Ovidrel Pen

(choriogonadotropin alfa (rch)) solution for injection pre-filled pen

Consumer Medicine Information

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.

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 that is produced in mammalian cells modified by recombinant DNA technology.

OVIDREL is used in women undergoing assisted reproductive techniques such as in vitro fertilisation (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.

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 be stimulated to produce eggs (primary ovarian failure or premature menopause)

uncontrolled thyroid or adrenal gland disease

a tumour of the hypothalamus 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.

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.

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.

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.

The dose of OVIDREL is one pre-filled pen (250 microgram in 0.5 mL) 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 pre-filled pen is for single use in one patient only. Discard any residue.

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.

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.

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.

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 OVIDREL.

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

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.

Be careful driving or operating machinery until you know how OVIDREL affects you.

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 includes 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.

Keep this medicine where young children cannot reach it.

OVIDREL must be stored at 2°C to 8°C (Refrigerate. Do not freeze) in its original container. Protect from light.

After injecting, you should discard the pen even if you have not injected all its contents. Pen and needle should be discarded in an appropriate disposal unit.

OVIDREL is supplied as solution for injection in a pre-filled pen. It contains no antimicrobial preservative.

Active ingredient:

choriogonadotropin alfa

Inactive Ingredients:

mannitol

monobasic sodium phosphate monohydrate

dibasic sodium phosphate dihydrate

phosphoric acid

sodium hydroxide

poloxamer

methionine

water for injections

OVIDREL is supplied in Australia by:

Merck Healthcare Pty Ltd

Suite 1, Level 1, Building B

11 Talavera Road

Macquarie Park NSW 2113

E-mail: [email protected]

Phone: 1800 633 463

OVIDREL is supplied in New Zealand by:

Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks, Auckland

E-mail: [email protected]

Phone: 0800 426 252

The Australian registration number for:

OVIDREL choriogonadotropin alfa (rch) 250 microgram/0.5mL solution for injection pre-filled pen is AUST R 170446.

 

This leaflet was amended in March 2020.

 

A006-0320