Nebido® (Testosterone Undecanoate) 1000 mg/4 ml solution for IM injection

What is Nebido® (Testosterone Undecanoate) 1000 mg/4 ml?

Nebido® is a long-acting testosterone therapy designed to address testosterone deficiency (hypogonadism) in men.

It is an injectable solution containing testosterone undecanoate at a concentration of 250 mg/ml.

With a single injection, it provides a steady release of testosterone for up to 10-14 weeks, minimizing the need for frequent administration.

This therapy is intended for men with clinically and biochemically confirmed testosterone deficiency.

Symptoms may include fatigue, low libido, erectile dysfunction, and decreased muscle mass. Nebido® is not intended for use by women or children under 18.

How Does Nebido® Work?

Nebido® (testosterone undecanoate) is a long-acting testosterone therapy specifically designed to maintain stable testosterone levels in men with hypogonadism.

Its mechanism of action relies on the slow and consistent release of testosterone from the injection site into the bloodstream, ensuring prolonged therapeutic effects.

Key Mechanisms of Action:

1. Intramuscular Depot Formation
   After an injection, the testosterone undecanoate in Nebido® forms a depot in the muscle tissue (typically the gluteal muscle). This depot gradually releases the hormone into the bloodstream over a period of several weeks.

2. Conversion to Active Testosterone
   Once released, testosterone undecanoate undergoes enzymatic breakdown in the body, converting it into active testosterone. This hormone binds to androgen receptors in various tissues, triggering physiological responses that restore normal testosterone function.

3. Maintained Hormonal Balance
   Unlike shorter-acting testosterone treatments that can cause fluctuations in hormone levels, Nebido® provides a steady release, minimizing peaks and troughs. This reduces the likelihood of mood swings, energy dips, or other side effects associated with inconsistent testosterone levels.

   
   

Effects on the Body:

• Muscle and Bone Health: Testosterone plays a vital role in maintaining muscle mass, strength, and bone density. Nebido® helps restore these functions, reducing the risk of muscle wasting and bone fractures.

• Sexual Function: Testosterone is crucial for libido, erectile function, and overall sexual health. Nebido® helps normalize these functions in men experiencing deficiencies.

• Mood and Cognitive Benefits: Low testosterone levels are often linked to fatigue, depression, and irritability. By stabilizing testosterone, Nebido® can improve mood, focus, and overall quality of life.

• Metabolic Regulation: Testosterone influences fat distribution, energy levels, and insulin sensitivity. Nebido® may support metabolic balance and reduce the symptoms of low testosterone, such as weight gain or lethargy.

  
  

Administration for Long-Lasting Effects:

Nebido® is formulated to provide therapeutic testosterone levels for 10-14 weeks with a single injection. The long-acting nature of the therapy makes it particularly convenient for patients, eliminating the need for frequent doses required by other forms of testosterone replacement therapy (e.g., gels or shorter-acting injections).

Monitoring and Adjustments:

To ensure effectiveness:

• Blood tests are conducted to monitor testosterone levels during the treatment.
• Adjustments to the dosing interval may be made if levels are too high or too low, ensuring that testosterone levels remain within the optimal range.

By delivering a controlled and sustained release of testosterone, Nebido® provides a reliable solution for managing hypogonadism, helping men regain vitality and balance in their live

When is Nebido® Recommended?

Nebido® is prescribed for testosterone replacement therapy in men diagnosed with hypogonadism. This condition is confirmed through clinical symptoms and laboratory tests showing low testosterone levels. Common signs of deficiency include:

• Reduced sexual desire and erectile dysfunction
• Loss of secondary sexual characteristics
• Muscle weakness and fatigue
• Depressive mood or irritability

It is crucial to confirm these symptoms through thorough medical evaluations before starting therapy.

What Precautions Should You Take Before Using Nebido®?

1. Medical Assessments

Before starting Nebido®, a detailed medical examination is necessary. This includes ruling out conditions like prostate cancer, which androgens may worsen. Regular monitoring, including prostate exams and blood tests, is essential during treatment.

2. Conditions to Avoid

Nebido® is contraindicated in men with:

• Prostate or breast cancer
• Liver tumors (current or historical)
• Allergies to testosterone or its excipients

It should also be used cautiously in individuals with:

• Severe heart, kidney, or liver disease
• High blood pressure or a history of blood clots
• Migraines, epilepsy, or sleep apnea

How is Nebido® Administered?

Nebido® is a solution for intramuscular injection. The standard dose is 1000 mg every 10-14 weeks.

Administration Guidelines:

• Initial Dose: In some cases, the first injection interval may be shortened to 6 weeks for faster stabilization.
• Maintenance Dose: Regular monitoring ensures that testosterone levels remain within a healthy range. Adjustments to injection intervals may be made based on test results and symptoms.

Important Notes:

• The injection must be administered deeply into the gluteal muscle by a healthcare professional.
• Avoid injecting into blood vessels.
• Allow the solution to reach room temperature before use to ensure proper consistency.

Are There Potential Side Effects?

Like all medications, Nebido® may cause side effects. Commonly reported reactions include:

• Injection Site Issues: Pain, redness, or swelling
• Acne and Skin Reactions
• Weight Gain
• Mood Changes: Irritability or aggression
• Prostate Changes: Increased PSA levels or benign prostatic hyperplasia

Rare but severe reactions may include:

• Lung microembolism, causing shortness of breath or chest pain
• Liver abnormalities
• Cardiovascular issues, including increased blood pressure

If you experience severe or persistent side effects, consult your healthcare provider immediately.

How Should Nebido® Be Stored?

To preserve its effectiveness, Nebido® should be stored:

• At temperatures not exceeding 25°C (77°F)
• In a dry place away from children

Avoid freezing the solution, as it may alter its consistency. If stored in cold conditions, bring the vial to room temperature before use.

Who Should Not Use Nebido®?

Nebido® is not suitable for:

• Women or children under 18
• Men with prostate or breast cancer
• Individuals with known liver tumors or severe liver impairment

Additionally, it is not intended for enhancing athletic performance or muscle growth in healthy individuals.

Why Choose Nebido®?

Nebido® offers a convenient, long-term solution for testosterone replacement therapy.

With fewer injections required, it supports a better quality of life for men with hypogonadism.

By maintaining stable testosterone levels, it helps restore energy, vitality, and overall well-being.