REANDRON

What it is

Reandron 1000 is a hormonal preparation that contains 1000 mg testosterone undecanoate in 4 mL of oily solution. Reandron 1000 is a clear, colourless to yellowish brown oily solution for injection. The medicine is administered by deep intramuscular injection into the gluteal muscle and is strictly for intramuscular injection.

Approved indications

— Testosterone replacement in primary and secondary male hypogonadism.

Dosing overview

Reandron 1000 is injected every 10 to 14 weeks for testosterone replacement, where testosterone deficiency has been confirmed by clinical features and biochemical tests. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance, with this loading dose achieving sufficient steady-state testosterone levels more rapidly. It is advisable to measure and monitor testosterone serum levels regularly, particularly if the dosage regimen is changed or if there is clinical concern about the adequacy or excessiveness of testosterone replacement, with measurements performed at the end of an injection interval and clinical symptoms considered.

Key safety warnings

Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude the risk of pre-existing prostatic cancer, and careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients. Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia. 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. Deep intramuscular injection of testosterone undecanoate is not advisable in men with any form of bleeding or coagulation disorder, including those using anti-coagulants because of the risk of haematoma. As with all oily solutions, Reandron 1000 must be injected strictly intramuscularly and very slowly, as pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhydrosis, chest pain, dizziness, paraesthesia, or syncope that may occur during or immediately after injection and are reversible, and the patient should be observed during and immediately after each injection. Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia. Concomitant use of testosterone replacement therapy and sodium-glucose co-transporter 2 inhibitors has been associated with an increased risk of erythrocytosis, and monitoring of haematocrit and haemoglobin levels is recommended in patients receiving both treatments.

Contraindications

The use of Reandron 1000 is contraindicated in men with androgen-dependent carcinoma of the prostate or of the male mammary gland, hypercalcaemia accompanying malignant tumours, hypersensitivity to the active substance or to any of the excipients, or past or present liver tumours, and the use of Reandron 1000 in women is contraindicated.

Regulatory history

Reandron 1000 was first registered on the Australian Register of Therapeutic Goods on 26 October 2005 as an ampoule formulation, and a vial formulation was registered on 7 January 2014.