Powder and solvent for solution for injection
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 MENOPUR?
MENOPUR is used to treat infertility (reproduction related conditions) in women. It
contains the active ingredient human menopausal gonadotrophin. For more information,
see Section
1. Why am I using MENOPUR? in the full CMI.
2. What should I know before I use MENOPUR?
Do not use MENOPUR if you have ever had an allergic reaction to human menopausal gonadotrophin,
gonadotrophins, or to any of the ingredients listed at the end of the CMI, see Section
7. Product details.
There are several circumstances in which a person should not use this medicine or
may need to use it with caution. It is important to understand if any of these apply
to you before using MENOPUR.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section
2. What should I know before I use MENOPUR? in the full CMI.
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 MENOPUR and affect how it works. For more information,
see
Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use MENOPUR?
You should only use MENOPUR under the supervision of a doctor experienced in the treatment
of infertility.
Always use this medicine exactly as your doctor has told you. You should check with
your doctor if you are unsure. Your doctor will determine your dose of MENOPUR depending
on your condition.
Before using MENOPUR, you must be educated on how to prepare the injection solution
and how to perform injections. Your first injection must be supervised by a trained
health practitioner.
More instructions can be found in Section
4. How do I use MENOPUR? in the full CMI and in the ‘Instructions for Use’ leaflet inside the carton.
5. What should I know while using MENOPUR?
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Things you should do
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Tell any doctor, dentist or pharmacist you visit that you are using MENOPUR.
Be sure to keep all your doctor’s appointments so your progress can be checked regularly.
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Things you should not do
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Do not stop using this medicine or change the dose without talking to your doctor.
Do not give this medicine to anyone else even if they have the same condition as you.
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Looking after your medicine
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Store MENOPUR in a refrigerator (2°C to 8°C). Do not freeze.
Always store MENOPUR in the original pack until it is time to use it.
After mixing powder with solvent, the solution may be stored in a refrigerator for
up to 28 days.
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6. Are there any side effects?
All medicines can have side effects. Most of them are minor and temporary but some
may need medical attention.
Tell your doctor if you experience any side effects.
Common side effects include skin reactions at the site where MENOPUR has been injected,
such as redness, pain and swelling.
Pain and/or swelling in the abdomen or pelvic region, nausea, vomiting, diarrhoea,
weight gain, having difficulty breathing and/or reduced urination may be a sign of
too much activity in the ovaries and may require urgent medical attention in hospital.
For more information, see Section
6. Are there any side effects? in the full CMI.
Powder and solvent for solution for injection
Active ingredient:
human menopausal gonadotrophin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MENOPUR. 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 MENOPUR.
Where to find information in this leaflet:
1. Why am I using MENOPUR?
MENOPUR is used to treat infertility (reproduction related conditions) in women. It
belongs to a class of medicines called gonadotrophins.
MENOPUR contains the active ingredient highly purified human menopausal gonadotrophin
(hMG) obtained from the urine of post-menopausal women. hMG is a mixture of hormones
found naturally in humans, with follicle stimulating hormone (FSH) activity and luteinising
hormone (LH) activity.
MENOPUR is used to stimulate the ovaries to grow and develop egg sacs (‘follicles’).
MENOPUR is used to stimulate the follicles in women undergoing Assisted Reproductive
Technology (ART) procedures to help them become pregnant. ART procedures include IVF/ET
(in vitro fertilisation/embryo transfer), GIFT (gamete intrafallopian transfer) and ICSI (intracytoplasmic
sperm injection).
MENOPUR is also used in women who are not ovulating (not releasing eggs) naturally
and who have not responded to another medicine called clomiphene citrate.
2. What should I know before I use MENOPUR?
Warnings
Do not use MENOPUR if:
you are allergic to human menopausal gonadotrophin, gonadotrophins, 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 or breastfeeding
you have cancer of the uterus (womb), ovaries, or breasts
you have a tumour of the pituitary gland or hypothalamus
you have enlarged ovaries or cysts on your ovaries not caused by polycystic ovarian
disease
you have bleeding from the vagina where the cause is not known
your ovaries have failed
you have malformations of the sexual organs, which make a normal pregnancy impossible
you have fibroids, or tumours, of the uterus (womb), which make a normal pregnancy
impossible.
Do not use MENOPUR if the expiry date printed on the pack has passed.
Tell your doctor if you:
have or have had any other medical conditions, especially the following:
adrenal problems
thyroid problems
high prolactin levels in the blood
blood clots, a history of blood clots, or any condition that puts you at risk of blood
clots
polycystic ovarian syndrome (PCOS)
ovarian hyperstimulation syndrome (OHSS)
fallopian tube disease
kidney or liver disease.
take any medicines for any other condition.
Your doctor will assess you and your partner's fertility. This may include tests for
other medical conditions, including medical conditions which may interfere with your
ability to become pregnant. If necessary, other medical conditions may be treated
before starting infertility treatments, including the use of MENOPUR.
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
Do not use MENOPUR if you are pregnant or breastfeeding.
It may affect your developing baby if you use it during pregnancy. Talk to your doctor
immediately if you become pregnant while using MENOPUR.
Pregnancy risks
The risk of a pregnancy outside of the womb (ectopic pregnancy) may be higher after
assisted reproduction than if you conceive naturally. If you have a history of tubal
disease, you have an increased risk of ectopic pregnancy.
Compared to natural conception, the frequency of pregnancy loss is higher in patients
undergoing fertility treatments.
Multiple pregnancy, more than one baby at a time, carries greater risks for mothers
and babies. In patients undergoing ART procedures, the risk of multiple pregnancy
is related to the number of embryos replaced, their quality and your age. Your doctor
will monitor your response to treatment to minimise the chance of multiple pregnancies.
There may be a slightly increased risk of birth defects in women using assisted reproductive
technologies. This may be due to increased maternal age, genetic factors, multiple
pregnancies or the procedures.
Some women who have been given multiple medicines for infertility treatment have developed
tumours in the ovaries and other reproductive organs. It is not yet known if treatment
with hormones like MENOPUR causes these problems.
Ovarian hyperstimulation syndrome (OHSS)
Some people have an exaggerated response to hormones used in ART, including MENOPUR.
This may lead to ovarian hyperstimulation syndrome (OHSS). This is when your follicles
develop too much causing your ovaries to swell and become painful.
Talk to your doctor if you have:
abdominal pain, discomfort or swelling
nausea
vomiting
diarrhoea
weight gain
difficulty in breathing
decreased urination.
Blood clots
Tell your doctor if you or a family member have or have had blood clots or signs of
blood clots (e.g. pain, warmth, redness, numbness or tingling in the arm or leg).
Blood clots are more likely to form inside your blood vessels when you are pregnant.
This is more likely if you have had treatment to help you become pregnant and:
you are overweight (BMI > 30 kg/m2)
you have a condition that increases your risk of having blood clots ‘thrombophilia’
you or someone in your family (blood relative) has had blood clots.
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 MENOPUR and affect how it works.
Clomiphene citrate is another medicine used in the treatment of infertility. If MENOPUR
is used at the same time as clomiphene citrate, the effect on the ovaries may be increased.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MENOPUR.
4. How do I use MENOPUR?
Treatment with MENOPUR should be started under the supervision of a specialist doctor
experienced in the treatment of infertility.
How much to use
Always use this medicine exactly as your doctor has told you. You should check with
your doctor if you are unsure.
The dose of MENOPUR and the length of treatment will be determined by your doctor
depending on your condition.
Women who are not ovulating (not releasing eggs) without treatment:
The initial dose is normally 75-150 IU daily.
Your doctor may change the dose, according to your response to the treatment, up to
a maximum of 225 IU per day.
The same dose should be given for at least 7 days before the dose is changed by the
doctor.
Your doctor will monitor the effect of MENOPUR treatment. The cycle of treatment should
be stopped if there is no response after 4 weeks.
Women undergoing Assisted Reproductive Technology (ART):
The initial dose of MENOPUR is normally 150-225 IU.
Your doctor may change the dose, according to your response to the treatment, up to
a maximum of 450 IU per day.
Normally treatment should not continue for more than 20 days.
When to use MENOPUR
Women who are not ovulating (not releasing eggs) without treatment:
Treatment should start within the first 7 days of the menstrual cycle (Day 1 is the
first day of your period). Treatment should be given every day for at least 7 days.
When a good response is obtained, a single injection of another hormone called human
chorionic gonadotrophin (hCG), should be given 1 day following the last MENOPUR injection.
It is recommended that you have sexual intercourse on the day of the hCG injection
and the day after. Alternatively, artificial insemination (injection of sperm directly
into the womb) may be performed. Your doctor will closely monitor your progress for
at least 2 weeks after you have received the hCG injection.
Your doctor will monitor the effect of MENOPUR treatment. Depending on your progress,
your doctor may decide to stop treatment with MENOPUR and not give you the hCG injection.
In this case, you will be instructed to use a barrier method of contraception (e.g.
condom) or not have sexual intercourse until your next period has started.
Women undergoing Assisted Reproductive Technology (ART):
If you are also receiving treatment with a GnRH agonist (a medicine that acts like
a hormone called Gonadotrophin Releasing Hormone, GnRH), MENOPUR should be started
approximately 2 weeks after the start of the GnRH agonist therapy.
In patients receiving a GnRH antagonist, MENOPUR treatment should be started on day
2 or 3 of the menstrual cycle (Day 1 is the first day of your period).
Treatment should be given every day for at least 5 days.
If enough follicles have developed, you will be given a single injection of a medicine
called human chorionic gonadotrophin (hCG) to stimulate the final maturation of the
eggs in the follicles prior to collection and fertilisation.
Your doctor will closely monitor your progress for at least 2 weeks after you have
received the hCG injection.
Your doctor will monitor the effect of MENOPUR treatment. If you have responded too
strongly to MENOPUR, your doctor may decide to stop treatment with MENOPUR and not
give you the hCG injection. In this case, you will be instructed to use a barrier
method of contraception (e.g. condom) or not have sexual intercourse until your next
period has started.
How to inject MENOPUR
MENOPUR is to be injected under the skin of your abdomen using a new area of the abdomen
on each occasion.
Before using MENOPUR, you must be educated on how to prepare the injection solution
and how to perform injections.
Your first injection must be supervised by a trained health practitioner.
Step-by-step instructions on how to prepare and inject MENOPUR are provided in the
‘Instructions for Use’ leaflet inside the carton.
Do not self-inject MENOPUR until you are sure of how to do it.
If you forget to use MENOPUR
If you forget an injection or are not sure what to do, contact your doctor or nurse
immediately for advice.
Do not inject a double dose to make up for the dose you missed.
If you use too much MENOPUR
MENOPUR may cause hyperstimulation of the ovaries known as ovarian hyperstimulation
syndrome (OHSS). OHSS is a potentially serious complication of infertility treatment
and could be fatal without proper management in hospital. The initial symptoms may
consist of abdominal pain, abdominal swelling and/or nausea and vomiting.
If you think that you have used too much MENOPUR, 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 using MENOPUR?
Things you should do
Call your doctor straight away if you:
feel pain in the abdomen or pelvic region
notice swelling in the abdomen
experience nausea (feeling sick) or vomiting
develop diarrhoea
gain weight
have trouble breathing
notice you are urinating less.
Tell your doctor straight away if you notice any of the above symptoms, even if the
symptoms develop some days after the last injection has been given.
This can be a sign of high levels of activity in the ovaries known as OHSS and the
symptoms could become severe.
If these symptoms become severe, treatment with MENOPUR should be stopped and you
should receive urgent medical attention in hospital.
Keeping to your recommended dose and careful monitoring of your treatment will reduce
your chances of getting these symptoms.
You should also contact your doctor right away if you:
become pregnant
have unusual vaginal bleeding.
Be sure to keep all your doctor's appointments so your progress can be checked.
Your doctor will normally arrange for you to have ultrasound scans and do some blood
and other tests from time to time to check on your progress and detect any unwanted
side effects.
Tell any doctor, dentist or pharmacist you visit that you are using MENOPUR. If you
are going to have surgery, tell the surgeon or anaesthetist that you are using MENOPUR.
Things you should not do
Do not stop using this medicine or change your dose without talking to your doctor.
Do not give this medicine to anyone else even if they have the same condition as you.
Driving or using machines
MENOPUR should not normally interfere with your ability to drive or operate machinery.
Be careful before you drive or use any machines or tools until you know how MENOPUR
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
It is unknown how drinking alcohol will affect MENOPUR.
Looking after your medicine
Keep MENOPUR in a refrigerator at a temperature of 2°C to 8°C. Do not freeze.
Always store MENOPUR in the original pack until it is time to use it.
After mixing powder with solvent, the solution may be stored in a refrigerator at
a temperature of 2°C to 8°C for up to 28 days. After 28 days, the vial containing
any unused medicine should be discarded.
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.
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
Discard MENOPUR if it has been opened and reconstituted for more than 28 days.
Do not use this medicine after the expiry date.
Once you have injected MENOPUR, do not re-use the needles and syringes. Discard the
used needles and syringes into an approved, puncture-resistant sharps container and
keep it out of reach of children. Never put used needles and syringes into your normal
household rubbish bin.
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.
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, nurse or pharmacist
if you have any further questions about side effects.
Side effects
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Side effects
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What to do
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Common side effects (affect more than 1 in 100 users):
headache
reactions at the injection site:
redness
itchiness
tenderness
pain or discomfort
warmth or burning
stinging
swelling
Uncommon side effects (affect less than 1 in 100 users):
breast swelling, pain (including nipple pain), tenderness or discomfort
hot flush
dizziness
tiredness.
Rare side effects (affect less than 1 in 1,000 users):
generalised rash or itchiness
acne.
Frequency unknown:
fever
generally feeling unwell
problems with your eyes
pain in muscles or joints including back, neck and/or extremities such as the hands
or feet.
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These side effects are not usually serious but can become serious.
Seek immediate medical care if you have any concerns.
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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 MENOPUR contains
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Active ingredient
(main ingredient)
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human menopausal gonadotrophin
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Other ingredients
(inactive ingredients)
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Powder:
lactose monohydrate
polysorbate 20
dibasic sodium phosphate heptahydrate
phosphoric acid.
Solvent:
metacresol
water for injections.
|
Do not use this medicine if you are allergic to any of these ingredients.
MENOPUR 600 IU: Contains human menopausal gonadotrophin corresponding to follicle stimulating hormone
(FSH) activity 600 IU and luteinising hormone (LH) activity 600 IU.
MENOPUR 1200 IU: Contains human menopausal gonadotrophin corresponding to follicle stimulating hormone
(FSH) activity 1200 IU and luteinising hormone (LH) activity 1200 IU.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
What MENOPUR looks like
MENOPUR is supplied in packs containing medicine powder (vial), solvent for reconstitution
and needle for reconstitution. Disposable alcohol pads and single-use administration
syringes (graduated in FSH/LH units with pre-fixed needles) are supplied separately.
Inspect the medicine vial before use to ensure that a white powder cake is visible.
The cake may seem to disappear after the needle tip enters the rubber top, but you
can continue with the reconstitution as long as the cake was visible on first inspection.
MENOPUR 600 IU:
The MENOPUR 600 IU pack contains one vial of powder, one pre-filled syringe with solvent
for reconstitution and one needle for reconstitution (AUST R 161984).
MENOPUR 1200 IU:
The MENOPUR 1200 IU pack contains one vial of powder, two pre-filled syringes with
solvent for reconstitution and one needle for reconstitution (AUST R 161985).
Who distributes MENOPUR
MENOPUR is distributed in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1,
20 Bridge Street, Pymble NSW 2073
This leaflet was prepared in April 2022
#12118-v20A