Nebido Dosage/Direction for Use

Method of administration: Solution for injection.
Dosage regimen: Testosterone undecanoate (Nebido) (1 vial corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.
The injections must be administered very slowly. Testosterone undecanoate (Nebido) is strictly for intramuscular injection. Special care must be given to avoid intravasal injection. See Instructions for use/handling under Cautions for Usage to avoid injury when opening.
Start of treatment: Serum testosterone levels should be measured before start of treatment. The first injection interval may be reduced to a minimum of 6 weeks. With this loading dose, steady-state levels will be reached quickly.
Individualization of treatment: It is advisable to measure testosterone serum levels occasionally at the end of an injection interval. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered. The injection interval should remain within the recommended range of 10 to 14 weeks.
Additional information on special populations: Pediatric patients: Testosterone undecanoate (Nebido) is not indicated for use in children and adolescents and it has not been clinically evaluated in males under 18 years of age (see Precautions).
Geriatric patients: Limited data do not suggest the need for a dosage adjustment in elderly patients (see Precautions).
Patients with hepatic impairment: No formal studies have been performed in patients with hepatic impairment. The use of Testosterone undecanoate (Nebido) is contraindicated in men with past or present liver tumors (see Contraindications).
Patients with renal impairment: No formal studies have been performed in patients with renal impairment.