Orgalutran

Package leaflet: Information for the patient

Orgalutran 0.25 mg/0.5 mL solution for injection

ganirelix
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Orgalutran is and what it is used for

Orgalutran contains the active substance ganirelix and belongs to a group of medicines called
"gonadotropin-releasing hormone antagonists" which block the actions of the natural
gonadotropin-releasing hormone (GnRH). GnRH regulates the release of gonadotropins (luteinizing hormone (LH) and follicle-stimulating hormone (FSH)).
Gonadotropins play an important role in human fertility and reproduction. In women,
FSH is necessary for the growth and development of follicles in the ovaries. Follicles are small, round sacs that contain the egg cells. LH is necessary for the release of mature egg cells from the follicles and ovaries (i.e., ovulation). Orgalutran inhibits the action of GnRH, resulting in suppression of the release of LH, in particular.
Orgalutran is used
In women undergoing assisted reproductive techniques, including in vitro fertilization (IVF) and other methods, ovulation may occasionally occur too early, leading to a significant reduction in the chances of becoming pregnant. Orgalutran is used to prevent the premature release of LH, which could cause premature release of egg cells.
In clinical studies, Orgalutran has been used in combination with recombinant follicle-stimulating hormone (FSH) or corifollitropin alfa, a long-acting follicle-stimulating agent.

2. What you need to know before using Orgalutran

Do not use Orgalutran

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Orgalutran
Allergic reactions
If you currently have an allergic condition, inform your doctor. Your doctor will decide, depending on the severity, whether additional monitoring during treatment is necessary. Cases of allergic reactions have been reported, even after the first dose.
Allergic reactions, both generalized and local, have been reported, including urticaria, swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis). (See also section 4.) If you experience an allergic reaction, stop taking Orgalutran and contact a doctor immediately.
Ovarian hyperstimulation syndrome (OHSS)
Ovarian hyperstimulation syndrome may occur during or after hormonal stimulation of the ovaries. This syndrome is related to the gonadotropin stimulation procedure. Please read the package leaflet of the gonadotropin-containing medicine prescribed to you.
Multiple births and congenital abnormalities
The incidence of congenital malformations following assisted reproductive techniques may be slightly higher than after spontaneous conception. This slightly increased incidence is thought to be related to patient characteristics associated with fertility treatment (e.g. maternal age, sperm characteristics) and the higher incidence of multiple pregnancies following assisted reproductive techniques. The incidence of congenital malformations following assisted reproductive techniques using Orgalutran is no different from that observed with other GnRH analogues used in assisted reproductive techniques.
Pregnancy complications
There is a slightly increased risk of pregnancy outside the uterus (ectopic pregnancy) in women with damaged fallopian tubes.
Women with body weight below 50 kg or above 90 kg
The efficacy and safety of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg. Please consult your doctor for further information.
Children and adolescents
The use of Orgalutran in children or adolescents is not recommended.
Other medicines and Orgalutran
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Pregnancy, breastfeeding and fertility
Orgalutran is intended for use during controlled ovarian stimulation in assisted reproductive techniques (ART). Do not use Orgalutran during pregnancy or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies on the ability to drive vehicles or operate machinery have been conducted.
Orgalutran contains sodium
Orgalutran contains less than 1 mmol (23 mg) of sodium per injection, i.e., essentially "sodium-free".

3. How to use Orgalutran

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Orgalutran is used as part of assisted reproductive technology (ART) treatments, including in vitro fertilization (IVF). Ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin may begin on day 2 or 3 of the cycle. The injection of Orgalutran (0.25 mg) should be administered subcutaneously (just under the skin) once daily, starting on day 5 or 6 of stimulation. Based on your ovarian response, your doctor may decide to start treatment on a different day.

Orgalutran and FSH should be administered approximately at the same time. However, the preparations must not be mixed, and the injections must be given at different sites.

Daily treatment with Orgalutran must continue until there are enough follicles of adequate size. Final maturation of the oocytes within the follicles can then be triggered by administering human chorionic gonadotropin (hCG). The interval between two Orgalutran injections, and between the last Orgalutran injection and the hCG injection, must not exceed 30 hours; otherwise, premature ovulation (i.e., release of oocytes) may occur.

Therefore, if Orgalutran is administered in the morning, treatment with Orgalutran must continue throughout the entire gonadotropin treatment period, including on the day of ovulation induction. If Orgalutran is administered in the afternoon, the last Orgalutran injection must be given the afternoon before the day of ovulation induction.

Instructions for use

Injection site

Orgalutran is supplied in pre-filled syringes and must be injected slowly just under the skin, preferably in the thigh. Check the solution before use. Do not use if the solution contains particles or is not clear. You may notice air bubbles in the pre-filled syringe. This is normal and there is no need to remove the air bubbles. If you or your partner will be administering the injections, follow the instructions below carefully. Do not mix Orgalutran with any other medicine.

Preparing the injection site

Wash your hands thoroughly with soap and water. Clean the injection site with a disinfectant (e.g., alcohol) to remove bacteria from the surface. Wipe an area of approximately 5 centimeters (two inches) around the site where the needle will enter and allow the area to dry for at least one minute before proceeding.

Inserting the needle

Remove the cap from the needle. Pinch a large area of skin between your thumb and index finger. Insert the needle at a 45° angle into the base of the pinched skin, between the two fingers. Change the injection site with each administration.

Checking correct needle placement

Gently pull back the plunger to check whether the needle is correctly positioned. The presence of blood in the syringe indicates that the needle has entered a blood vessel. If this occurs, do not inject Orgalutran; instead, withdraw the needle, cover the injection site with a disinfectant-soaked swab, and apply pressure. Bleeding will stop within one or two minutes. Do not reuse the syringe; dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle is correctly placed, slowly and steadily push the plunger to ensure the solution is properly injected and to avoid damaging the skin tissue.

Removing the syringe

Quickly withdraw the needle and apply pressure to the injection site using a disinfectant-soaked swab.

Use each pre-filled syringe only once.

If you use more Orgalutran than you should

Contact your doctor.

If you forget to use Orgalutran

If you think you have missed a dose, administer the injection as soon as possible.

Do not use a double dose to make up for the missed dose.

If more than 6 hours have passed since the usual injection time (so that the interval between two injections exceeds 30 hours), administer the missed dose as soon as possible and consult your doctor for further advice.

If you stop using Orgalutran

Do not stop treatment with Orgalutran unless advised by your doctor, as this may affect the outcome of the treatment.

If you have any questions about 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 will experience them.
The likelihood of experiencing a side effect is described according to the following categories:
Very common: may affect more than 1 in 10 women

• Local skin reactions at the injection site (mainly redness, with or without swelling). Local reactions usually disappear within 4 hours after administration.

Uncommon: may affect up to 1 in 100 women

• Headache
• Nausea
• Malaise

Very rare: may affect up to 1 in 10,000 women

• Allergic reactions have been observed, even with the first dose.
  • Skin rash
  • Facial swelling
  • Difficulty breathing (dyspnoea)
• Swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis)
• Urticaria
  • In one subject, after the first dose of Orgalutran, worsening of a pre-existing skin rash (eczema) was reported.

In addition, side effects related to the treatment for controlled ovarian hyperstimulation have been reported (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the uterus), and miscarriage (see the package leaflet of the FSH-containing preparation used for treatment).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Orgalutran

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label, after "Exp.". The expiry date refers to the last day of that month.
Do not freeze.
Store in the original packaging to protect from light.
Check the syringe before use. Only use syringes containing clear solutions, free from particles, and with intact packaging.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Orgalutran contains

• The active substance is ganirelix (0.25 mg in 0.5 mL of solution).
• The other components are acetic acid, mannitol, and water for injectable preparations. The pH (a measure of acidity) may be adjusted with sodium hydroxide and acetic acid.

Description of the appearance of Orgalutran and contents of the pack
Orgalutran is a clear, colourless, ready-to-use aqueous injectable solution. The solution is intended for subcutaneous administration.
Orgalutran is available in packs containing 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
The Netherlands

Manufacturer
N.V. Organon,
Kloosterstraat 6,
Postbus 20,
5340 BH Oss,
The Netherlands.

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Organon Belgium Organon Pharma B.V. Lithuania atstovybė
Tél/Tel: 0080066550123 (+32 2 2418100) Tel.: +370 52041693
[email protected] [email protected]

България Luxembourg/Luxemburg
Органон (И.А.) Б.В. - клон България Organon Belgium
Тел.: +359 2 806 3030 Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected] [email protected]

Česká republika Magyarország
Organon Czech Republic s.r.o. Organon Hungary Kft.
Tel: +420 233 010 300 Tel.: +36 1 766 1963
[email protected] [email protected]

Danmark Malta
Organon Danmark ApS Organon Pharma B.V., Cyprus branch
Tlf: +45 4484 6800 Tel: +356 2277 8116
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH N.V. Organon
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10) Tel: 00800 66550123 (+32 2 2418100)
[email protected] [email protected]

Eesti Norge
Organon Pharma B.V. Estonian RO Organon Norway AS
Tel: +372 66 61 300 Tlf: +47 24 14 56 60
[email protected] [email protected]

Ελλάδα Österreich
BIANEΞ Α.Ε. Organon Healthcare GmbH
Τηλ: +30 210 80091 11 Tel: +49 (0) 89 2040022 10
[email protected] [email protected]

España Polska
Organon Salud, S.L. Organon Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel.: +48 22 105 50 01
[email protected] [email protected]

France Portugal
Organon France Organon Portugal, Sociedade Unipessoal Lda.
Tél: +33 (0) 1 57 77 32 00 Tel: +351 218705500
[email protected]

Hrvatska România
Organon Pharma d.o.o. Organon Biosciences S.R.L.
Tel: +385 1 638 4530 Tel: +40 21 527 29 90
[email protected] [email protected]

Ireland Slovenija
Organon Pharma (Ireland) Limited Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +353 15828260 Tel: +386 1 300 10 80
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Organon Slovakia s. r. o.
Sími: +354 535 7000 Tel: +421 2 44 88 98 88
[email protected]

Italia Suomi/Finland
Organon Italia S.r.l. Organon Finland Oy
Tel: +39 06 90259059 Puh/Tel: +358 (0) 29 170 3520
[email protected] [email protected]

Κύπρος Sverige
Organon Pharma B.V., Cyprus branch Organon Sweden AB
Tel: +357 22866730 Tel: +46 8 502 597 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Ārvalsts komersanta “Organon Pharma B.V.” Organon Pharma (UK) Limited
pārstāvniecība Tel: +44 (0) 208 159 3593
Tel: +371 66968876 [email protected]
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.