TESTOGEL

What it is

TESTOGEL is a testosterone product registered on the Australian Register of Therapeutic Goods (ARTG) by Besins Healthcare. It is available as a transdermal gel in two formulations: a pump pack delivering 12.5 mg per 1.25 g dose, and sachets containing 50 mg in 5 g.

Approved indications

— Androgen replacement therapy for confirmed testosterone deficiency in males.

Dosing overview

Dosing for TESTOGEL is individualised based on patient response and serum testosterone levels. Serum testosterone levels should be measured before the start of treatment and periodically during treatment as recommended by current treatment guidelines.

Key safety warnings

Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia, and androgens can enhance the growth of an existing prostatic carcinoma. Carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations. Regular examinations of the prostate are recommended as a precaution. Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia. Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of hormonal substances such as testosterone. Unusual upper abdominal complaints which do not disappear spontaneously within a short time should be reported to a doctor, and a hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur. Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism, as there have been post-marketing studies and reports of thrombotic events such as deep-vein thrombosis, pulmonary embolism, and ocular thrombosis in these patients during testosterone therapy. Caution should be exercised in patients predisposed to oedema, for example in case of severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, as treatment with androgens may result in increased retention of sodium and water. Testosterone may cause a rise in blood pressure and TESTOGEL should be used with caution in men with hypertension.

Contraindications

TESTOGEL is contraindicated in prostatic carcinoma, mammary carcinoma in males, hypercalcaemia accompanying malignant tumours, previous or existing liver tumours, and hypersensitivity to any of the ingredients.

PBS listing

TESTOGEL is listed on the PBS as two items for each formulation (pump pack and sachets). Both formulations are restricted to authority required status, with an ex-manufacturer price of A$60.92.

Regulatory history

TESTOGEL sachets (testosterone 1% 5 g sachets) were first registered on the ARTG on 7 January 2005, and the gel bottle formulation was first registered on 7 November 2014.