GONAL f 300iu Pen 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 300IU Pen is used for
In adult women, GONAL f 1050iu 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 that are not ovulating because their 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.
What is Infertility
Infertility is when a couple cannot get pregnant (conceive) despite having regular unprotected sex.
Around 1 in 7 couples may have difficulty conceiving.
About 84% of couples will conceive naturally within a year if they have regular unprotected sex (every 2 or 3 days).
For couples who have been trying to conceive for more than 3 years without success, the likelihood of getting pregnant naturally within the next year is 1 in 4, or less.
Some people get pregnant quickly, but for others it can take longer. It’s a good idea to see a GP if you have not conceived after a year of trying.
Women aged 36 and over, and anyone who’s already aware they may have fertility problems, should see their GP sooner.
surgical procedures such as treatment for endometriosis, repair of the fallopian tubes, or removal of scarring (adhesions) within the womb or abdominal cavity
Some treatments for infertility, such as IVF, can cause complications.
For example:
multiple pregnancy – if more than 1 embryo is placed in the womb as part of IVF treatment there’s an increased chance of having twins; this may not seem like a bad thing, but it significantly increases the risk of complications for you and your babies
ectopic pregnancy – the risk of having an ectopic pregnancy is slightly increased if you have IVF
There are many possible causes of infertility, and fertility problems can affect either partner. But in a quarter of cases it is not possible to identify the cause.
Common causes of infertility include:
lack of regular ovulation (the monthly release of an egg)
poor quality semen
blocked or damaged fallopian tubes
endometriosis – where tissue that behaves like the lining of the womb (the endometrium) is found outside the womb
RISK FACTORS
There are also several factors that can affect fertility.
These include:
age – fertility declines with age
weight – being overweight or obese (having a BMI of 30 or over) reduces fertility; in women, being overweight or severely underweight can affect ovulation
sexually transmitted infections (STIs) – several STIs, including chlamydia, can affect fertility
smoking – can affect fertility: smoking (including passive smoking) affects your chance of conceiving and can reduce semen quality; read more about quitting smoking
alcohol – the safest approach is not to drink alcohol at all to keep risks to your baby to a minimum. Drinking too much alcohol can also affect the quality of sperm (the chief medical officers for the UK recommend adults should drink no more than 14 units of alcohol a week, which should be spread evenly over 3 days or more)
environmental factors – exposure to certain pesticides, solvents and metals has been shown to affect fertility, particularly in men
stress – can affect your relationship with your partner and cause a loss of sex drive; in severe cases, stress may also affect ovulation and sperm production
There’s no evidence to suggest caffeinated drinks, such as tea, coffee and colas, are associated with fertility problems.
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How to use GONAL-f 300iu Pen
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 prepared solution 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 inject GONAL-f before you can inject yourself.
• If you administer GONAL-f to yourself, please carefully read and follow the instructions at the end of this leaflet called “How to prepare and use the GONAL-f powder and solution”.
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), which reflects the grading of the administration syringes
provided in the pack.
If you use another syringe, which shows millilitres (mL) instead of IUs, you can take the correct amount for injection in mL from the following table:
Dose to be injected (IU) Volume to be injected (mL)
75 0.13
150 0.25
225 0.38
300 0.50
375 0.63
450 0.75
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, OHSS). For the following cycle, your doctor will give you a lower dose of GONAL-f
than before.
If you are not ovulating, having no periods and 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 may be performed by placing the sperm into the womb cavity.
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, 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, 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.
Delivery Options
Delivery options
All deliveries are subject to the availability of the product and product sale conditions been met.
Order & Collect
Free next-day collection from In-Store
UK Delivery
Standard Delivery within the UK £3.50 Delivery time 3-4 days First Class Delivery within the UK £5.90 Delivery time 1-2 days Priority Delivery within the UK £7.10. Next day delivery by 1pm. Order must be placed by 1pm. Priority delivery is only available Monday to Thursday.
Europe Delivery
Standard Delivery within EEC from £12.50 Delivery time up to 5 days depending on the local delivery service within your country. Expedited Delivery within EEC £39.50 Delivery time 2 days. Delivery by DHL, UPS or TNT.
Rest of the World
Standard Delivery Rest of the World from £16.10 Delivery Time 10 – 15 Days Expedited Delivery Rest of the World £55.09 Delivery 5 days. Delivery service by DHL, TNT or UPS
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
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 and benzyl alcohol
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
When prepared with the solvent provided, this medicine contains 1.23 mg benzyl alcohol in each 75 IU dose which is equivalent to 9.45 mg/mL. Benzyl alcohol may cause allergic reactions.
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 vial label or carton after EXP.
The expiry date refers to the last day of that month.
Prior to reconstitution, do not store above 25°C.
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.
Once the solution has been prepared, it may be stored for a maximum of 28 days.
• Please write on the GONAL-f vial the day you prepared the solution.
• Do not store above 25°C. Do not freeze.
• Store in the original container, in order to protect from light.
• Do not use any GONAL-f solution left in the vial 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.
GONAL-f 1050 IU/1.75 mL powder should not be mixed with other medicines in the same injection.
GONAL-f 1050 IU/1.75 mL powder is not to be mixed with other GONAL-f containers within the same vial or syringe
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”). 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
Ingredients
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 300 IU (22 micrograms) in 0.5 mL.
• The other ingredients are poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate
monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium
hydroxide 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 8 disposable needles.
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