Medical examination: Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Physicians should consider monitoring patients receiving Sustanon before the start of treatment, at quarterly intervals for the first 12months and yearly thereafter for the following parameters: digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate hyperplasia or a sub-clinical prostate cancer (see Contraindications), hematocrit and hemoglobin to exclude polycythaemia.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: hemoglobin and hematocrit liver function tests and lipid profile.
Conditions that need supervision: Patients, especially the elderly, with the following conditions should be monitored for: Tumours: Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.
Pre-existing conditions: In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterized by edema with or without congestive cardiac failure. In such a cases, treatment must be stopped immediately. 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. In such cases treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure and Sustanon should be used with caution in men with hypertension.
Epilepsy or Migraine: (or a history of these conditions), since androgens may occasionally induce fluid and sodium retention.
Diabetes mellitus: Androgens in general and Sustanon can improve glucose tolerance in diabetic patients (see Interactions).
Anti-coagulant therapy: Androgens in general and Sustanon can enhance anticoagulant action of coumarin-type agents (see also Interactions).
Sleep apnoea: Caution should be applied when treating men with sleep apnoea. There have been reports that testosterone can cause or exacerbate pre-existing sleep apnoea. However, there is a lack of evidence regarding the safety of testosterone in men with the condition. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.
Adverse events: If androgen-associated adverse reactions occur (see Adverse Reactions), treatment with Sustanon should be discontinued and upon resolution of the complaints resumed with lower dosages.
Virilisation: Patients should be informed about the potential occurrence of signs of virilisation. In particular, singers and women with speech professions should be informed about the risk of deepening of the voice. The voice changes may be irreversible.
If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.
(Mis)use in sports: Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Sustanon can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
Drug abuse and dependence: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone and other anabolic androgenic steroids carries serious health risks and is to be discouraged.
Excipients: Sustanon contains Arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Sustanon (see Contraindications).
Sustanon contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer, careful monitoring should be undertaken.
Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment, to reduce the possible increased risk of endometrial and ovarian cancer.
Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy, as testosterone may not fully reverse the decline in bone density in these patients.
Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy and bilateral oophorectomy.
Clotting disorders: Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy. In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.
Effects on ability to drive and use machines: Sustanon has no influence on the ability to drive and use machines.
Use in Children: In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Sustanon in high dosages may accelerate epiphyseal closure and sexual maturation.
Use in the Elderly: There is limited experience on the safety and efficacy of the use of Sustanon in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.