Patient leaflet - Gonal-F 75 IU powder and solvent for solution for injection
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.
How to prepare and use the GONAL-f powder and solvent
- 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:
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 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).
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 starting dose of GONAL-f is usually
individualised and may be adjusted in a stepwise manner.
The daily dose of GONAL-f should not exceed
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, the continuation of that treatment cycle with GONAL-f should be evaluated and managed accordingly to the standard clinical practice.
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.
Package leaflet: Information for the user
75 IU
powder and solvent for solution for injection
follitropin alfa
MUP-001410 • 1 vial containing GONAL-f (the white powder) • 1 needle for preparation
- 1 fine bore needle for injection under the skin Not provided in the pack:
2 alcohol swabs
- 1 sharps container
- Preparing the solution
Remove the protective caps from the powder vial and from the
pre-filled syringe.
- Attach the needle for preparation to the pre-filled syringe, insert it into the powder vial and slowly inject all the solvent. Swirl gently without removing the syringe. Do not shake.
- Check that the resulting solution is clear and does not contain any particles.
- Turn the vial upside down and gently draw the solution back into the syringe by pulling the plunger.
Remove the syringe from the
vial and set it down carefully. Do not touch the needle and do not allow the needle to touch any
surface.
(If you have been prescribed more than one vial of GONAL-f, slowly re-inject the solution into another powder vial, until you have the prescribed number of powder vials dissolved in the solution. If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each product separately. After dissolving the lutropin alfa powder, draw the solution back into the syringe and re-inject it into the vial containing GONAL-f. Once the powder has dissolved, draw the solution back into the syringe. Inspect for particles as before, and do not use if the solution is not clear. Up to three containers of powder may be dissolved in 1 mL of solvent.)
4. Getting ready the syringe for injection
- Change the needle for the fine bore needle.
Remove any air bubbles: If you see air bubbles in the syringe,
hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top. Push the plunger until the air bubbles are gone.
- Injecting the dose
Immediately inject the solution:
Your doctor or nurse will have already advised you where to
inject (e.g. tummy, front of
thigh). To minimise skin irritation, select a different injection site each day. • Clean the chosen skin area with an alcohol swab using a circular motion.
- Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
- Inject under the skin by pushing gently the plunger, as you were taught. Do not inject directly into a vein. Take as much time as you need to inject all the solution.
- Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
- After the injection
Dispose of all used items: Once you have finished your injection, immediately discard all needles and empty glass containers safely preferably in the sharps container. Any unused solution must be discarded.
TW 3864471
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 vial after EXP. The expiry date refers to the last day of that month. 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.
The medicine must be administered immediately after preparation.
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 should not be administered as a mixture with other medicines in the same injection, except for lutropin alfa. Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
6. Contents of the pack and other information
What GONAL-f contains
The active substance is follitropin alfa. • Each vial contains 5.5 micrograms of
follitropin alfa.
After preparation of the final solution for
injection, there are 75 IU (5.5 micrograms) of follitropin alfa in each millilitre of solution. • The other ingredients are sucrose, sodium
dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, as well as concentrated phosphoric acid and sodium hydroxide for pH adjustment. • The solvent is water for injections.
What GONAL-f looks like and contents of the pack
GONAL-f is presented as a powder and solvent
for solution which are used to prepare a solution for injection.
The powder is a white pellet in a glass vial. • The solvent is a clear colourless liquid in pre-
filled syringes, each containing 1 mL. • GONAL-f is supplied in packs of 1, 5, 10 vials
of powder with the corresponding number of solvent in pre-filled syringes. Not all pack sizes may be marketed.
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 September 2023.
HOW TO PREPARE AND USE THE GONAL-f POWDER AND SOLVENT
This section tells you how to prepare and use
your GONAL-f powder and solvent. • Before starting the preparation, please read
these instructions the whole way through first. • Give yourself the injection at the same time
each day.
- Wash your hands and find a clean area
It is important that your hands and the items
you use be as clean as possible.
A good place is a clean table or kitchen
surface.
- Get together everything you need and lay them out:
1 pre-filled syringe containing the solvent (the
clear liquid)