INFORMATION FOR CONSUMERS

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GONAL-f

Recombinant human follicle stimulating hormone (follitropin alfa [rch])

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.

In women

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).

In men

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.

For women

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.

For men

Do not use GONAL-f if:

• you have 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 medicines;
• other substances such as foods, preservatives or dyes.

Tell your doctor if you have or have had any other medical conditions, especially the following:

• thyroid disorders;
• adrenal glands disorders;
• high prolactin levels in the blood;
• cancer of the pituitary or hypothalamus.

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.

How much to inject

The following is a guide to the usual dose

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.

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 (33.0 microgram)

Once you have responded, a hCG injection is given 24-48 hours after the last GONAL-f injection.

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

For women

The length of treatment varies with each patient. It is possible to have more than one treatment cycle of GONAL-f.

For men

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 GONAL-f

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 0800 764 766) 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 GONAL-f.

If you plan to have surgery, tell your doctor or dentist that you are using GONAL-f.

Tell all doctors, dentists and pharmacists who are treating you that you are using GONAL-f

GONAL-f does not interfere with your ability to drive a car or operate machinery.

For Women

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

For Women

• 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.

SIDE EFFECTS

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.

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;

For women

Tell your doctor if you notice any of the following:

• headache, dizziness;
• stomach cramps or pain;
• nausea, vomiting;
• diarrhoea;
• breast tenderness;
• hair loss, dry skin;
• pain, redness, itching or swelling at the site of injection;
• 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.

For men

Tell your doctor if you notice any of the following:

• acne;
• some breast development;
• weight gain.

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

Storage

Prior to reconstitution keep GONAL-f stored in the original package, below 25°C and away from light.

Once the GONAL-f powder is dissolved with the solvent provided, follow the instructions below carefully.

GONAL-f 37.5 IU (2.73 microgram) 75 IU, (5.46 microgram) and 150 IU (10.92 microgram)
The dissolved solution should be injected immediately. This is due to the solvent not containing preservatives. Any left over solution must be discarded.

GONAL-f Multidose for Injection
The dissolved solution can be stored for up to 14 days in the refrigerator at 2°C to 8°C (Do not freeze). This is due to the solvent containing a preservative. Individual reconstituted vials should be for single use only.

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.

Disposal

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.

Product description

What it looks like

GONAL-f is a sterile white powder in a vial.

Each vial contains the following ingredients:

Active ingredient
Monodose presentation

• Follitropin alfa 37.5 IU (2.73 microgram), 75 IU (5.46 microgram) 150 IU (10.92 microgram)

Other ingredients -

• Sucrose
• sodium phosphate - dibasic dihydrate
• sodium phosphate - monobasic
• Sodium hydroxide
• Phosphoric acid
• Methionine
• polysorbate 20

Active ingredient
Multidose presentation

• Follitropin alfa [600 IU/mL (retrievable doses 1050 IU (76.44 microgram) and 450 IU (32.76 microgram))]

Other ingredients

• Sucrose
• sodium phosphate - dibasic dihydrate
• sodium phosphate - monobasic
• Sodium hydroxide
• Phosphoric acid

This medicine (monodose presentation) is supplied in kits. The kits for the 37.5 IU (2.73 microgram), 75 IU (5.46 microgram) and 150 IU (10.92 microgram) strengths contain the following:

• 1 or 5 or10 or 50 vials of GONAL-f powder
• 1 or 5 or 10 or 50 vials or pre-filled syringe of Water for Injections
• 1 or 5 or 10 or 50 reconstitution needle(s)
• 1 or 5 or 10 or 50 administration needle(s).

The kit for the 450 IU (32.76 microgram) and 1050 IU (76.44 microgram) multidose presentations contains the following:

• 1 vial of GONAL-f powder
• 1 pre-filled syringe containing Water for Injections containing a preservative (benzyl alcohol 0.9%)
• 6 [450 IU] or 15 [1050 IU] disposable syringes

Australian Registration Numbers and Pack Sizes:

Vial Presentations - monodose

37.5 IU (2.73 microgram) AUST R 91562
packs of 1 or 5's or 10's

75 IU (5.46 microgram) AUST R 91563
packs of 1 or 5's or 10's

150 IU (10.92 microgram) AUST R 91564
packs of 1 or 5's or 10's

Vial and Pre-filled Syringe Presentation - Monodose

GONAL-f 37.5 IU (2.73 microgram) AUST R 93506
packs of 1 or 5's or 10's or 50's

GONAL-f 75 IU (5.46 microgram) AUST R 93043
packs of 1 or 5's or 10's or 50's

GONAL-f 150 IU (10.92 microgram) AUST R 93044
in packs of 1 or 5's or 10's or 50's

Vial and pre-filled syringe presentation - Multidose

450 IU (32.76 microgram) AUST R 96114 in packs of 1

1050 IU (76.44 microgram) AUST R 81623 in packs of 1

GONAL-f is supplied in Australia by:

Serono Australia Pty Ltd
3-4/25 Frenchs Forest Road
Frenchs Forest NSW 2086
Tel. (612) 8977 4100

GONAL-f supplied in New Zealand by:

Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks, Auckland

This leaflet was prepared in May 2006
Copyright 2003

How to prepare and inject GONAL-f 75 IU

	Wash your hands well with soap and water. Assemble everything you need to prepare for your injection in a clean area: 1 x pre-filled syringe containing the solvent 1 x GONAL-f vial 1 thick needle for reconstitution and 1 thin needle for injection
	Preparing the GONAL-f Solution using the solvent in a pre-filled syringe Remove the protective cap from the GONAL-f vial and the needle cover from the solvent pre-filled syringe. Attach the thick needle for reconstitution to the pre-filled syringe and slowly inject all the solvent into the vial of GONAL-f powder. Allow pressure to equalise as you were taught. Swirl the vial gently without removing the syringe. Do not shake the vial.
	After the powder has dissolved, check that the resulting solution is clear and does not contain any particles. Turn the vial upside down, gently draw the prescribed volume of solution back into the syringe. Remove the syringe from the vial.
	Preparing for the GONAL-f injection Exchange the thick needle for the thin needle and look for any air bubbles in the syringe. If you see air bubbles, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top. Carefully push the plunger up slowly until the air bubbles are gone.
	Injecting a dose Injections should be administered in either the thigh or the abdomen. Gently pinch the skin together around the chosen injection site and insert the needle at a 90° angle using a gliding motion. Inject as you were taught. Do not inject directly into a vein. Inject the solution by pushing gently on the plunger. Take as much time as you need to inject the prescribed volume of solution. Gently withdraw the needle.
	Immediately discard the needle and syringe and GONAL-f 75 IU vial into a Sharps Container. Wash your hands again with soap and water.

How to prepare and inject GONAL-f Multidose 450 IU or 1050 IU

	Wash your hands well with soap and water. Assemble everything you need to prepare for your injection in a clean area. 1 x 2mL pre-filled syringe containing the solvent 1 x GONAL-f vial 1 x 1mL fixed needle and syringe
	Preparing the GONAL-f Solution Remove the protective cap from the GONAL-f vial and the needle cover from the solvent pre-filled syringe. Slowly inject all the solvent into the vial of GONAL-f. Allow pressure to equalise before removing needle as you were taught. Discard the used solvent syringe into the Sharps Container.
	Gently swirl the vial to ensure that all the powder is dissolved. Do not shake the vial.
	Preparing for the GONAL-f injection Remove the needle cap from the 1mL fixed needle and syringe and insert the needle through the exact center of the rubber stopper. Turn the vial upside down and draw out the prescribed volume of solution into the syringe. With the needle still in the vial, remove any air bubbles by flicking the side of the syringe until all the air collects at the top. Carefully push the plunger up slowly to expel the air back into the vial. Re-adjust the plunger to the prescribed volume of solution.
	Injecting a dose Injections should be administered in either the thigh or the abdomen. Gently pinch the skin together around the chosen injection site and insert the needle at a 90° angle using a gliding motion. Inject as you were taught. Do not inject directly into a vein. Inject the solution by pushing gently on the plunger. Take as much time as you need to inject the prescribed volume of solution. Gently withdraw the needle.
	Immediately discard the needle and syringe into a Sharps Container. Wash your hands again with soap and water. Any unused GONAL-f solution must be refrigerated. For your next injection repeat steps 6 to 19 for the duration of your treatment. It is important to rotate your injection site as you were taught. Any unused GONAL-f solution should be discarded in a Sharps Container after 14 days from opening.