TESTAVAN

What it is

TESTAVAN is a testosterone 2% w/w gel in a metered-dose dispenser with a cap applicator. It is supplied as a transdermal gel pump pack containing 23 mg per 1.15 g dose.

Approved indications

— Androgen replacement therapy for confirmed testosterone deficiency in males.

Dosing overview

Dosing information for TESTAVAN gel is not provided in the available product documentation. Patients should refer to the product information or consult their healthcare provider for specific dosing instructions for this formulation.

Key safety warnings

Androgens can enhance the growth of an existing prostatic carcinoma. Carcinoma of the prostate must be excluded before starting therapy with testosterone preparations, and regular examinations of the prostate are recommended. Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia. Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism, as there have been post-marketing reports of thrombotic events including deep-vein thrombosis, pulmonary embolism and ocular thrombosis during testosterone therapy. Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur. Caution should be exercised in patients predisposed to oedema, such as those with 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 should be used with caution in men with hypertension.

Contraindications

TESTAVAN 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

TESTAVAN transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses is listed on the PBS with authority required restriction at an ex-manufacturer price of A$65.99.

Regulatory history

TESTAVAN was first registered on the ARTG on 26 May 2017.