SUSTANON Solution for injection Ref.[28068] Active ingredients: Testosterone

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 250 before the start of treatment, at quarterly intervals for the first 12 months 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 section 4.3),
• Haematocrit and haemoglobin to exclude polycythaemia.

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, 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 characterised by oedema with or without congestive cardiac failure. In such 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 250 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 250 can improve glucose tolerance in diabetic patients (see section 4.5).

Anti-coagulant therapy: Androgens in general and Sustanon 250 can enhance the anti-coagulant action of coumarin-type agents (see also section 4.5).

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 section 4.8), treatment with Sustanon 250 should be discontinued and, upon resolution of complaints, resumed with a lower dose.

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 250 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 250 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 250 (see section 4.3).

Sustanon 250 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.

Female-to-male transsexual supportive therapy

Before initiating Sustanon 250 for female-to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment. A complete personal and medical history should be taken. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual. The following should be monitored:

• signs of osteoporosis,
• changes in lipid profile.

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.

Paediatric population

In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Sustanon 250 in high dosages may accelerate epiphyseal closure and sexual maturation.

Older People

There is limited experience on the safety and efficacy of the use of Sustanon 250 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.

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.

Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase testosterone levels. Therefore, adjustment of the dose of Sustanon 250 may be required.

Insulin and other anti-diabetic medicines

Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients (see section 4.4).

Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Sustanon 250 treatment.

Anti-coagulant therapy

High doses of androgens may enhance the anticoagulant action of coumarin type agents (see section 4.4). Therefore, close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.

ACTH or Corticosteroids

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation therefore these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema (see section 4.4).

Laboratory test interactions

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Sustanon 250 is contra-indicated in women who are pregnant (see section 4.3).

Pregnancy

There are no adequate data for the use of Sustanon 250 in pregnant women. In view of the risk of virilisation of the foetus, Sustanon 250 should not be used during pregnancy (see section 4.3). Treatment with Sustanon should be discontinued when pregnancy occurs.

Breastfeeding

There are no adequate data for the use of Sustanon 250 during lactation. Therefore, Sustanon 250 should not be used during lactation.

Fertility

In men treatment with androgens can lead to fertility disorders by repressing sperm-formation (see section 4.8).

In women treatment with androgens can lead to an infrequent or repressed menstrual cycle (see section 4.8).

Sustanon 250 has no influence on the ability to drive and use machines.

Due to the nature of Sustanon 250 side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local reaction at the injection site.

The following adverse reactions have been associated with androgen therapy in general.

All adverse reactions are listed by system organ class and frequency; common (≥1/100 to <1/10) and not known (cannot be estimated from the available data).

¹ Progression of a sub-clinical prostatic cancer
² Prostatic growth (to eugonadal state)
³ Decrease in serum LDL-C, HDL-C and triglycerides

The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.

Treatment in women

Treatment with Sustanon 250 may induce signs of virilisation in women (see section 4.4). Symptoms of virilisation may include hoarseness, acne, hirsutism, menstrual irregularity and alopecia.

Paediatric population

The following undesirable effects have been reported in prepubertal children using androgens (see section 4.4): precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.