Recombinant human follicle stimulating hormone (follitropin alfa [rch])
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 or nurse or pharmacist.
All medicines have risks and benefits.Your doctor has weighed the risks of you using GONAL-f against the benefits it will have for you.
If you have any concerns about using this medicine, ask your doctor or nurse or pharmacist.
GONAL-f is available only on a doctor’s prescription.
Keep this information with your medicine.You may want 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 in the growth and development of egg cells
(follicles) in women and sperm production in men.
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).
GONAL-f is used in combination with human chorionic gonadotrophin (hCG) to stimulate the production of sperm.
Before you are given GONAL-f
When you must not use GONAL-f
Do not use GONAL-f if:
you have history of allergy to any of the ingredients listed at the end of this leaflet;
tumour of the hypothalamus or pituitary gland.
Do not use GONAL-f if:
you are pregnant;
you are breastfeeding;
your ovaries are enlarged;
you have an ovarian cyst;
you have unexplained vaginal bleeding;
you have fibroids of the uterus that would prevent you maintaining a pregnancy;
your ovaries have failed;
you have cancer of the reproductive organs or breast.
Do not use GONAL-f if:
you have an increased levels of gonadotrophins indicating failure of the testes;
your infertility is due to disorders, other than hypogonadotrophic hypogonadism (low levels of gonadotrophins).
Do not use GONAL-f if the packaging is torn or shows signs of tampering, or the product does not look quite right.
Do not use GONAL-f after the expiry date (month/year) on the packaging has passed.
If you use this medicine after the expiry date has passed, it may not work as well.
If it has expired or is damaged, return it to your pharmacist/clinic for disposal.
If you are not too sure about using GONAL-f talk to your doctor.
Before you start to use GONAL-f
You and your partner’s
fertility should be assessed to see if treatment with GONAL-f is appropriate for you.
Tell your doctor if you are breastfeeding or intend to breastfeed.
Tell your doctor if you have any allergies to:
other substances such as foods, preservatives or dyes.
Tell your doctor if you have or have had any other medical conditions, especially the following:
adrenal glands disorders;
high prolactin levels in the blood;
cancer of the pituitary or hypothalamus.
Treatment with GONAL-f and hCG may increase the risk of blood clots forming in your blood vessels. Discuss this with your doctor especially if you or your family have or have had experienced the signs of blood clots (pain, warmth, redness, numbness or tingling in your arm or leg).
If you have any of the above, tell your doctor before you start to use GONAL-f.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without prescription from your pharmacy, supermarket or health food shop.Your doctor has more information on medicines to be careful with or avoid while using GONAL-f.
How GONAL-f is given
GONAL-f is given as a subcutaneous (under the skin) injection in the stomach or thigh.
The injection site should be changed daily to lessen possible injection site reactions.
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.
Follow all instructions given to you by your doctor carefully.
Please see the end of this leaflet for instructions on how to administer the dose using the pre-filled pen.
How much to inject
The following is a guide to the usual dose
1.Women who are not ovulating
The dose usually starts at 75-150 IU (5.46 to 10.92 microgram) daily. This may be gradually increased by 37.5 IU (2.73 microgram) until adequate response to treatment is obtained. The maximal daily dose is usually not higher than 225 IU (16.5 microgram).
Once you have responded, an hCG injection (to stimulate ovulation) is given 24-48 hours after the last
GONAL-f injection. You are recommended to have sexual intercourse on the day of, and the day following the hCG injection.
2.Women undergoing assisted reproductive technologies
The dose usually starts at 150-225 IU (10.92 microgram to 16.5 microgram) daily, commencing on day 2 or 3 of the cycle. The dose may be adjusted according to your response. The maximal daily dose is usually not higher than 450 IU (32.76 microgram).
Once you have responded, a hCG injection is given 24-48 hours after the last GONAL-f injection.
3.Men with hypogonadotrophic hypogonadism
Treatment usually begins with hCG only. If an adequate response is not obtained with hCG, your doctor may decide to give you a combination of hCG
and GONAL-f 150 IU (10.92 microgram) three times a week.
Have your injections at the same time each day.
How long to use GONAL-f for
The length of treatment varies with each patient. It is possible to have more than one treatment cycle of GONAL-f.
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 use
If you forget an injection or are not sure what to do contact your doctor or nurse immediately for advice. Do not double the dose on any day.
If you inject too much
Immediately contact your doctor or the Poisons Information Centre (In Australia telephone 131 126. In New Zealand telephone ) if you are concerned that you have given yourself too much GONAL-f.
While you are using GONAL-f
Your doctor may monitor your response to GONAL-f by using ultrasound, blood tests or semen analysis.
Things you must do
You are required to see your doctor regularly so you can be monitored closely throughout your treatment.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using
If you plan to have surgery, tell your doctor or dentist that you are using
Tell all doctors, dentists and pharmacists who are treating you that you are using GONAL-f.
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
Treatment with GONAL-f and hCG may increase your risk of multiple pregnancies or births;
Ovarian Hyperstimulation Syndrome (OHSS) – may occur (see side effects).
To minimise this risk, your doctor may monitor your treatment with regular ultrasounds and blood tests.
GONAL-f does not interfere with your ability to drive a car or operate machinery.
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.
If you get any side effects, do not stop using GONAL-f without first talking to your doctor.
Tell your doctor if you notice pain, redness, itching or swelling at the site of injection during your treatment with GONAL-f.
However, should you notice any of the following side effects contact your doctor immediately or go to the accident and emergency section of your nearest hospital:
swelling of the face, lips, tongue, or other parts of the body;
shortness of breath, wheezing or difficulty breathing;
skin rash, itching or hives.
Tell your doctor if you notice any of the following:
stomach cramps,pain or discomfort;
hair loss, dry skin;
ovarian enlargement, bloating.
These are common side effects.
If any of the following happen, stop using GONAL-f, contact your doctor immediately or go to the accident and emergency section of your nearest hospital:
inflammation, swelling or clotting of the blood vessels;
severe pelvic pain, nausea and vomiting and weight gain, these are early warnings of OHSS.
Other side effects associated with OHSS are:
severe enlargement of the ovaries, indigestion, diarrhoea, reduced amounts of urine, weight gain, shortness of breath.
Ectopic pregnancy (embryo implanted outside the womb) may occur after treatment with GONAL-f. This is a rare side effect.
Tell your doctor if you notice any of the following:
some breast development;
These are common side effects.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects.You may not experience any of them.
After Using GONAL-f
Prior to using, store GONAL-f PEN at 2°C to 8°C (Refrigerate. Do not Freeze). Should refrigeration be unavailable, the GONAL-f PEN can be stored below 25°C for up to 3 months and away from light. After first piercing the GONAL-f PEN with a needle, GONAL-f PEN 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 the dissolved solution if it contains particles or is not clear.
Do not store GONAL-f in the bathroom or near a sink.
Do not leave GONAL-f in the car.
Keep GONAL-f where children cannot reach it.
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.
What it looks like
GONAL-f PEN is pre-filled and available as solution for injection in three strengths of 300 IU (21.84 microgram), 450 IU (32.76 microgram) and 900 IU (65.52 microgram).
GONAL-f PEN is pre-filled with a clear, colourless solution of 0.5 mL (300 IU), 0.75 mL (450 IU) or 1.5 mL (900 IU).
Each cartridge contains the following ingredients:
Follitropin alfa 300 IU (21.84 microgram), 450 IU (32.76 microgram) and 900 IU (65.52 microgram)
Other ingredients –
Sodium phosphate - dibasic dihydrate
Sodium phosphate - monobasic
Water for Injections
GONAL-f 300 IU/0.5 mL (21.84 microgram/0.5 mL) PEN is supplied in packs of:
1 cartridge pre-assembled in a disposable pen and 5 needles for administration.
GONAL-f 450 IU/0.75 mL (32.76 microgram/0.75 mL) PEN is supplied in packs of:
1 cartridge pre-assembled in a disposable pen and 7 needles for administration.
GONAL-f 900 IU/1.5 mL (65.52 microgram/1.5 mL) PEN is supplied in packs of:
1 cartridge pre-assembled in a disposable pen and 13 needles for administration.
Australian Registration Numbers:
GONAL-f 300 IU PEN for injection AUST R 96230
GONAL-f 450 IU PEN for injection AUST R 96236
GONAL-f 900 IU PEN for injection AUST R 96237
GONAL-f PEN is supplied in Australia by:
Merck Serono Australia Pty Ltd
3-4/25 Frenchs Forest Road
Frenchs Forest NSW 2086
For enquiries call:
GONAL-f PEN is supplied in New Zealand by:
58 Richard Pearse Drive
Airport Oaks, Auckland
This leaflet was prepared in March 2010
HOW TO USE GONAL-f PEN FOR INJECTION
Individual pre-filled pens should not be shared with other patients. You should prepare the GONAL-f PEN and inject the solution once you have selected the dose prescribed by your doctor or nurse. Your injection should be done at the same time each day.
Before you use ‘GONAL-f PEN for injection’ yourself, please read the following instructions carefully and completely:
STEP 1. Getting ready
1.1 Wash your hands thoroughly with soap and water and assemble everything you need to prepare for your injection in a clean area.
1x pre-filled GONAL-f PEN
1x needle (Caution: Only use the single-use disposable needles provided within the GONAL-f PEN pack or distributed separately by Serono).
1.2 If the GONAL-f PEN has been stored in the refrigerator, remove it from the refrigerator a few minutes before you begin your preparations to bring it to room temperature.
The diagram above shows you the parts of your GONAL-f PEN that you need to know to prime for your injection.
2. dosage control scale
3. grey indicator of complete dose delivery
4. dosage dial (in IU FSH)
5. dose arrow
6. reservoir holder
7. plunger piston
8. threaded tip
9. pen cap
10. removable needle
11. inner needle cap
12. outer needle cap
13. peel tab
STEP 2. Preparing the GONAL-f PEN
2.1 Attaching the needle
2.1.1 Remove the GONAL-f PEN cap.
2.1.2 Take a new needle for each injection. If the peel tab closing the outer needle cap is damaged or loose, do not use that needle. Discard it and take a new one. Remove the peel tab from the outer needle cap. Press the threaded tip of the GONAL-f PEN into the outer needle cap and twist it clockwise until it is securely fixed.
2.2 Priming the GONAL-f PEN for injection
Note: The GONAL-f PEN only needs to be primed prior to the administration of the first dose. Once properly primed, the PEN does not need to be re-primed prior to subsequent injections.
2.2.1 Check to ensure that the dose arrow (5.) is set at 37.5. If not, turn the dosage dial (4.) in either direction so as to reach this position.
2.2.2 Pull out the injection button (1.) as far as it will go.
2.2.3 Pull off the outer needle cap (do not throw away as you will need it later) and the inner needle cap, hold the GONAL-f PEN with the needle pointing upwards and tap the reservoir holder (6.) gently with your finger to help air bubbles rise to the top of the reservoir holder (6.).
2.2.4 With the needle still pointing upwards, push the injection button (1.) completely inwards. A drop of liquid must appear at the tip of the needle. This indicates that your GONAL-f PEN is primed for injection.
2.2.5 If you do not see a drop of liquid appear at the tip of the needle, repeat all steps of 2.2.
2.3 Set the prescribed dose
2.3.1 If not already correctly set, select the dose as prescribed by your doctor by turning the dosage dial (4.) in either direction until the dose arrow (5.) is pointing to the dose you require (the dosage dial lets you set the dose in increments of 37.5 IU).
Arrows and corresponding numbers will appear on final printed version
2.3.2 As the dose cannot be corrected after the dose has been loaded, carefully check the dosage dial (4.) before pulling out the injection button (1.).
2.3.3 Once you have dialled your dose correctly, load it by pulling the injection button (1.) out as far as it will go. Take care to pull the button straight and not to twist it out, this might change the set dose. The loaded dose is indicated by the dose arrow (5.) and confirmed on the dose control scale (2.) (see example of 150 IU as illustrated in the diagram). Note: The dosage control scale (2.) on the injection button enables you to check whether your next dose will be complete or not. The injection button can only be pulled out as far as the arrow indicating the amount of dose left. If the loaded dose is not enough to complete your injection, you have two possibilities:
•Inject the partial dose (left in this pen) and then immediately complete the injection of the rest of the dose using a new GONAL-f PEN (do not forget to record the partial dose).
•Discard the GONAL-f PEN and inject the full dose using a new GONAL-f PEN.
2.3.4 Should you select the incorrect dose by mistake and the dose has been loaded you should not inject. Discard the dose to waste and repeat the dose setting correctly.
Note: If the same dose is required every time, then the dose arrow can be left pointing at the same position on the dosage dial. If a different dose is required next time, then repeat all steps of 2.3.
STEP 3. Self injecting
3.1 Injecting the dose
3.1.1 Your doctor or nurse will tell you where to inject.
It is important to use a different injection site each day.
3.1.2 To inject, gently pinch the skin around the chosen injection site and gently insert the needle at a 90 degree angle straight through the skin and then completely push in the injection button (1.). Check that the grey indicator on the injection indicator button is no longer visible. This confirms that the delivery of the dose is complete.
3.1.3 Gently withdraw the needle.
3.1.4 Record the date and amount of GONAL-f injected each day.
STEP 4. After your injection
4.1 Removing the needle
4.1.1 Hold the GONAL-f PEN by the reservoir holder (6.). Carefully put the outer needle cap back onto the needle.
4.1.2 Hold the outer needle cap and unscrew the needle by turning it anticlockwise.
4.1.3 Discard the used needle with its cap in a sharps container.
4.1.4 Place the pen cap back on the GONAL-f PEN.
IMPORTANT: Never store your GONAL-f PEN with the needle attached.
4.2 Storing the GONAL-f PEN
1.Store the GONAL-f PEN (preferably in the original package) in the refrigerator at 2°C to 8° C (Refrigerate. Do Not Freeze). If refrigeration is not available and before the GONAL-f PEN is in use, it may be stored below 25°C for a single period of 3 months.
2.Once you have started giving your injections, you can store the GONAL-f PEN at room temperature, below 25°C for a maximum of 21 days and away from light.
3.When you have used the last dose from the GONAL-f PEN, discard it in a sharps container.
IMPORTANT: Once you have completed your treatment, return the sharps container to your pharmacy for disposal.
Published by MIMS/myDr November 2010
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