SUSTANON

What it is

Sustanon 250 is a solution for injection containing testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, and testosterone decanoate. Each ampoule or vial contains 30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate in 1 mL arachis oil. All four compounds are esters of the natural hormone testosterone. Sustanon 250 is an androgenic solution for intramuscular injection administered by deep intramuscular injection.

Approved indications

— Androgen replacement therapy for confirmed testosterone deficiency in males.

Dosing overview

For adults including elderly patients, usually one injection of 1 mL per three weeks is adequate for Sustanon 250. Dosage should be adjusted according to the response of the individual patient.

Key safety warnings

Testosterone level should be monitored at baseline and at regular intervals during treatment. Physicians should consider monitoring patients before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for digital rectal examination of the prostate and PSA to exclude benign prostate hyperplasia or subclinical prostate cancer, and hematocrit and haemoglobin to exclude polycythaemia. Patients with pre-existing cardiac, renal or hepatic insufficiency or disease should be monitored as androgen treatment may cause complications characterised by oedema with or without congestive heart failure. Patients who experienced myocardial infarction, cardiac, hepatic or renal insufficiency, hypertension, epilepsy or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease, and treatment must be stopped immediately in such cases. 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 in these patients during testosterone therapy; in thrombophilic patients, VTE cases have been reported even under anticoagulation treatment. As with all oily solutions, Sustanon 250 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; the patient should be observed during and immediately after each injection. Sustanon 250 contains arachis (peanut) oil and should not be taken by patients known to be allergic to peanut; patients with soya allergy should also avoid Sustanon 250 due to a possible relationship between allergy to peanut and allergy to soya.

Contraindications

Sustanon 250 is contraindicated in known or suspected carcinoma of the prostate or breast, hypercalcaemia and/or hypercalciuria, and hypersensitivity to the active substances or any of the excipients, including arachis oil. Sustanon 250 is therefore contraindicated in patients allergic to peanuts or soya.

Regulatory history

Sustanon 250 injection ampoule was first registered on the Australian Register of Therapeutic Goods on 20 September 1991. The vial formulation was first registered on 23 December 2011.