Joffe, MD, MMSc, director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Jatenzo carries a Boxed Warning describing an increase in blood pressure, increasing the risk of myocardial infarction, stroke, and cardiovascular death. Clinicians should assess the patient’s risk of heart disease and ensure adequately controlled blood pressure prior to initiating Jatenzo; periodic monitoring during treatment is also recommended.

Headache, increased hematocrit, decreased HDL, high blood pressure, and nausea were the most common adverse effects as well as an increase in prostate specific antigen (PSA).

Jatenzo will be available as 158 mg, 198 mg, and 237 mg strength capsules in 120-count bottles.

For more information call (800) 208-4115 or visit ClarusTherapeutics.com.

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This article originally appeared on MPR