Europe — EMA
Nebido (Testosterone Undecanoate)
GNH USA supplies Nebido (Testosterone Undecanoate), a testosterone replacement therapy for male hypogonadism and testosterone deficiency.
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What is Testosterone Undecanoate?
Testosterone undecanoate, the active ingredient in Nebido, is an androgen presented as a long‑acting intramuscular injection for intramuscular use. It provides sustained physiological testosterone levels and is indicated for testosterone replacement therapy to treat male hypogonadism and other conditions associated with testosterone deficiency in adult men.
GNH USA supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across global markets.
What is Testosterone Undecanoate used for?
Nebido is an androgen used in testosterone replacement therapy to address disorders of low endogenous testosterone. - Male hypogonadism: restores normal testosterone concentrations and alleviates symptoms such as reduced libido, fatigue, and loss of muscle mass. - Primary hypogonadism: compensates for testicular failure by providing exogenous testosterone. - Secondary hypogonadism: replaces deficient gonadotropin‑stimulated testosterone production due to hypothalamic or pituitary dysfunction.
What are the side effects of Testosterone Undecanoate?
Nebido may cause a range of adverse reactions, varying from mild to serious.
Common Side Effects: - Injection site pain or erythema - Acne or oily skin - Increased red blood cell count (polycythemia) - Fluid retention or peripheral edema - Headache or dizziness - Mood changes or irritability
Serious or Rare Side Effects: - Severe allergic reaction (anaphylaxis) - Significant polycythemia leading to thrombosis - Cardiovascular events such as myocardial infarction or stroke - Liver function abnormalities - Prostate enlargement or aggravation of existing prostate disease - Testicular atrophy or infertility
What precautions apply to Testosterone Undecanoate?
Before initiating Nebido therapy, clinicians should consider several safety measures. - Screen for prostate cancer: perform baseline PSA and digital rectal exam. - Monitor hematocrit: check every 3–6 months to detect polycythemia. - Assess cardiovascular risk: evaluate history of heart disease or stroke. - Avoid use in patients with known hypersensitivity to testosterone products. - Pregnancy and breastfeeding: not indicated; avoid exposure in women. - Store at ambient temperature: keep in original packaging, protect from moisture and light.
What does Testosterone Undecanoate interact with?
Nebido can interact with several medicines, requiring careful management.
Major Interactions (Avoid): - Warfarin: may increase anticoagulant effect and bleeding risk. - Insulin or oral hypoglycemics: testosterone can alter glucose metabolism, necessitating dose adjustments. - Strong CYP3A4 inhibitors (e.g., ketoconazole): can raise testosterone levels and increase adverse event risk.
Moderate Interactions (Monitor Closely): - Other anticoagulants (e.g., apixaban): monitor coagulation parameters. - Glucocorticoids: may exacerbate fluid retention. - Statins: possible additive effect on liver enzymes; periodic liver function testing recommended.



