Europe — EMA
Nebido (Testosterone Undecanoate)
GNH USA supplies Nebido (Testosterone Undecanoate), a androgen‑and 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 androgen‑and anabolic steroid presented as a 1000 mg per 3 mL vial for intramuscular injection. It is indicated for testosterone replacement therapy, addressing testosterone deficiency and male hypogonadism in adult men, and is marketed across the European Union.
GNH USA supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing regulatory‑approved product for global procurement. The company follows stringent quality standards and offers cold‑chain logistics where required.
What is Testosterone Undecanoate used for?
Nebido (testosterone undecanoate) is used in testosterone replacement therapy to restore normal androgen levels. - Male hypogonadism: restores physiological testosterone concentrations and improves related symptoms such as low libido, fatigue and reduced muscle mass. - Testosterone deficiency: alleviates low energy, diminished sexual drive and loss of bone density associated with low endogenous testosterone. - Delayed puberty in males (hypogonadotropic): supports development of secondary sexual characteristics and normal growth.
What are the side effects of Testosterone Undecanoate?
Nebido may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Acne or oily skin - Increased red blood cell count (polycythemia) - Fluid retention or peripheral edema - Elevated prostate‑specific antigen (PSA) levels - Mood swings or irritability - Pain, swelling or bruising at the injection site
Serious or Rare Side Effects: - Erythrocytosis leading to thromboembolic events - Cardiovascular complications such as myocardial infarction or stroke - Severe allergic reactions (anaphylaxis, angioedema) - Progression of pre‑existing prostate cancer - Significant sleep‑apnea worsening - Hepatotoxicity or liver enzyme elevation
What precautions apply to Testosterone Undecanoate?
Before initiating Nebido therapy, clinicians should assess several safety parameters. - Hematocrit monitoring: regularly check red blood cell levels to detect polycythemia. - Prostate evaluation: perform baseline PSA testing and digital rectal exam. - Cardiovascular risk assessment: consider history of heart disease or stroke. - Sleep‑apnea screening: use caution in patients with known obstructive sleep‑apnea. - Women of childbearing potential: avoid exposure; the drug is not indicated for use in pregnancy or lactation. - 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, altering its efficacy or safety profile.
Major Interactions (Avoid): - 5‑alpha‑reductase inhibitors (e.g., finasteride): may reduce the conversion of testosterone to dihydrotestosterone, affecting therapeutic outcomes. - Warfarin: testosterone can enhance coagulation, potentially increasing INR. - Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise serum testosterone levels, increasing risk of adverse effects.
Moderate Interactions (Monitor Closely): - Antihypertensives: fluid retention from testosterone may blunt blood‑pressure control. - Anticoagulants (other than warfarin): monitor for changes in bleeding risk. - Other anabolic steroids: additive androgenic effects may increase toxicity. - Lithium: possible increase in lithium levels. - NSAIDs: concurrent use may affect renal function, especially in volume‑depleted patients.



