SUMMARY CMI

ORGALUTRAN^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using ORGALUTRAN?

ORGALUTRAN contains the active ingredient ganirelix (as acetate). ORGALUTRAN is used together with other medications to regulate hormone response in women undergoing fertility treatments such as in vitro fertilisation (IVF).

For more information, see Section 1. Why am I using ORGALUTRAN? in the full CMI.

2. What should I know before I use ORGALUTRAN?

Do not use if you have ever had an allergic reaction to ganirelix (as acetate) or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ORGALUTRAN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ORGALUTRAN and affect how it works.

See Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ORGALUTRAN?

• Treatment should be initiated under the supervision of a fertility specialist.
• ORGALUTRAN is given as a subcutaneous (under the skin) injection in the thigh or stomach, on specific days of your menstrual cycle. Your doctor will tell you when to inject ORGALUTRAN.

More instructions can be found in Section 4. How do I use ORGALUTRAN? in the full CMI.

5. What should I know while using ORGALUTRAN?

For more information, see Section 5. What should I know while using ORGALUTRAN? in the full CMI.

6. Are there any side effects?

Common side effects include local skin reactions at the site of injection. Serious side effects include allergic reactions (i.e. hives, swelling of the face, difficulty breathing, etc.), vaginal bleeding, miscarriage, ectopic pregnancy and ovarian hyperstimulation syndrome (OHSS).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

ORGALUTRAN^®

Active ingredient(s): ganirelix (as acetate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using ORGALUTRAN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ORGALUTRAN.

Where to find information in this leaflet:

1. Why am I using ORGALUTRAN?
2. What should I know before I use ORGALUTRAN?
3. What if I am taking other medicines?
4. How do I use ORGALUTRAN?
5. What should I know while using ORGALUTRAN?
6. Are there any side effects?
7. Product details

1. Why am I using ORGALUTRAN?

ORGALUTRAN contains the active ingredient ganirelix (as acetate), which inhibits actions of the natural gonadotropin releasing hormone (GnRH).

ORGALUTRAN is used together with other medications to regulate hormone response in women undergoing Assisted Reproductive Technology such as in vitro fertilisation (IVF).

ORGALUTRAN works by preventing women from ovulating (releasing an egg from the ovary) too soon during stimulation of their ovaries to produce a mature egg.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

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

2. What should I know before I use ORGALUTRAN?

Warnings

Do not use ORGALUTRAN if:

• you are allergic (hypersensitive) to ganirelix, or any other components of ORGALUTRAN, including the ingredients listed at the end of this leaflet.
• you are allergic to any other similar medicines
• you are pregnant
• you are breastfeeding
• you have moderate to severe kidney or liver disease
• the solution is not clear and colourless
• the expiry date on the pack has passed
• the package shows any signs of tampering

If you are not sure whether you should start using ORGALUTRAN, talk to your doctor.

Tell your doctor if:

• you have allergies to any other medicines, substances such as foods, preservatives or dyes
• you are currently experiencing allergic symptoms
• have any other medical conditions
• take any medicines for any other condition

Cases of allergic reactions, both generalised and local, including hives (urticaria), swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing (angioedema and/or anaphylaxis) have been reported, as early as with the first dose. (See also Section 6. Are there any side effects). If you have an allergic reaction, stop taking ORGALUTRAN and seek immediate medical assistance.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not use ORGALUTRAN if you are pregnant or breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Do not mix ORGALUTRAN with any other medicines.

4. How do I use ORGALUTRAN?

Treatment with ORGALUTRAN should be started under the supervision of a fertility specialist.

ORGALUTRAN is given as a subcutaneous (under the skin) injection in the thigh or stomach.

The injection site should be changed every day to lessen possible injection site reactions.

If your doctor or nurse decides you can give the injections yourself, they will teach you the injection technique.

Do not attempt self-injection until you are sure of how to do it.

Follow all instructions given to you by your doctor or nurse carefully.

How much to inject

• The usual dose is the contents of one pre-filled syringe of ORGALUTRAN once a day on specific days of the menstrual cycle. Your doctor will tell you when to inject ORGALUTRAN.
• You may notice air bubbles in the pre-filled syringe. This is expected, and removal of the air bubbles is not needed.

How to use ORGALUTRAN

Follow these steps:

1. Prepare the injection site

Wash your hands thoroughly with soap and water. Swab the injection site with a disinfectant to remove any surface bacteria. Clean about 5 cm around the point where the needle will go in. Let the disinfectant dry for at least one minute before proceeding.

2. Open the outer pack and plastic container inside

While waiting for the disinfectant to dry, open the ORGALUTRAN pack and remove the plastic container. Carefully open the plastic container and remove the ORGALUTRAN syringe. You will see the needle is already attached, covered by a grey needle shield.

3. Prepare the syringe for injection

Remove needle shield and discard it in a sharps-disposable bin. You are now ready to inject ORGALUTRAN.

4. Inserting the needle and injecting

ORGALUTRAN is injected in either the thigh or the abdomen, usually near the navel.

Pinch up a large bit of skin between your finger and thumb. Insert the needle at the base of the pinched-up skin at an angle of 45 degrees to 90 degrees to the skin surface. Gently draw back on the plunger to see if the needle is inserted correctly.

If any blood appears in the syringe, the needle is not inserted correctly so do not inject ORGALUTRAN. Remove the needle, cover the injection site with a sterile swab and dispose of the syringe in a sharps-disposable container. Start again with a new syringe. If the needle has been inserted correctly, depress the plunger slowly and steadily until all the solution has been injected.

Vary the injection site each time to minimise local irritation.

5. Removing the needle

Pull the needle out of the skin quickly and apply pressure to the site with a swab containing disinfectant. Dispose of the syringe (with the attached needle) in a Sharps Container.

Use the syringe only once and then dispose of it in the Sharps Container.

How long to use ORGALUTRAN

Your doctor will tell you when to inject ORGALUTRAN and when to stop injecting it.

If you forget to use ORGALUTRAN

• If you forget an injection, contact your doctor or IVF clinic immediately for advice.
• Do not inject a double-dose to make up for the forgotten dose.

If you inject too much ORGALUTRAN

If you think that you have injected too much ORGALUTRAN, you may need urgent medical attention.

You should immediately:

• contact your doctor or IVF clinic, or
• phone the Poisons Information Centre
  (by calling 13 11 26) for Australia, or National Poisons Centre (telephone 0800 POISON or 0800 764 766) for New Zealand, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ORGALUTRAN?

Things you should do

Contact your doctor immediately if you have severe pelvic pain, nausea and vomiting and weight gain.

These are early warning signs of Ovarian Hyperstimulation Syndrome (OHSS).

Other symptoms of OHSS can include:

• indigestion
• diarrhoea
• shortness of breath
• reduced amounts of urine
• painful breast

OHSS is a possible complication of hormonal stimulation of the ovaries.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor will want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood.

Make sure that all doctors, dentists and pharmacists who are treating you know you are using ORGALUTRAN.

Tell the hospital doctor that you are using ORGALUTRAN if you need to have an operation, or go to hospital in an emergency.

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using ORGALUTRAN.

Things you should not do

If you are self injecting:

• Do not stop using this medicine suddenly without telling your doctor
• Do not change the dose unless your doctor tells you to
  Changing your dose without telling your doctor can increase your risk of unwanted side effects or can prevent the drug from working properly.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints.

Things you should be careful of

• Compared to natural conception, the frequency of multiple pregnancies and births is increased in patients undergoing assisted reproductive techniques. Discuss the risk of multiple pregnancies and births with your doctor.

Driving or using machines

No effects on ability to drive and use machines have been observed.

Be careful before you drive or use any machines or tools until you know how ORGALUTRAN affects you.

ORGALUTRAN is not addictive.

Looking after your medicine

• Keep ORGALUTRAN at room temperature below 30°C. Do not put it in the freezer as the syringe may break.
• Keep the syringe in the outer carton to protect it from light.
• Keep ORGALUTRAN in a safe place away from the sight and reach of children.
  A locked cupboard at least one-and-a-half-metres above the ground is a good place to store medicines.
• Follow the instructions in the carton on how to take care of your medicine properly.

Store ORGALUTRAN in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Disposal

Dispose of your ORGALUTRAN syringe and needle safely into a yellow plastic Sharps Container.

If your doctor tells you to stop using ORGALUTRAN or the expiry date has passed, ask your pharmacist or IVF clinic what to do with any ORGALUTRAN that is left over.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Other side effects are known to occur with Assisted Reproductive Technology (ART) procedures. These may include:

• Ovarian Hyperstimulation Syndrome.
  Since overstimulation can occur rapidly you must contact your doctor if you experience any of the following: pain in the abdomen or pelvis, indigestion, nausea, vomiting, weight gain, shortness of breath, reduced amounts of urine, diarrhoea and painful breasts.
• vaginal bleeding
• miscarriage
• ectopic pregnancy
  The incidence of ectopic pregnancies (embryo implanted outside the womb) may be increased in women undergoing ART. Your doctor will perform an ultrasound scan early during pregnancy to confirm that a pregnancy is intrauterine (in the womb).

These side effects are probably unrelated to treatment with ORGALUTRAN.

The incidence of congenital malformations (a physical defect present in a baby at birth) after ART may be slightly higher than after spontaneous conceptions. The slightly higher incidence is thought to be related amongst other factors to characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) and to the higher incidence of multiple gestations after ART. The incidence of congenital malformations after ART using ORGALUTRAN is not different from that after using other GnRH analogues in the course of ART.

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What ORGALUTRAN contains

Do not take this medicine if you are allergic to any of these ingredients.

What ORGALUTRAN looks like

ORGALUTRAN is a clear colourless solution. It comes in a pre-filled syringe with fixed needle closed by a needle shield.

ORGALUTRAN is available in packs of 1 or 5 pre-filled syringes (Aust R 74931).

Who distributes ORGALUTRAN

Organon Pharma Pty Ltd
Level 5, 66 King St
Sydney NSW 2000
Australia

Organon (New Zealand) Limited
Level 7, 36 Brandon Street
Wellington 6011
New Zealand

This leaflet was prepared in April 2025.

CCPPI-OG-8761-I-032023

Published by MIMS June 2025

1 Name of Medicine

Ganirelix acetate.

2 Qualitative and Quantitative Composition

Orgalutran 250 microgram ganirelix (as acetate)/0.5 mL solution for injection.

3 Pharmaceutical Form

Solution for injection.
Orgalutran (ganirelix acetate) is presented as a sterile, ready for use, clear and colourless aqueous solution intended for subcutaneous administration.

4 Clinical Particulars

4.1 Therapeutic Indications

For the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.

4.2 Dose and Method of Administration

Orgalutran should only be prescribed by a specialist experienced in the treatment of fertility.

Dosage.

Method of administration.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the components (see Section 6.1 List of Excipients; Section 6.5 Nature and Contents of Container).
Hypersensitivity to GnRH or any other GnRH analogue.
Pregnancy or lactation.
Moderate to severe renal impairment and hepatic impairment.

4.4 Special Warnings and Precautions for Use

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalised and local), have been reported with Orgalutran, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema, and urticaria (see Section 4.8 Adverse Effects (Undesirable Effects)). If a hypersensitivity reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered. Use of Orgalutran in patients with active allergic symptoms has not been investigated. Administration of Orgalutran is not advised to patients with currently severe allergic symptoms. Patients should be advised to contact the attending physician before administering the next injection in case a general or an extensive local allergic reaction occurs.
Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg.

Congenital abnormalities.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

In clinical studies, interactions of Orgalutran with other medicines have not been investigated. Therefore, interactions with commonly used medicinal products can not be excluded.
In the absence of incompatibility studies, this medicinal product must not be mixed with other medicinal products.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

General disorders and administrative site conditions.

Immune system disorders.

Nervous system disorders.

Gastrointestinal disorders.

Reporting suspected adverse effects.

4.9 Overdose

Overdosage in humans may result in a prolonged duration of action. In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
No data on acute toxicity of Orgalutran in humans are available. Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic side-effects. Clinical signs of systemic toxicity including collapse, laboured respiration and inactivity in rats or facial flushing in monkeys were observed after intravenous administration of ganirelix at 2.0 and 3.0 mg/kg, respectively. Blood pressure was also reduced by about 50% in rats treated with an intravenous ganirelix dose of 0.9 mg/kg.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: anti-gonadotrophin releasing hormone; ATC code: H01CC01.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The Orgalutran solution for injection also contains acetic acid, mannitol and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Store at room temperature below 30°C in the original package. Do not freeze as the syringe may break. Protect from light.

6.5 Nature and Contents of Container

Orgalutran is supplied in disposable prefilled syringes (siliconised type I glass), containing 250 microgram ganirelix/0.5 mL of sterile, ready to use, aqueous solution closed with a rubber piston that does not contain latex. A 1 mL long pre-filled class syringe is affixed with a staked needle closed by a rigid needle shield.
Boxes of Orgalutran contain 1 or 5 prefilled syringes.
Australian Registration No.: AUSTR 74931.

6.6 Special Precautions for Disposal

This product is for single use only. Discard any remaining contents.
Any unused product or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in Ac-D-Nal-D-4-CI-Phe-D-Pal-L-Ser-L-Tyr-diEt-hArg-L-Leu-diEt-hArg-L-Pro-D-Ala-NH₂ with a molecular weight of 1570.4 (anhydrous free base).
Molecular formula: C₈₀H₁₁₃N₁₈O₁₃Cl. xCH₃CO₂H. yH₂O, hydrated salt where 2 ≤ x ≤ 3 and y ≤ 10.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes