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 long‑acting intramuscular injection for intramuscular use. It is employed to restore physiological testosterone levels in men with hypogonadism, providing both androgenic and anabolic effects.

GNH India supplies Nebido as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to EU quality standards and providing reliable cold‑chain logistics where required. The product is manufactured under strict GMP conditions and is available for export to multiple regions.

Manufacturer / TM Owner

Grünenthal Gmbh

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Indications & Clinical Uses

  • Nebido is used in androgen replacement therapy to address conditions associated with low endogenous testosterone.
  • Male hypogonadism: restores normal testosterone levels, improving fatigue, libido and muscle mass.
  • Secondary hypogonadism: provides exogenous testosterone when pituitary or hypothalamic dysfunction reduces hormone production.
  • Testosterone replacement therapy: maintains physiological testosterone concentrations in men requiring long‑acting supplementation.
  • Age‑related testosterone decline: helps alleviate symptoms of low testosterone in older men.

How It Works

  • Testosterone undecanoate is a lipophilic ester of testosterone that, after intramuscular injection, is slowly hydrolysed by esterases to release free testosterone. The liberated testosterone binds to intracellular androgen receptors, modulating gene transcription and promoting anabolic processes such as protein synthesis, while also exerting androgenic effects on secondary sexual characteristics. It also influences the hypothalamic‑pituitary‑gonadal axis by providing negative feedback, reducing luteinizing hormone secretion, which helps stabilize endogenous production.

Side Effects

Nebido may be associated with a range of adverse reactions, which are generally classified by frequency and severity.

Common Side Effects

  • Injection site pain: mild discomfort or bruising at the injection site.
  • Acne: increased sebaceous gland activity leading to breakouts.
  • Fluid retention: mild edema, especially in lower extremities.
  • Increased hematocrit: rise in red blood cell mass causing thicker blood.
  • Headache: transient mild to moderate headache.

Serious or Rare Side Effects

  • Cardiovascular events: rare cases of myocardial infarction or stroke.
  • Severe allergic reaction: anaphylaxis, urticaria, or angioedema.
  • Prostate abnormalities: rapid growth of existing prostate cancer or significant PSA rise.

Precautions & Warnings

Before initiating Nebido therapy, several precautions should be considered to ensure safe use.

  • Screen for prostate cancer: perform baseline PSA and digital rectal exam.
  • Assess cardiovascular risk: evaluate history of heart disease, stroke, or thrombosis.
  • Monitor hematocrit: regular blood tests to detect polycythemia.
  • Avoid in patients with untreated severe sleep apnea.
  • Contraindicated in known hypersensitivity to testosterone undecanoate or excipients.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): increased risk of thrombosis due to elevated hematocrit.
  • Insulin or oral hypoglycemics: testosterone may enhance insulin resistance, requiring dose adjustment.
  • CYP3A4 inhibitors (e.g., ketoconazole): may increase testosterone levels, raising risk of adverse effects.
  • 5α‑reductase inhibitors: may reduce conversion to dihydrotestosterone, affecting efficacy.

Moderate Interactions (Monitor Closely)

  • Glucocorticoids: may exacerbate fluid retention.
  • Thiazide diuretics: can potentiate blood pressure changes.
  • Estrogen therapy: may counteract androgenic effects.

Frequently Asked Questions

Nebido is indicated for testosterone replacement therapy in men with primary or secondary hypogonadism, as well as for managing age‑related testosterone decline. It helps restore normal hormone levels, improving symptoms such as low libido, fatigue, loss of muscle mass, and mood changes.

Testosterone undecanoate is a long‑acting ester that, after intramuscular injection, is slowly hydrolysed to free testosterone. The released hormone binds to androgen receptors, influencing gene expression that drives anabolic processes, sexual development, and maintenance of secondary male characteristics.

The dosing regimen for Nebido is determined by the prescribing clinician based on the patient’s age, weight, baseline testosterone levels, and clinical response. Typically, an initial loading dose is followed by maintenance injections at intervals recommended by the treating physician.

Nebido is not indicated for use in women, and its safety in pregnancy or lactation has not been established. It is generally contraindicated for pregnant or nursing individuals because testosterone can affect fetal development and milk production.

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 where required) and necessary import documentation.

Nebido offers a long‑acting depot effect, typically requiring injection only every 10‑12 weeks, whereas shorter‑acting esters such as testosterone enanthate or cypionate need weekly or bi‑weekly dosing. This reduces clinic visits and provides more stable serum testosterone levels, but the longer half‑life may delay adjustment of dose if side effects occur.

Nebido should be stored at 2‑8 °C in a refrigerator, protected from light. Do not freeze or shake the vial. Keep it in the original packaging until use and discard any product that has been exposed to temperatures outside the recommended range.

Nebido is given as an intramuscular injection, usually into the gluteal muscle. After an initial loading dose, maintenance injections are administered at intervals prescribed by the healthcare provider, commonly every 10‑12 weeks, to maintain stable testosterone concentrations.

Serious risks associated with Nebido include cardiovascular events such as myocardial infarction or stroke, severe allergic reactions (anaphylaxis, angioedema), and rapid progression of undiagnosed prostate cancer. Patients should be monitored regularly for cardiovascular health, hematocrit levels, and prostate status.

Nebido is contraindicated in individuals with known hypersensitivity to testosterone undecanoate or any excipients, untreated severe sleep apnea, active prostate or breast cancer, and those with uncontrolled cardiovascular disease. It should also be avoided in women who are pregnant, planning pregnancy, or breastfeeding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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