Product image of Nebido (Testosterone Undecanoate) supplied by GNH India

Nebido

Active Ingredient:
Testosterone Undecanoate
Origin:
EU

Nebido (Testosterone Undecanoate)

Testosterone undecanoate, the active ingredient in Nebido, is an androgen; anabolic steroid presented as a 1000 mg/4 mL (250 mg/mL) intramuscular injection solution for intramuscular use. It treats male hypogonadism, testosterone deficiency and delayed puberty in males.

GNH India supplies Nebido as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Grünenthal Pharma Ltd.

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Indications & Clinical Uses

Nebido (testosterone undecanoate) is used in androgen replacement therapy to restore physiological testosterone levels.

  • Male hypogonadism: restores normal testosterone concentrations, improving libido, energy and muscle mass.
  • Testosterone deficiency: normalizes serum testosterone, supporting mood, bone health and erythropoiesis.
  • Delayed puberty in males: provides exogenous testosterone to initiate and sustain pubertal development.

How It Works

  • Testosterone undecanoate is a long‑acting ester of testosterone. After intramuscular injection, the ester is slowly hydrolyzed, releasing testosterone into the bloodstream. The hormone binds intracellular androgen receptors, forming a complex that translocates to the nucleus and binds androgen‑responsive elements, modulating transcription of genes involved in male sexual development, protein synthesis, erythropoiesis and bone metabolism.

Side Effects

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 pimples.
  • Fluid retention: mild edema, especially in lower extremities.
  • Increased hematocrit: rise in red blood cell count, potentially causing thicker blood.

Serious or Rare Side Effects

  • Polycythemia: excessive increase in red blood cells that may raise thrombotic risk.
  • Cardiovascular events: rare occurrences of myocardial infarction or stroke.
  • Hepatotoxicity: very rare liver enzyme elevations.

Precautions & Warnings

Before initiating Nebido, clinicians should assess individual risk factors and monitor patients regularly.

  • Cardiovascular assessment: evaluate history of heart disease before starting therapy.
  • Hematocrit monitoring: check blood counts periodically to detect polycythemia.
  • Prostate evaluation: screen for prostate cancer or benign prostatic hyperplasia prior to treatment.
  • Sleep apnea screening: assess for sleep‑disordered breathing as testosterone may worsen it.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Nebido can interact with several medicines; interactions are grouped by clinical significance.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): testosterone‑induced erythropoiesis may increase clot risk.
  • Insulin or oral hypoglycemics: testosterone may affect glucose metabolism, requiring dose adjustments.
  • Corticosteroids: concurrent use may exacerbate fluid retention.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may reduce metabolism of testosterone undecanoate, raising serum levels.
  • GnRH analogues: may blunt the intended androgenic effect.
  • 5α‑reductase inhibitors (e.g., finasteride): may alter conversion to dihydrotestosterone, affecting efficacy.

Frequently Asked Questions

Nebido is indicated for testosterone replacement in adult men with primary or secondary hypogonadism, for patients diagnosed with testosterone deficiency, and for the treatment of delayed puberty in adolescent males. The therapy aims to restore normal physiological testosterone levels and alleviate associated symptoms.

Testosterone undecanoate is a long‑acting ester of testosterone. After intramuscular injection, the ester is hydrolyzed, releasing testosterone that binds androgen receptors in target tissues. This receptor activation regulates gene expression involved in sexual development, muscle growth, bone density, and red blood cell production.

The specific dose and dosing interval of Nebido are determined by the prescribing clinician based on the patient’s clinical condition, baseline testosterone levels, and response to therapy. Physicians typically individualize the regimen; patients should follow the prescriber’s instructions without self‑adjusting the dose.

Nebido is not intended for use in women, and its safety in pregnancy or lactation has not been established. The product is classified for male hormone replacement, and it should be avoided in pregnant or nursing women. If exposure occurs, medical advice should be sought promptly.

To order Nebido, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials and respond with pricing, availability, shipping details (including cold‑chain handling if required) and any necessary import documentation.

Nebido provides a long‑acting intramuscular formulation that requires dosing every 10‑12 weeks, reducing injection frequency compared with shorter‑acting esters such as testosterone enanthate or cypionate. Transdermal gels and patches offer daily administration but may cause skin irritation. Choice of product depends on patient preference, adherence considerations, and clinical response.

Nebido should be stored at 2‑8 °C in a refrigerator, protected from light. Do not freeze or shake the vial. If temporary storage at room temperature is unavoidable, limit exposure to less than 30 °C for a short period and return the product to refrigeration promptly.

Nebido is administered as a deep intramuscular injection, typically into the gluteal muscle. The injection is performed by a qualified healthcare professional using aseptic technique. The volume is 4 mL containing 1000 mg of testosterone undecanoate, and the dosing schedule is set by the prescriber.

Serious risks include polycythemia (elevated red blood cell count), which can increase clotting risk; cardiovascular events such as myocardial infarction or stroke; and potential exacerbation of prostate disease. Patients should be monitored regularly for hematocrit, cardiovascular status, and prostate health throughout therapy.

Nebido is contraindicated in individuals with known hypersensitivity to testosterone undecanoate, in patients with active prostate or breast cancer, in those with severe untreated sleep‑apnea, and in men with uncontrolled cardiovascular disease. It should also be avoided in women and children, as the product is intended for male hormone replacement.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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