2. What should I know before I am given Diphereline?
Do not use if you have ever had an allergic reaction to triptorelin 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 am given Diphereline? in the full CMI.
3. What if I am taking other medicines?
4. How am I given Diphereline?
Your doctor or nurse will give you an injection of Diphereline into your muscle (intramuscular).
More instructions can be found in Section
4. How am I given Diphereline? in the full CMI.
5. What should I know while being given Diphereline?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Diphereline.
Keep your follow-up appointments with your doctor.
Call your doctor straight away if you experience any of these symptoms a few weeks
after receiving your injection: pain in the bones or backbone, difficulty passing
urine, weakness, tingling or numbness in your arms and legs.
|
|
Things you should not do
|
Do not stop using this medicine suddenly.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Diphereline affects you.
If your child is begin given Diphereline, be careful of riding bicycles or climbing
until you know how the medicine affects them.
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|
Drinking alcohol
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Tell your doctor if you drink alcohol.
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|
Looking after your medicine
|
Keep your medicine in a cool, dry place where the temperature stays below 25°C.
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6. Are there any side effects?
Like all medicines, Diphereline can cause side effects, although not everybody gets
them. 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.
Some side effects may need medical attention, tell your doctor straight away if you
notice any of the following:
In men: severe back pain, difficulty passing urine. These could be signs of temporary
worsening of your prostate tumour.
In men: chest pain. This could be a sign of heart-related problems.
If your child complains of: vision problems, severe headaches, pain behind the eye,
ringing in the ears, dizziness, nausea. These could be signs of increased pressure
around the brain.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
triptorelin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Diphereline. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being given Diphereline.
Where to find information in this leaflet:
1. Why am I being given Diphereline?
Diphereline contains the active ingredient triptorelin. Diphereline belongs to a group of medicines called Gonadotrophin Releasing Hormone
agonists (GnRHa).
In males, Diphereline works by lowering the production of testosterone. Testosterone
is a natural male sex hormone. In some types of prostate cancer, testosterone may
help the cancer cells to grow. By lowering testosterone, Diphereline may slow or stop
the growth of cancer.
In females, Diphereline lowers the levels of the hormone oestrogen. Oestrogen is a
natural female sex hormone.
In adult men, Diphereline is used to treat prostate cancer that has spread into surrounding
tissue and/or to other parts of the body. It is not a cure for prostate cancer.
In children, Diphereline 22.5 mg is used to treat puberty that occurs at a very young
age (Central Precocious Puberty).
2. What should I know before I am given Diphereline?
Warnings
You should not be given Diphereline if:
there are signs that the tumour doesn't rely on hormones to grow (check with your
doctor).
you have had surgical removal of your testes.
you have severe back pain as a result of your prostate cancer spreading and pressing
into the nerves of your backbone.
you are allergic to triptorelin, polysorbate 80, Gonadotropin Releasing Hormone (GnRH)
or any other Gonadotrophin Releasing Hormone agonists (GnRHa), or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or trouble breathing
Check with your doctor if you:
take any medicines for any other condition.
have an enlargement (benign tumour) of your pituitary gland. If you are unaware of
any enlargement, it may be discovered during treatment with Diphereline.
are allergic to food, dyes, preservatives or any other medicines.
In men:
have cancer related pain (metastatic pain).
experience difficulty or pain when passing urine.
have osteoporosis, a family history of osteoporosis or risk factors for developing
osteoporosis (such as heavy drinking, smoking, a diet low in calcium, poor mobility,
a slight build or treatment with steroid medicines or anticonvulsants).
get sudden headaches, and/or have blurred vision.
have high blood sugar or diabetes.
have heart or vascular problems or other cardiovascular risk factors.
have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia),
or are being treated with medicines for these conditions. The risk of heart rhythm
problems may be increased when using Diphereline.
are taking medicines to lower your blood pressure.
In children:
If your child has progressive brain tumour, tell their doctor. This may affect the
way your doctor decides to treat your child.
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?
Pregnancy and breastfeeding
You should not be given Diphereline if you are pregnant or breastfeeding.
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Mood changes and depression
There have been reports of mood changes and depression in patients taking GnRH analogues,
such as Diphereline, which may be severe. In very rare cases, severe depression can
lead to suicidal thoughts or attempts. If you are being given Diphereline and develop
depressed mood or have any thoughts of self-harm, inform your doctor or nurse straight
away.
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 Diphereline and affect how it works.
medicines used to prevent blood clots (anti-coagulants), including warfarin. There
is a possible risk of haematoma formation (bruising, bleeding) at the site of the
injection.
medicines that increase levels of another hormone, prolactin.
medicines affecting secretion of gonadotrophins.
Diphereline might interfere with some medicines used to treat heart rhythm problems,
such as:
quinidine
disopyramide
amiodarone
sotalol
Diphereline might increase the risk of heart rhythm problems when used with some other
drugs, such as:
methadone (used for pain relief and part of drug addiction detoxification)
moxifloxacin (an antibiotic)
antipsychotics (used for serious mental illnesses)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Diphereline.
4. How am I given Diphereline?
How much is given
Your doctor will decide how much to give depending on the condition being treated:
a 3.75 mg injection given once a month, or
a 11.25 mg injection given once every 3 months (4 times a year), or
a 22.5 mg injection given every 6 months (2 times a year).
Only the 22.5 mg injection is used to treat Central Precocious puberty in children.
When am I given Diphereline
Your doctor will decide how frequently and for how long you will be given the injection.
Your child's doctor will decide when treatment should be stopped. Normally this will
happen when your child is about 12-13 years old if they are a girl, and about 13-14
years old if they are a boy.
How am I given Diphereline
Your doctor or nurse will inject Diphereline into a muscle, usually your bottom.
If you forget to get your Diphereline injection
Tell your doctor as soon as you realise that you have missed an injection. You will then be given your next injection.
Make a doctor's appointment for your next injection date. Keep a diary of when your next dose is due.
If you are given too much Diphereline
Diphereline is given to you by a doctor or nurse, so it is unlikely that you or your
child will be given too much. However, if you think that you or your child have been
given too much Diphereline, you may need urgent medical attention.
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 being given Diphereline?
Things you should do
Call your doctor straight away if you:
experience any of the following symptoms within the first few weeks of treatment:
pain in the bones or backbone
difficulty passing urine
weakness, tingling or numbness in your arms and legs
At the start of treatment with medicines like Diphereline (GnRHa medicines), you will
have an increased amount of testosterone in your body which may cause the symptoms
of your cancer to get worse.
Tell your doctor immediately if you continue to experience these symptoms. It may be a sign that the cancer is growing. Your doctor may give you other medicines
to manage these symptoms.
Talk to your doctor or pharmacist if:
your female child experiences some vaginal bleeding in the first month of treatment.
you feel that your medicine is not helping your condition (or your child's condition).
Remind any doctor, dentist or pharmacist you visit that you (or your child) are using
Diphereline.
Keep follow-up appointments with your doctor. It is important to have your follow-up doses at the appropriate times to get the
best effects from your treatments.
Your doctor will monitor you during treatment to check that you do not develop high
blood sugar or diabetes. You will also be monitored for any symptoms or signs of
cardiovascular disease.
Things you should not do
Do not stop using this medicine suddenly.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Diphereline
affects you.
Diphereline may cause dizziness, blurred vision, or seizures in some people.
Be careful of your child riding bicycles or climbing (such as trees or playground
equipment) until you know how Diphereline affects them.
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking alcohol may make dizziness or light-headedness worse when you are taking
Diphereline.
Looking after your medicine
Your doctor will keep the medicine at the doctor's clinic or surgery, or at the pharmacy.
If you need to store Diphereline at home:
Keep it in a cool, dry place, where the temperature stays below 25°C.
Keep it in the original container.
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; 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.
Some side effects (for example, high blood pressure or changes in liver function)
can only be found when your doctor does tests to check on your progress.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
|
Serious side effects
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What to do
|
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Symptoms of an allergic reaction:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or trouble breathing
Prostate cancer:
seizures or convulsions
difficulty breathing
high blood pressure
Signs of tumour flare:
temporary worsening of symptoms of your cancer
severe back pain
Signs of thrombocytosis:
sharp, stabbing pain or swelling in your lower leg
swelling and redness along a vein which is extremely tender when touched
increase in white blood cells
chest pain
sudden headaches
Signs of gout:
painful, swollen joints (particularly in the big toe)
Signs of enlargement of pituitary gland (benign tumour):
sudden headache
vomiting
problems with eyesight
paralysis of the eyes
Signs of changes in ECG (record of the electrical activity of the heart) (QT prolongation):
fast or irregular heartbeats, also called palpitation
fainting, loss of consciousness
seizure
Central Precocious puberty:
changes to vision
seizures or convulsions
Signs of high blood pressure in the brain:
headache
blurred vision, double vision
loss of vision
pain behind the eye or pain with eye movement
ringing in the ears
dizziness
nausea
|
Call your doctor or your child's doctor straight away, or go straight to the Emergency
Department at your nearest hospital if you notice any of these serious side effects.
|
Less serious side effects
|
Less serious side effects
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What to do
|
|
Prostate cancer:
Gastrointestinal related:
feeling sick (nausea)
dry mouth
Nervous system related:
pins and needles sensation in the legs
dizziness
headache
Heart or circulatory system related:
hot flushes
Mental health related:
reduced or no libido
mood changes, depression
anxiety
Reproductive system and breast related:
impotence (difficulty to get or maintain an erection)
Skin related:
excess sweating
raised itchy bumps, swollen patches of skin, welts which appear suddenly
Muscle or bone related:
back pain
muscle and bone pain
pain in the arms and legs
lower abdominal pain
Kidney or bladder related:
problems passing urine (difficulty or uncontrollable and involuntary)
General:
weakness
pain, bruising, redness and swelling at the injection site
build-up of fluid in the body tissues (oedema)
weight gain
general discomfort
Central Precocious puberty:
Heart or circulatory system related:
hot flushes
Mental health related:
changes in mood
Reproductive system and breast related:
vaginal bleeding which may occur in girls in the first month of treatment
pain in breast
Gastrointestinal related:
stomach pain or discomfort
vomiting
constipation
nausea
Nervous system related:
headache
Skin related:
acne
General:
pain, redness and swelling at the injection site
general discomfort
Skin related:
overweight
Muscle or bone related:
neck pain
Respiratory related:
nosebleeds
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Speak to your doctor or your child's doctor if you or your child has any of these
less serious side effects and they worry you.
|
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 Diphereline contains
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Active ingredient
(main ingredient)
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triptorelin embonate
|
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Other ingredients
(inactive ingredients)
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polyglactin
mannitol
carmellose sodium
polysorbate 80
sterile water
|
Do not take this medicine if you are allergic to any of these ingredients.
What Diphereline looks like
Diphereline is available in 3.75 mg (1 month formulation), 11.25 mg (3 month formulation),
and 22.5 mg (6 month formulation) (AUST R 109854, 109856, 159173).
Each pack contains 1 vial of Diphereline, 1 ampoule of solvent, 1 empty polypropylene
syringe and 2 needles.
The vial of Diphereline contains a small pellet of white to slightly yellow powder
which must be mixed with the contents of the ampoule (solvent) before injection.
Australian Sponsor of Diphereline
Ipsen Pty Ltd
Level 5, 627 Chapel Street
South Yarra VIC 3141
Diphereline® is a registered trademark of Ipsen Pharma S.A.S.
This leaflet was prepared in December 2025.