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Nebido (Testosterone Undecanoate)

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Also Known As

Testosterone undecanoate, TU, Aveed (US brand name for injectable testosterone undecanoate), Andriol (oral testosterone undecanoate brand name), Jatenzo (oral testosterone undecanoate brand name), Tlando (oral testosterone undecanoate brand name), Kyzatrex (oral testosterone undecanoate brand name)

Definition

Nebido is a medication containing testosterone undecanoate, a long-acting ester of the naturally occurring androgen testosterone. It is used in adult men for testosterone replacement to treat various health problems caused by a deficiency of testosterone (male hypogonadism)1,2. Testosterone undecanoate works by being slowly released into the body after intramuscular injection, where it is then converted to testosterone. Testosterone is the primary male sex hormone responsible for the development and maintenance of male reproductive tissues and secondary sexual characteristics. The purpose of Nebido is to restore testosterone levels to the physiological range, thereby alleviating symptoms associated with testosterone deficiency, such as decreased libido, erectile dysfunction, fatigue, depressed mood, and loss of muscle mass and bone density1,3.

Clinical Context

Nebido is clinically used for testosterone replacement therapy in adult men diagnosed with male hypogonadism, where testosterone deficiency has been confirmed by both clinical features and biochemical tests1,3. Clinical features indicative of testosterone deficiency include regression of secondary sexual characteristics, changes in body composition (e.g., increased body fat, decreased muscle mass), asthenia (weakness), reduced libido, erectile dysfunction, and mood disturbances1,3. Patient selection criteria require a confirmed diagnosis of hypogonadism (either primary or secondary) and exclusion of other causes for the symptoms. Before initiating treatment, patients must undergo a detailed medical examination, including checks for pre-existing prostate cancer. Regular monitoring of the prostate gland, breast, testosterone levels, haemoglobin, haematocrit, liver function, and lipid profile is necessary during therapy1.

Nebido is administered as an intramuscular injection of 1000 mg testosterone undecanoate, typically every 10 to 14 weeks. This frequency is designed to maintain sufficient testosterone levels without leading to accumulation. The injection must be administered very slowly (over two minutes) by a healthcare professional. Expected outcomes include the alleviation of hypogonadal symptoms, such as improvements in libido, sexual function, mood, energy levels, muscle mass, and bone density3.

Scientific Citation

[1] Nebido 1000 mg/4 ml solution for injection - Summary of Product Characteristics (SmPC). Electronic Medicines Compendium (emc). Last updated 08 Mar 2023. Available from: https://www.medicines.org.uk/emc/product/14631/smpc

[2] Bayer PLC. NEBIDO 1000 mg/4 ml, solution for injection. Patient Information Leaflet.

[3] Campbell K, Muthigi A, Ghomeshi A, Schuppe K, Sandler MD, Ramasamy R. Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights. Drug Healthc Patient Saf. 2023 Mar 31;15:73-84. DOI: 10.2147/DHPS.S383130.

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