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‑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 India 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.

Manufacturer / TM Owner

Grünenthal Pharmaceuticals Gmbh & Co. Kg

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Indications & Clinical Uses

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.

How It Works

  • Testosterone undecanoate is slowly hydrolyzed after intramuscular injection to release testosterone. The liberated testosterone diffuses into target cells, binds intracellular androgen receptors, and the hormone‑receptor complex translocates to the nucleus where it binds androgen‑responsive elements on DNA, modulating gene transcription. This drives anabolic effects on muscle and bone and androgenic effects on sexual development and maintenance of secondary male characteristics.

Side Effects

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

Precautions & Warnings

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.

Avoid Interactions

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.

Frequently Asked Questions

Nebido is a long‑acting injectable formulation of testosterone undecanoate used in testosterone replacement therapy. It is prescribed to men with clinically confirmed testosterone deficiency or hypogonadism to restore normal hormone levels and improve associated symptoms such as low libido, fatigue, loss of muscle mass, and decreased bone density.

Testosterone undecanoate is hydrolyzed after intramuscular injection to release testosterone. The hormone binds to intracellular androgen receptors, and the resulting complex regulates gene transcription. This modulation promotes anabolic processes in muscle and bone and supports the development and maintenance of male secondary sexual characteristics.

The dosing regimen for Nebido is individualized by the prescribing clinician based on the patient’s serum testosterone levels, clinical response, and safety monitoring. Typically, a 1000 mg vial is administered as an intramuscular injection, with the interval between doses determined by the treating physician.

Nebido is not indicated for use in women, and its safety in pregnancy or lactation has not been established. Testosterone exposure can cause fetal harm, and the product should be avoided by pregnant or breastfeeding women. Men receiving Nebido should take precautions to prevent transfer to women of child‑bearing potential.

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 the necessary import documentation.

Nebido provides a prolonged release of testosterone, allowing dosing intervals of up to 12 weeks, which is longer than many other injectable testosterone esters that require more frequent administration. This can improve patient convenience and adherence, though individual response and safety profiles should be evaluated by the prescriber.

Nebido must be stored refrigerated at 2‑8 °C. Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking the product. If temporary temperature excursions occur, follow the manufacturer’s guidance before use.

Nebido is given as an intramuscular injection, usually into the gluteal muscle. The injection should be performed by a qualified healthcare professional using aseptic technique. The volume per vial is 3 mL containing 1000 mg of testosterone undecanoate.

Serious risks include erythrocytosis leading to thromboembolic events, worsening of pre‑existing prostate cancer, cardiovascular complications such as myocardial infarction or stroke, severe allergic reactions, and significant sleep‑apnea exacerbation. Regular monitoring of hematocrit, PSA, and cardiovascular status is essential.

Nebido is contraindicated in men with known or suspected prostate or breast cancer, severe untreated sleep‑apnea, uncontrolled heart failure, or a history of thromboembolic disease. Women, especially those who are pregnant or breastfeeding, should not be exposed to the product.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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