Consumer medicine information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Primoteston Depot. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Primoteston Depot against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

WHAT PRIMOTESTON DEPOT IS USED FOR

Primoteston Depot is used to replace the body’s natural hormone testosterone when not enough is made by the body.

Testosterone is a natural hormone, known as an androgen, which controls normal sexual development and function in men.

Testosterone is essential for the development and maintenance of the male reproductive organs as well as other male characteristics, such as facial and body hair growth, deep voice, sexual drive, muscle mass and body fat distribution.

The depot effect of testosterone enantate permits long intervals between injections. An injection of Primoteston Depot can maintain its effect for 2-4 weeks, depending on your initial hormonal status.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

BEFORE YOU ARE GIVEN PRIMOTESTON DEPOT

When you must not be given it

Do not use Primoteston Depot if you have an allergy to:

• testosterone enantate, the active ingredient in Primoteston Depot
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Do not use Primoteston Depot if you have:

• prostate cancer
• breast cancer in males
• high blood calcium levels associated with malignant tumours
• previous or existing liver tumours

Do not use this medicine after the expiry date printed on the pack and vial. The expiry date is printed on the carton and on each vial after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not use this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Primoteston Depot is recommended for use in men only.

It is not recommended to give this medicine to a child under the age of 18 years.

Use of androgens for reasons other than what your doctor prescribed carries a serious health risk and is strongly discouraged.

Primoteston Depot may quicken the growth of existing prostatic tumours and prostatic hyperplasia (enlargement of the prostate gland), particularly if you are an older patient. Before treatment, your doctor should conduct tests to check that you do not have existing prostate cancer. In addition, your doctor will regularly check your prostate while you are using Primoteston Depot.

If you use Primoteston Depot over long periods of time, you may develop an abnormal increase in the number of red blood cells in the blood (polycythaemia). Your doctor may organise regular blood counts to monitor this.

Tell your doctor if you have, or have had, any of the following medical conditions:

• a tendency to retain fluid (signs may include swollen feet or ankles)
• high blood pressure or if you are being treated for high blood pressure as testosterone may cause a rise in blood pressure
• sleep apnoea (abnormal pauses in breathing during sleep)
• a bleeding disorder
• thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis - blood clots in blood vessels)

If you are suffering from severe heart, liver or kidney disease, treatment with Primoteston may cause severe complications in the form of water retention in your body and sometimes accompanied by (congestive) heart failure. Please inform your doctor immediately if you notice any signs of water retention.

If you have not told your doctor about any of the above, tell them before you start using Primoteston Depot.

Taking other medicines

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

Some medicines and Primoteston Depot may interfere with each other. These include:

• barbiturates, medicines used to treat nervousness or sleeping problems
• oxyphenbutazone, a mediciens used to treat pain and inflammation
• oral anticoagulants, ‘blood thinning’ medications to treat or prevent blood clots such as warfarin
• medicines used to control blood sugar levels in diabetes

These medicines may be affected by Primoteston Depot or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

HOW PRIMOTESTON DEPOT IS GIVEN

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

How it is given

Primoteston Depot is injected slowly into the muscle by your doctor.

Experience shows that the short-lasting reactions (urge to cough, coughing fits, difficulty in breathing) which occur in very rare cases during or immediately after the injection of oily solutions can be avoided by injecting the solution slowly.

How much is given

Before treatment with Primoteston Depot, your doctor will measure your blood testosterone levels.

Initially, one prefilled syringe is injected into the muscle every 2 – 3 weeks by your doctor. The injection interval will depend on your testosterone levels.

To maintain the effect of Primoteston Depot, 1 prefilled syringe is injected into the muscle every 3 – 4 weeks.

Your doctor will decide how often your injection interval is, based on results from blood testosterone tests conducted during treatment with Primoteston Depot.

If you are given too much (overdose)

As Primoteston Depot is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However if you experience any side effects after being given it, tell your doctor immediately.

Immediately telephone the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have been given too much Primoteston Depot. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

WHILE YOU ARE RECEIVING PRIMOTESTON DEPOT

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Primoteston Depot.

Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.

Keep all of your doctor’s appointments.

Always take this medicine exactly as your doctor or pharmacist has told you.

Abuse of testosterone, especially if you take too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver.

Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dosage changes significantly or is stopped immediately. You should not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks. See “Side effects”.

Primoteston Depot helps control the symptoms of your condition, but does not cure it. Therefore, your doctor must administer Primoteston Depot every 3 – 4 weeks.

If you experience prolonged stomach pain, blood in the stools or vomit, or yellowing of the skins and eyes during treatment with Primoteston Depot, tell your doctor immediately. There have been cases reported of patients developing liver tumours while using Primoteston Depot. Your doctor may tell you to stop using Primoteston Depot.

Your doctor may examine your prostate and conduct other tests (including blood tests) from time to time, particularly if you are elderly. This is to make sure the medicine is working and to check for unwanted side effects.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving Primoteston Depot.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Tell you doctor if you notice any of the following and they worry you:

• pain, redness, swelling, heat or itching at the injection site
• cough
• shortness of breath, difficulty in breathing
• rash, itching or hives
• acne
• hair loss or growth
• changes in libido
• breast development
• fluid retention
• weight gain
• hostility/aggression

These side effects may occur during or immediately after the injection.

Long term treatment or treatment with high doses of Primoteston Depot can affect sperm production.

Tell your doctor immediately, or go to the Accident and Emergency department at your nearest hospital if you notice any of the following:

• severe stomach pain or tenderness which do not disappear within a short time
• weakness, tiredness, headache, light-headedness, fainting
• signs of allergy such as rash, swelling of the face, lips, mouth, throat or other parts of the body, wheezing or trouble breathing
• chest pain
• yellowing of the skin and eyes, also called jaundice
• unwanted, frequent or prolonged and painful erections

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

AFTER RECEIVING PRIMOTESTON DEPOT

Storage

Keep Primoteston Depot in the pack until it is time to use it.

Keep Primoteston Depot in a cool, dry place out of direct sunlight where the temperature stays below 25°C.

Do not store Primoteston Depot or any other medicine in the bathroom or near a sink.

Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Primoteston Depot is a clear, yellowish oily solution and comes in 1 mL prefilled syringes. Each pack contains 3 syringes.

Ingredients

Active ingredient:

Primoteston Depot – 250 mg testosterone enantate per prefilled syringe.

Inactive ingredients:

• benzyl benzoate
• castor oil

Supplier

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Australian Registration Number

Primoteston Depot
– AUST R 10707

Date of preparation

January 2021

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

® Registered trademark of the Bayer group, Germany

© Bayer Australia Ltd

All rights reserved.

Published by MIMS March 2021

1 Name of Medicine

Testosterone enantate.

2 Qualitative and Quantitative Composition

1 mL Primoteston Depot contains 250 mg testosterone enantate (equivalent to approximately 180 mg testosterone).
Primoteston Depot contains: benzyl benzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
In clear, yellowish 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

Like all oily solutions, Primoteston Depot must be injected intramuscularly, immediately after drawing up into the syringe, and extremely slowly (see Section 4.4 Special Warnings and Precautions for Use).
For the development and stimulation of still underdeveloped androgen-dependent target organs and for the initial treatment of deficiency symptoms: 1 prefilled syringe i.m. every 2-3 weeks.
To maintain an adequate androgenic effect, 1 prefilled syringe i.m. every 3-4 weeks. Shorter injection intervals may be necessary depending on the individual requirement for hormone, but longer intervals of up to 6 weeks are also sufficient in many cases.
Serum testosterone levels should be measured before start of treatment and periodically during the treatment as recommended by current treatment guidelines.
The product should be inspected visually for particles prior to administration. Only clear solution free from particles should be used.

4.3 Contraindications

Prostatic carcinoma, mammary carcinoma in males.
Hypercalcaemia accompanying malignant tumours.
Previous or existing liver tumours.
Hypersensitivity to any of the ingredients.

4.4 Special Warnings and Precautions for Use

The general aim of androgen replacement therapy for confirmed testosterone deficiency in males is to keep serum testosterone levels within the reference range for the age group concerned. Over-replacement should be avoided.
Androgens are not indicated for enhancing muscular development in healthy individuals or for increasing physical ability.
Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia. Androgens can enhance the growth of an existing prostatic carcinoma. Therefore, carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.
As a precaution, regular examinations of the prostate are recommended. Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia (see Section 4.8 Adverse Effects (Undesirable Effects).
In general, the risk of bleeding from using intramuscular injections in patients with acquired or inherited bleeding disorders always has to be taken into account. Testosterone and its derivatives have been reported to increase the activity of coumarin-derived oral anticoagulants (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.
Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of hormonal substances such as the one contained in Primoteston Depot. The doctor must therefore be informed of the occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time as it may then be necessary to withdraw the preparation. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in men using Primoteston Depot.
Caution should be exercised in patients predisposed to oedema. e.g. in case of severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, as treatment with androgens may result in increased retention of sodium and water. In case of severe complications characterised by oedema with or without congestive heart failure, treatment must be stopped immediately (see Section 4.8 Adverse Effects (Undesirable Effects).
Testosterone may cause a rise in blood pressure and Primoteston Depot should be used with caution in men with hypertension.
Primoteston Depot must not be used in women, due to possible virilising effects.
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.
Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use.
Abuse of testosterone along with other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events.
Pre-existing sleep apnoea may be potentiated.
As with all oily solutions, Primoteston Depot must be injected intramuscularly and extremely slowly. Pulmonary microembolism of oily solutions can lead to signs and symptoms such as cough, dyspnoea and chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible.
Treatment is usually supportive, e.g. by administration of oxygen.

Clotting disorders.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs that affect testosterone.

Barbiturates and other enzyme inducers.

Effects of androgens on other drugs.

Oxyphenbutazone.

Oral anticoagulants.

Hypoglycaemics.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Not known.

4.8 Adverse Effects (Undesirable Effects)

The most commonly reported adverse reactions with Primoteston Depot are injection site pain, injection site erythema, and cough and/or dyspnoea during or immediately after the injection.
Injections of oily solutions such as Primoteston Depot have been associated with systemic reactions: cough, dyspnoea and chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia or syncope.
High-dosed or long-term administration of testosterone, including Primoteston Depot, increases the tendency to water retention and oedema.
Spermatogenesis is inhibited by long-term and high-dosed treatment with Primoteston Depot.
If, in individual cases, frequent or persistent erections occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.
Various skin reactions including injection site reactions (injection site pain, injection site erythema, injection site induration, injection site swelling, injection site inflammation) may occur.
Other events reported with Primoteston Depot include benign and malignant liver tumours, polycythaemia, hypersensitivity reactions, weight increase, liver function test abnormalities, jaundice, acne, alopecia, rash, urticaria, pruritus, prostatic specific antigen (PSA) increase, libido increase, libido decrease, gynaecomastia and post marketing reports of venous thromboembolism.
As with other testosterone-containing products, the use of Primoteston Depot may commonly cause an increase in haematocrit, red blood cell count or haemoglobin.
Hostility/aggression and increased hair growth have been reported under treatment with testosterone-containing preparations.
Regarding adverse effects associated with the use of androgens, please also see Section 4.4 Special Warnings and Precautions for Use.

Reporting suspected adverse effects.

4.9 Overdose

No special therapeutic measure apart from termination of therapy with the drug or dose reduction is necessary after overdosage.
Acute toxicity data show that testosterone enantate, the ester contained in Primoteston Depot, can be classified as non-toxic following single intake. Even following single administration of a multiple of the dose required for therapy, no toxicity risk is to be expected.
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.

Clinical trials.

5.2 Pharmacokinetic Properties

The depot effect of testosterone enantate permits long intervals between injections. This ester not only has a long-lasting, but also a very intensive androgenic effect. The duration of action of 1 mL Primoteston Depot is approximately 2-4 weeks depending on the initial hormonal status.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl benzoate, castor oil.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. Please see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Primoteston Depot should be stored below 25°C. Keep out of reach of children. Protect from light.

6.5 Nature and Contents of Container

1 mL prefilled syringes containing 250 mg testosterone enantate.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine.

Summary Table of Changes