22 March 2018
Important update for GPs prescribing testosterone replacement therapy
Doctors will need to be proactive to ensure their patients are not adversely affected by supply issues impacting testosterone replacement therapy.
Following the sudden withdrawal of Axiron (2% w/v transdermal testosterone gel) by Eli Lilly late last year, the sachet presentation of Testogel (1% transdermal testosterone gel) is now subject to global supply shortage and will be unavailable in Australia for several months.
However, manufacturer Besins Healthcare has emphasised that ready supplies of the Testogel metered-dose pump, which provides the same dosage range and strength as the sachet presentation, are available and under no supply pressure.
However, doctors need to be aware that prescriptions for Testogel sachets cannot be substituted for the Testogel pump presentation by pharmacists due to PBS Authority restrictions. As such, men with a prescription for Testogel sachets will be directed back to their doctor to receive a new prescription for Testogel metered-dose pump.
The good news is that GPs can provide these patients with a new prescription for the Testogel metered-dose pump without having to refer them to a specialist.
Steps for doctors to minimise treatment disruption:
- Contact patients treated with Testogel sachets and advise that they will need to receive a new prescription for the Testogel metered-dose pump.
- To switch a patient from Testogel sachets to the pump presentation, simply ring the PBS approvals line and quote the name of the original specialist in order to obtain a new Authority Required approval.
- Prescribe the metered-pump presentation for men who have been treated with Axiron and you consider Testogel a suitable alternative.
Besins Healthcare, the manufacturer of Testogel, offers its sincerest apologies for the inconvenience to doctors and their patients, especially with the market undergoing a period of change.
Minimum Product Information: Testogel® (Minimum Product Information) Testogel is 1% testosterone gel. INDICATIONS: Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. CONTRAINDICATIONS: known or suspected prostatic cancer/breast carcinoma; known hypersensitivity to testosterone or any other ingredient, use in women or children. PRECAUTIONS: Regular monitoring of the prostate gland and breast, hypercalcaemia, severe cardiac, hepatic or renal insufficiency, ischaemic heart disease, hypertension, diabetes, epilepsy and migraine. Risk of sleep apnoea. Effect on doping tests. Must not be used in women. Testosterone transfer to others via skin contact. Must not be used in pregnant women. Must not be used in breast-feeding women. INTERACTIONS WITH OTHER MEDICINES: Oral anticoagulants, ACTH or corticosteroids, oxyphenbutazone, insulin requirements, buproprion, cyclosporine. In general, any substance which affects liver function should not be taken with testosterone. ADVERSE EFFECTS: Reaction at the application site, erythema, acne, dry skin, changes in laboratory tests, headache, prostatic disorders, gynaecomastia, mastodynia, dizziness, paraethesia, amnesia, hyperaesthesia, mood disorders, hypertension, diarrhoea, alopecia, urticaria. DOSAGE AND ADMINISTRATION: Adult Men: 5g of gel applied once daily at about the same time, preferably in the morning. Depending on clinical/laboratory response, the dose may be adjusted by 2.5g steps to a maximum 10g of gel per day.
Besins Healthcare Australia Pty Ltd. ABN 68 164 882 062. Suite 3, Level 2, Tower 1, 495 Victoria Ave, Chatswood, NSW 2067. Office phone (02) 9904 7473. For medical information call 1800 BESINS (237 467). www.besins-healthcare.com.au Approval date 2/18
®Testogel is a registered trademark of Besins Healthcare.