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 presented as an intramuscular injection for intramuscular use. It is indicated for the treatment of male hypogonadism and testosterone deficiency in adult men, helping to restore normal physiological testosterone levels.

GNH India supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution across EU and other regulated markets.

Manufacturer / TM Owner

Grünenthal Österreich Gmbh

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Indications & Clinical Uses

Nebido is an androgen replacement therapy used to address conditions related to insufficient endogenous testosterone.

  • Male hypogonadism: restores serum testosterone to physiological ranges, improving symptoms such as fatigue and reduced libido.
  • Testosterone deficiency: supports normal sexual function, muscle mass, and bone density in affected men.
  • Secondary hypogonadism: provides exogenous testosterone when pituitary or hypothalamic dysfunction limits natural production.

How It Works

  • Testosterone undecanoate is hydrolyzed after intramuscular administration to release testosterone, which binds to intracellular androgen receptors. The hormone‑receptor complex then translocates to the nucleus, modulating gene transcription that promotes anabolic processes, spermatogenesis, and secondary sexual characteristics, thereby normalizing deficient testosterone levels.

Side Effects

Nebido may cause a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Injection site pain: mild discomfort at the injection site.
  • Acne: increased sebaceous gland activity.
  • Fluid retention: mild edema, especially in lower extremities.
  • Increased red blood cell count: polycythemia risk.
  • Breast tenderness: occasional gynecomastia.
  • Elevated libido: heightened sexual desire.

Serious or Rare Side Effects

  • Polycythemia: excessive hematocrit requiring monitoring.
  • Cardiovascular events: potential increased risk of thrombosis.
  • Liver toxicity: rare hepatic enzyme elevations.
  • Prostate enlargement: possible worsening of benign prostatic hyperplasia.
  • Severe hypertension: significant blood pressure rise.
  • Allergic reactions: anaphylaxis or severe skin rash.

Precautions & Warnings

Nebido requires careful patient assessment and monitoring.

  • Cardiovascular assessment: evaluate history of heart disease before initiation.
  • Hematocrit monitoring: check blood counts regularly to detect polycythemia.
  • Prostate evaluation: screen for prostate cancer or BPH prior to therapy.
  • Liver function: assess hepatic enzymes periodically.
  • Pregnancy and breastfeeding: contraindicated; avoid exposure in women of childbearing potential.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Nebido can interact with several medications, altering efficacy or safety.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased bleeding risk.
  • Insulin or oral hypoglycemics: may affect glucose control.
  • CYP3A4 inhibitors (e.g., ketoconazole): raise testosterone levels.

Moderate Interactions (Monitor Closely)

  • Glucocorticoids: may exacerbate fluid retention.
  • Statins: potential for altered lipid metabolism.
  • Antihypertensives: possible attenuation of blood pressure control.

Frequently Asked Questions

Nebido is prescribed to treat adult men with male hypogonadism or testosterone deficiency. By providing a long‑acting source of testosterone, it helps alleviate symptoms such as low libido, fatigue, loss of muscle mass, and decreased bone density, restoring normal hormonal balance.

Testosterone undecanoate is hydrolyzed after intramuscular injection to release testosterone. The hormone binds to intracellular androgen receptors, influencing gene expression that promotes anabolic effects, spermatogenesis, and development of secondary sexual characteristics, thereby compensating for low endogenous testosterone.

The dosing regimen for Nebido is determined by the prescribing physician based on the individual’s clinical condition, serum testosterone levels, and response to therapy. Physicians typically follow approved labeling guidelines, and patients should follow the specific instructions provided by their healthcare professional.

Nebido is contraindicated in women who are pregnant or breastfeeding. Testosterone can cause fetal harm and may affect milk production. Women of childbearing potential should use effective contraception during treatment and for a period after the last dose as advised by their clinician.

To request Nebido, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling if needed), and necessary import documentation.

Nebido offers a long‑acting intramuscular formulation that requires dosing every 10‑12 weeks, compared with shorter‑acting testosterone esters that may need weekly or bi‑weekly injections. This extended interval can improve adherence and reduce injection‑site discomfort, while providing comparable efficacy in restoring testosterone levels.

Nebido should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and do not freeze or shake the product. Maintaining the cold chain ensures the stability and potency of the testosterone undecanoate suspension.

Nebido is given as an intramuscular injection, typically into the gluteal muscle. A healthcare professional administers the dose using a sterile technique. The injection volume and frequency are determined by the prescribing clinician, and patients should receive the injection in a clinical setting.

Serious risks include polycythemia (elevated red blood cell count), cardiovascular events such as thrombosis, liver toxicity, worsening of prostate disease, and severe allergic reactions. Regular monitoring of hematocrit, liver function, and prostate health is essential to mitigate these risks.

Nebido is contraindicated in men with known hypersensitivity to testosterone undecanoate, those with prostate or breast cancer, severe untreated sleep apnea, uncontrolled heart failure, or significant liver disease. Women who are pregnant, breastfeeding, or of childbearing potential without effective contraception should also avoid this medication.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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