Choriogonadotropin alfa (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Ovidrel.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Ovidrel against the benefits it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this information with your medicine. You may want to read it again later.

What Ovidrel is used for

Ovidrel belongs to a family of hormones known as gonadotrophins, which are involved in the normal control of reproduction. The active substance of Ovidrel is choriogonadotropin alfa, and is made in the laboratory by special recombinant DNA technology which uses a recombinant human chorionic gonadotrophin hormone produced in mammalian cells

Ovidrel is used in women undergoing assisted reproductive techniques such as in vitro fertilization (IVF). Other medicines are given first to bring about the growth and development of several follicles, to produce eggs. Follicles are the structures in your ovaries that contain the egg. Ovidrel is then used to ripen (mature) these follicles.

Ovidrel is also used in women who do not produce eggs (anovulation), or who produce too few eggs (oligo-ovulation). It is used to trigger the release of eggs (ovulation), after other medicines have been used to develop the follicles.

Your doctor may prescribe Ovidrel for another reason. Ask your doctor if you have any questions about why Ovidrel has been prescribed for you.

Ovidrel is not addictive.

This medicine is available only with a doctor’s prescription.

Before you use Ovidrel

When you must not use it

Do not use Ovidrel if:

• you have a history of allergy to choriogonadotropin alfa, or a similar medicine, or any other inactive ingredients (listed at the end of this leaflet).

Symptoms of an allergic reaction to Ovidrel may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take Ovidrel if you have, or have had, any of the following medical conditions:

• your ovaries are unable to produce eggs (primary ovarian failure or premature menopause).
• uncontrolled thyroid or adrenal gland disease.
• a tumour of the hypothalmus or pituitary gland.
• ovarian enlargement or one or more large ovarian cysts.
• cancer of your ovaries, uterus (womb) or breasts.
• fibroid tumours in your uterus which would make pregnancy impossible.
• if you have been through menopause.

Ovidrel should not be used in the elderly or in children.

Do not take Ovidrel after the expiry date printed on the pack.

Do not take Ovidrel if the packaging is torn or shows signs of tampering. If your medicine has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using Ovidrel, contact your doctor.

Before you start to use it

• Your doctor will assess you and your partner’s infertility. This may include tests for other medical conditions, which may interfere with your ability to become pregnant. If necessary, other medical conditions may be treated before starting infertility treatments and Ovidrel.

Tell your doctor if you have or have had any other pre-existing medical conditions.

Treatment with Ovidrel may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS). This is when the ovaries over react to the hormonal treatment and develop too many follicles. The most common symptom is stomach pain. During stimulation your doctor will monitor your treatment by use of ultrasound and blood tests to measure oestrogen levels. This will help to indicate if you are likely to develop OHSS. If necessary, your Doctor will delay or cancel your Ovidrel injection.

Compared to natural conception, the frequency of multiple pregnancies and births is increased in patients receiving this treatment. The majority of these are twins. In assisted reproduction techniques, the number of babies is related to the number of embryos replaced. Please discuss with your doctor.

There may be a slightly increased risk of birth defects in women using assisted reproductive technologies. This may be due to maternal age, genetic factors, multiple pregnancies or the assisted reproductive technologies. Talk to your doctor about any concerns you may have before undergoing treatment.

Tell your doctor if you or your family have or have had increased risk of developing blood clots e.g. stroke, heart attacks.

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.

Ovidrel may interfere with the results of a blood or urinary hCG (pregnancy) test for up to 10 days. This may lead to a false positive pregnancy test.

How Ovidrel is given

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Treatment with Ovidrel should be started under the supervision of a specialist doctor experienced in fertility treatment

How much to inject

The dose of Ovidrel is one vial (250 microgram) given as a single injection after stimulation of follicle growth by other medicines.

Dosage may need to be varied on the instruction of your doctor and you should be confident in your ability to adjust the dose.

Please consult your doctor or pharmacist if you are in any doubt.

Your doctor will explain exactly when to give the injection.

Each vial is for single use only.

How to inject

Ovidrel is given as an injection under the skin (subcutaneously), usually near your stomach.

Ovidrel is intended to be injected by yourself or by your partner.

Your doctor or nurse will instruct and assist you in learning the procedure and technique of self-injection. Do not attempt self-injection until you are sure of how to do it.

Your partner may be trained to give the injection at home.

Your doctor or nurse can also give the injection to you.

Where to inject

Ovidrel is usually given in the stomach area (except around navel and waistline) or the front of your thigh.

Do not inject into any areas in which you feel lumps, firm knots, depressions, pain or discolouration. Talk to your doctor if you find anything unusual when injecting.

If you forget to inject Ovidrel

You should contact your doctor immediately.

It is important that Ovidrel is injected on the correct day and at the correct time as instructed by your doctor. You must inform your doctor if your injection was not given when directed.

Ask your doctor if you are not sure what to do or have trouble remembering to inject your medicine.

If you inject too much

Immediately contact your doctor or the Poisons Information Centre (in Australia telephone 13 11 26. In New Zealand telephone 0800 764 766) if you are concerned that you have given yourself too much Ovidrel.

While you are using Ovidrel

Things you must do

Tell your doctor if you start taking any new medication while using Ovidrel.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours or if they have the same condition as you.

Do not use Ovidrel to treat any other complaints unless your doctor says to.

Do not stop Ovidrel or change the dose without checking with your doctor.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are taking Ovidrel.

Tell your doctor immediately if you experience any of the following:

Early signs of ovarian hyperstimulation syndrome (OHSS) which include severe stomach pain, nausea, vomiting, diarrhoea, shortness of breath and low urine production.

Tell your doctor if you notice any of the following and they worry you:

Common side effects:

• injection site soreness/redness
• headache
• tiredness
• nausea/vomiting, abdominal pain
• rash

Uncommon side effects:

• diarrhoea
• depression
• irritability
• restlessness
• breast pain
• Severe OHSS
• mild allergic reaction
• warning signs of blood clots (such as pain, warmth, redness, numbness or tingling in arm or leg)
• warning signs of stroke or heart attack

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 Ovidrel

Storage

Keep this medicine where young children cannot reach it.

Ovidrel must be stored below 25°C (air-conditioned room temperature). The vial and water for injection container should be kept in the original package, away from light.

Once the powder is mixed with the water for injection provided it must be used immediately. Any unused solution (liquid) must be discarded.

Disposal

After injecting, you should discard the syringe even if you have not injected all its contents. Syringes should be discarded in an appropriate disposal unit.

Product description

What it looks like

Ovidrel is supplied in a clear glass vial with rubber stopper and aluminium seal and flip-off cap.

The water for injection is supplied in a clear colourless vial or ampoule.

Ingredients

Active ingredient:

• choriogonadotropin alfa

Inactive Ingredients:

• sucrose
• phosphoric acid
• sodium hydroxide

Water for injection ingredient:

• Water for Injections

Manufacturer/Supplier

Ovidrel is supplied in Australia by:
Serono Australia Pty. Ltd.
3-4/25 Frenchs Forest Road
Frenchs Forest NSW 2086

Ovidrel is supplied in New Zealand by:
Healthcare Logistics
58 Richard Pearse Drive
Airport Oakes, Auckland

The Australian registration numbers for:
Ovidrel 250 microgram with diluent ampoule is AUST R 91561.
Ovidrel 250 microgram with diluent vial is AUST R 91752

This leaflet was prepared in
July 2009.

How should I administer Ovidrel (Water for injection Container: Vial)

Follow the directions below for mixing and injecting Ovidrel.

Remove the protective cap from the water for injection vial. Attach the needle for reconstitution (the bigger needle) to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark. Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the water for injection.
Set the syringe down carefully on the work-surface taking care not to touch the needle.

Remove the protective cap from the Ovidrel powder vial, pick up your syringe and slowly inject the water for injection into the vial of Ovidrel. Swirl gently. Do not shake. The powder should dissolve into a clear solution immediately.

Turn the vial upside down, gently draw the solution back into the syringe.

Change the needle for the fine-bore needle and 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. Gently push the plunger until the air bubbles are gone.

Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh). Wipe the chosen area with an alcohol swab. Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion. Inject under the skin, 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 all the solution. Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.

Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container. Any unused solution must be discarded.

How should I administer Ovidrel (Water for injection container: Ampoule)

Ovidrel is given by injection under the skin. Each ampoule is for single use only.

Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injection at home.

If you administer Ovidrel to yourself, please carefully read the following instructions:

On the head of the water for injection ampoule, you will see a small coloured dot. Directly below it is where the neck of the ampoule has been treated to make it easier to break. Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber. Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot. Carefully place the open ampoule upright on the work-surface.

Attach the needle for reconstitution to the syringe, with the syringe in one hand, pick up the open ampoule, insert the needle and draw up all of the water for injection. Carefully set the syringe down on the work-surface, taking care not to touch the needle.

Remove the protective cap from the Ovidrel powder vial, pick up your syringe and slowly inject the water for injection into the vial of Ovidrel. Swirl gently. Do not shake. The powder should dissolve into a clear solution immediately.

Turn the vial upside down, gently draw the solution back into the syringe.

Change the needle for the fine-bore needle and 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. Gently push the plunger until the air bubbles are gone.

Immediately inject the solution: Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh). Wipe the chosen area with an alcohol swab. Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion. Inject under the skin, 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 all the solution. Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.

Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container. Any unused solution must be discarded.

Published by MIMS November 2009

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