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 PERGOVERIS?
PERGOVERIS contains the active ingredients follitropin alfa (recombinant follicle
stimulating hormone (FSH)) and lutropin alfa (recombinant luteinising hormone (LH)).
PERGOVERIS is used for the stimulation of follicular development in women with severe
LH and FSH deficiency.
2. What should I know before I use PERGOVERIS?
Do not use if you have ever had an allergic reaction to PERGOVERIS 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,
are pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with PERGOVERIS and affect how it works.
4. How do I use PERGOVERIS?
It is usually recommended that your treatment with PERGOVERIS starts with 150 IU of
follitropin alfa/75 IU of lutropin alfa once a day as a subcutaneous (under the skin)
injection in your lower abdominal area or thigh. Your doctor will tell you how much
PERGOVERIS to use and when to inject it. Your treatment should be tailored according
to your individual response.
Follow all directions given to you by your doctor or pharmacist carefully, including
the Instructions for Use provided in the pack.
5. What should I know while using PERGOVERIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using PERGOVERIS.
Tell your doctor if you become pregnant while using PERGOVERIS
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Things you should not do
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Do not stop using this medicine suddenly without telling your doctor.
Change the dose unless your doctor tells you to.
Give this medicine to anyone else, even if their symptoms seem similar to yours.
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Driving or using machines
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Be careful driving or operating machinery until you know how PERGOVERIS affects you.
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Looking after your medicine
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Prior to use, store PERGOVERIS in the original package at 2°C to 8°C (Refrigerate.
Do not freeze). Protect from light. After the first injection, the pen may be stored
below 25°C for a maximum of 28 days with the cap on, in order to protect the product
from light.
Keep this medicine where children cannot reach it.
Do not use the medicine after the expiry date on the label.
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6. Are there any side effects?
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. Tell your doctor if you experience any side effects. Most common side
effects include injection site reactions, headache, dizziness, ovarian enlargement
or cysts.
Active ingredient(s):
follitropin alfa (rch) and lutropin alfa (rch)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using PERGOVERIS. 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 PERGOVERIS.
Where to find information in this leaflet:
1. Why am I using PERGOVERIS?
PERGOVERIS contains the active ingredient follitropin alfa, a recombinant follicle
stimulating hormone (FSH) and lutropin alfa, a recombinant luteinising hormone (LH). These hormones are essentially similar to the hormones found naturally in humans,
but they are made by means of biotechnology. They belong to the family of hormones
called gonadotrophins, which are involved in the normal control of reproduction.
PERGOVERIS is used for the stimulation of follicular development in women with severe
LH and FSH deficiency.
2. What should I know before I use PERGOVERIS?
Warnings
Do not use PERGOVERIS if:
you are allergic to 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
you are breastfeeding
you have an unexplained ovarian enlargement or cyst
you have unexplained vaginal or uterine bleeding
you have cancer of the ovaries, uterus or breasts
you have tumours of the pituitary gland or hypothalamus.
If you are not certain whether these conditions apply to you, or if you are worried
about anything on the list, tell your doctor.
Check with your doctor if you:
take any medicines for any other condition
have or have had any other medical conditions, such as:
premature menopause
disorders of thyroid glands
disorders of the adrenal glands
high prolactin levels in the blood
fibroid tumours in your uterus which would make pregnancy impossible
you have been through menopause
kidney disease
liver disease
you or your family have increased risk factors for developing blood clots, e.g. stroke,
heart attacks
porphyria or a family history of porphyria.
Your doctor will assess you and your partner's infertility. This may include tests
for other medical conditions, which may interfere with your ability to become pregnant.
If necessary, other medical conditions may be treated before starting infertility
treatments with PERGOVERIS.
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 PERGOVERIS if you are pregnant or breastfeeding.
Check with your doctor if you are pregnant while using PERGOVERIS.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Compared to natural conception, the frequency of multiple pregnancies and births is
increased.
Your doctor will monitor your ovarian response to minimise the chance of multiple
pregnancies, because of the greater risks they carry for mothers and babies. However,
this risk can be minimised by using the recommended dose and time of injections.
Compared to natural conception, the frequency of pregnancy loss is higher in patients
undergoing treatment to stimulate follicular growth.
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. An effect of medicines used to induce ovulation has
not been excluded.
Talk to your doctor about any concerns you may have before undergoing treatment with
PERGOVERIS.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PERGOVERIS.
4. How do I use PERGOVERIS?
How much to use
It is usually recommended that your treatment with PERGOVERIS starts with 150 IU of
follitropin alfa/75 IU of follitropin alfa once a day.
Your treatment should be tailored according to your individual response. Your doctor
will tell you how much PERGOVERIS to use.
When to use PERGOVERIS
Your doctor will tell you when to take PERGOVERIS.
PERGOVERIS is given as a course of daily injections. You should have your injection
at the same time each day.
How to use PERGOVERIS
PERGOVERIS should be injected daily under the skin (subcutaneous) in the lower abdominal
area or thigh (except around the navel and waistline).
The injection site should be changed daily to lessen possible injection site reactions.
Before using PERGOVERIS, your doctor or nurse can teach you the injection technique.
Read the Instructions for Use provided in the pack carefully before commencing injections.
Talk to your doctor if you find anything unusual when injecting.
Do not self-inject until you are sure of how to do it.
If you forget to use PERGOVERIS
PERGOVERIS should be used regularly at the same time each day. If you miss your dose
at the usual time, contact your doctor or nurse immediately for advice.
If you use too much PERGOVERIS
If you think that you have used too much PERGOVERIS, 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 PERGOVERIS?
Things you should do
See your doctor regularly. Your doctor will monitor you closely throughout your treatment.
Tell your doctor immediately if you become pregnant while using PERGOVERIS.
If you plan to have surgery, tell your doctor or dentist that you are using PERGOVERIS.
Remind any doctor, dentist or pharmacist you visit that you are using PERGOVERIS.
Things you should not do
Do not stop using this medicine suddenly without telling your doctor.
Do not change the dose unless your doctor tells you to.
Give this medicine to anyone else even if they have the same condition as you.
Ovarian Hyperstimulation Syndrome (OHSS)
Treatment with PERGOVERIS may increase your risk of developing a condition called
ovarian hyperstimulation syndrome (OHSS). This is when the ovaries overreact to the
hormonal treatment and become larger.
The most common symptom is lower abdominal pain. During stimulation your doctor will
monitor your treatment by using ultrasound and blood tests to help determine if you
are likely to develop OHSS.
If necessary, your doctor will delay or cancel your PERGOVERIS injection. You may
also be advised to refrain from sexual intercourse or use barrier methods until the
end of the cycle if this occurs.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PERGOVERIS
affects you.
Looking after your medicine
Store PERGOVERIS in the original package at 2°C to 8°C (Refrigerate. Do not freeze).
Protect from light.
After the first injection, the pen may be stored below 25°C for a maximum of 28 days
with the cap on, in order to protect the product from light.
Follow the instructions in the carton on how to take care of your medicine properly.
Do not use PERGOVERIS is the solution contains particles or is not clear.
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.
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
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 PERGOVERIS contains
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Active ingredient
(main ingredient)
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follitropin alfa (rch) and lutropin alfa (rch)
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Other ingredients
(inactive ingredients)
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poloxamer
arginine hydrochloride
phenol
dibasic sodium phosphate dihydrate
monobasic sodium phosphate monohydrate
methionine
sucrose
phosphoric acid
sodium hydroxide
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What PERGOVERIS looks like
PERGOVERIS solution for injection contains sterile, clear, colourless to slightly
yellow solution for injection in a cartridge, pre-assembled in a disposable pen.
PERGOVERIS solution for injection is available in the following presentations and
pack sizes*:
300 IU of follitropin alfa and 150 IU of lutropin alfa in 0.48 mL. The pack contains
1 cartridge of solution for injection pre-assembled in a disposable pen and 5 needles
for administration (AUST R 288927).
450 IU of follitropin alfa and 225 IU of lutropin alfa in 0.72 mL. The pack contains
1 cartridge of solution for injection pre-assembled in a disposable pen and 7 needles
for administration (AUST R 288928).
900 IU of follitropin alfa and 450 IU of lutropin alfa in 1.44 mL. The pack contains
1 cartridge of solution for injection pre-assembled in a disposable pen and 14 needles
for administration (AUST R 288929).
* Not all presentations and pack sizes may be marketed.
Who distributes PERGOVERIS
PERGOVERIS solution for injection is supplied in Australia by:
Merck Healthcare Pty Ltd
Suite 1, Level 1, Building B
11 Talavera Road
Macquarie Park NSW 2113
For enquiries call: 1800 633 463
This leaflet was prepared in March 2023.