Europe — EMA
Nebido (Testosterone Undecanoate)
GNH USA supplies Nebido (Testosterone Undecanoate), an androgenic anabolic steroid for male hypogonadism, testosterone deficiency and delayed puberty
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What is Testosterone Undecanoate?
Testosterone undecanoate, the active ingredient in Nebido, is an androgenic anabolic steroid presented as a 1000 mg/3 mL vial for intramuscular use. It provides sustained release of testosterone after injection and is used to treat male hypogonadism, testosterone deficiency, and delayed puberty in males.
GNH USA supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Testosterone Undecanoate used for?
Nebido, a long‑acting testosterone replacement, is used in conditions related to androgen deficiency.
- Male hypogonadism: restores normal testosterone levels and alleviates symptoms such as low libido, fatigue, and loss of muscle mass. - Testosterone deficiency: improves energy, mood, and bone density in men with documented low serum testosterone. - Delayed puberty in males: supports the development of secondary sexual characteristics and normal growth.
What are the side effects of Testosterone Undecanoate?
Nebido may be associated with a range of adverse reactions, which are generally categorized by frequency and severity.
Common Side Effects: - Injection site pain: mild to moderate discomfort at the injection site. - Acne: increased sebaceous gland activity leading to skin eruptions. - Fluid retention: mild edema, especially in lower extremities. - Increased hematocrit: elevated red blood cell count.
Serious or Rare Side Effects: - Cardiovascular events: myocardial infarction or stroke. - Liver toxicity: abnormal liver function tests or hepatitis. - Polycythemia: excessive increase in red blood cell mass. - Allergic reactions: anaphylaxis or severe hypersensitivity.
What precautions apply to Testosterone Undecanoate?
Before initiating Nebido, several safety considerations should be reviewed.
- Cardiovascular assessment: evaluate history of heart disease before initiating therapy. - Hematocrit monitoring: check blood counts regularly to detect polycythemia. - Prostate evaluation: screen for prostate cancer or benign hyperplasia prior to treatment. - Sleep apnea screening: assess for obstructive sleep apnea as testosterone may worsen it. - Fertility considerations: discuss potential impact on spermatogenesis with patients desiring fertility. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Testosterone Undecanoate interact with?
Nebido can interact with other medicines, requiring attention to the level of risk.
Major Interactions (Avoid): - Anticoagulants: testosterone may enhance pro‑coagulant effects, increasing thrombosis risk. - Corticosteroids: combined use can exacerbate fluid retention and hypertension. - Insulin or oral hypoglycemics: testosterone may alter glucose metabolism, requiring dose adjustments.
Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole): may increase testosterone levels. - Warfarin: monitor INR as testosterone can affect clotting parameters. - GnRH analogues: concurrent use may blunt testosterone’s intended effects.



