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 a 1000 mg/4 mL intramuscular injection solution for intramuscular use. As a long‑acting ester prodrug, it is hydrolyzed after injection to release testosterone, treating male hypogonadism, providing testosterone replacement therapy, and addressing delayed puberty in males.

GNH India supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution across the European Union and adherence to stringent quality and regulatory standards, and reliable logistics for timely delivery.

Manufacturer / TM Owner

Sa Grünenthal N.V.

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Indications & Clinical Uses

  • Nebido (testosterone undecanoate) acts on the androgen pathway to restore physiological testosterone levels in men with deficiency states.
  • Male hypogonadism: restores normal testosterone concentrations, improving energy, libido and muscle mass.
  • Testosterone replacement therapy: alleviates symptoms of testosterone deficiency such as fatigue, loss of bone density and reduced sexual function.
  • Delayed puberty in males: supports development of secondary sexual characteristics and growth.

How It Works

  • Testosterone undecanoate is a long‑acting ester prodrug that, after intramuscular injection, is hydrolyzed to testosterone. The liberated testosterone binds to intracellular androgen receptors, modulating gene transcription and producing both androgenic and anabolic effects that restore normal hormonal balance in deficient individuals.

Side Effects

Nebido may be associated with a range of adverse reactions following intramuscular administration.

Common Side Effects

  • Injection site pain
  • Headache
  • Acne

Serious or Rare Side Effects

  • Polycythemia leading to thrombosis
  • Cardiovascular events such as myocardial infarction or stroke
  • Severe allergic reactions including anaphylaxis

Precautions & Warnings

  • Prior to initiating Nebido, several safety considerations should be observed.
  • Monitor hematocrit: check blood counts regularly to detect polycythemia.
  • Assess prostate health: evaluate for benign hypertrophy or cancer before initiating therapy.
  • Evaluate cardiovascular risk: consider history of heart disease before treatment.
  • Avoid use in known breast cancer: contraindicated due to androgenic stimulation.
  • Use caution in liver disease: adjust monitoring if hepatic impairment present.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Nebido can interact with other medicines; some combinations should be avoided while others require close monitoring.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased bleeding risk.
  • Insulin or oral hypoglycemics: altered glucose control, may require dose adjustment.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole): raise testosterone levels, risk of adverse effects.

Moderate Interactions (Monitor Closely)

  • Antihypertensives: may enhance blood pressure lowering effect.
  • Glucocorticoids: may suppress endogenous hormone axis, requiring monitoring.
  • Selective serotonin reuptake inhibitors (SSRIs): may affect libido, monitor patient response.

Frequently Asked Questions

Nebido is indicated for the treatment of male hypogonadism, testosterone replacement therapy in men with documented deficiency, and for the management of delayed puberty in adolescent males. It helps restore normal testosterone levels, improving symptoms such as low energy, reduced libido, loss of muscle mass, and delayed sexual development.

Testosterone undecanoate is a long‑acting ester that is hydrolyzed after intramuscular injection to release active testosterone. The testosterone binds to androgen receptors in target tissues, influencing gene expression that drives both androgenic and anabolic processes, thereby normalising hormonal balance and supporting male secondary sexual characteristics.

The specific dose and dosing interval of Nebido are determined by the prescribing clinician based on the patient’s age, weight, severity of testosterone deficiency, and treatment goals. Physicians typically follow approved labeling guidelines, and patients should follow the individualized regimen provided by their healthcare professional.

Nebido is not indicated for use in pregnant or breastfeeding individuals. Safety data are lacking, and testosterone therapy can affect fetal development and milk production. It is contraindicated in women who are or may become pregnant, and breastfeeding women should avoid exposure unless specifically advised by a qualified physician.

To order 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 required) and necessary import documentation.

Nebido provides a long‑acting intramuscular formulation that requires fewer injections (typically every 10‑14 weeks) 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 2‑8 °C in a refrigerator, protected from light. The vial must not be frozen or shaken. If temporary storage at ambient temperature is unavoidable for brief periods, the product should be returned to refrigeration as soon as possible to maintain stability.

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

Serious risks include polycythemia, which can increase the chance of blood clots, cardiovascular events such as heart attack or stroke, severe allergic reactions (anaphylaxis), and potential worsening of prostate disease. Patients should be monitored regularly for hematocrit levels, cardiovascular health, and prostate status.

Nebido is contraindicated in individuals with known or suspected prostate cancer, breast cancer, severe untreated sleep apnea, uncontrolled heart failure, or those who have experienced a severe allergic reaction to testosterone undecanoate or any excipients in the formulation. It should also be avoided in women who are pregnant or breastfeeding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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