Andropatch 2.5 mg / 24 hours Transdermal Patch

Each Andropatch 2.5 mg System contains 12.2 mg testosterone BP.

For full list of excipients, see section 6.1.

Andropatch 2.5 mg is a transdermal drug delivery system consisting of a beige self-adhesive patch surrounding a central drug reservoir of testosterone dissolved in an alcohol-based gel.

Each Andropatch 2.5 mg System delivers in vivo approximately 2.5 mg of testosterone over 24 hours across skin of average permeability. (Active surface area 7.5 cm^2).

Andropatch 2.5 mg is indicated for testosterone replacement therapy in conditions with a deficiency or an absence of endogenous testosterone associated with primary or secondary hypogonadism.

Adults and Elderly

The usual dose is two Andropatch 2.5 mg Systems applied nightly (approximately 10 pm) and worn for 24 hours, providing approximately 5 mg testosterone per day. The dose can be adjusted up to the equivalent of 7.5 mg nightly or down to 2.5 mg nightly depending on the serum testosterone measured in the morning after application. Measurement of serum testosterone should be repeated taking care to ensure proper system adhesion and correct time of application before the dose is adjusted. Three systems per day may be required for men with a higher body weight >130 kg). Treatment in non-virilised patients may be initiated with one system applied nightly. The dose should be adjusted as appropriate.

The duration of treatment and frequency of testosterone measurements is determined by the physician.

The adhesive side of the Andropatch 2.5 mg System should be applied to a clean, dry area of the skin on the back, abdomen, upper arms, or thighs. Bony prominences, such as the shoulder and hip areas, and areas that may be subjected to prolonged pressure during sleeping or sitting should be avoided. Application to these sites has been associated with burn-like blister reactions (see Section 4.8). Do not apply to broken or damaged skin. Do not apply to the scrotum. The sites of application should be rotated, with an interval of seven days between applications to the same site. The area selected should not be oily, damaged or irritated.

The system should be applied immediately after opening the pouch and removing the protective release liner. The system should be pressed firmly in place, making sure there is good contact with the skin, especially around the edges.

Children

Andropatch 2.5 mg is not indicated for use in children as there has been no clinical experience of its use below the age of 15.

Androgens are contra-indicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, nephrotic syndrome, hypercalcaemia and known hypersensitivity to testosterone.

Andropatch 2.5 mg is contra-indicated in men with known hypersensitivity to other constituents of the patch.

Andropatch 2.5 mg has not been evaluated in women and must not be used in women. Testosterone may be harmful to the foetus.

Elderly men treated with androgens may be at an increased risk for the development of prostatic hyperplasia.

Elderly men and others with an increased risk of developing prostatic cancer, should be assessed before starting testosterone replacement therapy because testosterone may promote the growth of subclinical prostate cancer.

As in men without testosterone deficiency, patients on testosterone replacement therapy should be periodically evaluated for prostate cancer.

Care should be taken in patients with skeletal metastases due to the risk of hypercalcaemia/hypercalcuria developing from androgen therapy.

If the patient develops an application site reaction, treatment should be reviewed and discontinued if necessary.

Testosterone may cause a rise in blood pressure and Andropatch 2.5 mg should be used with caution in patients with hypertension.

Oedema, with or without congestive heart failure, may result from androgen treatment in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Andropatch 2.5 mg should be used with caution in patients with ischaemic heart disease, epilepsy and migraine as these conditions may be aggravated.

When given simultaneously with anticoagulants the anticoagulant effect can increase. Patients receiving oral anticoagulants require close monitoring especially when androgens are started or stopped.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may alter blood glucose and, therefore, insulin requirements.

Andropatch 2.5 mg therapy has not been evaluated in and must not be used in women under any circumstances. Testosterone may be harmful to the foetus.

There is no evidence that Andropatch 2.5 mg will affect the ability of a patient to drive or to use machines.

In the majority of cases, transient mild to moderate skin reactions have been observed at the site of application at some time during treatment. These include pruritus; irritation with erythema, induration or burning, rash and allergic contact dermatitis. Burn-like lesions characterised by blisters, skin necrosis, and ulceration that healed over several weeks with scarring in some cases have also been observed.

The burn-like lesions occurred sporadically, usually only at one site, (most commonly over bony prominences or areas that may have been subjected to prolonged pressure during sleeping or sitting). Such lesions should be treated as burns.

As seen with other testosterone treatments, prostate abnormalities, prostate cancer, headache, depression and gastrointestinal bleeding were also observed.

Other known undesirable effects associated with testosterone treatments include hirsuitism, male pattern baldness, seborrhoea, acne, excessive frequency and duration of penile erections, nausea, cholestatic jaundice, increased or decreased libido, anxiety, generalised paraesthaesia. Oligospermia may occur at high doses. Prolonged testosterone administration may cause electrolyte disturbances, e.g. retention of sodium, chloride, potassium, calcium, inorganic phosphates and water.

This is not likely due to the mode of administration. Serum testosterone has a half-life of 70 minutes and therefore falls rapidly once the Andropatch 2.5 mg Systems are removed.

Andropatch 2.5 mg delivers physiologic amounts of testosterone producing circulating testosterone concentrations that mimic the normal circadian rhythm of healthy young men.

Testosterone, the primary androgenic hormone is responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.

Male hypogonadism results from insufficient secretion of testosterone and is characterised by low serum testosterone concentrations. Symptoms associated with male hypogonadism include the following: impotence and decreased sexual desire; fatigue and loss of energy; mood depression; regression of secondary sexual characteristics.

Androgens promote retention of nitrogen, sodium, potassium and phosphorus, decreases urinary excretion of calcium, increase protein anabolism, decrease protein catabolism, are also responsible for the growth spurt of adolescence and for the eventual termination of linear growth and stimulate the production of red blood cells by enhancing erythropoietin production.

Exogenous administration of androgens inhibits endogenous testosterone release. With large doses of exogenous androgens, spermatogenesis may be suppressed.

Following Andropatch 2.5 mg application to non-scrotal skin, testosterone is continuously absorbed during the 24-hour dosing period. Daily application of two Andropatch 2.5 mg patches at approximately 10 pm results in a serum testosterone concentration profile which mimics the normal circadian variation observed in healthy young men. Maximum concentrations occur in the early morning hours with minimum concentrations in the evening.

In hypogonadal men, application of two Andropatch 2.5 mg Systems to the back, abdomen, thighs or upper arms resulted in average testosterone absorption of 4 to 5 mg over 24 hours. Applications to the chest and shins resulted in greater inter individual variability and average 24-hour absorption of 3 to 4 mg. The serum testosterone concentration profiles during application were similar for all sites.

Normal range morning serum testosterone concentrations are reached during the first day of dosing. There is no accumulation of testosterone during continuous treatment.

Upon removal of the Andropatch 2.5 mg Systems, serum testosterone concentrations decrease with an apparent half-life of approximately 70 minutes. Hypogonadal concentrations are reached within 24 hours following system removal.

None therapeutically relevant.

Ethanol, Purified Water, Glycerol (E422), glycerol mono-oleate, methyl laurate, Carbomer Copolymer B, Sodium Hydroxide.

No specific incompatibilities.

2 years.

Do not store above 25ºC. Apply to skin immediately upon removal from the protective pouch. Store in the original package.

Each Andropatch 2.5 mg System contains 12.2 mg testosterone BP for delivery of 2.5 mg testosterone per day. Each Andropatch 2.5 mg System is individually pouched and supplied in cartons of* 10, 30 and 60 pouches. The pouch is made from paper, low density polyethylene and aluminium foil.

*Not all pack sizes may be marketed.

Components of the patch :

Silicone-coated polyester liner,

Acrylic adhesive/silicone-coated PET laminate,

Peelable LDPE/aluminium/polyester film,

Microporous HMWPE (high molecular weight polyethylene) film.

Backing film: inner layer of EVA, Surlyn® and metallised polyethylene, outer layer: polyethylene layer, pigmented with alcohol resistant beige ink to form a beige, plastic film.

Andropatch 2.5 mg may be discarded with household waste in a manner that avoids accidental contact by others.

Damaged systems should not be used.

The drug reservoir may be burst by excessive heat or pressure.

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

PL 10592/0069

02 January 2002

12 September 2007

POM