Active ingredients: Testosterone (testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone decanoate)
SUSTANON 250 mg / ml solution for injection for intramuscular use
Indications Why is Sustanon used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Sex hormones and modulators of the genital system, androgens, 3-oxoandrostene derivatives.
THERAPEUTIC INDICATIONS
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by the clinical picture and biochemical analyzes.
Contraindications When Sustanon should not be used
Hypersensitivity to the active substance, to other androgens, or to any of the excipients.
History or presence of known or suspected prostate or breast cancer (see Special Warnings).
Hypertension, nephrotic syndrome, severe liver dysfunction, history of primary liver cancer, established hypercalciuria and hypercalcaemia (see Precautions for use).
The medicine contains peanut oil so it should not be used in patients with a soy or peanut allergy (see Special warnings).
The medicine contains benzyl alcohol so it should not be given to children under 3 years of age (see Special warnings).
Pregnancy and breastfeeding (see Special warnings).
Precautions for use What you need to know before taking Sustanon
Physicians should consider monitoring the subjects to be treated with Sustanon before the start of treatment, every three months for the first 12 months and then once a year with observation of the following parameters:
- digital rectal examination (EDR) of the prostate and determination of the PSA value to exclude benign prostatic hypertrophy or subclinical prostate cancer,
- hematocrit and hemoglobin to rule out polycythemia.
Testosterone levels should be monitored at baseline and at regular intervals during treatment. Physicians should adjust the dose on an individual basis from patient to patient to ensure maintenance of eugonadal testosterone levels.
Patients, especially the elderly, with the following conditions should be monitored for:
- hypercalcemia and / or conditions leading to hypercalcemia such as nephropathies, prostate, breast cancer, other cancers and skeletal metastases (see Contraindications). Hypercalcemia can also occur during treatment with androgens. Hypercalcemia must first be treated appropriately and, after normal calcium levels are restored, hormone therapy can be resumed.
- Comorbid conditions - In patients with severe heart, liver or kidney failure or ischemic heart disease, testosterone treatment can induce severe complications characterized by edema with or without congestive heart failure. In this case, the treatment must be stopped immediately. Patients who have had myocardial infarction, heart, liver or kidney failure, hypertension, epilepsy or migraine should be monitored for the risk of worsening or recurrence. In such cases, treatment should be stopped immediately.
- Testosterone can cause blood pressure to rise and Sustanon should be used with caution in hypertensive individuals.
- Diabetes mellitus - Androgens in general and Sustanon can improve glucose tolerance in diabetic patients (see Interactions).
- Anticoagulant therapy - Androgens in general and Sustanon may enhance the anticoagulant action of coumarin-type agents (see Interactions).
- Sleep apnea - There is insufficient evidence for a recommendation regarding the safety of testosterone ester treatment in men with sleep apnea. Careful medical evaluation and caution are required in patients with risk factors such as overweight or chronic lung disease
Stimulation that increases nervous, mental and physical activity beyond the patient's cardiovascular capacity should be avoided.
If priapism or other signs of sexual over-stimulation occur, therapy should be discontinued (see Undesirable Effects).
It is not recommended in psychic impotence since its prolonged use can lead to a hypotrophy of the testicles, which are normal and perfectly functional in themselves.
Adverse events:
If adverse reactions associated with the use of androgens occur (see Undesirable Effects), treatment with Sustanon should be discontinued and, upon resolution of the disorder, it should be resumed at a lower dose.
Pediatric population:
In prepubertal children, height growth and sexual development should be monitored as androgens in general and Sustanon in high doses can accelerate epiphysis sealing and sexual maturation.
Patients over 65 years of age:
There is limited experience on the safety and efficacy of the use of Sustanon in patients over the age of 65. There is currently no agreement on age-specific testosterone reference values. However, it must be considered that serum testosterone levels decrease physiologically with increasing age.
Interactions Which drugs or foods can modify the effect of Sustanon
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
Other medicines may affect the effects of Sustanon or Sustanon may affect the effects of other medicines. Therefore, you should tell your doctor or pharmacist if you are taking or about to take:
- Insulin and / or other medicines to control blood sugar levels;
- Medicines to reduce blood clotting (anticoagulants).
Enzyme inducers can reduce testosterone levels, while enzyme inhibitors can increase them, therefore Sustanon dose adjustment may be required. Androgens can improve glucose tolerance and reduce the need for insulin or other antidiabetic medicines in people with diabetes (see Precautions for use).
High doses of androgens can potentiate the anticoagulant action of coumarin drugs allowing for a reduction in dose (see Precautions for use). Also tell your doctor or pharmacist if you are taking or about to take ACTH hormone or corticosteroids (used to treat various conditions, such as rheumatism, arthritis, allergic conditions and asthma). Administration of androgens such as Sustanon may increase. the risk of water retention, especially if your heart and liver are not functioning properly.
Androgens can also affect the results of some laboratory tests (e.g. those of the thyroid gland). Therefore, you should inform your doctor or the laboratory staff performing the tests that you are using this medicine.
Warnings It is important to know that:
Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
In men, Sustanon treatment can lead to fertility problems through the suppression of sperm formation.
Pregnancy and breastfeeding
Treatment with Sustanon is intended for use in men only, therefore it should not be used by women who are pregnant or breastfeeding (see Contraindications). When used during pregnancy Sustanon exposes the fetus to risk of virilization.
Effects on ability to drive and use machines
Sustanon does not affect the ability to drive or use machines
Important information about some of the ingredients
- This medicine contains peanut oil. Do not use it if you are allergic to peanuts or soy (see Contraindications).
- This medicine contains benzyl alcohol (100 mg per ml of solution). This medicine should not be given to premature babies or newborns. It can cause toxic and allergic reactions in children up to 3 years of age.
For those who carry out sporting activities
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
(Improper) use in sport:
Patients participating in competitions regulated by the World Anti-Doping Agency (WADA) must consult the WADA code before using this medicine as Sustanon can interfere with doping tests.
Misuse of this medicine to improve sports ability carries serious health risks and should be discouraged.
Dosage and method of use How to use Sustanon: Dosage
Sustanon should be administered by deep intramuscular injection.
Typically the dose is one 1 ml injection every three weeks. In general, the dose should be adjusted based on the individual patient's response.
Pediatric population
Safety and efficacy in children have not yet been established.
Overdose What to do if you have taken too much Sustanon
In case of accidental administration of an overdose of Sustanon, notify your doctor immediately or go to the nearest hospital.
Acute testosterone toxicity is slow.
If symptoms of chronic overdose occur (e.g. polycythemia, priapism), treatment should be stopped and resumed at lower doses when symptoms disappear.
If you forget to give your Sustanon injection
If you have forgotten a scheduled injection, tell your doctor or nurse as soon as possible. Double doses should not be given to make up for forgotten single doses.
If you stop taking Sustanon
The effects of this medicine do not go away immediately after stopping, but gradually lessen.
If treatment with this medicine is stopped, the symptoms that occurred before treatment may return within a few weeks.
If you have any questions about the use of Sustanon, ask your doctor or pharmacist.
Side Effects What are the side effects of Sustanon
Like all medicines, Sustanon can cause side effects, although not everybody gets them.
* MedDRA version 15.0
1 Increased growth of a small prostate cancer that was not yet recognized (progression of subclinical prostate cancer)
2 Prostate growth up to eugonadal state (increase in size of the prostate to a size representative of the age group in question)
3 Changes in cholesterol levels: reduction in serum levels of LDL-C, HDL-C and triglycerides.
Hypercalcaemia may also occur, especially in patients with metastatic breast cancer (usually a sign of evolution of bone metastases) and a possible decrease in PBI (Protein Bound Iodine) without clinical significance.
Pediatric population:
The following undesirable effects have been reported in prepubertal children using androgens (see Precautions for use): early sexual development, increased frequency of erections, penile enlargement and premature sealing of epiphyses.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Store below 30 ° C. Do not refrigerate or freeze. Store in the original package and keep the container in the outer carton to protect from light.
Since an opened vial cannot be resealed to further ensure the sterility of the contents, the solution should be used immediately.
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
COMPOSITION
A 1ml vial contains:
active principles:
- testosterone propionate 30 mg
- testosterone phenylpropionate 60 mg
- testosterone isocaproate 60 mg
- testosterone decanoate 100 mg
excipients: peanut oil and benzyl alcohol
PHARMACEUTICAL FORM AND CONTENT
Clear, light yellow solution for injection for intramuscular use.
1 ampoule of 1 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SUSTANON 250 MG / ML SOLUTION FOR INJECTION FOR INTRAMUSCULAR USE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sustanon is a solution in oil. Each vial contains 1 ml of peanut oil containing the following active ingredients:
testosterone propionate 30 mg
testosterone phenylpropionate 60 mg
testosterone isocaproate 60 mg
testosterone decanoate 100 mg
All four compounds are esters of the natural hormone testosterone.
The total amount of testosterone per ml is 176 mg.
Excipients with known effects: peanut oil, benzyl alcohol
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Solution for injection for intramuscular use.
Clear, light yellow solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by the clinical picture and biochemical analyzes.
04.2 Posology and method of administration
Dosage:
In general, the dose should be adjusted according to each patient's response.
Adults
Usually 1 injection of 1 ml every 3 weeks is sufficient.
Pediatric population
Safety and efficacy in children have not yet been established.
Method of administration:
Sustanon should be administered by deep intramuscular injection.
04.3 Contraindications
• Hypersensitivity to the active substance, to other androgens or to any of the excipients listed in section 6.1, including peanut oil. Sustanon is therefore contraindicated in patients with peanut or soy allergy (see section 4.4).
• Known or suspected prostate or breast cancer (see section 4.4).
• Hypertension, nephrotic syndrome, severe liver dysfunction, history of primary liver cancer, established hypercalciuria and hypercalcaemia (see section 4.4).
• The medicinal product contains benzyl alcohol so it should not be given to children under 3 years of age (see section 4.4).
• Pregnancy and lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use
Medical examination:
Testosterone levels should be monitored at baseline and at regular intervals during treatment. Physicians should adjust the dose on an individual basis from patient to patient to ensure maintenance of eugonadal testosterone levels.
Physicians should consider monitoring patients to be treated with Sustanon prior to the start of treatment, every three months for the first 12 months and annually thereafter with observation of the following parameters:
• digital rectal examination (EDR) of the prostate and determination of the PSA value to exclude benign prostatic hypertrophy or subclinical prostate cancer (see section 4.3),
• hematocrit and hemoglobin to exclude polycythemia.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored at regular intervals: hemoglobin and hematocrit, liver function parameters and lipid profile.
Conditions that need supervision:
Patients, especially the elderly, with the following conditions should be monitored for:
• hypercalcaemia and / or conditions leading to hypercalcaemia such as nephropathies, prostate and breast cancer, other cancers and skeletal metastases (see section 4.3). Hypercalcemia can also occur during treatment with androgens. Hypercalcemia must first be treated appropriately and, after normal calcium levels are restored, hormone therapy can be resumed.
• Comorbid conditions - In patients with severe heart, liver or kidney failure or ischemic heart disease, testosterone treatment can induce severe complications characterized by edema with or without congestive heart failure. In this case, the treatment must be stopped immediately.
Patients who have had myocardial infarction, heart, liver or kidney failure, hypertension, epilepsy or migraine should be monitored for the risk of worsening or recurrence. In such cases, treatment should be stopped immediately.
Testosterone can cause blood pressure to rise and Sustanon should be used with caution in hypertensive individuals.
• Diabetes mellitus - Androgens in general and Sustanon can improve glucose tolerance in diabetic patients (see section 4.5).
• Anticoagulant therapy - Androgens in general and Sustanon may potentiate the anticoagulant action of coumarin-type agents (see section 4.5).
• Sleep apnea - There is insufficient evidence for a recommendation regarding the safety of treatment with testosterone esters in men with sleep apnea. Careful medical evaluation and caution are required in patients with risk factors such as overweight or chronic lung disease.
Stimulation that increases nervous, mental and physical activity beyond the patient's cardiovascular capacity should be avoided.
If priapism or other signs of sexual over-stimulation occur, therapy should be discontinued (see section 4.8).
A reduction in PBI (Protein Bound Iodine) may occur during therapy; however, this data has no clinical significance.
It is not recommended in psychic impotence since its prolonged use can lead to hypotrophy of the testicles which are in themselves normal and perfectly functional.
Adverse events:
If adverse reactions associated with the use of androgens occur (see section 4.8), Sustanon should be discontinued and resumed at a lower dose upon resolution of the disorder.
(Improper) use in sport:
Patients participating in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA code before using this medicine as Sustanon can interfere with doping tests. Misuse of androgens to improve ability in sport carries serious risks for health and should be discouraged.
Pediatric population:
In prepubertal children, height growth and sexual development should be monitored as androgens in general and Sustanon in high doses can accelerate epiphysis sealing and sexual maturation.
Important information about some of the ingredients:
Sustanon contains peanut oil. Refined peanut oil may contain peanut proteins. The monograph of the European Pharmacopoeia does not provide for an assay for residual proteins.
Sustanon contains 100 mg of benzyl alcohol per ml of solution and should not be given to premature babies or newborns. Benzyl alcohol can cause toxic and anaphylactic reactions in children up to 3 years of age.
Patients over 65 years of age:
There is limited experience on the safety and efficacy of the use of Sustanon in patients over the age of 65. There is currently no agreement on age-specific testosterone reference values. However, it must be considered that serum testosterone levels decrease physiologically with increasing age.
04.5 Interactions with other medicinal products and other forms of interaction
Enzyme inducers can reduce testosterone levels, while enzyme inhibitors can increase them, therefore Sustanon dose adjustment may be required.
Insulin and other antidiabetic medicines:
Androgens may improve glucose tolerance and reduce the need for insulin or other antidiabetic drugs in diabetic patients (see section 4.4).
Patients with diabetes mellitus should therefore be monitored especially at the start or end of treatment and at periodic intervals during treatment with Sustanon.
Anticoagulant therapy:
High doses of androgens may potentiate the anticoagulant action of coumarin-type agents (see section 4.4). Therefore close monitoring of prothrombin time and, if necessary, dose reduction of anticoagulants is required during therapy.
ACTH or corticosteroids:
Concomitant administration of testosterone and ACTH or corticosteroids can increase edema formation; therefore the combination of these active substances should be done with caution, especially in patients with cardiac or hepatic disease or in patients predisposed to edema (see section 4.4).
Interactions with laboratory tests:
Androgens can reduce thyroxine-binding globulin levels resulting in a reduction in total serum T4 levels and an increase in resin uptake of T3 and T4. However, free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.
04.6 Pregnancy and lactation
Pregnancy and breastfeeding:
Treatment with Sustanon is intended for use in men only, therefore it should not be used by pregnant or breastfeeding women (see section 4.3). When used during pregnancy Sustanon exposes the fetus to a risk of virilization (see section 5.3). ).
Fertility
In men, androgen treatment can lead to impaired fertility by suppressing sperm formation (see section 4.8).
04.7 Effects on ability to drive and use machines
Sustanon does not affect the ability to drive or use machines.
04.8 Undesirable effects
The frequency of undesirable effects listed below is defined using the following convention: Very common (≥ 1/10), common (≥ 1/100 to
Hypercalcaemia may also occur, especially in patients with metastatic breast cancer (usually a sign of evolution of bone metastases) and a possible decrease in PBI (Protein Bound Iodine) without clinical significance.
Pediatric population:
The following undesirable effects have been reported in prepubertal children using androgens (see section 4.4): early sexual development, increased frequency of erections, penile enlargement and premature sealing of the epiphyses.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse".
04.9 Overdose
Acute toxicity of testosterone is low.
If symptoms of chronic overdose occur (e.g. polycythemia, priapism), treatment should be stopped and resumed at a lower dose when symptoms disappear.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, androgens, 3-oxoandrostene derivatives.
ATC code: G03BA03.
Treatment of hypogonadal men with Sustanon results in a clinically significant increase in plasma concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione, as well as a decrease in sex hormone binding globulin (SHBG). Luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the normal range. In men with hypogonadism, treatment with Sustanon improves symptoms of testosterone deficiency. In addition, testosterone increases density. bone mineral. Treatment also improves sexual function, including libido and erectile function. Treatment reduces serum levels of LDL-C, HDL-C and triglycerides and increases hemoglobin and hematocrit, while no changes were observed. clinically relevant liver enzymes and PSA. Treatment may lead to an increase in prostate size, however no adverse effects on prostatic symptoms have been observed. In boys with constitutional retardation of growth and puberty, treatment with Sustanon accelerates growth and induces the development of secondary sexual characteristics.
05.2 Pharmacokinetic properties
Sustanon contains four testosterone esters with different duration of action. The esters are hydrolyzed into the natural hormone testosterone as soon as they enter the general circulation.
Absorption:
A single dose of Sustanon results in elevation of total plasma testosterone with peak levels of approximately 70 nmol / l (Cmax), which are reached approximately 24-48 hours (tmax) after administration. In men, plasma testosterone levels return to the lower limit of the normal range after approximately 21 days.
Distribution:
In in vitro tests, testosterone exhibits high (over 97%) non-specific binding to plasma proteins and sex hormone binding globulin.
Biotransformation:
Testosterone is metabolised into dihydrotestosterone and estradiol, which are further metabolised in the normal pathways.
Elimination:
Excretion occurs mainly through the urine in the form of conjugates of ethiocholanolone and androsterone.
05.3 Preclinical safety data
Preclinical data with androgens in general reveal no risk to humans. The use of androgens in different species has been shown to cause virilization of the external genitalia of female fetuses (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Peanut oil
Benzyl alcohol
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
Sustanon can be used until the expiration date indicated on the package.
Since an opened vial cannot be resealed to further ensure the sterility of the contents, the solution should be used immediately.
06.4 Special precautions for storage
Store at a temperature below 30 ° C. Do not refrigerate or freeze. Store in the original package and keep the container in the outer carton to protect from light.
06.5 Nature of the immediate packaging and contents of the package
Each Type I glass vial contains 1ml of Sustanon.
One pack of Sustanon contains 1 ampoule.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
08.0 MARKETING AUTHORIZATION NUMBER
AIC N ° 016094017.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
1.12.1959 - May 2010
10.0 DATE OF REVISION OF THE TEXT
October 2015
