Nebido Testosterone Undecanoate Injection

Description

Nebido is a testosterone preparation for intramuscular injection. One ampoule contains 1,000 mg testosterone undecanoate in 4 mL oily vehicle (castor oil). The shelf life of Nebido is 5 years. Nebido is the first long-acting testosterone injection for the treatment of male hypogonadism. Nebido contains 1,000 mg of testosterone undecanoate in a 4 mL oily solution in an innovative formulation which offers a superior kinetic profile. After administration of Nebido, testosterone levels remain within the physiological range for about 12 weeks. Therefore, only 4 injections per year are required in long-term testosterone therapy. Nebido avoids unphysiological peaks and troughs in serum testosterone. It has been established in clinical studies that testosterone levels are already back to the normal range 3 days after the first administration of Nebido. On testosterone concentrations in the blood Pharmacokinetic studies have demonstrated that testosterone levels are restored to the physiological range within 3 days after the first administration of Nebido. With an interval between injections of about 12 weeks, testosterone concentrations remain constantly within the physiological range. The first dosing interval may be reduced to six weeks, which enables steady state testosterone levels to be achieved more rapidly. On clinical symptoms Nebido improves the symptoms associated with testosterone deficiency. Nebido exerts a positive effect on sexual function and mood, increases muscle mass and muscle strength and decreases body fat. The most frequent side effects observed with Nebido are reactions at the injection site. These reactions are generally mild and transient. All other side effects observed in isolated cases are typical of testosterone (such as diarrhoea, joint pain, sweating, headache, acne, chest pain and gynaecomastia). Pulmonary oil microembolism has been observed after injection during routine clinical practice and in rare cases lead to signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. The patient should therefore be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism. Treatment is usually supportive, e.g. by administration of supplemental oxygen. Attention should be paid to the following recommendations for dosage: First and second administration of Nebido 6 weeks apart. Subsequently, depending on the needs of the individual patient, an interval of about 12 weeks is recommended. The first interval between injections may also be shortened to six weeks for patients who have switched from other testosterone preparations to Nebido, under observation of clinical symptoms. Ideally one ampoule of Nebido is injected deeply into the gluteal muscle slowly over a period of approximately 2 minutes. Measurement of serum trough testosterone levels and clinical symptoms should be considered for individualization of therapy with Nebido. Serum trough testosterone levels should be in the lower third of the normal range. Since steady state serum testosterone levels can be assumed to be achieved after the first six months of treatment, it appears advisable to control serum testosterone before the fourth injection (usual spacing between administrations provided).