What it's for (Indications)
- Testosterone undecanoate is indicated for testosterone replacement therapy in males for conditions associated with symptoms of primary and secondary hypogonadism.
- Prior to initiation, diagnosis of hypogonadism must be confirmed by measuring morning serum testosterone concentrations on at least two separate days, ensuring levels are below the normal range.
- The dosage is dependent on the patient's age, condition, and its severity.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Prior to initiating treatment, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these concentrations are below the normal range. For intramuscular use only, administered by a medical professional. The recommended dose is 3 mL (750 mg) injected deeply into the gluteal muscle at initiation, at 4 weeks, and every 10 weeks thereafter. Following each injection, patients must be observed in the healthcare setting for 30 minutes to provide appropriate medical treatment in the event of serious POME reactions or anaphylaxis. |
Safety & Warnings
Common Side Effects
- Commonly reported adverse reactions (≥2%) include acne, injection site pain, increased prostatic specific antigen (PSA), increased estradiol, hypogonadism, fatigue, irritability, increased hemoglobin, insomnia, and mood swings.
- Other potential side effects may be mild, but consultation with a healthcare provider is recommended.
Serious Warnings
- Black Box Warning: WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS. Serious POME reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope; and episodes of anaphylaxis, including life-threatening reactions, have been reported to occur during or immediately after the administration of testosterone undecanoate injection. These reactions can occur after any injection of testosterone undecanoate during the course of therapy, including after the first dose.
- Patients may experience dizziness or fatigue after using this medicine; therefore, caution should be exercised when driving or performing tasks requiring alertness.
- This medicine may have mild effects on the liver and kidneys, warranting caution and potential monitoring.
- Patients with allergies to any of the medicine’s components or severe diseases unrelated to testosterone should use this medicine cautiously.
- Pregnancy: Not recommended for pregnant females, as testosterone can cause virilization of the female fetus and may cause fetal harm.
- Lactation: Not recommended for lactating females.
- Prior to administration, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.
- Following each injection, observe patients in the healthcare setting for 30 minutes to provide appropriate medical treatment in the event of serious Pulmonary Oil Microembolism (POME) reactions or anaphylaxis.
How it Works (Mechanism of Action)
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of male sex organs and for the maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution (facial, pubic, chest, axillary); laryngeal enlargement; vocal cord thickening; and alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies: primary hypogonadism (defects of the gonads) and secondary hypogonadism (failure of the hypothalamus or pituitary to produce sufficient gonadotropins). Testosterone undecanoate replaces deficient endogenous testosterone.
Commercial Brands (Alternatives)
No other brands found for this formula.