Product Details

What you need to know before you use GONAL-f 900iu Pen
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
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
GONAL-f is not indicated for use in children.
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 “sodiumfree”.

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.