Europe — EMA
Nebido (Testosterone Undecanoate)
GNH USA supplies Nebido (testosterone undecanoate), a androgenic anabolic steroid for male hypogonadism and testosterone deficiency.
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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/4 ml vial for intramuscular injection. It is used to restore normal physiological testosterone levels in adult men with male hypogonadism or testosterone deficiency.
GNH USA supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across markets.
What is Testosterone Undecanoate used for?
Nebido (testosterone undecanoate) is employed in androgen replacement therapy to address conditions related to low endogenous testosterone. - Male hypogonadism: restores normal testosterone levels, improving symptoms such as fatigue, reduced libido, and muscle loss. - Testosterone deficiency: supports physiological hormone balance, aiding in the maintenance of secondary sexual characteristics and bone density. - Secondary hypogonadism due to pituitary or hypothalamic disorders: provides exogenous testosterone to compensate for impaired endogenous production.
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: mild to moderate discomfort at the injection site. - Headache: transient cranial pain. - Acne: increased sebaceous gland activity. - Fluid retention: mild peripheral edema.
Serious or Rare Side Effects: - Thromboembolic events: deep vein thrombosis or pulmonary embolism. - Cardiovascular complications: myocardial infarction or stroke. - Severe allergic reaction: anaphylaxis or angioedema. - Prostate abnormalities: rapid growth or cancer progression.
What precautions apply to Testosterone Undecanoate?
When prescribing Nebido, clinicians should consider several precautionary measures to ensure safe use. - Cardiovascular assessment: evaluate history of heart disease before initiating therapy. - Hematocrit monitoring: check red blood cell levels periodically to detect polycythemia. - Prostate evaluation: perform baseline prostate‑specific antigen testing and digital exam. - Liver function: assess hepatic enzymes prior to treatment and during therapy. - Contraindications: avoid use in patients with known hypersensitivity to testosterone undecanoate. - 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, influencing its efficacy or safety.
Major Interactions (Avoid): - Anticoagulants (e.g., warfarin): increased risk of thrombosis. - CYP3A4 inhibitors (e.g., ketoconazole): may raise testosterone levels, heightening adverse effects. - Glucocorticoids: can exacerbate fluid retention and hypertension.
Moderate Interactions (Monitor Closely): - Insulin or oral hypoglycemics: testosterone may affect glucose control. - Antihypertensives: possible reduction in blood pressure response. - Thyroid hormones: may alter thyroid function tests.



