What is the indication for Nebido (testosterone undecanoate)?

Indications for Nebido (Testosterone Undecanoate)

Nebido (testosterone undecanoate) is indicated for testosterone replacement therapy in adult men for conditions associated with hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. 1

Diagnostic Criteria for Testosterone Deficiency

To qualify for testosterone replacement therapy with Nebido, patients must meet the following criteria:

1. Laboratory confirmation:

   • Total testosterone level below 300 ng/dL 1
   • Measurements must be taken on two separate occasions in the early morning 1
   • Both measurements must consistently show low testosterone levels

2. Clinical symptoms and signs:

   • Sexual symptoms: decreased libido, erectile dysfunction 1
   • Physical symptoms: reduced energy, endurance, muscle mass, increased body fat 1
   • Psychological symptoms: depressed mood, reduced motivation, poor concentration, irritability 1

Specific Clinical Indications

Nebido is specifically indicated for:

• Primary hypogonadism (testicular failure) 1
• Secondary hypogonadism (hypothalamic-pituitary dysfunction) 1, 2
• Age-related hypogonadism with confirmed low testosterone levels and symptoms 1

Special Populations to Consider for Testing

Even in the absence of symptoms, testosterone levels should be measured in men with:

• Unexplained anemia
• Bone density loss
• Diabetes
• History of chemotherapy or testicular radiation exposure
• HIV/AIDS
• Chronic narcotic use
• Male infertility
• Pituitary dysfunction
• Chronic corticosteroid use 1

Advantages of Nebido Over Other Testosterone Formulations

Nebido offers several advantages as a long-acting injectable testosterone formulation:

• Requires only 4-5 injections per year (vs. ~16 injections for testosterone enanthate) 2
• Provides sustained physiological testosterone levels without major fluctuations 3, 2
• Avoids the "roller coaster" effect seen with shorter-acting testosterone injections 1
• Shows superior clinical and laboratory effectiveness compared to other injectable testosterone formulations 4

Administration Protocol

The recommended administration schedule for Nebido is:

• First injection: 1000 mg testosterone undecanoate (4 ml)
• Second injection: 6 weeks after the first injection
• Subsequent injections: Every 12 weeks 2
• Individualized adjustments: Intervals may be shortened (10 weeks) or extended (14 weeks) based on testosterone levels 2

Expected Benefits

Patients may experience improvements in:

• Sexual function and libido 1, 2, 5
• Bone mineral density 1
• Lean body mass 1
• Energy levels and vitality 1
• Depressive symptoms 1
• Metabolic parameters in patients with metabolic syndrome 5

Monitoring Requirements

Before initiating Nebido therapy:

• Measure hemoglobin/hematocrit (withhold if Hct >50%) 1
• Assess cardiovascular risk factors 1
• Measure PSA in men over 40 years to exclude prostate cancer 1

During Nebido therapy:

• Monitor testosterone levels to ensure therapeutic range
• Monitor hematocrit (intervention required if Hct >54%) 1
• Follow PSA levels in men over 40 years 1

Important Precautions

• Fertility concerns: Testosterone therapy suppresses spermatogenesis and should not be used in men planning reproduction in the near future 1, 5
• Prostate monitoring: Regular PSA monitoring is recommended for men over 40 1
• Cardiovascular risk: Assess cardiovascular risk factors before initiating therapy 1
• Polycythemia risk: Monitor hematocrit regularly, especially with injectable formulations 1

Contraindications

Nebido should not be used in:

• Men with prostate cancer
• Men with breast cancer
• Men actively trying to conceive children 1, 5
• Men with severe untreated sleep apnea 1