ANDROFEME

5 ml) applied once daily, at approximately the same time each day, to either the upper outer thigh or buttock. 0 ml) daily with review of the serum testosterone concentration approximately 3 weeks after dose adjustment and a clinical review three months after that to evaluate efficacy.

Clinical trials of transdermal testosterone therapy have shown that there is a four to eight-week time lag between starting testosterone treatment and an improvement in sexual motivation. Treatment on optimised dosing with AndroFeme requires regular monitoring at 6 monthly intervals to ensure no evidence of overuse of drug by clinical assessment (acne or hirsutism), with measurement of serum testosterone and sex hormone binding globulin (SHBG), and dose adjustment if indicated.

If there is no improvement in symptoms after 6 months of continuous optimised therapy, treatment should be discontinued and alternative options considered. Women should be made aware before initiating testosterone treatment of the lack of long-term clinical trial safety data beyond 24 months, for doses that approximate physiological concentrations in premenopausal women.

Treatment with AndroFeme should be an informed decision between physician and patient if treatment is to be continued beyond 24 months. Special populations Renal impairment No studies have been conducted in patients with renal insufficiency.

Hepatic impairment No studies have been conducted in patients with hepatic impairment. Elderly There is limited experience in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values.

However, it should be taken into account that physiological testosterone serum levels increase with age beyond the age of 70 years, thus adding to the uncertainty of benefit of use in women beyond the age of 70 years. Paediatric population AndroFeme is not indicated in children.

5). Method of administration The patient should be directed to measure the appropriate dose using the graduated applicator and immediately apply to clean dry skin on the upper outer thigh or buttock. The cream should be massaged evenly until absorption is complete (typically around 30 seconds).

The patient should be instructed to wash their hands with soap and water after each application. To clean the applicator after use, rinse in hot water. Absorption may be more variable if applied to other areas of the body. Do not apply to the genitalia or perineum.

2, when physiological testosterone concentrations for premenopausal women were approximated. Table 1. Common (≥ 1/100 to < 1/10) adverse events reported in clinical trials System organ class Adverse Events Skin and subcutaneous tissue disorders Acne Increased hair growth Alopecia Respiratory, thoracic and mediastinal disorders Voice change Post marketing adverse reaction reports include thinning of hair and dizziness.

The frequency of these side effects cannot be estimated from the available data. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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g. acne, changes in hair growth or hair loss). Patients should be advised to self-assess for androgenic undesirable effects. Signs of virilisation, such as voice deepening, hirsutism or clitoromegaly, may be irreversible and discontinuation of treatment should be considered.

Patients with cardiac, hepatic or renal diseases All patients with pre-existing cardiac, hepatic or renal diseases need to be monitored closely when undergoing androgen treatment. Use in athletes High level athletes need to be aware of the rules governing androgen use if prescribed AndroFeme cream.

Potential for transfer It has been reported that high dose transdermal testosterone preparations used in men can be transferred to other persons by close skin to skin contact, resulting in increased testosterone serum levels and, with repeated contact, possibly adverse effects.

While the recommended dose of testosterone in AndroFeme is low by comparison to male doses, close skin contact with the area of application by a partner or child should be avoided. Patients should be made aware of the consequences of making sustained long-term close physical contact with young children.

Long-term continual exposure may result in passive absorption and may have adverse effects, including virilisation, in young children. The risk of transfer is substantially reduced by wearing clothes covering the application area. The majority of residual testosterone is removed from the skin surface by washing with soap and water prior to contact.

As a result, the following precautions are recommended:

For the patient: • For external use only. • Wash hands thoroughly with soap and water after applying the cream. • Cover the application area with clothing once the cream has dried. • Wash before any situation in which skin-to-skin contact is foreseen.

1. Known, suspected or past history of cancer of the breast or known or suspected estrogen-dependent neoplasia, or any other condition consistent with the contraindications for the use of estrogen.