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 an oil solution for intramuscular injection use. It is employed in hormone replacement therapy to address male hypogonadism by restoring physiological testosterone levels.

GNH India supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution aligned to EU regulatory standards. The company ensures product quality, traceability and compliance with cold‑chain requirements where applicable through rigorous quality control and validated shipping processes.

Manufacturer / TM Owner

Grünenthal Pharma Ltd.

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Indications & Clinical Uses

Nebido is used in androgen deficiency conditions to restore normal testosterone levels.

  • Male hypogonadism: restores physiological testosterone concentrations, improving symptoms such as low libido, fatigue and loss of muscle mass.
  • Testosterone replacement therapy: provides long‑acting testosterone support for men requiring hormone supplementation.
  • Secondary hypogonadism: compensates for insufficient endogenous testosterone production due to pituitary or hypothalamic dysfunction.

How It Works

  • Testosterone undecanoate is a long‑acting prodrug that, after intramuscular injection, is hydrolyzed to testosterone. The released testosterone binds to intracellular androgen receptors, modulating gene transcription and producing androgenic and anabolic effects that restore normal male hormonal function.

Side Effects

Nebido may cause a range of adverse reactions.

Common Side Effects

  • Injection site pain or swelling.
  • Acne or oily skin.
  • Increased hematocrit (red blood cell count).
  • Gynecomastia (breast tenderness or enlargement).

Serious or Rare Side Effects

  • Polycythemia leading to thrombosis.
  • Severe allergic reaction (anaphylaxis).
  • Cardiovascular events such as myocardial infarction.

Precautions & Warnings

Before initiating Nebido therapy, several safety considerations are recommended.

  • Assess baseline testosterone levels: confirm diagnosis before initiating therapy.
  • Monitor hematocrit and hemoglobin: check regularly to detect polycythemia.
  • Evaluate prostate health: conduct PSA testing and digital exam prior to treatment.
  • Review cardiovascular risk: consider history of heart disease before use.
  • Avoid use in men with known breast cancer: contraindicated.
  • Store at ambient temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Nebido can interact with other medicines; awareness of major and moderate interactions helps manage risk.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased risk of thrombosis due to elevated hematocrit.
  • CYP3A4 inhibitors (e.g., ketoconazole): may raise testosterone levels excessively.
  • Insulin or oral hypoglycemics: testosterone can alter glucose metabolism.

Moderate Interactions (Monitor Closely)

  • Glucocorticoids: may exacerbate fluid retention.
  • Antihypertensives: testosterone may affect blood pressure control.
  • Lipid‑lowering agents: monitor lipid profile as testosterone can modify cholesterol.

Frequently Asked Questions

Nebido is indicated for hormone replacement therapy in men with male hypogonadism or other conditions requiring testosterone supplementation. It helps restore normal testosterone levels, alleviating symptoms such as reduced libido, fatigue, loss of muscle mass, and mood changes.

Testosterone undecanoate is a long‑acting prodrug that is hydrolyzed after intramuscular injection to release testosterone. The active hormone binds to androgen receptors in target tissues, influencing gene expression and producing anabolic and androgenic effects that normalize male hormonal function.

The dosing regimen for Nebido is individualized by the prescribing healthcare professional based on the patient’s clinical condition, baseline testosterone levels, and response to therapy. Only a qualified prescriber should determine the appropriate dose and injection interval.

Nebido is not intended for use in women, and safety data for pregnancy or breastfeeding are lacking. It is contraindicated in women of child‑bearing potential unless effective contraception is used, and it should not be administered to nursing mothers.

To place an order, submit an enquiry on the Nebido 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 required import documentation.

Nebido offers a long‑acting formulation that typically requires only two injections per year, reducing the frequency of clinic visits compared with shorter‑acting testosterone esters that may need weekly or bi‑weekly dosing. This extended dosing interval can improve patient convenience and adherence while maintaining stable serum testosterone levels.

Nebido should be stored at ambient temperature, preferably below 25 °C, in its original packaging. Protect the vial from direct light, moisture and extreme temperature fluctuations. Do not freeze the product, and handle it with aseptic technique when preparing for intramuscular injection.

Nebido is administered as an intramuscular injection, usually into the gluteal muscle, by a qualified healthcare professional. The injection is given as a deep intramuscular depot, allowing the testosterone undecanoate to be released slowly over several months.

Serious risks include polycythemia, which can increase the chance of blood clots; cardiovascular events such as myocardial infarction or stroke; and potential exacerbation of prostate disease. Patients should be monitored regularly for hematocrit levels, cardiovascular health, and prostate-specific antigen (PSA) changes.

Nebido is contraindicated in men with known or suspected prostate or breast cancer, severe untreated sleep apnea, uncontrolled heart failure, or those who have experienced allergic reactions to testosterone undecanoate or any component of the formulation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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