ANDROFORTE

What it is

ANDROFORTE 5 is a testosterone 5% w/v cream containing 50 mg in 1 mL or 100 mg in 2 mL. The product is a white, opaque, oil-in-water cream. It contains tree nut products (almond oil) and hydroxybenzoates.

Approved indications

— Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Dosing overview

For adult men aged 18 years and above, the recommended starting dose when applied to the scrotum is 0.5 mL of cream (25 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on clinical and laboratory response, not exceeding 1 mL of cream per day, with adjustment achieved by 0.25 mL increments. When applied to the upper body, the recommended starting dose is 2 mL of cream (100 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on clinical and laboratory response, not exceeding 4 mL of cream per day, with adjustment achieved by 1 mL increments.

Key safety warnings

Androgens may accelerate the progression of sub-clinical prostate cancer and benign prostatic hyperplasia. Prior to testosterone initiation, all patients must undergo a detailed examination to assess for pre-existing prostate cancer, and careful and regular monitoring of the prostate gland by digital rectal examination and serum PSA estimation, and breast examination must be performed at least once yearly and twice yearly in elderly and at-risk patients. 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. Increased haematocrit may increase the risk for a thromboembolic event. Transdermal testosterone cream 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 including facial and body hair growth, voice deepening and menstrual irregularities in women, and premature puberty and genital enlargement in children. The risk of transfer is substantially reduced by wearing clothes covering the application area, and the majority of residual testosterone is removed from the skin surface by washing with soap and water prior to contact.

Contraindications

Testosterone is contraindicated in men with known or suspected carcinoma of the breast or prostate. Hypersensitivity to the active substance (testosterone) or to any of the excipients is also a contraindication.

PBS listing

ANDROFORTE 5 transdermal cream 50 mg per mL, 50 mL is listed on the PBS with 2 items and authority required restriction, with an ex-manufacturer price of A$87.50.

Regulatory history

ANDROFORTE 5 was first listed on the Australian Register of Therapeutic Goods on 11 July 2014. The Pharmaceutical Benefits Scheme Advisory Committee recommended the product for testosterone deficiency in March 2021.