Testosterone replacement in primary and secondary male hypogonadism.
Dosage/Instructions for Use
Dosing Regimen: Testosterone undecanoate (Nebido) is injected once every 10 to 14 weeks (1 vial is equivalent to 1000 mg of testosterone undecanoate). Injections at this frequency maintain adequate testosterone levels without causing accumulation.
Injections must be given very slowly. Testosterone undecanoate (Nebido) is strictly for intramuscular use. Special care must be taken to avoid intravascular injection.
Additional Information for Special Populations: Pediatric Patients: Testosterone undecanoate (Nebido) is not indicated for use in children and adolescents and has not been clinically evaluated in males under 18 years of age
Geriatric Patients: Limited data suggest that no dose adjustment is required in elderly patients
Patients with Hepatic Insufficiency: No formal studies have been conducted in patients with hepatic insufficiency. Testosterone undecanoate (Nebido) is contraindicated in men with past or current liver tumors
Patients with Renal Insufficiency: No formal studies have been conducted in patients with renal insufficiency.
Contraindications
Malignancy with hypercalcemia.
Previous or current liver tumors.
Hypersensitivity to the active substance or any of the excipients.
Testosterone undecanoate (Nebido) is contraindicated in women.
Drug interactions
Effects of androgens on other drugs: Oxyphenidyl: Increased serum concentrations of oxyphenidyl have been reported.
Oral anticoagulants: Testosterone and its derivatives have been reported to increase the activity of coumarin-derived oral anticoagulants, which may require dose adjustment. Independent of this finding, the risk of bleeding caused by intramuscular injections must always be taken into account as a general rule in patients with acquired or inherited bleeding disorders.
Hypoglycemic agents: Androgens may potentiate the hypoglycemic effect of insulin. Therefore, a reduction in the dose of hypoglycemic agents may be required.
Precautions for use
Instructions for use/handling: Vials: The vials are for single use only. The contents of the vial should be injected intramuscularly immediately after drawing into the syringe. After removing the plastic cap, do not remove the metal ring or crimp cap.
