Tlando (testosterone undecanoate) is now available 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 conditions such as 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 [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) 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.

The Food and Drug Administration (FDA) approved Tlando in March 2022 based on data from a multicenter, open-label, single-arm phase 3 study (ClinicalTrials.gov Identifier: NCT03242590), which evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients. Results demonstrated that the trial met the primary endpoint with 80% (95% CI, 72-88) of patients achieving a 24-hour average serum testosterone concentration within the normal range of 300-1080ng/dL on the final visit of the study.

Tlando carries a Boxed Warning regarding blood pressure increases that can increase the risk of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke and cardiovascular death. Due to this risk, Tlando should only be used for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. 

The most common adverse reactions reported with Tlando include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, increased weight, headache, and musculoskeletal pain. 

Tlando is supplied as 112.5mg of testosterone undecanoate capsules in a 120-count bottle; it is not substitutable with other oral testosterone undecanoate products.

Prior to initiating treatment, a diagnosis of hypogonadism should be confirmed by ensuring that serum testosterone concentrations have been measured in the morning on at least 2 separate days and that these serum testosterone concentrations are below the normal range. Serum testosterone should be monitored 3 to 4 weeks after starting Tlando and periodically thereafter.

References

  1. Halozyme announces commercial launch of Tlando™, an oral treatment for testosterone replacement therapy. News release. Halozyme Therapeutics, Inc. Accessed June 7, 2022. https://www.prnewswire.com/news-releases/halozyme-announces-commercial-launch-of-tlando-an-oral-treatment-for-testosterone-replacement-therapy-301562608.html
  2. Tlando. Package insert. Antares Pharma Inc.; 2022. Accessed June 7, 2022. https://www.antarespharma.com/application/files/6316/4851/6244/TLANDO-PI-Medguide_-3.22.2022.pdf