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.
Hemoglobin and hematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythemia (see Adverse Reactions).
As a general rule, the risk of bleeding from using intramuscular injections in patients with acquired or inherited bleeding disorders always has to be taken into account. Testosterone and derivatives have been reported to increase the activity of coumarin derived oral anticoagulants (see also Interactions).
Testosterone 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.
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 Testosterone undecanoate (Nebido), a liver tumor should be included in the differential-diagnostic considerations.
Caution should be exercised in patients predisposed to edema, e.g. in case of severe cardiac, hepatic, or renal insufficiency or ischemic heart disease, as treatment with androgens may result in increased retention of sodium and water. In case of severe complications characterized by edema with or without congestive heart failure, treatment must be stopped immediately (see Adverse Reactions).
Testosterone may cause a rise in blood pressure and Testosterone undecanoate (Nebido) should be used with caution in men with hypertension.
Clinical trials with Testosterone undecanoate (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, bone maturation and premature epiphyseal closure, thereby reducing final height. The appearance of common acne has to be expected.
Preexisting sleep apnea may be potentiated.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids.
Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use.
Abuse of testosterone along with other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events.
As with all oily solutions, Testosterone undecanoate (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, 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.
Suspected anaphylactic reactions after Testosterone undecanoate (Nebido) injection have been reported.
Effects on ability to drive or use machines: No observed effects.