Nebido® - the first registered testosterone undecanoate preparation for intramuscular injection

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Product name: Nebido®

Indications: Hypogonadism

Licensed for: Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. Nebido® is licensed in more than 80 countries worldwide.

Disease or condition: Typical signs of testosterone deficiency, known as hypogonadism, may include: Increased irritability or depression, fatigue, decreased concentration, noticeable decrease in lean body mass and increase in fat mass, particularly abdominal fat, decreased libido and sex drive, erectile dysfunction and decreased frequency of morning erections, reduced muscle mass and strength, loss of body hair, osteoporosis.

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    Package: 4 ml solution containing 1000 mg testosterone undecanoate as active ingredient (corresponding to 631.5 mg testosterone) and benzyl benzoate and castor oil as excipients.

    Durability: As stability tests have shown that Nebido® is stable at a temperature of 30°C for at least 24 months and at a temperature of 40°C for at least 6 months, there are no particular precautions for storing the product. It is recommended to store the product at room temperature. Shelf life is 5 years in most countries. The medicinal product must be used immediately after first opening.

    Nebido® - dosage: Nebido® is injected in intervals of 10-14 weeks. It is advisable to reduce the first interval to 6 weeks in order to reduce the time until steady state conditions are reached. (During the initial time of treatment the mean concentration of testosterone is slowly increasing with each injection. Steady state is reached when the amount of testosterone supplied with an injection replaces exactly what has been metabolised from the intramuscular depot). Individualisation of therapy is required and should be based on serum testosterone levels achieved under Nebido® treatment and clinical symptomatology.

    Nebido® provides testosterone to men whose testes do not produce enough testosterone. The injection is an intramuscularly administered depot preparation of testosterone undecanoate. Following intramuscular injection of testosterone undecanoate as an oily solution, the compound is gradually released from the depot and immediately cleaved by serum esterases into testosterone and undecanoic acid. An increase in serum levels of testosterone above basal values may be seen immediately after administration. The muscle serves as a depot for the sustained release of testosterone into the systemic circulation.

    Circulating testosterone is chiefly bound in the serum to sex hormone-binding globulin (SHBG) and albumin. The albumin-bound fraction of testosterone easily dissociates from albumin and is presumed to be bioactive. The portion of testosterone bound to SHBG is not considered biologically active. The amount of SHBG in the serum and the total testosterone level will determine the ratio of bioactive and non-bioactive androgen. SHBG-binding capacity is high in prepubertal children, declines during puberty and adulthood, and increases again during the later decades of life. Approximately 60 % of testosterone in plasma is bound to SHBG, 2 % remains unbound (free) and the rest is bound to albumin and other proteins1.

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