TESTIM Transdermal Gel Ref.[7123] Active ingredients: Testosterone

Posology

Adults and the Elderly

The recommended starting dose of TESTIM is testosterone 50mg (1 tube)/per day.

Dose titration should be based on serum testosterone levels or the persistence of clinical signs and symptoms related to testosterone deficiency. To ensure proper serum testosterone levels are achieved, early morning serum testosterone should be measured before applying the next dose, approximately 7-14 days after initiation of therapy. Currently there is no consensus about age specific testosterone levels. The normal serum testosterone level for young eugonadal men is generally accepted to be approximately 300–1000 ng/dL (10.4–34.6 nmol/L). However, it should be taken into account that physiologically testosterone levels are lower with increasing age. If serum testosterone concentrations are below the normal range, the daily testosterone dose may be increased from 50mg (one tube) to 100mg (two tubes) once a day. The duration of treatment and frequency of subsequent testosterone measurements should be determined by the physician. Non-virilised patients may require treatment with one tube for a longer period of time before the dose is increased, as needed. At any time during treatment, after initial titration, the dose may need to be reduced if serum testosterone levels are raised above the upper limit of the normal range. If morning serum testosterone levels are above the normal range while applying 50mg (1 tube) of TESTIM, the use of TESTIM should be discontinued. If serum testosterone levels are below the normal limit, the dose may be increased, not exceeding 100mg per day.

Because of the variability in analytical values amongst diagnostic laboratories, all testosterone measurements should be performed at the same laboratory.

Female population

TESTIM is not indicated for use in women.

Paediatric population

TESTIM is not indicated in children and has not been clinically evaluated in males under 18 years of age.

Method of administration

The gel should be applied once a day, at about the same time each day, to clean, dry, intact, skin of the shoulders and/or upper arms. It is preferable that the gel is applied in the morning. For patients who wash in the morning, TESTIM should be applied after washing, bathing or showering.

To apply the gel, patients should open one tube and squeeze the entire contents into the palm of one hand. They should then apply the gel immediately to their shoulders and/or upper arms. The gel should be spread on the skin gently as a thin layer. The gel should then be rubbed until no gel is left on the skin. This process should then be repeated with a second tube of TESTIM by patients who have been prescribed a daily dose of testosterone 100mg. It is suggested that patients who require two tubes of gel each day use both shoulders (one tube per shoulder) and/or upper arms as application sites. Patients should thoroughly wash their hands immediately with soap and water after TESTIM has been applied. After application of the gel, patients should allow the application sites to dry for a few minutes and then dress with clothing that covers the application sites.

Patients should be advised not to apply TESTIM to the genitals.

Reports describing overdose have included doses up to TESTIM 150 mg. No dose limiting toxicity has been reported from these spontaneous cases.

Shelf life: 24 months.

Do not store above 25°C.

This medicinal product is flammable and should be protected from direct sunlight.

TESTIM is supplied in unit dose aluminium tubes with epoxy phenolic liners and screw caps, each containing 5g gel. The tubes are packed in cartons containing 7, 14, 30 and 90 tubes.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.