In March 2019, after many years of refusal by the FDA and legal wrangles with its direct competition, Lipocine, Clarus Therapeutics testosterone capsule Jatenzo (testosterone undecanoate) was finally approved. This approval has meant that for the first time in over 60 years, a new oral testosterone drug has made its way to the market.
In November 2019 another new oral testosterone drug, Tlando (testosterone undecanoate) received a tentative approval from the FDA. This is not the same as the approval that Jatenzo has received as Tlando is not allowed on to the open market until March 2022 (Jatenzo has an exclusivity period which does not expire until March 2022).
Both Jatenzo and Tlando are claimed to be liver safe, in that, unlike previous oral testosterone treatments they do not cause Hepatotoxicity – which is effectively liver damage caused by certain drugs (including oral testosterone).
Jatenzo is designed to treat both primary hypogonadism (congenital or acquired) which includes but is not limited to klinefelter’s syndrome, chemotherapy damage, toxic damage from alcohol and bilateral torsion and hypogonadotropic hypogonadism (congenital or acquired) which includes but is not limited to injury from tumours, trauma or radiation and luteinizing hormone deficiency.
Jatenzo is available in 5 different dosing options: 1 x 158 mg daily, 1 x 198 mg daily, 1 x 237 mg daily, 2 x 158 mg daily (316 mg) and 2 x 198 mg daily (396 mg) softgels. Dosage is individual based on serum testosterone levels.
Tlando is made by Lipocine Enhancing Health based in Salt Lake City, Utah, USA. Tlando is available as a single dosing option where 450 mg is split between two doses of 225 mg orally (one x am, one x pm). This makes for fewer doctor visits as no dosage adjustment is required.
Directions
The starting dose for Jatenzo is 1 x 237 mg softgel in the morning with food followed by a further 1 x 237 mg softgel in the evening with food.
The starting dose for Tlando is 1 x 225 mg softgel in the morning with food followed by a further 1 x 225 mg softgel in the evening with food.
Precautions
Jatenzo and Tlando carries a “black box” warning stating that the patients’ blood pressure (BP) could increase to the point of the risk of major adverse cardiovascular events.
Advantages
Offers patients a convenient way to get their testosterone dose. Eliminates gel transference, skin irritation from patches or pain from injections.
Disadvantages
Cannot be taken by patients under the age of 18. Risk of major adverse cardiovascular events. Jatenzo and Tlando may cause gastro-intestinal issues such as burping, diarrhoea and heart burn.
