(follitropin alfa [rch]) solution for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about GONAL-f.
It does not contain all the available information.
It does not take the place of talking to your doctor, nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
GONAL-f against the benefits it is expected to have for you.
If you have any concerns about using this medicine, ask your doctor, nurse or pharmacist.
Keep this information with your medicine.
You may need to read it again later.
What is GONAL-f used for
GONAL-f contains follitropin alfa, which is similar to follicle stimulating hormone
(FSH) found naturally in humans.
GONAL-f belongs to a class of hormones called gonadotrophins. FSH is necessary for
the growth and development of egg cells (follicles) in women, and sperm production
in men.
In women
GONAL-f can be used to bring about the development of follicles in women who are not
ovulating and who have not responded to treatment with clomiphene citrate.
GONAL-f is also used to stimulate the development of several follicles in women undergoing
assisted reproductive technologies (ART) such as in vitro fertilisation (IVF).
In men
GONAL-f is used in combination with human chorionic gonadotrophin (hCG) to stimulate
the production of sperm.
Ask your doctor if you have any questions about why GONAL-f has been prescribed for
you.
Your doctor may have prescribed it for another reason.
GONAL-f is available only on a doctor's prescription.
GONAL-f is not habit-forming.
Before you are given GONAL-f
When you must not use GONAL-f
Do not use GONAL-f if you have a history of allergy to any of the ingredients listed
at the end of this leaflet.
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.
Do not use GONAL-f if you have tumours of the hypothalamus or pituitary gland.
For women
Do not use GONAL-f if:
you are pregnant
you are breastfeeding
your ovaries are enlarged
you have an unexplained ovarian cyst
you have unexplained vaginal or uterine bleeding
you have cancer of the ovaries, uterus or breasts
your ovaries have failed
you have fibroids in your uterus which would make pregnancy impossible
For men
Do not use GONAL-f if:
you have increased levels of gonadotrophins indicating failure of the testes
your infertility is due to disorders other than hypogonadotrophic hypogonadism (low
levels of gonadotrophins)
If you are not certain whether these conditions apply to you, or you are worried about
anything on this list, tell your doctor.
Do not give this medicine to a child or elderly person.
Do not use this medicine after the expiry date (month/year) on the packaging has passed,
or if the packaging is torn or shows signs of tampering.
If your medicine has expired or is damaged, return it to your pharmacist / clinic
for disposal.
If you are not sure whether you should start using GONAL-f, talk to your doctor.
Before you start to use GONAL-f
Your doctor will assess you and your partner's fertility. 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 including GONAL-f.
Tell your doctor if you have any allergies to any foods, dyes, preservatives or any
other medicines.
Tell your doctor if you have or have had any of the following medical conditions:
disorders of the thyroid gland
disorders of the adrenal glands
high prolactin levels in the blood
porphyria or a family history of porphyria
For women
Your doctor will assess if you have any medical conditions which interfere with your
ability to become pregnant.
Treatment with GONAL-f may increase your risk of developing a condition called ovarian
hyperstimulation syndrome (OHSS). This is when the ovaries over-react to the hormonal
treatment and become larger.
The most common symptom is lower abdominal pain. During stimulation your doctor will
monitor your treatment by the use of ultrasound and/or blood tests to help determine
if you are likely to develop OHSS. If necessary your doctor will delay or cancel your
GONAL-f injection. You may also be advised to refrain from sexual intercourse until
the end of the cycle if this occurs.
Compared to natural conception, the frequency of multiple pregnancies and births is
higher in patients receiving treatments that stimulate follicle growth for ovulation
induction. The majority of these are twins. Your doctor will monitor your response
to treatment to minimise the chance of multiple pregnancies, because of the greater
risks they carry for mothers and babies.
Compared to natural conception, the frequency of pregnancy loss is higher in patients
undergoing treatments to stimulate follicle growth for ovulation induction.
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.
Tell your doctor if you or a family member have or have had signs of blood clots (e.g.
pain, warmth, redness, numbness or tingling in the arm or leg).
Treatment with GONAL-f and hCG may increase the risk of blood clots forming in your
blood vessels.
Talk to your doctor about any concerns you may have before undergoing treatment or
before you start using GONAL-f.
For men
Elevated FSH blood levels are indicative of testicular failure. Your doctor may ask
you for a semen analysis to assess your response to treatment.
Talk to your doctor about any concerns you may have before you start using GONAL-f
Taking other medicines
Tell your doctor if you are taking any other medicines, including:
all prescription medicines
any medicines, vitamins, herbal supplements or natural therapies you buy without prescription
from your pharmacy, supermarket, naturopath or health food shop
Some medicines may be affected by GONAL-f or may affect how well it works.
Your doctor has more information on medicines to be careful with or avoid while using
GONAL-f.
How GONAL-f is given
Follow all directions given to you by your doctor, nurse or pharmacist carefully.
They may differ from the information contained in this leaflet.
Treatment with GONAL-f should be started under the supervision of a specialist doctor
experienced in fertility treatment.
GONAL-f is given as a course of daily injections.
You should have your injection at the same time each day.
Do not use GONAL-f on anyone else.
It is for your use only.
How much to inject
Your doctor will decide the correct dose of GONAL-f for you. Your dose of GONAL-f
may be adjusted depending on your individual response to treatment. Please consult
your doctor if you are in any doubt.
The following is a guide to the common dose.
1. Women who are not ovulating
The common dose usually starts at 75IU (5.46 microgram) daily. The dose may be adjusted
as your treatment progresses. The maximal daily dose is usually not higher than 225
IU (16.5 microgram).
2. Women undergoing assisted reproductive technologies
The common dose usually starts at 150 IU (10.92 microgram) daily, commencing on day
2 or 3 of the cycle. The dose may be adjusted as your treatment progresses. The maximal
daily dose is usually not higher than 450 IU (32.76 microgram).
3. Men with hypogonadotrophic hypogonadism
GONAL-f is commonly given with hCG. The common dose usually starts at 150 IU (10.92
microgram) three times a week.
How to inject
GONAL-f is given as a subcutaneous (under your skin) injection in the lower abdominal
area or thigh.
GONAL-f is intended to be injected by you or your partner.
Alternatively your doctor or a nurse may give you these injections.
If your doctor or nurse decides you can give the injections yourself, the doctor or
nurse will teach you the injection technique.
Do not self-inject until you are sure of how to do it.
Read the Instructions for Use provided in the pack carefully before commencing injections.
Your partner may be trained to give the injection at home.
Where to inject
GONAL-f is usually given in the lower abdominal area (except around the navel and
waistline) or the front of your thigh. The injection site should be changed daily
to lessen possible injection site reactions.
Do not inject into any areas in which you feel lumps, firm knots, depressions, pain,
or see any discolouration.
Talk to your doctor if you find anything unusual when injecting.
How long to use GONAL-f for
For women
The length of treatment varies with each patient. It is possible to have more than
one treatment cycle of GONAL-f.
For men
The combination treatment of GONAL-f and hCG could continue for at least 4 months
and may continue for up to 18-24 months.
If you forget to inject GONAL-f
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 on any day.
Ask your doctor if you are not sure what to do or have trouble remembering to inject
your medicine.
If you injected too much
Immediately contact your doctor or the Poisons Information Centre (In Australia telephone
131 126. In New Zealand telephone 0800 764 766) if you are concerned that you have
given yourself too much or someone else has injected themselves with GONAL-f.
While you are using GONAL-f
Your doctor will carefully monitor your response to GONAL-f by using ultrasound, blood
tests or semen analysis.
Things you must do
See your doctor regularly.
Your doctor will monitor you closely throughout your treatment.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are using GONAL-f.
If you plan to have surgery, tell your doctor or dentist that you are using GONAL-f.
Tell all doctors, dentists and pharmacists who are treating you that you are using
GONAL-f.
For Women
Tell your doctor immediately if you become pregnant while using GONAL-f.
Things you must not do
If you are self-injecting do not:
Stop using GONAL-f without telling your doctor.
Change the dose unless your doctor tells you to.
Changing your dose without advising your doctor can increase your risk of unwanted
side effects or can prevent the drug from working properly.
Give this medicine to anyone else, even if their symptoms seem similar to yours or
if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how GONAL-f affects you.
Side Effects
Tell your doctor as soon as possible if you do not feel well while using GONAL-f.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
If you get any side effects, do not stop using GONAL-f without first talking to your
doctor.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
signs of an allergic reaction, including swelling of the face, lips, tongue, or other
parts of the body; shortness of breath, wheezing or difficulty breathing; severe skin
rash, itching or hives.
Tell your doctor if you notice any of the following and they worry you:
pain, redness, itching or swelling at the site of injection during your treatment
with GONAL-f
For women
vaginal bleeding
inflammation, swelling or pain in your legs
signs of severe OHSS such as severe lower abdominal pain, severe pelvic pain, nausea,
vomiting, diarrhoea followed by rapid weight gain, reduced amounts of urine and shortness
of breath
warning signs of stroke or heart attack
warning signs of blood clots such as pain, warmth, redness, numbness or tingling in
your arm or leg
Ectopic pregnancy (embryo implanted outside the womb) may occur, especially in women
with prior tubal disease.
Tell your doctor if you notice any of the following and they worry you:
headache, dizziness
stomach pain, abdominal distension or abdominal discomfort
nausea, vomiting
diarrhoea
For men
acne
some breast development
weight gain
These are common side effects.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
After Using GONAL-f
Storage
Prior to using, store GONAL-f in the original package at 2°C to 8°C (Refrigerate.
Do not freeze.). Protect from light.
Should refrigeration be unavailable, GONAL-f can be stored below 25°C for up to 3
months and away from light.
After first piercing GONAL-f pen with a needle, GONAL-f may be stored below 25°C for
a maximum of 21 days with the cap on, in order to protect the product from light.
Do not use GONAL-f if the solution contains particles or is not clear.
Do not use the product after the expiry date printed on the label.
Do not use GONAL-f if you notice any visible signs of deterioration or damage to the
container.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half-metres above the ground is a good place
to store medicines.
Disposal
If you are self-injecting, you should discard all sharps into a disposal unit.
If you have any GONAL-f that has expired or is left over from your treatment refer
this to your clinic/pharmacy.
Product description
What it looks like
GONAL-f contains sterile solution for injection in a cartridge, pre-assembled in a
pen.
GONAL-f solution for injection is available in the following strengths and pack sizes:
300 IU/0.5 mL (21.84 microgram). The pack contains 1 cartridge of solution for injection
pre-assembled in a pen and 8 needles for administration.
450 IU/0.75 mL (32.76 microgram). The pack contains 1 cartridge of solution for injection
pre-assembled in a pen and 12 needles for administration.
900 IU/1.5 mL (65.52 microgram). The pack contains 1 cartridge of solution for injection
pre-assembled in a pen and 20 needles for administration.
Each cartridge contains the following ingredients:
Active ingredient
Follitropin alfa (rch)
Other ingredients
Sucrose
Dibasic sodium phosphate dihydrate
Monobasic sodium phosphate monohydrate
Sodium hydroxide
Phosphoric acid
Poloxamer
Methionine
Metacresol
Water for injections
Australian Registration Numbers:
GONAL-f follitropin alfa (rch) 300 IU/0.5 mL solution for injection cartridge pre-assembled
in a pen: AUST R 96230
GONAL-f follitropin alfa (rch) 450 IU/0.75 mL solution for injection cartridge pre-assembled
in a pen: AUST R 96236
GONAL-f follitropin alfa (rch) 900 IU/1.5 mL solution for injection cartridge pre-assembled
in a pen: AUST R 96237
Supplier
GONAL-f 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
GONAL-f is supplied in New Zealand by:
Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks, Auckland
For enquiries call: 0800 426 252
This leaflet was prepared in December 2019.
A011-1219