Europe — EMA
Nebido (Testosterone Undecanoate)
GNH USA supplies Nebido (Testosterone Undecanoate), a androgen for male hypogonadism, testosterone replacement therapy and delayed puberty in males.
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What is Testosterone Undecanoate?
Testosterone undecanoate, the active ingredient in Nebido, is an androgen presented as a 1000 mg per 4 ml vial for intramuscular injection. It is used to restore normal testosterone levels in men with primary or secondary hypogonadism, to provide long‑term testosterone replacement therapy in adult males, and to support delayed puberty in adolescent boys.
GNH USA supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance and timely delivery.
What is Testosterone Undecanoate used for?
Nebido (testosterone undecanoate) is used in androgen replacement therapy to address conditions related to low endogenous testosterone. Male hypogonadism (primary or secondary): Restores physiological testosterone levels, improving fatigue, libido, muscle strength and bone density. Testosterone replacement therapy in adult men: Maintains normal serum testosterone, supporting sexual function, mood, and metabolic health. Delayed puberty in males: Provides exogenous testosterone to stimulate development of secondary sexual characteristics.
What are the side effects of Testosterone Undecanoate?
Nebido may be associated with a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Injection site pain: Discomfort, erythema, or swelling at the injection site. - Headache: Transient mild to moderate headache. - Acne: Increased sebaceous gland activity leading to acneiform eruptions. - Fluid retention: Mild peripheral edema.
Serious or Rare Side Effects: - Polycythemia: Elevated red blood cell mass that may increase thrombosis risk. - Cardiovascular events: Rare occurrences of myocardial infarction or stroke. - Hepatotoxicity: Uncommon liver enzyme elevations or hepatic dysfunction.
What precautions apply to Testosterone Undecanoate?
Before prescribing Nebido, clinicians should consider several precautionary measures to ensure safe use. - Cardiovascular assessment: Evaluate history of heart disease, hypertension, or thromboembolic disorders. - Hematocrit monitoring: Check blood counts regularly to detect polycythemia. - Prostate evaluation: Perform baseline prostate-specific antigen testing and digital exam. - Liver function: Monitor hepatic enzymes in patients with pre‑existing liver disease. - Sleep apnea: Assess for obstructive sleep apnea, as testosterone may worsen the condition. - Store at ambient temperature: Keep vials below 25 °C, protected from light, and do not freeze.
What does Testosterone Undecanoate interact with?
Nebido can interact with other medicines, altering its efficacy or increasing the risk of adverse effects.
Major Interactions (Avoid): - Anticoagulants: Testosterone may enhance erythrocytosis, potentially affecting anticoagulation control. - CYP3A4 inhibitors: Strong inhibitors can increase testosterone levels, raising risk of side effects. - Glucocorticoids: May exacerbate fluid retention and hypertension.
Moderate Interactions (Monitor Closely): - Insulin and oral hypoglycemics: Testosterone can affect glucose metabolism, requiring dose adjustments. - Anabolic steroids: Combined use may increase androgenic effects and liver strain. - Warfarin: Altered hematocrit may influence INR stability.



