Nebido Special Precautions

Older patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia. Although there are no clear indications that androgens actually generate prostatic carcinoma, these can enhance the growth of any existing prostatic carcinoma. Therefore carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.
As a precaution, regular examinations of the prostate are recommended in men.
Testosterone replacement therapy should only be given to men when deficiency of the hormone has been confirmed by clinical features and biochemical tests. Testosterone levels should then be monitored regularly during treatment. Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly.
Hemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythemia (see Adverse Reactions).
As a general rule, the limitations of using intramuscular injections in patients with acquired or inherited bleeding disorders must always be observed. Testosterone and derivatives have been reported to increase the effect of coumarin derived anticoagulants (see also Interactions).
Venous Thromboembolism: There have been post-marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products such as Nebido. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Nebido and initiate appropriate workup and management. Caution is advised when testosterone is used in patients with thrombophilia, as cases of thrombosis have been reported among this patient group during therapy with testosterone in post-marketing studies and reports.
Cases of benign and malignant liver tumors have been reported in users of hormonal substances, such as androgen compounds. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur in men using Nebido, a liver tumor should be included in the differential-diagnostic considerations.
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 (see Adverse Reactions). In such a case, treatment must be stopped immediately.
Caution is advised in patients with pre-existing hypertension, since testosterone may cause an increase in blood pressure. Clinical trials with Nebido in children or adolescents under the age of 18 have so far not been conducted.
In children testosterone, besides masculinization, can cause accelerated growth and bone maturation and premature epiphyseal closure, thereby reducing final height. The appearance of common acne has to be expected.
There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age. It should be borne in mind that physiological testosterone levels naturally decrease somewhat with age.
Preexisting sleep apnea may be potentiated.
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. Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnea, 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.
Suspected anaphylactic reactions after Nebido injection have been reported.