Consumer medicine information

Sustanon '250' Injection

Testosterone propionate; Testosterone phenylpropionate; Testosterone isocaproate; Testosterone decanoate

BRAND INFORMATION

Brand name

Sustanon 250

Active ingredient

Testosterone propionate; Testosterone phenylpropionate; Testosterone isocaproate; Testosterone decanoate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sustanon '250' Injection.

SUMMARY CMI

SUSTANON '250' injection

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I being given SUSTANON?

SUSTANON contains four testosterone esters as the active ingredients which are turned into testosterone by your body. SUSTANON is used to treat confirmed testosterone deficiency in males.

For more information, see Section 1. Why am I being given SUSTANON? in the full CMI.

2. What should I know before I receive SUSTANON?

Do not use if you have ever had an allergic reaction to any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are planning to father a child.

For more information, see Section 2. What should I know before I receive SUSTANON? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SUSTANON and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is SUSTANON given?

  • The usual dose is one injection of SUSTANON '250' every 3 weeks. Your doctor may adjust this dose based on your needs.
  • The injections are given deeply into a muscle (e.g. the buttock, upper leg or upper arm), by a doctor or nurse only.

More instructions can be found in Section 4. How is SUSTANON given? in the full CMI.

5. What should I know while using SUSTANON?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using SUSTANON
  • If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or nurse immediately.
Driving or using machines
  • As far as is known this medicine has no influence on driving and using machines.
Looking after your medicine
  • Keep SUSTANON in the original box in a safe place out of reach and sight of children.
  • Keep it in a cool dark place where the temperature stays between below 30°C.
  • Do not refrigerate as this makes the product difficult to inject.

For more information, see Section 5. What should I know while using SUSTANON? in the full CMI.

6. Are there any side effects?

Less serious side effects of SUSTANON include pain at injection site, itching, acne, nausea, muscle pain, increased weight, high blood pressure, increased or decreased libido, disturbed sperm formation, breast enlargement in men, prostate enlargement, fluid retention, a size reduction of testes, hair loss, and various changes in blood test results. Less serious side effects found in children also include early sexual development, penis enlargement, an increased frequency of erections, and growth limitation (limited body height).

Serious side effects of SUSTANON include mood changes; signs of an allergic reaction; yellowing of the skin and eyes (jaundice); prolonged abnormal, painful erection of the penis; growth of undetected prostate cancer; coughing, increased sweating, chest pain, and feeling faint; and pain, swelling, redness, and enlarged veins in the affected area.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

SUSTANON '250' injection

Active ingredients: testosterone propionate, testosterone phenylpropionate, testosterone isocaproate and testosterone decanoate.

Consumer Medicine Information (CMI)

This leaflet provides important information about using SUSTANON '250' (or SUSTANON).

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SUSTANON.

Where to find information in this leaflet:

1. Why am I being given SUSTANON?
2. What should I know before I receive SUSTANON?
3. What if I am taking other medicines?
4. How is SUSTANON given?
5. What should I know while using SUSTANON?
6. Are there any side effects?
7. Product details

1. Why am I being given SUSTANON?

SUSTANON is used to treat confirmed testosterone deficiency in males.

SUSTANON contains four testosterone esters as the active ingredients which are turned into testosterone by your body. Testosterone is the natural male hormone known as an androgen. In men, testosterone is produced by the testicles. It is necessary for the growth, development and function of the male sex organs and for secondary male sex characteristics. It is necessary for the growth of body hair, the development of bones and muscles and it stimulates the production of red blood cells. It also makes men's voices deepen.

Preparations containing testosterone are used to replace testosterone in a person who has low or no natural testosterone (a condition known as hypogonadism).

Ask your doctor if you have any questions about why this medicine has been prescribed to you.

Your doctor may have prescribed it for another reason.

2. What should I know before I receive SUSTANON?

Warnings

You should not be given SUSTANON if:

  • you are allergic to peanuts, soya or any of the ingredients listed at the end of this leaflet.
    - Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; rash, itching or hives on the skin
  • you have any of the following medical conditions:
    - a current or past prostate or breast tumour or are suspected to have one of these tumours
    - high levels of calcium in the blood (hypercalcaemia)
    - high levels of calcium in the urine (hypercalciuria).
  • you are a woman
  • in children under the age of 3 years
  • it has passed the expiry date printed on the pack
  • the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • have had any allergy to any other medicines, or any other substances, such as foods, preservatives, or dyes.
  • have any other medical conditions, especially the following:
    - breast cancer which has spread to the bones
    - kidney or lung cancer
    - heart disease
    - kidney disease
    - liver disease
    - high blood pressure
    - clotting disorder
    - diabetes mellitus
    - epilepsy
    - migraine, headaches
    - prostatic complaints (such as problems with passing urine). Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).
    - sleep apnoea (temporarily stopping breathing during your sleep).

Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Fertility, pregnancy and breastfeeding

If you are planning to have a baby, ask your doctor for advice before taking this medicine.

In men, treatment with SUSTANON can lead to fertility disorders by repressing sperm formation.

SUSTANON is not for use in women, therefore this medicine must not be taken by women who are pregnant or think that they are pregnant, or by women who are breast-feeding. It may give increased male characteristics to an unborn baby.

There is not enough data available for the safe use of SUSTANON during lactation.

Use in children and adolescents

The safety and efficacy of this medicine has not been adequately determined in children and adolescents.

Extra supervision by your doctor is necessary in the treatment of children and adolescents since testosterone administration in general may cause early sexual development and limit growth.

SUSTANON should not be given to children under 3 years of age.

SUSTANON contains benzyl alcohol which may cause toxic or allergic reactions in infants and children up to 3 years old.

Improper use

Misuse of androgens to enhance ability in sports carries serious health risks and is discouraged.

If you are a patient who participates in competitions governed by the World Anti-Doping Agency (WADA), then you should consult the WADA-code before using this medicine as SUSTANON can interfere with anti-doping testing.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with SUSTANON and affect how it works. These include:

  • anticoagulants or medicines used to prevent blood clots
  • anti-diabetic medicines such as insulin used to treat diabetes and/or other medicines to control blood sugar levels
  • adrenocorticotrophic hormone (ACTH)
  • corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SUSTANON.

4. How is SUSTANON given?

How much is given

Standard treatment is usually one injection of SUSTANON every 3 weeks. The dosage will be adjusted by your doctor in response to your individual requirements.

Pre-pubertal children using this medicine will be monitored by your doctor.

How it is given

This medicine should only be given by a doctor or a nurse.

The injections are given deeply into a muscle (e.g. the buttock, upper leg or upper arm). The contents of each ampoule are for one injection only.

Using SUSTANON with food and drink

This medicine can be injected without taking consideration of meals and drinks.

If you forget to get your injection of SUSTANON

If you miss a scheduled injection, then talk to your doctor or nurse as soon as possible.

No double dose should be injected to make up for forgotten individual doses.

If you are given too much SUSTANON

These injections are given under medical supervision, and it is very unlikely that you will be given too much.

If several doses are given at once it is not a medical emergency. However, you should consult your doctor as side-effects are dependent on dosage, dose interval and your individual sensitivity.

5. What should I know while using SUSTANON?

Things you should do

Remind any doctor, dentist, or pharmacist you visit that you are using SUSTANON.

SUSTANON may affect the results of some laboratory tests e.g. thyroid gland. Therefore, you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.

Keep all your appointments so that your progress can be checked.

Your doctor may do some blood tests at regular intervals to make sure the medicine is working and to prevent unwanted side effects.

Talk to your doctor or nurse immediately if you have the impression that the effect of this medicine is too strong or too weak.

After using SUSTANON

The effects of this medicine do not stop immediately after discontinuation, but gradually subside.

When treatment with this medicine is stopped, complaints such as those experienced before treatment may re-occur within a few weeks.

Ask your doctor or pharmacist if you have any further questions on the use of this medicine.

Driving or using machines

As far as is known, this medicine has no influence on driving and using machines.

Looking after your medicine

Keep SUSTANON in the original box in a safe place out of reach and sight of children.

Keep it in a cool dark place where the temperature stays between below 30°C.

Do not refrigerate as this makes the product difficult to inject.

Getting rid of any unwanted medicine

Return any unused medicine to your pharmacist.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • pain at the injection site
  • itching
  • acne
  • nausea
  • muscle pain
  • increased weight
  • high blood pressure
  • increase in the number of red blood cells
  • increased or decreased sexual desire
  • disturbed formation of sperm
  • breast enlargement in men
  • prostate enlargement
  • fluid retention e.g. swelling of ankles and feet and weight gain
  • reduction in size of testes
  • hair loss
Some side effects have no symptoms and are seen only in blood tests:
  • changes in liver function tests
  • changes in cholesterol levels (changes in lipid metabolism)
  • increased levels of a blood marker which is associated with prostate cancer (PSA increased)
  • increase in the number of red blood cells
  • increase blood pressure.
In children and adolescents:
  • early sexual development
  • penis enlargement
  • an increased frequency of erections
  • growth limitation (limited body height).
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • depression, nervousness, mood alterations
  • signs of allergy such as rash, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing
  • yellowing of the skin and eyes, also called jaundice
  • prolonged abnormal, painful erection of the penis
  • growth of undetected prostate cancer
  • coughing, increased sweating, chest pain, feeling faint
  • pain, swelling, redness, and enlarged veins in the affected area.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

SUSTANON is also associated with an increased risk of prostate cancer.

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor, nurse or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What SUSTANON contains

Active ingredients
(main ingredients

Contains a total testosterone content of 176 mg/mL in four separate compound forms:

  • testosterone propionate 30 mg
  • testosterone phenylpropionate 60 mg
  • testosterone isocaproate 60 mg
  • testosterone decanoate 100 mg.
Other ingredients
(inactive ingredients)
  • arachis (peanut) oil (base)
  • benzyl alcohol (preservative).
Potential allergens
  • peanut oil.

Do not take this medicine if you are allergic to any of these ingredients.

What SUSTANON looks like

SUSTANON is a clear, colourless glass ampoule containing 1 mL of pale yellow oily solution.

Pack size of 1 ampoule.

Australian Registration number: AUST R 14521

Who distributes SUSTANON

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was revised in April 2025.

Published by MIMS July 2025

BRAND INFORMATION

Brand name

Sustanon 250

Active ingredient

Testosterone propionate; Testosterone phenylpropionate; Testosterone isocaproate; Testosterone decanoate

Schedule

S4

 

1 Name of Medicine

Sustanon '250' (250 mg/mL solution for injection).

Testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone decanoate.

2 Qualitative and Quantitative Composition

Each ampoule or vial of Sustanon 250 contains 30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate in 1 mL arachis oil. All 4 compounds are esters of the natural hormone testosterone. The total amount of testosterone per mL is 176 mg.

List of excipients with known effects.

Arachis (peanut) oil.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sustanon '250' is a clear, colourless glass ampoule or vial containing 1 mL of pale yellow oily solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Androgen replacement therapy for confirmed testosterone deficiency in males.

4.2 Dose and Method of Administration

Sustanon '250' is an androgenic solution for intra-muscular injection.
In general, dosage should be adjusted according to the response of the individual patient.

Adults including elderly.

Usually, one injection of 1 mL per three weeks is adequate for Sustanon '250'.
Sustanon '250' should be administered by deep intramuscular injection.
Safety and efficacy have not been adequately determined in children and adolescents. Prepubertal children treated with Sustanon '250' should be treated with caution. Sustanon '250' contains benzyl alcohol and should not be given to children under 3 years of age.

4.3 Contraindications

Known or suspected carcinoma of the prostate or breast.
Hypercalcaemia and/or hypercalciuria.
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 (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

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 subclinical prostate cancer;
hematocrit and haemoglobin to exclude polycythaemia.

Conditions that need supervision.

Patients, especially the elderly, with the following conditions should be monitored for:
In patients with pre-existing cardiac, renal or hepatic insufficiency/disease androgen treatment may cause complications characterized by oedema with or without congestive heart 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.
Tumours - Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcemia may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcemia should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.
Ischaemic heart disease, as androgens may produce hypercholesterolaemia.
Urethral obstruction in patients with benign prostatic hypertrophy receiving testosterone.
Diabetes mellitus - Androgens in general and Sustanon '250' can improve glucose tolerance in diabetic patients (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
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.
Anti-coagulant therapy - Androgens in general and Sustanon '250' can enhance the anti-coagulant action of coumarin type agents.
There is insufficient evidence for a recommendation regarding the safety of treatment with testosterone esters in men with sleep apnoea. Good clinical judgement and caution should be employed in patients with risk factors such as adiposity or chronic lung disease.
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.
If androgen-associated adverse reactions occur, Sustanon '250' treatment should be interrupted and, upon resolution of the complaints, be resumed at a lower dosage.
Sustanon '250' contains arachis (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 Contraindications).

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. (See Section 4.8 Adverse Effects (Undesirable Effects)).

Use in the elderly.

Risk of developing prostatic hypertrophy and prostatic carcinoma may be increased in geriatric patients receiving androgens.

Paediatric use.

Sustanon '250' contains 100 mg benzyl alcohol per mL solution and must not be given to children under 3 years of age, including premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Safety and efficacy have not been adequately determined in children.
In prepubertal children statural growth and sexual development should be monitored since androgens in general and Sustanon '250' in high doses may accelerate epiphyseal closure and sexual maturation.
In prepubertal boys androgens may cause accelerated bone maturation without compensatory gain in linear growth. This may compromise adult stature; younger the patient, higher the risk. Effect on bone maturation should be monitored by assessing bone age of wrist and hand every 6 months.

Effects on laboratory tests.

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, however, and there is no clinical evidence of thyroid dysfunction.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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. Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Sustanon '250' treatment.
Androgens may potentiate the effects of cyclosporins and increase risk of nephrotoxicity.
Sustanon '250' may interfere with a number of clinical laboratory tests, e.g. those for glucose tolerance and thyroid function, suppression of clotting factors II, V, VII and X.
A decrease in protein bound iodine (PBI) may occur, but this has no clinical significance.
Enzyme inducing agents may decrease and enzyme inhibiting drugs may increase testosterone levels. Therefore, adjustment of the dose of Sustanon '250' may be required.

Anti-coagulant therapy.

High doses of androgens may enhance the anti-coagulant action of coumarin type agents. Therefore close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy. C-17 substituted derivatives of testosterone have been reported to decrease the anti-coagulant requirements. Patients receiving oral anti-coagulants require close monitoring, especially when androgens are started or stopped. However, this interaction has not been reported for Sustanon '250' to date.

ACTH or corticosteroids.

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In men, treatment with androgens can lead to fertility disorders by repressing sperm formation.
(Category D)
Sustanon '250' is not indicated for treatment in women and therefore must not be used by pregnant women. If used during pregnancy Sustanon '250' poses a risk of virilization of the fetus.
 Sustanon '250' is not indicated for treatment in women and therefore must not be used by breast-feeding women.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

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 (common).
The following adverse reactions have been associated with androgen therapy in general (see Table 1).
The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.

Paediatric population.

The following undesirable effects have been reported in pre-pubertal children using androgens: precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.

Drug abuse and dependence.

Testosterone, often in combination with other anabolic androgenic steroids (AAS), has been subject to abuse at doses higher than recommended for the approved indication (see Section 4.4 Special Warnings and Precautions for Use). The following additional adverse reactions have been reported in the context of testosterone/AAS abuse.

Endocrine disorders.

Secondary hypogonadism1.

Psychiatric disorders.

Hostility, aggression1, psychotic disorder1, mania, paranoia and delusion.

Cardiovascular disorders.

Myocardial infarction1, cardiac failure1, cardiac failure chronic1,2, cardiac arrest, sudden cardiac death, cardiac hypertrophy1,2, cardiomyopathy1, ventricular arrhythmia, ventricular tachycardia1, venous/arterial thrombotic and embolic events (including deep venous thrombosis1, pulmonary embolism1, coronary artery thrombosis, carotid artery occlusion1,2, intracranial venous sinus thrombosis1,2), cerebrovascular accident and ischaemic stroke.

Hepatobiliary disorders.

Peliosis hepatis1, cholestasis, liver injury, jaundice1 and hepatic failure.

Skin and subcutaneous tissue disorders.

Alopecia1.

Reproductive system and breast disorders.

Testicular atrophy, azoospermia, infertility (in males), enlarged clitoris and breast atrophy (in females).
1 Has been reported with Sustanon '250'.
2 With fatal outcomes in some cases.

Post-marketing experience.

Venous thromboembolism.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

The acute toxicity of testosterone is low. There are no specific recommendations for the management of overdosage with Sustanon '250'. If symptoms of chronic overdose occur (e.g. polycythemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at a lower dosage.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Treatment of hypogonadal men with Sustanon '250' results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone, oestradiol and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). Luteinising hormone (LH) and follicle-stimulating hormone (FSH) are restored to the normal range. In hypogonadal men, treatment with Sustanon '250' results in an improvement of testosterone deficiency symptoms. Moreover, treatment increases bone mineral density and lean body mass, and decreases body fat mass. Treatment also improves sexual function, including libido and erectile function. Treatment decreases serum LDL-C, HDL-C and triglycerides, increases haemoglobin and hematocrit, whereas no clinically relevant changes to PSA have been reported. Treatment may result in an increase in prostate size, but no adverse effects on prostate symptoms have been observed. In hypogonadal diabetic patients, improvements of insulin sensitivity and/or reduction in blood glucose have been reported with the use of androgens.
In female to male transsexuals treatment with androgens/ Sustanon '250' induces masculinisation.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Sustanon '250' contains 4 esters of testosterone with different duration of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation.
A single dose of Sustanon '250' leads to an increase of total plasma testosterone with peak-levels of approximately 70 nanomol/L (Cmax), which are reached approximately 24-48 h (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 21 days.

Distribution.

Testosterone displays high binding (over 97%) to plasma proteins and sex hormone binding globulin.

Metabolism.

Testosterone is metabolized to dihydrotestosterone and oestradiol, which are further metabolised via the normal pathways.

Excretion.

Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.

5.3 Preclinical Safety Data

Genotoxicity.

The genotoxic potential of testosterone has not been fully investigated, although limited data suggest that it is not genotoxic.

Carcinogenicity.

Sex hormones are known to promote the growth of certain hormone dependent tissues and tumours. Subcutaneous implantation of testosterone produced cervical and uterine tumours in female mice, which metastasised in some cases. Metastasising prostatic adenocarcinomas occurred in male rats after chemical induction and subcutaneous implantation of testosterone. Testosterone promotes hepatocarcinogenesis in mice and rats.
Hepatocellular carcinoma has been reported in patients receiving long-term therapy with androgens. Chronic androgen deficiency is a protective factor for prostatic disease.
Hypogonadal men receiving androgen replacement therapy require surveillance for prostate disease similar to that recommended for eugonadal men of comparable age. Geriatric patients treated with androgens may be at an increased risk for development of prostatic hyperplasia and prostatic cancer.

6 Pharmaceutical Particulars

6.1 List of Excipients

Inactive excipients: Arachis (peanut) oil and benzyl alcohol (10%).
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Sustanon '250' injection ampoule (AUST R 14521).

Store between 8°C - 30°C. Do not refrigerate and protect from light. Store in the original packaging and keep container in the outer carton.
Since an opened ampoule cannot be resealed in such a way to further guarantee the sterility of the contents, the solution should be used immediately.

Sustanon '250' injection vial (AUST R 190717).

Store between 8°C - 30°C. Do not refrigerate. Protect from light. Store in the original packaging and keep container in the outer carton.
The vial is for single use in one patient only. The solution should be injected immediately after withdrawing the contents from the vial using a sterile syringe and needle.

6.5 Nature and Contents of Container

Sustanon '250' injection is supplied in a clear, glass ampoule or vial.

Sustanon '250' injection ampoule (AUST R 14521).

Pack Sizes: 1 x 1 mL ampoule.
3 x 1 mL ampoule*.

Sustanon '250' injection vial (AUST R 190717).

Pack Sizes: 1 x 1 mL vial*.
3 x 1 mL vial*.
* Not available commercially.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Pharmacotherapeutic group: Androgens. ATC code G03B A03.
Testosterone propionate, testosterone phenylpropionate, testosterone isocaproate and testosterone decanoate are all white to creamy white crystals or powder. They are practically insoluble in water but are soluble in chloroform, ethanol and fixed oils. They have melting points in excess of 50°C. They are prepared synthetically from plant origins. They are fatty acid esters of the naturally occurring androgen testosterone.

Chemical structure.

Testosterone propionate.

Testosterone propionate is 3-oxoandrost-4-en-17β-yl propionate.

CAS number.

57-85-2.

Testosterone phenylpropionate.

Testosterone phenylpropionate is 3-oxoandrost-4-en- 17β-yl 3-phenylpropionate.

CAS number.

1255-49-8.

Testosterone isocaproate.

Testosterone isocaproate is 3-oxoandrost-4-en-17β-yl 4- methylpentanoate.

CAS number.

15262-86-9.

Testosterone decanoate.

Testosterone decanoate is 3-oxoandrost-4-en-17β-yl-decanoate.

CAS number.

5721-91-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes