Description
What is Gonal F
Gonal-f pens are designed as fertility treatment medicine delivery systems for men and women alike. This medicine is primarily used by women due to the specific nature of its results, however. What does Gonal F do specifically for fertility issues in women? Successful treatments stimulate the healthy production of eggs by the ovaries. This is accomplished by injecting the pregnancy hormone hCG (human chorionic gonadotropin) with afollicle-stimulating hormone known as Follitropin alfa the body.
Use your Gonal-F pen 900iu as directed by your doctor. Purchase Gonal F pens at a significant discount through ivfsmart.com. Enjoy up to a 65% discount on prescribed infertility medications.
Gonal-f pen systems are sold in 300, 450 and 900 IU dosage strengths. Multi-dose systems contain 450 or 1050 IU dosage strengths. Use your pen as directed by your fertility specialist, who will also instruct you on the proper way to use it. Expect higher costs on Gonal F pen when purchasing through traditional drug stores. To save on expensive fertility medications, those often requiring multiple doses, a greater savings can be experienced using a reliable online pharmacy.
Follow injection and usage directions as provided by both your health care specialist and pharmacist. Each kit includes an instruction pamphlet as sold by your pharmacy. Regular monthly injection schedules might also be ordered to improve efficacy and potency. Be certain to sterilize all injection sites with rubbing alcohol before injecting. Use a new clean pen needle for every injection.
Most side effects are minor and go away with time. These include headaches, pain at the injection site, stomach upset or nausea. More serious symptoms will be discussed with you by your doctor. If you experience any of the severe symptoms, or the mild symptoms do not go away, seek medical attention immediately.
Gonal F Pen 900 IU can be easily purchased from ivfsmart.com.
Official Gonal F 900 leaflet:
Package leaflet: Information for the user
GONAL-f 900 IU/1.5 mL (solution for injection in pre-filled pen
follitropin alfa
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What GONAL-f is and what it is used for
2. What you need to know before you use GONAL-f
3. How to use GONAL-f
4. Possible side effects
5. How to store GONAL-f
6. Contents of the pack and other information
Instructions for use
1. What GONAL-f is and what it is used for
What GONAL-f is
GONAL-f contains a medicine called “follitropin alfa”. Follitropin alfa is a type of “follicle
stimulating hormone” (FSH) which belongs to the family of hormones called “gonadotropins”.
Gonadotropins are involved in reproduction and fertility.
What GONAL-f is used for
In adult women, GONAL-f is used:
• to help release an egg from the ovary (ovulation) in women that cannot ovulate and that did not
respond to treatment with a medicine called “clomiphene citrate”.
• together with another medicine called “lutropin alfa” (“luteinising hormone” or LH) to help
release egg from the ovary (ovulation) in women whose body is producing very little
gonadotropins (FSH and LH).
• to help develop several follicles (each containing an egg) in women undergoing assisted
reproductive technology procedures (procedures that may help you to become pregnant) such as
“in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”.
In adult men, GONAL-f is used:
• together with another medicine called “human chorionic gonadotropin” (hCG) to help produce
sperm in men that are infertile due to a low level of certain hormones.
2. What you need to know before you use GONAL-f
You and your partner’s fertility should be evaluated before the treatment is started by a doctor
experienced in treating fertility disorders.
Do not use GONAL-f
• if you are allergic to follicle stimulating hormone or any of the other ingredients of this
medicine listed in section 6.
• if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
• if you are a woman:
– with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
– with unexplained vaginal bleeding.
– with cancer in your ovaries, womb or breasts.
– with a condition that usually makes normal pregnancy impossible, such as ovarian failure
(early menopause), or malformed reproductive organs.
• if you are a man:
– with damaged testicles that cannot be healed.
Do not use GONAL-f if any of the above applies to you. If you are not sure, talk to your doctor before
using this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Gonal-f.
Porphyria
Tell your doctor before you start treatment, if you or any member of your family have porphyria (an
inability to break down porphyrins that may be passed on from parents to children).
Tell your doctor straight away if:
• your skin becomes fragile and easily blistered, especially skin that has been frequently in the
sun, and/or
• you have stomach, arm or leg pain.
In case of the above events your doctor may recommend that you stop treatment.
Ovarian hyper-stimulation syndrome (OHSS)
If you are a woman, this medicine increases your risk of developing OHSS. This is when your
follicles develop too much and become large cysts. If you get lower abdominal pain, gain any weight
rapidly, feel sick or are vomiting or if you have difficulty in breathing, talk to your doctor straight
away who might ask you to stop using this medicine (see section 4).
In case you are not ovulating, and if the recommended dose and schedule of administration are
adhered to, the occurrence of OHSS is less likely. GONAL-f treatment seldom causes severe OHSS
unless the medicine that is used for final follicular maturation (containing human chorionic
gonadotropin, hCG) is administered. If you are developing OHSS your doctor may not give you any
hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive
method for at least four days.
Multiple pregnancy
When using GONAL-f, you have a higher risk of being pregnant with more than one child at the same
time (“multiple pregnancy”, mostly twins), than if you conceived naturally. Multiple pregnancy may
lead to medical complications for you and your babies. You can reduce the risk of multiple pregnancy
by using the right dose of GONAL-f at the right times. When undergoing assisted reproductive
technology, the risk of having a multiple pregnancy is related to your age, the quality and the number
of fertilised eggs or embryos placed inside you.
Miscarriage
When undergoing assisted reproductive technology or stimulation of your ovaries to produce eggs,
you are more likely to have a miscarriage than the average woman.
Blood clotting problems (thromboembolic events)
If you had in the past or recently blood clots in the leg or in the lung, or a heart attack or stroke, or if
those happened in your family, then you might have a higher risk that these problems occur or
become worse with GONAL-f treatment.
Men with too much FSH in their blood
If you are a man, having too much FSH in your blood can be a sign of damaged testicles. GONAL-f
usually does not work if you have this problem.
If your doctor decides to try GONAL-f treatment, to monitor the treatment, they may ask you to
provide semen for analysis 4 to 6 months after starting treatment.
Children and adolescents
GONAL-f is not for use in children and adolescents below 18 years old.
Other medicines and GONAL-f
Tell your doctor if you are taking, have recently taken or might take any other medicines.
• If you use GONAL-f with other medicines which help ovulation (such as hCG or clomiphene
citrate), this may increase the response of your follicles.
• If you use GONAL-f at the same time as a “gonadotropin-releasing hormone” (GnRH) agonist
or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you
may need a higher dose of GONAL-f to produce follicles.
Pregnancy and breast-feeding
Do not use GONAL-f if you are pregnant or breast-feeding.
Driving and using machines
It is not expected that this medicine will affect your ability to drive and use machines.
GONAL-f contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose that is to say essentially
“sodium-free”.
3. How to use GONAL-f
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Using this medicine
• GONAL-f is intended to be given by injection just under the skin (subcutaneously). The prefilled pen can be used for several injections.
• The first injection of GONAL-f should be given under supervision of your doctor.
• Your doctor or nurse will show you how to use the GONAL-f pre-filled pen to inject the
medicine.
• If you administer GONAL-f to yourself, please carefully read and follow the “Instructions for
use”.
How much to use
Your doctor will decide how much medicine you will take and how often. The doses described below
are stated in International Units (IU).
Women
If you are not ovulating and have irregular or no periods.
• GONAL-f is usually given every day.
• If you have irregular periods, start using GONAL-f within the first 7 days of your menstrual
cycle. If you do not have periods you can start using the medicine on any convenient day.
• The usual starting dose of GONAL-f is 75 to 150 IU each day.
• Your dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until you
get the desired response.
• The maximum daily dose of GONAL-f is usually not higher than 225 IU.
• When you get the desired response, you will be given a single injection of 250 micrograms of
“recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or
5 000 to 10 000 IU of hCG, 24 to 48 hours after your last GONAL-f injection. The best time to
have sex is on the day of the hCG injection and the day after.
If your doctor cannot see a desired response after 4 weeks, that treatment cycle with GONAL-f should
be stopped. For the following treatment cycle, your doctor will give you a higher starting dose of
GONAL-f than before.
If your body responds too strongly, your treatment will be stopped and you will not be given any hCG
(see section 2, “Ovarian hyper-stimulation syndrome (OHSS)”). For the following cycle, your doctor
will give you a lower dose of GONAL-f than before.
If you have been diagnosed with very low levels of FSH and LH hormones
• The usual starting dose of GONAL-f is 75 to 150 IU together with 75 IU of lutropin alfa.
• You will use these two medicines each day for up to five weeks.
• Your dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until you
get the desired response.
• When you get the desired response, you will be given a single injection of 250 micrograms of
“recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or
5 000 to 10 000 IU of hCG, 24 to 48 hours after your last injections of GONAL-f and lutropin
alfa. The best time to have sex is on the day of the hCG injection and the day after.
Alternatively, intrauterine insemination or another medically assisted reproduction procedure
may be performed based on your doctor’s judgment.
If your doctor cannot see a response after 5 weeks, that treatment cycle with GONAL-f should be
stopped. For the following cycle, your doctor will give you a higher starting dose of GONAL-f than
before.
If your body responds too strongly, your treatment with GONAL-f will be stopped and you will not be
given any hCG (see section 2, “Ovarian hyper-stimulation syndrome (OHSS)”). For the following
cycle, your doctor will give you a lower dose of GONAL-f than before.
If you need to develop several eggs for collection prior to any assisted reproductive technology
• The usual starting dose of GONAL-f is 150 to 225 IU each day, from day 2 or 3 of your
treatment cycle.
• GONAL-f dose may be increased, depending on your response. The maximum daily dose is
450 IU.
• Treatment is continued until your eggs have developed to a desired point. This usually takes
about 10 days but can take any time between 5 and 20 days. Your doctor will use blood tests
and/or an ultrasound machine to check when this is.
• When your eggs are ready, you will be given a single injection of 250 micrograms
“recombinant hCG” (r-hCG, an hCG made in a laboratory by a special recombinant DNA
technique), or 5 000 IU to 10 000 IU of hCG, 24 to 48 hours after the last GONAL-f injection.
This gets your eggs ready for collection.
In other cases, your doctor may first stop you from ovulating by using a gonadotropin-releasing
hormone (GnRH) agonist or antagonist. Then GONAL-f is started approximately two weeks after
start of agonist treatment. The GONAL-f and GnRH agonist are then both given until your follicles
develop as desired. For example, after two weeks of GnRH agonist treatment, 150 to 225 IU
GONAL-f is administered for 7 days. The dose is then adjusted according to your ovarian response.
Men
• The usual dose of GONAL-f is 150 IU together with hCG.
• You will use these two medicines three times a week for at least 4 months.
• If you have not responded to treatment after 4 months, your doctor may suggest that you
continue using these two medicines for at least 18 months.
If you use more GONAL-f than you should
The effects of taking too much GONAL-f are unknown. Nevertheless, one could expect ovarian
hyper-stimulation syndrome (OHSS) to occur, which is described in section 4. However, the OHSS
will only occur if hCG is also administered (see section 2, “Ovarian hyper-stimulation syndrome
(OHSS)”).
If you forget to use GONAL-f
If you forget to use GONAL-f, do not take a double dose to make up for a forgotten dose. Please talk
to your doctor as soon as you notice that you forgot a dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects in women
• Lower abdominal pain together with nausea or vomiting may be the symptoms of ovarian
hyper-stimulation syndrome (OHSS). This may indicate that the ovaries over-reacted to the
treatment and that large ovarian cysts developed (see also in section 2. under “Ovarian hyperstimulation syndrome (OHSS)”). This side effect is common (may affect up to 1 in 10 people).
• The OHSS may become severe with clearly enlarged ovaries, decreased urine production,
weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
This side effect is uncommon (may affect up to 1 in 100 people).
• Complications of OHSS such as twisting of ovaries or blood clotting may occur rarely (may
affect up to 1 in 1 000 people).
• Serious blood clotting complications (thromboembolic events) sometimes independent of
OHSS may be found very rarely (may affect up to 1 in 10 000 people). This could cause chest
pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting
problems”).
Serious side effects in men and women
• Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing
can sometimes be serious. This side effect is very rare (may affect up to 1 in 10 000 people).
If you notice any of the above-listed side effects, you should immediately contact your doctor
who might ask you to stop using GONAL-f.
Other side effects in women
Very common (may affect more than 1 in 10 people):
• Sacs of fluid within the ovaries (ovarian cysts)
• Headache
• Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Common (may affect up to 1 in 10 people):
• Abdominal pain
• Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
Very rare (may affect up to 1 in 10 000 people):
• Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing
may occur. These reactions can sometimes be serious.
• Your asthma may get worse.
Other side effects in men
Very common (may affect more than 1 in 10 people):
• Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Common (may affect up to 1 in 10 people):
• Swelling of the veins above and behind the testicles (varicocele)
• Breast development, acne or weight gain
Very rare (may affect up to 1 in 10 000 people):
• Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty in
breathing may occur. These reactions can sometimes be serious.
• Your asthma may get worse.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store GONAL-f
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge label or carton after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being
refrigerated again and must be discarded if it has not been used after 3 months.
Store in the original package in order to protect from light.
Do not use GONAL-f if you notice any visible signs of deterioration, if the liquid contains particles or
is not clear.
Please write on the GONAL-f pre-filled pen the day you first use it. For this purpose, a sticker is
provided with the “Instructions for use”.
• Once opened, the pen may be stored for a maximum of 28 days outside of the fridge (at or
below 25°C).
• Do not use any medicine left in your pre-filled pen after 28 days.
At the end of the treatment any unused solution must be discarded.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What GONAL-f contains
• The active substance is follitropin alfa.
• There are 600 IU (44 micrograms) of follitropin alfa in each millilitre of liquid. Each pre-filled
pen with multidose cartridge delivers 900 IU (66 micrograms) in 1.5 mL.
• The other ingredients are poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate
monohydrate, disodium phosphate dihydrate, m-cresol, as well as concentrated phosphoric acid
and sodium hydroxide for pH adjustment and water for injections.
What GONAL-f looks like and contents of the pack
• GONAL-f is presented as a clear, colourless liquid for injection in a pre-filled pen.
• It is supplied in packs with 1 pre-filled pen and 20 disposable needles.
Marketing Authorisation Holder
Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK
Manufacturer
Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italy
This leaflet was last revised in 11/2022.
Disclaimer: information taken from:
https://www.medicines.org.uk/emc/files/pil.71.pdf
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