Nebido® (Testosterone undecanoate) EU Essential Information
Nebido® 1000 mg/ 4 ml, solution for injection. Refer to SmPC (date of revision: 16 August 2018) before prescribing.
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.
Testosterone replacement therapy of confirmed male hypogonadism.
Androgen-dependent carcinoma of the prostate or of the male mammary gland; past or present liver tumours; hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions:
Nebido® is not recommended for use in children and adolescents. Nebido® is not indicated for use in women. Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate gland and breast must be performed. The following laboratory parameters should be checked periodically: testosterone, haemoglobin, haematocrit, and liver function tests. Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia. Nebido® should be used with caution in cancer patients at risk of hypercalcaemia. Regular monitoring of serum calcium concentrations is recommended in these patients. Benign and malignant liver tumours have been reported in patients receiving testosterone replacement therapy. In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately. The limitations of using intramuscular injections in patients with acquired or inherited blood clotting irregularities always have to be observed. Testosterone and derivatives have been reported to increase the activity of coumarin-derived oral anticoagulants. Nebido® should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy. Nebido® should be used with caution in patients with epilepsy and migraine, as the conditions may be aggravated. Athletes should be advised that Nebido® contains an active substance which may produce a positive reaction in anti-doping tests. Androgens are not suitable for enhancing muscular development in healthy individuals or for increasing physical ability. As with all oily solutions, Nebido® must be injected strictly intramuscularly and very slowly (over two minutes). Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhydrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Treatment is usually supportive, e.g. by administration of supplemental oxygen.
Most frequent undesirable effects: acne and injection site pain. Suspected anaphylactic reactions after Nebido® injection have been reported. Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia. Other common adverse drug reactions (ADRs): polycythaemia, weight increased, hot flush, prostate specific antigen increased, prostate examination abnormal, benign prostate hyperplasia, injection site reactions (injection discomfort, pruritus, erythema, haematoma, irritation and reaction). Uncommon ADRs: Haematocrit increased, red blood cell count increased, haemoglobin increased, hypersensitivity, increased appetite, glycosylated haemoglobin increased, hypercholesterolaemia, blood triglycerides increased, blood cholesterol increased, depression, emotional disorder, insomnia, restlessness, aggression, irritability, headache, migraine, tremor, cardiovascular disorder, hypertension, dizziness, bronchitis, sinusitis, cough, dyspnoea, snoring, dysphonia, diarrhoea, nausea, liver function test abnormal, aspartate aminotransferase increased, alopecia, erythema, rash, pruritus, dry skin, arthralgia, pain in extremity, muscle disorders, musculoskeletal stiffness, blood creatine phosphokinase increased, urine flow decreased, urinary retention, urinary tract disorder, nocturia, dysuria, prostatic intraepithelial neoplasia, prostate induration, prostatitis, prostatic disorder, libido changes, testicular pain, breast induration, breast pain, gynaecomastia , oestradiol increased, testosterone increased, fatigue, asthenia, hyperhidrosis. Pulmonary oil microembolism is listed as a rare ADR. Other known ADRs of testosterone containing preparations: nervousness, hostility, sleep apnoea, various skin reactions including seborrhoea, increased hair growth, increased frequency of erections, rare cases of persistent, painful erections (priapism), in very rare cases jaundice. Therapy with high doses of testosterone commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles. High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.
Posology and method of administration:
Nebido® is injected every 10 to 14 weeks. Nebido® is strictly for intramuscular injection and must be administered very slowly (over two minutes). Care should be taken to inject Nebido® deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection. The first injection interval may be reduced to a minimum of 6 weeks. Nebido® is not indicated for use in children and adolescents and it has not been evaluated clinically in males under 18 years of age.
Medicinal product subject to medical prescription.
Marketing Authorisation holder:
Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen, Germany. For further details contact your local Bayer Pharma organisation.