ORGALUTRAN 0.25 mg/0.5 mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Orgalutran 0.25 mg/0.5 ml solution for injection

ganirelix

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Orgalutran and what is it used for
2. What you need to know before you use Orgalutran
3. How to use Orgalutran
4. Possible side effects
5. Storage of Orgalutran
6. Contents of the pack and other information

1. What is Orgalutran and what is it used for

Orgalutran contains the active substance ganirelix and belongs to a group of medicines called gonadotropin-releasing hormone (GnRH) antagonists. It works by blocking the action of GnRH, which regulates the release of gonadotropins (luteinizing hormone (LH) and follicle-stimulating hormone (FSH)). Gonadotropins play an important role in human fertility and reproduction. FSH is necessary in women for the growth and development of follicles in the ovaries. The follicles are small, rounded sacs that contain the eggs. LH is necessary for the release of mature eggs from the follicles in the ovaries (i.e., ovulation). Orgalutran suppresses the release of LH.

What Orgalutran is used for

In women undergoing assisted reproduction techniques, such as in-vitro fertilization (IVF) and other methods, premature ovulation may occasionally occur, resulting in a significant reduction in the likelihood of becoming pregnant. Orgalutran is used to prevent premature release of LH, which can cause premature ovulation.

In clinical studies, Orgalutran was used with recombinant follicle-stimulating hormone (FSH) or corifollitropin alfa, a long-acting follicular stimulant.

2. What you need to know before you use Orgalutran

Do not use Orgalutran

• if you are allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6);
• if you are hypersensitive to gonadotropin-releasing hormone (GnRH) or its analogues;
• if you have moderate or severe kidney or liver disease;
• if you are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start using Orgalutran

Allergic reactions

If you have an active allergy, inform your doctor. Your doctor will decide, depending on the severity, if additional monitoring is needed during treatment. Allergic reactions have been observed, even after the first dose.

Allergic reactions, both generalized and localized, including hives (urticaria), swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4), have been reported. If you experience an allergic reaction, stop using Orgalutran and seek medical attention immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

During or after hormonal stimulation of the ovaries, OHSS may develop. This syndrome is related to the gonadotropin stimulation procedure. We recommend that you read the package leaflet of the gonadotropin medicine that you have been prescribed.

Multiple births or birth defects

The incidence of congenital malformations after the use of assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is considered to be related to the characteristics of patients undergoing fertility treatments (e.g., woman's age, semen characteristics) and the higher incidence of multiple pregnancies reported after the use of assisted reproduction techniques. The incidence of congenital malformations after the use of assisted reproduction techniques with Orgalutran is not different from the incidence with the use of other GnRH analogues in assisted reproduction techniques.

Pregnancy complications

There is a slight increase in the risk of an ectopic pregnancy (a pregnancy outside the uterus) in women with damaged Fallopian tubes.

Women weighing less than 50 kg or more than 90 kg

The efficacy and safety of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg. Consult your doctor for more information.

Children and adolescents

Orgalutran is not intended for use in children or adolescents.

Using Orgalutran with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

Orgalutran should be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not use Orgalutran during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Orgalutran contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per injection; it is essentially "sodium-free".

3. How to use Orgalutran

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Orgalutran is used as part of the treatment in assisted reproduction techniques (ART), including in-vitro fertilization (IVF).

Ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin alfa may start on the second or third day of your menstrual period. You should inject Orgalutran (0.25 mg) once daily just under the skin, starting on the fifth or sixth day of stimulation. Depending on your ovarian response, your doctor may decide to start on another day.

Preparations of Orgalutran and FSH should not be mixed, although they should be administered approximately at the same time, injected in different locations.

Daily treatment with Orgalutran should continue until there are sufficient follicles of adequate size. Final maturation of the eggs in the follicles can be induced by administering human chorionic gonadotropin (hCG). The time between two Orgalutran injections and between the last Orgalutran injection and the hCG injection should not exceed 30 hours; otherwise, premature ovulation may occur (i.e., release of the eggs). Therefore, if the Orgalutran injection is given in the morning, treatment with Orgalutran should be maintained throughout the entire gonadotropin treatment period, including the day of ovulation induction. If the Orgalutran injection is given in the evening, the last Orgalutran injection should be administered on the evening before the day of ovulation induction.

Instructions for use

Injection site

Orgalutran is presented in pre-filled syringes and should be injected slowly just under the skin, preferably in the thigh. Check the solution before use. Do not use the solution if it contains particles or is not transparent. You may notice air bubbles in the pre-filled syringe. This is to be expected and does not require removal of the air bubbles. If you or your partner administer the injections, follow the instructions carefully. Do not mix Orgalutran with other medicines.

Preparing the injection site

Wash your hands thoroughly with soap and water. The injection site should be cleaned with a disinfectant (e.g., alcohol) to remove bacteria from the surface. Clean an area of about 5 cm around the injection site and let the disinfectant dry for at least one minute before injecting.

Inserting the needle

Remove the needle protector. Pinch a large area of skin between your thumb and index finger. Insert the needle into the skin at the base of the pinched area at an angle of 45 degrees to the skin surface. The injection site should be varied for each injection.

Checking the correct position of the needle

Gently pull back the plunger to check if the needle is correctly placed. If blood enters the syringe, it means that the needle tip has entered a blood vessel. If this happens, do not inject Orgalutran; instead, remove the syringe, cover the injection site with a swab with disinfectant, and press; it should stop bleeding within one or two minutes. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle is correctly placed, press the plunger slowly and steadily to inject the solution correctly and avoid damaging the skin tissues.

Removing the syringe

Remove the syringe quickly and press on the injection site with a swab with disinfectant.

Use the pre-filled syringe only once.

If you use more Orgalutran than you should

Consult your doctor.

If you forget to use Orgalutran

If you realize you have forgotten to inject a dose, administer it as soon as possible.

Do not administer a double dose to make up for forgotten doses.

If you delay for more than 6 hours (i.e., the interval between two injections is extended by more than 30 hours), administer the dose as soon as possible andconsult your doctor for advice.

If you stop using Orgalutran

Do not stop using Orgalutran unless your doctor tells you to, as this may affect the outcome of your treatment.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The likelihood of experiencing a side effect is classified as follows:

Very common: may affect more than 1 in 10 women

• Local reactions at the injection site (mainly redness, with or without swelling). The local reaction usually disappears within 4 hours after administration.

Uncommon: may affect up to 1 in 100 women

• Headache
• Nausea
• Discomfort

Rare: may affect up to 1 in 10,000 women

• Allergic reactions have been observed, even after the first dose.

• Rash
• Facial swelling
• Difficulty breathing (dyspnea)
• Swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• Hives (urticaria)

• Worsening of a pre-existing eczema has been reported after the first dose of Orgalutran.

Additionally, side effects related to controlled ovarian hyperstimulation treatment (such as abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the uterus), and miscarriage (see the package leaflet of the FSH medicine you are using)) have been observed.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orgalutran

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date is the last day of the month shown.

Do not freeze.

Store in the original package to protect from light.

Inspect the syringe before use. The syringe should only be used if the solution is transparent and particle-free and the packaging is not damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orgalutran

• The active substance is ganirelix (0.25 mg in 0.5 ml solution).
• The other ingredients are acetic acid, mannitol, water for injections. The pH (a measure of acidity) may have been adjusted with sodium hydroxide and acetic acid.

Appearance and packaging of Orgalutran

Orgalutran is a clear and colorless aqueous solution for injection. The solution is ready to use and is administered subcutaneously.

Orgalutran is available in packs of 1 or 5 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Manufacturer

N.V. Organon

Kloosterstraat 6

Postbus 20

5340 BH Oss

Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{month YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.