SUMMARY CMI

REANDRON^® 1000

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 using REANDRON?

REANDRON contains the active ingredient testosterone undecanoate. REANDRON is used to replace the body's testosterone in male hypogonadism a condition where there are low levels of testosterone in the body.

For more information, see Section 1. Why am I using REANDRON? in the full CMI.

2. What should I know before I use REANDRON?

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

Talk to your doctor if you have any other medical conditions such as diabetes, fluid retention, bleeding disorders, high blood pressure, prostate tumours, epilepsy or if you take any other medicines

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

3. What if I am taking other medicines?

Some medicines may interfere with REANDRON and affect how it works. Let your doctor know if you take medicines to thin the blood, control blood sugar levels, suppress the immune system, for pain and inflammation or for treatment of sleeping problems and nervousness.

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

4. How do I use REANDRON?

REANDRON is injected by your healthcare professional every 10-14 weeks.

More instructions can be found in Section 4. How do I use REANDRON? in the full CMI.

5. What should I know while using REANDRON?

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

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Reandron.

• Less severe side effects may include weight gain, acne, enlarged prostate, hot flushes, injection site reactions
• Severe side effects including chest pains, sweating, signs of an allergic reaction, jaundice, prolonged painful erections, severe stomach pains or blood clots require immediate medical attention.

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

REANDRON^® 1000 (Ree·ANNE·dron)

Active ingredient(s): testosterone undecanoate

Consumer Medicine Information (CMI)

This leaflet provides important information about using REANDRON. 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 REANDRON.

Where to find information in this leaflet:

1. Why am I using REANDRON?
2. What should I know before I use REANDRON?
3. What if I am taking other medicines?
4. How do I use REANDRON?
5. What should I know while using REANDRON?
6. Are there any side effects?
7. Product details

1. Why am I using REANDRON?

REANDRON contains the active ingredient testosterone undecanoate. Testosterone undecanoate is a natural male hormone, known as an androgen, which controls normal sexual development in men.

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

REANDRON is used to replace the body's testosterone in male hypogonadism a condition where there are low levels of testosterone in the body.

Reandron is injected into a location in your body (buttock muscle) where it can be stored and gradually released over a period of time.

2. What should I know before I use REANDRON?

Warnings

Do not use REANDRON if:

• you are allergic to testosterone undecanoate, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• have or are suspected to have:
  - prostate cancer
  - male breast cancer
  - high blood calcium levels associated with tumours
  - past or present liver tumours
• Do not use REANDRON if you are a woman.

Check with your doctor if you:

• Have or had any of the following medical conditions:
  - diabetes
  - a bleeding disorder
  - thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis - blood clots in blood vessels)
  - 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
  - epilepsy
  - migraines
  - sleep apnoea (abnormal pauses in breathing during sleep)
  - severe heart, liver or kidney disease.
  Treatment with REANDRON 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.
• take any medicines for any other condition

REANDRON may increase the rate of progression of prostatic tumours including benign prostatic hypertrophy (enlargement of the prostate gland) and/or prostate cancer. Before treatment, your doctor will conduct tests to ensure that you do not have prostate cancer.

People using testosterone replacement over long periods of time 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.

Athletes should note that the active substance testosterone undecanoate may produce a positive reaction in anti-doping tests.

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

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?

Children and Adolescents

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

Drug abuse and dependence

• 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 6. Are there any side effects?)

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 and REANDRON may interfere with each other. These include:

• oral anticoagulants, ‘blood thinning’ medications to treat or prevent blood clots
• medicines used to control blood sugar levels in diabetes
• oxyphenbutazone, a medicine used to treat pain and inflammation
• cyclosporin, a medicine used to suppress the immune system
• barbiturates, medicines used to treat nervousness and sleeping problems

4. How do I use REANDRON?

How much is given

REANDRON (1 ampoule/vial corresponding to 1000 mg testosterone undecanoate) will be injected by your healthcare professional every 10-14 weeks.

At the start of treatment your doctor will measure your blood testosterone levels. Depending on the results, the second injection may be given before 10 weeks. This is so that the necessary testosterone levels can be reached more quickly.

How REANDRON is given

The injection will be administered very slowly into your buttock muscle by your doctor.

If you use too much REANDRON

Since REANDRON 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. Side effects such as irritability, nervousness, weight gain, or prolonged or frequent erections may indicate the need for dosage adjustment.

If you suspect you have received too much REANDRON you should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using REANDRON?

Things you should do

• If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using REANDRON.
• Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
• Keep all of your doctor's appointments.
  REANDRON helps control the symptoms of your condition, but does not cure it. Therefore, your doctor must administer REANDRON every 10 – 14 weeks.
  Your doctor may monitor your blood pressure, examine your prostate and conduct other 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.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight where the temperature stays below 30°C;

For example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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

Serious side effects

Tell your doctor 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 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 REANDRON contains

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

What REANDRON looks like

REANDRON is a clear, yellowish oily solution contained in a 5 mL glass ampoule or 6 mL glass vial.

REANDRON 1000 (ampoule) – AUST R 106946

REANDRON 1000 (vial) – AUST R 213942

Who distributes REANDRON

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

® Registered trademark of the Bayer Group, Germany

© Bayer Australia Ltd

All rights reserved

This leaflet was prepared in Aug 2023.

Published by MIMS November 2023

1 Name of Medicine

Testosterone undecanoate.

2 Qualitative and Quantitative Composition

Reandron 1000 is a hormonal preparation that contains 1000 mg testosterone undecanoate in 4 mL of oily solution.
Reandron contains benzyl benzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Reandron 1000 is a clear, colourless to yellowish brown oily solution for injection. Testosterone undecanoate is a white or off white crystalline substance.

4 Clinical Particulars

4.1 Therapeutic Indications

Testosterone replacement in primary and secondary male hypogonadism.

4.2 Dose and Method of Administration

Reandron 1000 (1 ampoule/ vial corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks for testosterone replacement, where testosterone deficiency has been confirmed by clinical features and biochemical tests. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.
The injections must be administered very slowly. Care should be taken to inject Reandron 1000 deeply into the gluteal muscle (the only site for which clinical experience has been obtained) following the usual precautions for intramuscular administration. Reandron 1000 is strictly for intramuscular injection. Special care must be taken to avoid intravenous injection and injections must not be given subcutaneously. See Instructions for use/ handling to avoid injury when opening.

Start of treatment.

Individualisation of treatment.

Instructions for use/ handling.

Handling the one-point-cut (OPC) ampoule.

Handling the vial.

4.3 Contraindications

The use of Reandron 1000 is contraindicated in men with:
androgen dependent carcinoma of the prostate or of the male mammary gland;
hypercalcaemia accompanying malignant tumours;
hypersensitivity to the active substance or to any of the excipients;
past or present liver tumours.
The use of Reandron 1000 in women is contraindicated.

4.4 Special Warnings and Precautions for Use

Reandron 1000 should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiologies responsible for the symptoms have been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction etc.), confirmed by biochemical tests (2 separate blood testosterone measurements) and according to contemporary diagnostic criteria established by endocrine societies. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels fall with increasing age.
Due to variability in laboratory values, all measures of testosterone should be carried out in the same laboratory.
Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude the risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial factors).
Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.
Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.
Androgens may enhance insulin sensitivity. The dosage of the hypoglycaemic agent may need to be lowered.
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 use of intramuscular injections in patients with acquired or inherited bleeding disorders is not recommended due to the risk of bleeding. Testosterone and its derivatives have been reported to increase the activity of coumarin-derived oral anticoagulants (also 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.
Deep intramuscular injection of testosterone undecanoate is not advisable in men with any form of bleeding or coagulation disorder, including those using anti-coagulants because of the risk of haematoma. Either alternative non-injectable testosterone products should be used or expert advice sought from a haematologist (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Cases of benign and malignant liver tumours have been reported in users of hormonal substances, such as androgen compounds. 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 Reandron 1000.
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)).
Caution must be taken in patients who have had elevated blood pressure, disturbance in renal function, epilepsy or migraine. The product may elevate blood pressure. The product is not recommended for patients with cardiac insufficiency.
Pre-existing sleep apnoea may be potentiated.
Using Reandron 1000 might result in a positive finding in doping tests.
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.
As with all oily solutions, Reandron 1000 must be injected strictly intramuscularly and very slowly. Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, 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 supplemental oxygen.
Suspected anaphylactic reactions after Reandron 1000 injection have been reported.
Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment. Periodic testosterone measurements should be made during treatment, particularly when considering dose adjustment.

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

Interactions can occur with drugs that induce microsomal enzymes, which can result in increased clearance of testosterone (e.g. barbiturates).
Androgens may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may be affected, e.g. increased oxyphenbutazone serum levels have been reported. The metabolism of cyclosporin might be slowed.
Moreover, testosterone and derivatives have been reported to increase the activity of coumarin derived oral anticoagulants, possibly requiring dose adjustment. Independently of this finding, the use of intramuscular injections in patients with acquired or inherited bleeding disorders is not recommended due to the risk of bleeding (see Section 4.4 Special Warnings and Precautions for Use).
Theoretically, any substance which affects liver function should not be taken with testosterone. Examples of herbal products include: Angelica dahurica, chapparal, comfrey, eucalyptus, germander tea, Jin Bu Huan, kava, penny royal oil, skullcap and valerian.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

The most frequently reported adverse effects during treatment with Reandron 1000 are acne and injection site pain.
Regarding adverse effects associated with the use of androgens, please also see Section 4.4 Special Warnings and Precautions for Use.
Table 1 shows adverse drug reactions (ADRs) classified by MedDRA system organ classes (MedDRA SOCs)* reported with Reandron 1000. The frequencies are based on clinical trial data and are defined as: common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100.
The following ADRs were reported in six clinical trials with over 400 patients, with a suspected relationship to Reandron 1000.
Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia or syncope. These reactions may occur during or immediately after the injections and are reversible. Cases suspected by the company or the reporter to represent pulmonary oily microembolism have been reported rarely in clinical trials (in ≥ 1/10,000 and < 1/1,000 injections) as well as from postmarketing experience (see Section 4.4 Special Warnings and Precautions for Use).
Suspected anaphylactic reactions after Reandron 1000 injection have been reported.
In addition to the above mentioned ADRs, nervousness, hostility, sleep apnoea, various skin reactions including seborrhoea, increased hair growth, increased frequency of erections and in very rare cases jaundice have been reported under treatment with testosterone containing preparations.
Therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism). High dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.
The following adverse events were noted during treatment in the comparative clinical study of Reandron 1000 (testosterone undecanoate) with testosterone enantate [Report No. A01198] (see Table 2).
In the literature, the following ADRs from testosterone containing preparations have been reported (see Table 3).

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.
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.

Research report no. A00315.

Research report no. A01198.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Steady-state conditions.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Reandron 1000 contains the excipients: benzyl benzoate and castor oil.

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

Store Reandron 1000 below 30°C and keep out of reach of children. Protect from light.

6.5 Nature and Contents of Container

Each 5 mL glass ampoule or 6 mL glass vial contains 4 mL oily solution with 1000 mg testosterone undecanoate. Not all presentations may be marketed.

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)

S4 (Prescription Only Medicine).

Summary Table of Changes