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 Ganirelix Theramex?
Ganirelix Theramex contains the active ingredient ganirelix (as acetate). Ganirelix
Theramex is used together with other medications to regulate hormone response in women
undergoing Assisted Reproductive Technology such as in vitro fertilisation (IVF).
2. What should I know before I use Ganirelix Theramex?
Do not use if you have ever had an allergic reaction to ganirelix 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.
3. What if I am taking other medicines?
Some medicines may interfere with Ganirelix Theramex and affect how it works.
4. How do I use Ganirelix Theramex?
Treatment with Ganirelix Theramex should be started under the supervision of a fertility
specialist
Ganirelix Theramex is given as a subcutaneous (under the skin) injection in the thigh
or stomach
The usual dose is the contents of one pre-filled syringe of Ganirelix Theramex once
a day on specific days of the menstrual cycle.
5. What should I know while using Ganirelix Theramex?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are using Ganirelix Theramex.
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Things you should not do
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Do not stop using this medicine without telling your doctor.
Do not change the dose unless your doctor tells you to.
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Driving or using machines
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No effects on ability to drive and use machines have been observed.
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Drinking alcohol
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Alcohol is not expected to interact with Ganirelix Theramex. If you drink alcohol,
talk to your doctor about the possible side effects of taking alcohol with this medicine.
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Looking after your medicine
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Store Ganirelix Theramex in a cool dry place, out of direct light, where the temperature
is below 30°C. Do not freeze as the syringe may break.
Keep Ganirelix Theramex in the original packaging, in a safe place, away from children.
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6. Are there any side effects?
The most common side effects are skin reactions at the site of injection. Other common
side effects include headache and nausea and tiredness. Serious side effects include
shortness of breath, vaginal bleeding, miscarriage or ectopic pregnancy.
Active ingredient(s):
ganirelix (as acetate) 250 micrograms in 0.5 milliliters
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Ganirelix Theramex. 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 Ganirelix Theramex.
Where to find information in this leaflet:
1. Why am I using Ganirelix Theramex?
Ganirelix Theramex contains the active ingredient ganirelix (as acetate). Ganirelix Theramex works by preventing women from ovulating (releasing an egg from
the ovary) too soon during stimulation of their ovaries to produce a mature egg.
Ganirelix Theramex is used together with other medications to regulate hormone response
in women undergoing Assisted Reproductive Technology such as in vitro fertilisation
(IVF).
2. What should I know before I use Ganirelix Theramex?
Do not use Ganirelix Theramex if:
you are allergic to ganirelix, 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 pregnant.
you are breastfeeding.
you have moderate to severe kidney or liver disease.
the solution is not clear and colourless.
the expiry date on the pack has passed.
the package shows any signs of tampering.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition.
Compared to natural conception, the frequency of multiple pregnancies and births is
increased in patients undergoing assisted reproductive techniques. Discuss the risk
of multiple pregnancies and births with your doctor.
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
Talk with your doctor if you are pregnant or if you are breastfeeding.
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.
4. How do I use Ganirelix Theramex?
How much to use
Treatment with Ganirelix Theramex should be started under the supervision of a fertility
specialist.
The usual dose is the contents of one pre-filled syringe of Ganirelix Theramex once
a day on specific days of the menstrual cycle.
When to use Ganirelix Theramex
Your doctor will tell you when to inject Ganirelix Theramex.
How to use Ganirelix Theramex
Ganirelix Theramex is given as a subcutaneous (under the skin) injection in the thigh
or stomach.
If your doctor or nurse decides you can give the injections yourself, they will teach
you the injection technique.
Do not attempt self-injection until you are sure of how to do it.
The injection site should be changed every day to lessen possible injection site reactions.
Follow all instructions given to you by your doctor or nurse carefully. Follow these
steps:
1.
Prepare the injection site
Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant
to remove any surface bacteria. Clean about 5 cm around the point where the needle
will go in. Let the disinfectant dry for at least one minute before proceeding.
2.
Open the outer pack and plastic container inside
While waiting for the disinfectant to dry, open the Ganirelix Theramex pack and remove
the plastic container. Carefully open the plastic container and remove the Ganirelix
Theramex syringe. You will see the needle is already attached, covered by a grey needle
shield.
3.
Prepare the syringe for injection
Remove needle shield and discard it in a sharps-disposable bin. You are now ready
to inject Ganirelix Theramex.
4.
Inserting the needle and injecting
Ganirelix Theramex is injected in either the thigh or the abdomen, usually near the
navel. Pinch up a large bit of skin between your finger and thumb. Insert the needle
at the base of the pinched-up skin at an angle of 45 degrees to 90 degrees to the
skin surface. Gently draw back on the plunger to see if the needle is inserted correctly.
If any blood appears in the syringe, the needle is not inserted correctly so do not
inject Theramex Ganirelix.
Remove the needle, cover the injection site with a sterile swab and dispose of the
syringe in a sharps-disposable container. Start again with a new syringe. If the needle
has been inserted correctly, depress the plunger slowly and steadily until all the
solution has been injected. Vary the injection site each time to minimise local irritation.
Pull the needle out of the skin quickly and apply pressure to the site with a swab
containing disinfectant. Dispose of the syringe (with the attached needle) in a Sharps
Container. Use the syringe only once and then dispose of it in the Sharps Container.
If you forget to use Ganirelix Theramex
If you forget an injection, contact your doctor or IVF clinic immediately for advice.
Do not inject a double-dose to make up for the forgotten dose.
If you use too much Ganirelix Theramex
If you think that you have used too much Ganirelix Theramex, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26)
contact your doctor, or IVF clinic 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 Ganirelix Theramex?
Things you should do
Call your doctor straight away if you:
Have sever pelvic pain, nausea and vomiting and weight gain. There are early warning
signs of Ovarian Hyperstimulation Syndrome (OHSS)
Other symptoms of OHSS can include indigestion, diarrhoea, shortness of breath, reduced
amounts of urine, painful breast
OHSS is a possible complication of hormonal stimulation of the ovaries.
Keep all of your doctor's appointments so that your progress can be checked. Your
doctor will want to follow the developing eggs inside the ovaries by doing an ultrasound
examination and measuring hormones in your blood.
Remind any doctor, dentist, or pharmacist you visit that you are using Ganirelix Theramex.
Tell the hospital doctor that you are using Ganirelix Theramex if you need to have
an operation or go to hospital in an emergency.
If you are about to be started on any new medicine, tell your doctor or pharmacist
that you are using Ganirelix Theramex.
Things you should not do
If you are self-injecting
Do not stop using Ganirelix Theramex without telling your doctor
Do not change the dose unless your doctor tells you to
Changing your dose without telling your doctor can increase your risk of unwanted
side effects or can prevent the drug from working properly.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not use this medicine to treat any other complaints.
Driving or using machines
No effects on ability to drive and use machines have been observed.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol is not expected to interact with Ganirelix Theramex. If you drink alcohol,
talk to your doctor about the possible side effects of taking alcohol with this medicine.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store Ganirelix Theramex in a cool dry place below 30°C 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.
Do not freeze as the syringe may break.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Dispose of your Ganirelix Theramex syringe and needle safely into a yellow plastic
Sharps Container.
If your doctor tells you to stop using Ganirelix Theramex or the expiry date has passed,
ask your pharmacist or IVF clinic what to do with any Ganirelix Theramex that is left
over.
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
Other side effects are known to occur with Assisted Reproductive Technology (ART)
procedures.
These may include:
Ovarian Hyperstimulation Syndrome. Since overstimulation can occur rapidly you must
contact your doctor if you experience any of the following: pain in the abdomen or
pelvis, indigestion, nausea, vomiting, weight gain, shortness of breath, reduced amounts
of urine, diarrhoea, and painful breasts.
Vaginal bleeding
Miscarriage
Ectopic pregnancy
The incidence of ectopic pregnancies (embryo implanted outside the womb) may be increased
in women undergoing ART. Your doctor will perform an ultrasound scan early during
pregnancy to confirm that a pregnancy is intrauterine (in the womb).
These side effects are probably unrelated to treatment with Ganirelix Theramex.
The incidence of congenital malformations (a physical defect present in a baby at
birth) after ART may be slightly higher than after spontaneous conceptions. The slightly
higher incidence is thought to be related amongst other factors to characteristics
of the patients undergoing fertility treatment (e.g., age of the female, sperm characteristics)
and to the higher incidence of multiple gestations after ART. The incidence of congenital
malformations after ART using Ganirelix Theramex is not different from that after
using other GnRH analogues in the course of ART.
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 Ganirelix Theramex contains
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Active ingredient
(main ingredient)
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250 micrograms of ganirelix (as acetate)
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Other ingredients
(inactive ingredients)
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Glacial acetic acid
Mannitol
Water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Ganirelix Theramex looks like
Ganirelix Theramex is a clear colourless solution. It comes in a pre-filled syringe
with fixed needle closed by a needle shield of elastomeric (latex free) rubber. Ganirelix
Theramex is available in packs of 1 or 5 pre-filled syringes (Aust R 384707).
Who distributes Ganirelix Theramex
Theramex Australia Pty Ltd
Level 22, 60 Margaret Street,
Sydney NSW 2000
1800 THERAMEX or 1800 843 726
This leaflet was prepared in February 2022.