Oral Treatment for Testosterone Replacement Available

Testosterone undecanoate (TLANDO), an oral treatment for testosterone replacement therapy in adult males, is now available. The medication is indicated for treatment of primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

The medication requires no titration, according to its manufacturer, Halozyme. It is a scheduled CIII controlled substance that was approved in March 2022. It is contraindicated in patients with carci+noma of the breast or known or suspected carcinoma of the prostate; pregnant women; and men with hypogonadal conditions that are not associated with structural or genetic etiologies.

Prescribing information for testosterone undecanoate contains a Boxed Warning addressing blood pressure increases that can increase the risk of major adverse cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. Consult product labeling for detailed information on risks and potential adverse effects of use.