Testosterone undecanoate is or has been marketed under a variety of brand names, including Andriol, Androxon, Aveed, Cernos Depot, Jatenzo, Kyzatrex, Nebido, Nebido-R, Panteston, Reandron 1000, Restandol, Sustanon 250, Undecanoate 250, and Undestor. In July 2022, the FDA approved Kyzatrex, another oral capsule formulation of the drug, to Marius Pharmaceuticals. The fourth attempt at approval was successful when the manufacturer agreed to implement a Risk Evaluation and Mitigation Strategy (REMS) to manage these potential respiratory and allergic reactions. Ciba Pharmaceutical Products first filed for a patent for an injectable combination drug (Triolandren) containing testosterone undecylenate (a precursor to the modern undecanoate ester) in Switzerland in 1954 and the US in 1955. A related testosterone ester with a similarly very long duration is testosterone buciclate. Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Of the153 patients enrolled in the pivotal clinical study utilizing AVEED, 26 (17.0%) were over 65 years of age. Reduced fertility is observed in some men taking testosterone replacement therapy. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy. In the 84-week clinical trial, 7 patients (4.6%) discontinued treatment because of adverse reactions. Table 1 presents adverse reactions reported by ≥1% of patients in the 84-week clinical study. Following each injection of AVEED, observe patients in the healthcare setting for 30 minutes in order to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis see WARNINGS AND PRECAUTIONS. AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of POME and anaphylaxis. It offers the advantages of less frequent dosing with injectable formulations and the convenience of oral administration. It’s crucial to use TU only as prescribed by a healthcare professional and to report any concerning side effects immediately. Injectable TU is administered as an intramuscular injection, typically into the buttock muscle. Some formulations, like Andriol, also undergo metabolism in the liver, which can decrease bioavailability and may be a concern for patients with liver disease. DHT concentrations increased in parallel with testosterone concentrations during AVEED treatment. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH see WARNINGS AND PRECAUTIONS. Androgens, including AVEED, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Intravascular injection of AVEED may lead to POME see WARNINGS AND PRECAUTIONS. Inject AVEED deeply into the gluteal muscle following the usual precautions for intramuscular administration; care must be taken to avoid intravascular injection see Administration Instructions. Withdrawal symptoms may occur if you stop taking this medication. Ease of use when considering either gels or orals allow for higher patient compliance.
