ANDROGEL GEL 16.2MG/G

Indication

ANDROGEL 16.2 mg/g gel is indicated in adults as replacement therapy for male hypogonadism when testosterone deficiency has been clinically and biologically confirmed.

Contraindications

ANDROGEL 16.2 mg/g, gel is contraindicated:

• in case of confirmed or suspected prostate cancer or breast carcinoma
• in case of hypersensitivity to the active ingredient or to any of the excipients.

Recommended Dosage

Adult and elderly populations

The recommended dose is two pump actuations (i.e. 40.5 mg of testosterone) applied once daily at approximately the same time, preferably in the morning. The daily dose will be adjusted by the doctor based on the clinical or laboratory response of each patient, not exceeding four pump actuations or 81 mg testosterone per day. The dose should be adjusted in increments by one press on the pump.

The dose should be determined based on morning blood testosterone concentrations prior to dosing. Steady state blood testosterone concentrations are reached from approximately the second day of treatment with ANDROGEL 16.2 mg/g, gel. The dosage is adjusted based on blood testosterone levels measured in the morning before application of the product, after steady state is reached. Testosterone blood levels should be evaluated periodically. The dosage may be reduced if the blood testosterone levels exceed the desired level. If the concentration is low, the dosage may be increased stepwise up to 81 mg of testosterone (four pump actuations).

Treatment should be discontinued if blood testosterone levels consistently exceed the normal range at the lowest daily dose of 20.25 mg (1.25 g gel, i.e. one pump actuation) or if normal blood testosterone levels are not achieved at the highest dose of 81 mg (5 g gel, i.e. four pump actuations).

Paediatric population

The safety and efficacy of ANDROGEL 16.2 mg/g gel in boys under 18 years of age have not been established. No data are available.

Mode of Administration

The application should be done by the patient himself, on clean, dry and healthy skin, on the right and left shoulders and upper arms.

The gel should be spread simply in a thin layer on the skin. It is not necessary to rub the skin. Allow to dry at least 3 to 5 minutes before getting dressed. Wash hands with soap and water after application and cover the application site(s) with clothing after the gel has dried. Wash the application site thoroughly with soap and water before any situation where contact is expected between the application site and another person’s skin.

For further information on post- dose washing see section on Warning and Precautions: Risk of inadvertent testosterone transfer – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Do not apply the gel to the genitals, as the high alcohol content in the gel may cause local irritation. To obtain a full first dose, it is necessary to prime the canister pump. To do this, with the canister in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. Pump priming is only necessary before the first dose.

After priming, fully depress the actuator to deliver 1.25 g of ANDROGEL 16.2 mg/g, gel into palm of hand and apply gel to shoulders and arms.