TESTAVAN®
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.
TESTAVAN contains the active ingredient testosterone. TESTAVAN is used only in adult
men, to replace the body's natural hormone, testosterone, when not enough is made
by the body.
For more information, see Section 1. Why am I using TESTAVAN? in the full CMI.
Do not use if you have ever had an allergic reaction to testosterone, propylene glycol
or 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 pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TESTAVAN? in the full CMI.
Some medicines may interfere with TESTAVAN 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.
The usual starting dose is 23 mg testosterone (one pump actuation) per day.
Read the package leaflet before use.
More instructions can be found in Section 4. How do I use TESTAVAN? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TESTAVAN.
Keep all of your doctor's appointments.
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Things you should not do
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Do not stop using TESTAVAN or lower the dosage without first checking with your doctor.
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Driving or using machines
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This medicine is not expected to affect your ability to drive a car or operate machinery.
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Looking after your medicine
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Keep TESTAVAN in a cool dry place where the temperature stays below 25°C.
Store TESTAVAN in the original container.
Store TESTAVAN away from moisture, heat or sunlight
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For more information, see Section 5. What should I know while using TESTAVAN? in the full CMI.
Common side effects are headaches, skin reactions, easy bruising, and high blood pressure.
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.
TESTAVAN®
Active ingredient:
testosterone
Consumer Medicine Information (CMI)
This leaflet provides important information about using TESTAVAN. 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 TESTAVAN.
For detailed instructions on how to apply TESTAVAN, please read the package insert
before use.
Where to find information in this leaflet:
TESTAVAN contains the active ingredient testosterone.
TESTAVAN is used only in adult men, to replace the body's natural hormone, testosterone,
when not enough is made by the body.
Testosterone is a natural male hormone, known as an androgen, which controls normal
sexual development and function in men.
Do not use TESTAVAN if:
you are allergic to testosterone, propylene glycol, or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you are a woman or a child.
you have or are suspected to have prostate cancer.
you have or are suspected to have breast cancer in males.
Check with your doctor if you:
have or have had any other medical conditions including the following:
high blood calcium levels associated with tumours (hypercalcaemia)
high levels of calcium in the urine (hypercalciuria)
high blood pressure or problems with your heart
a tendency to retain fluid (signs may include swollen feet or ankles)
problems with your liver
problems with your kidneys
epilepsy
migraines
sleep apnoea (problems with breathing during sleep)
a blood disorder where your body produces too many red blood cells
thrombophilia (a condition where you have an increased risk of blood clots in your
blood vessels)
thrombosis (blood clots) in the deeper veins of the body such as in your legs (deep-vein
thrombosis), in the lungs (pulmonary embolism) or in the veins of the eye (ocular
thrombosis).
Before treatment with TESTAVAN your doctor will organise tests for prostate or breast
cancer.
TESTAVAN may increase the risk of benign prostatic hyperplasia (enlargement of the
prostate gland) and/or prostate cancer. It may also increase the risk of breast cancer
in males.
If you use TESTAVAN 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.
Athletes should note that the active ingredient, testosterone, may produce a positive
reaction in anti- doping tests.
Tell your doctor if you take any medicines for any other condition.
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?
Women
TESTAVAN must not be used by women, particularly if they are, or anticipate becoming,
pregnant or are breastfeeding.
Pregnant women must avoid any contact with TESTAVAN treated skin.
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 TESTAVAN and affect how it works. These include:
oral anticoagulants, such as warfarin, medicines used to thin blood and to treat or
prevent blood clots
corticosteroids such as prednisone or hydrocortisone, or adrenocorticotropic hormone
(ACTH), hormones used to control inflammation
insulin, a medicine used to control blood sugar levels.
These medicines may be affected by TESTAVAN, or may affect how well it works. You
may need to take different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TESTAVAN.
How much to use
The usual starting dose is 23 mg testosterone (one pump actuation) per day. You should
not use more than 69 mg testosterone per day (which is equivalent to three pump actuations).
Your doctor will tell you the dose of TESTAVAN that is right for you.
When to use TESTAVAN
Apply TESTAVAN once daily at approximately the same time each day, preferably in the
morning.
TESTAVAN helps control the symptoms of your condition but does not cure it. Continue
taking your medicine for as long as your doctor tells you.
How to use TESTAVAN
Before beginning therapy and each time you get a new pack, you should read the package
insert, which contains detailed instructions for use.
Prior to using TESTAVAN you should read the package insert, which contains detailed
instructions for use.
If you do not understand the instructions printed on the pharmacist label or in the
package insert, ask your doctor or pharmacist for help.
Use TESTAVAN exactly as your doctor tells you to use it.
TESTAVAN is to be applied to the skin of the upper arm and shoulder only.
Before applying TESTAVAN, make sure the skin is clean, dry and that there is no broken
skin.
Apply TESTAVAN to the skin using the applicator. Do not apply TESTAVAN with fingers
or hands.
Hands should be washed well with soap and water after TESTAVAN has been applied.
Avoid swimming or showering for at least two (2) hours after applying TESTAVAN.
TESTAVAN is flammable until dry. Avoid fire, flame or smoking until the gel has dried.
Follow these steps when using TESTAVAN multi-dose pump:
1. Before using the pump for the first time, prime the pump by pressing the pump head all the way down over a tissue paper until gel appears.
2. Repeat (4) four more times by pressing the pump head all the way down into a tissue. Do not use the gel that appears.
3. Throw the used tissue into a rubbish bin to avoid accidental exposure to others.
4. Your TESTAVAN pump is ready to use.
5. The content of only one pump actuation should be applied to the applicator at a time.
6. The applicator should be used to spread the gel evenly across the skin of one upper arm and shoulder. Do not get any gel on your hands.
7. Allow the gel to dry completely before getting dressed.
8. When more than one pump actuation is needed, the procedure is repeated to the other arm and shoulder (as described in Table 1).
Table 1: Dosing Information for TESTAVAN 2% w/w Gel
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Testosterone
Dose
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Application Method
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23 mg
(1 pump actuation)
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Apply one pump actuation to an upper arm and shoulder.
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46 mg
(2 pump actuations)
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Apply one pump actuation to an upper arm and shoulder.
Repeat to apply one pump actuation to the opposite upper arm and shoulder.
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69 mg
(3 pump actuations)
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Apply one pump actuation to an upper arm and
shoulder. Repeat to apply one pump actuation to the opposite upper arm and shoulder.
Repeat again to apply the third pump actuation to the initial upper arm and shoulder.
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If you forget to use TESTAVAN
TESTAVAN should be used regularly at the same time each day.
If you forget to apply a dose, apply it as soon as you remember.
If you do not remember to apply the dose until the next dose is due, then just apply
one dose.
Do not apply a double dose to make up for the dose that you missed.
If you use too much TESTAVAN
If you think that you have used too much TESTAVAN, you may need urgent medical attention.
Wash the skin with soap and water and immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking TESTAVAN.
Remind any other doctors, dentists, and pharmacists who treat you that you are using
this medicine.
Keep all of your doctor's appointments. Your doctor may monitor your blood pressure,
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.
The use of TESTAVAN may affect the results of certain laboratory tests. If you are
about to have any tests, tell your doctor that you are using this medicine.
Athletes should note that the active ingredient, testosterone, may produce a positive
reaction in anti-doping tests.
Things you should not do
Do not use TESTAVAN to treat any other complaints unless your doctor tells you to.
Do not give your TESTAVAN to anyone else, even if they have the same condition as
you.
Do not stop using TESTAVAN or lower the dosage without first checking with your doctor.
Unwanted transfer of TESTAVAN to others
TESTAVAN can transfer from your body to others. This can happen if other people come
into contact with the area where TESTAVAN was applied.
If you expect another person to have direct skin-to-skin contact with the application
area, wash the contact area well with soap and water.
Unwanted transfer of testosterone to another person can be substantially reduced by
wearing a shirt or similar.
You should have a shower or bath before having intimate physical contact.
Women and children should avoid contact with the unwashed or unclothed area where
TESTAVAN has been applied. If your partner is pregnant, it is particularly important
that you take care to protect her from testosterone. If a woman or child contacts
the application area, the contact area on the woman or child should be washed well
with soap and water immediately.
Signs of increased testosterone in children include enlarged penis or clitoris, early
development of pubic hair, increased erections or sex drive, and aggressive behaviour.
In women, this may include changes in body hair and the development or worsening of
acne.
Driving or using machines
This medicine is not expected to affect your ability to drive a car or operate machinery.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may [insert effect relevant to use of the medicine].
Looking after your medicine
Keep TESTAVAN in a cool dry place where the temperature stays below 25°C.
Store TESTAVAN in the original container.
Store TESTAVAN away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
When to discard your medicine (as relevant)
Discard the medicine, if your doctor tells you to stop using this medicine, the expiry
date has passed, or more than 60 days have passed since you first opened the dispenser
bottle.
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
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Less serious and common effects
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What to do
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headaches
Skin-related:
skin reactions such as rash, redness, itching, dryness, and/or irritation
Blood or heart-related:
high levels of haemoglobin, the substance that carries oxygen in the blood
high triglyceride (fat) levels in the blood
increased levels of an enzyme, prostate-specific antigen (PSA), in the blood
easy bruising and/or the formation of blood clots
high blood pressure
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Side effects due to high doses or long-term treatment
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What to do
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increased tendency to retain fluid (signs may include swollen feet or ankles)
decreased sperm count, which may affect fertility
unwanted, frequent or prolonged and painful erections
severe stomach pain or tenderness, which do not disappear within a short time
increased risk of weight gain
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Allergic reaction
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
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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.
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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.
This medicine is only available with a doctor's prescription.
What TESTAVAN contains
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Active ingredient
(main ingredient)
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23 mg of testosterone per 1.15 g of gel.
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Other ingredients
(inactive ingredients)
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ethanol
purified water
propylene glycol
diethylene glycol monoethyl ether
carbomer 980
trolamine
disodium edetate
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Do not take this medicine if you are allergic to any of these ingredients.
Each metered-dose pump contains 85.5 g of gel. Each pump can dispense 56 metered individual
doses of 1.15 g of gel (1.25 mL). Each dose contains 23 mg of testosterone.
