Information for patients

Frequently asked questions about Nebido®

 
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  • How long can Nebido® be used?
    ScalesThere is no time limit for Nebido® treatment but regular monitoring should be performed in compliance with the guidelines.
  • What are the advantages of Nebido® compared to therapy with other testosterone medications?
    In comparison to conventional testosterone injections the use of Nebido® allows to avoid frequent unphysiological peaks and troughs and to reduce drastically the frequency of injections, the most frequent complaints of the patients. With Nebido® thinking about the condition “every day” is not necessary, a patient is not restricted in the activities of daily routine like bathing or swimming. As an injection Nebido® does not cause skin irritations like testosterone patches or gels and its resorption has no dependency on food intake like oral forms of testosterone.
  • What are the effects of Nebido®?
    1. Testosterone levels:

    Pharmacokinetic studies have shown that Nebido® maintains testosterone levels within the physiologic range. The recommended administration regime consists of one loading dose 6 weeks after the initial injection followed by intervals of 10 to 14 weeks (usually 3 months The initial short interval (loading dose) is advisable to quickly achieve steady state conditions. In order to adjust the treatment regimen to individual needs, a blood sample prior to the 4th injection, i.e. at trough level, is suggested. If testosterone levels are below the normal range, a shortening of the interval to 10 weeks may be considered. If testosterone levels are in the lower third of the normal range the 3-monthly interval should be maintained. If testosterone levels are above the lower third of the normal range, an extension of injection intervals can be considered. In any case, the clinical symptomatology of the patient must be taken into consideration.

    2. Clinical symptoms:

    As a consequence of the restoration of testosterone levels, significant improvements of certain clinical signs associated with the androgen deficit can be shown:

    • Nebido® has a favorable effect on body composition by increasing muscle mass and decreasing fat mass.
    • Muscle strength improves under therapy with Nebido®.
    • Sexual function parameters are improved with Nebido®.
    • Nebido® exerts a positive effect on mood, thus improving self-confidence and activity, and reduces fatigue and the feeling of exhaustion.
  • How is Nebido® used?
    The injections must be administered very slowly (over 1 to 2 minutes). It is possible and advisable to use a 22 G injection needle. Care should be taken to inject Nebido® deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be given to avoid intravasal injection. The content of an ampoule has to be injected intramuscularly immediately after opening the ampoule.

    Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. This is not specific for Nebido® and has been described for injections of testosterone in oily solutions in general. This can usually be avoided by injecting the solution very slowly and by making sure that the injection is strictly intramuscular.
  • When is the use of Nebido® contraindicated?
    Like every androgen therapy, the use of Nebido® is contraindicated in diagnosed or suspected carcinoma of the prostate or of the male mammary gland; hypercalcemia accompanying malignant tumors, past or present liver tumors; hypersensitivity to the active substance or to any of the excipients.

    Nebido® is not indicated for use in children and adolescents and it has not been evaluated clinically in males under 18 years of age. Furthermore, the use of Nebido® in women is contra-indicated.
  • Side effects
    The most frequent side effects of Nebido® observed are acne and injection site pain. These reactions are generally mild and transient. Other common side effects observed are typical of testosterone (e.g. polycythemia, weigth increase, hot flushes, prostate specific antigen increased, prostate examination abnormal, benign prostate hyperplasia).

    Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. This is not specific for Nebido® and has been described for injections of testosterone in oily solutions in general. This can usually be avoided by injecting the solution very slowly and by making sure that the injection is strictly intramuscular. Like with any medication, allergic reactions to any of the ingredients of the preparation may occur. With Nebido®, this has only been observed in extremely rare cases.
  • What happens if Nebido® and alcohol are used together?
    Intake of alcoholic drinks has no influence on the mode of action of Nebido®.
  • Does acne occur more frequently during Nebido® Therapy or can it make pre-existing acne worse?
    As with every testosterone therapy, acne can occur at the beginning of Nebido® therapy. This is not permanent, however, but subsides at varying rates. This is comparable to the occurrence of acne in adolescent boys during puberty, which is also linked to the rise in testosterone levels, but which subsides again either during or at the end of puberty.
  • Can I treat my hypogonadism by doing sport, i.e., by using the body’s own testosterone?
    Sport and a healthy diet are good supportive measures and contribute to general well-being but are not sufficient on their own. The amount of the body’s own testosterone which is released through the reduction of obesity by exercise is usually not sufficient to correct the hypogonadism.
  • What is the association between testosterone and doping?
    If the testosterone levels of a hypogonadal man (testosterone deficiency) are brought within the range of normal levels, this leads to a breakdown of fat and a build-up of muscle, the so-called anabolic effect. A very large testosterone overdose could be abused for doping purposes. However, all testosterone products are strictly prescription-only medicines. The indications for which they can be prescribed are listed in the package leaflet and have to be complied with very closely.
  • What is Bayer doing to avoid abuse/doping?
    Nebido® is only available on medical prescription, which lessens the risk of abuse. Since Nebido® is usually administered at the doctor’s office, the potential for abuse is largely reduced.

    A single injection of Nebido® cannot lead to overdosage, at least not to an elevation of mean testosterone serum levels above the normal range, provided that the testosterone serum levels have been in the low normal range or below. There have been studies with repeated injections in intervals of 6 weeks. Even then, most of the patients showed mean testosterone serum levels that remained within the normal range within 2-3 consecutive injections. One week after the injection, testosterone serum levels are at their maximum level. As with other depot-preparations, this peak may reach supraphysiological levels. However, peak levels have not been found to be of clinical relevance and sufficient for abuse as they are moderate and transient. In particular mood swings have not been reported under Nebido®, which could be explained by the slower velocity of level changes and the reduced absolute height.
  • Is it possible to overdose slightly with Nebido® with a subsequent risk of abuse? What happens then?
    Nebido® is packed in single units of one ampoule. Injections should be performed in the physician’s office in intervals of 10 to 14 weeks. Serum testosterone measurements should be performed for individualization of the therapy. An inadvertent overdose can thus be practically excluded. There have been reports of extreme overdoses with injection products. Normally, abuse should not occur if both the prescription (strictly according to the indication) and use (strictly according to the doctor’s instructions) are carried out in accordance with the treatment recommendations.

    A single injection of Nebido® cannot lead to overdosage, at least not to an elevation of mean testosterone serum levels above the normal range, provided that the testosterone serum levels have been in the low normal range or below. There have been studies with repeated injections in intervals of 6 weeks. Even then, most of the patient showed mean testosterone serum levels that remained within the normal range within 2-3 consecutive injections. One week after the injection, testosterone serum levels are at their maximum level. As with other depot-preparation, this peak may reach supraphysiological levels. However, peak levels have not been found to be of clinical relevance and sufficient for abuse as they are moderate and transient. In particular mood swings similar to short acting injections have not been reported under Nebido®, which could be explained by the slower velocity of level changes and the reduced absolute height.
Last updated: 2016
G.GM.MH.04.2015.0334