NEBIDO SOLUTION [SIN13281P]

Product Info

NEBIDO SOLUTION

[SIN13281P]

4.1 Indication(s)

Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests (see section 4.4, “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Dosage and method of administration

Method of administration

Solution for injection

Dosage regimen

Nebido (1 ampoule / 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. Nebido is strictly for intramuscular injection. Care should be taken to inject Nebido deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be given to avoid intravasal injection. The contents of an ampoule or vial are to be injected intramuscularly immediately after opening. See section “Instructions for use/ handling” to avoid injury when opening – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Start of treatment

  Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.

• Maintenance and individualization of treatment

  The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. 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 level may be considered.

Additional information on special populations

Paediatric patients

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 section “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients

Limited data do not suggest the need for a dosage adjustment in elderly patients (see section “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment

No formal studies have been performed in patients with hepatic impairment. The use of Nebido is contraindicated in men with past or present liver tumours (see section “Contraindications”).

Patients with renal impairment

No formal studies have been performed in patients with renal impairment.

4.3 Contraindications

• Androgen-dependent carcinoma of the prostate or of the male mammary gland

• Hypercalcemia accompanying malignant tumours

• Past or present liver tumours

• Hypersensitivity to the active substance or to any of the excipients.

The use of Nebido in women is contraindicated.