Testosterone Undecanoate

Status

FDA-approved. FDA-approved labeling exists as Aveed for testosterone replacement in men with primary or hypogonadotropic hypogonadism. It carries a boxed warning for pulmonary oil microembolism and anaphylaxis and is available only through a restricted REMS programme requiring a 30-minute post-injection observation period. Schedule III controlled substance.

What it is

A very long-acting testosterone ester given at long intervals in clinic.

What published research measured

The longest-acting injectable testosterone ester, formulated to allow dosing intervals of ten weeks or more after loading. Its trial base supports stable serum concentrations with fewer peaks and troughs than the shorter esters, which is the clinical argument for it. The AVEED label carries a boxed warning for serious pulmonary oil microembolism (POME) reactions — such as an urge to cough, shortness of breath and throat tightening — and anaphylaxis, which can occur during or after an injection. Because of that boxed warning, AVEED is available only through a restricted REMS programme with observation in the clinic after each injection. An oral undecanoate formulation also exists with a different absorption route and its own labeling.

Source

FDA labeling for Aveed, including the boxed warning and REMS requirement

Sources

• Testosterone cypionate label (DailyMed)