Ganirelix Gedeon Richter

Package leaflet: Information for the patient

Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe

ganirelix
Read this leaflet carefully before 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 you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Ganirelix Gedeon Richter is and what it is used for

Ganirelix Gedeon Richter 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 containing the egg cells. LH is required for the release of mature egg cells from the follicles and ovaries (i.e., ovulation). Ganirelix Gedeon Richter inhibits the action of GnRH, resulting in suppression of the release of LH, in particular.
Ganirelix Gedeon Richter is used for
In women undergoing assisted reproductive technologies, including in vitro fertilization (IVF) and other methods, ovulation may occasionally occur too early, significantly reducing the chances of becoming pregnant. Ganirelix Gedeon Richter is used to prevent the premature release of LH, which could cause premature release of egg cells.
In clinical studies, Ganirelix Gedeon Richter has been used in combination with recombinant follicle-stimulating hormone (FSH) or with corifollitropin alfa, a long-acting follicle-stimulating agent.

2. What you need to know before using Ganirelix Gedeon Richter

Do not use Ganirelix Gedeon Richter

• 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 Ganirelix Gedeon Richter.
Allergic reactions
If you currently have an allergic condition, inform your doctor. Depending on the severity, your doctor will decide 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 in breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If you experience an allergic reaction, stop using Ganirelix Gedeon Richter and consult a doctor immediately.
Ovarian hyperstimulation syndrome (OHSS)
During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may occur. 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 ganirelix is not 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 damage to the Fallopian tubes.
Women weighing less than 50 kg or more than 90 kg
The efficacy and safety of ganirelix 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 Ganirelix Gedeon Richter in children or adolescents is not recommended.
Other medicines and Ganirelix Gedeon Richter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Ganirelix Gedeon Richter is intended for use during controlled ovarian stimulation in assisted reproductive techniques (ART).
Do not use Ganirelix Gedeon Richter during pregnancy or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies have been conducted on the effects of Ganirelix Gedeon Richter on the ability to drive vehicles or operate machinery.
Ganirelix Gedeon Richter contains sodium
Ganirelix Gedeon Richter contains less than 1 mmol (23 mg) of sodium per injection, i.e. it is essentially "sodium-free".

3. How to use Ganirelix Gedeon Richter

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Ganirelix Gedeon Richter 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 Ganirelix Gedeon Richter injection (0.25 mg) must be administered into the fatty layer just beneath the skin (subcutaneously) once daily, starting on day 5 or 6 of stimulation. Based on your ovarian response, your doctor may decide to start on a different day.
Ganirelix Gedeon Richter 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 Ganirelix Gedeon Richter must continue until a sufficient number of follicles of adequate size are present. Final maturation of the oocytes within the follicles can then be induced by administering human chorionic gonadotropin (hCG).
The time interval between two Ganirelix Gedeon Richter injections, and between the last Ganirelix Gedeon Richter injection and the hCG injection, must not exceed 30 hours; otherwise, premature ovulation (i.e., release of oocytes) may occur.
Therefore, when administering Ganirelix Gedeon Richter in the morning, treatment with Ganirelix Gedeon Richter must be continued throughout the entire gonadotropin treatment period, including on the day of ovulation induction.
When administering Ganirelix Gedeon Richter in the afternoon, the last Ganirelix Gedeon Richter injection must be given the afternoon before the day of ovulation induction.

Instructions for use
Before administering this medicine, it is very important to read carefully and strictly follow the instructions for use detailed at the end of this leaflet.

Injection site
Ganirelix Gedeon Richter is supplied in pre-filled syringes and must be injected slowly into the fatty layer just beneath 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 expected and removal of the air bubbles is not necessary. If you or your partner will be administering the injections, follow carefully the instructions provided below and at the end of this leaflet. Do not mix

Ganirelix Gedeon Richter with any other medicine.

Preparation of the injection site
Wash hands thoroughly with water and soap. Wipe the injection site with a
disinfectant (e.g. alcohol) to remove bacteria from the surface. Clean an area of approximately 5
centimetres (two inches) around the point where the needle will enter and allow the area to dry for
at least one minute before proceeding.
Insertion of the needle
Remove the cap from the needle. Grasp a large area of skin between thumb and index finger. The needle should
be inserted at the base of the skin fold pinched between the two fingers, at an angle of 45°
to the skin surface. The injection site should be changed 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 Ganirelix Gedeon Richter; instead, remove the needle, cover the injection
site with a disinfectant-soaked swab and apply pressure; the bleeding will stop within one or two
minutes. Do not use the syringe but dispose of it appropriately. Start again with a new syringe.
Injecting the solution
Once the needle is correctly positioned, push the plunger slowly and steadily so that the solution is
properly injected and the skin tissue is not damaged. Push the plunger down until the syringe is empty and
wait for 5 seconds.
Removing the syringe
Remove the needle quickly and apply pressure to the injection site using a disinfectant-soaked swab. Use the pre-filled syringe only once.
If you use more Ganirelix Gedeon Richter than you should
Contact your doctor.
If you forget to use Ganirelix Gedeon Richter
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 the two
injections exceeds 30 hours), administer the injection as soon as possible and consult your doctor for
further advice.
If you stop using Ganirelix Gedeon Richter
Do not stop treatment with Ganirelix Gedeon Richter unless advised by your
doctor, as this may affect the treatment outcome.
If you have any doubts about how to use this medicine, consult 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 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). The local reaction usually disappears within 4 hours after administration.

Uncommon: may affect up to 1 in 100 women

• Headache
• Nausea
• Feeling of general discomfort (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 in 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 a single subject, worsening of a pre-existing skin rash (eczema) has been reported after the first dose of ganirelix.

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 possible side effects 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ganirelix Gedeon Richter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton, after "Exp.". The expiry date refers to the last day of that month.
Do not freeze.
Store in the original packaging to protect the medicine from light.
Check the syringe before use. Only use syringes containing clear solutions free from particles and with intact packaging.
Each pre-filled syringe is for single injection use only.
Alcohol swabs, gauze, and sharps containers are required for administration of this medicine, but are not supplied with the pack.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ganirelix Gedeon Richter contains

• The active substance is ganirelix (0.25 mg in 0.5 mL of solution).
• The other components are glacial acetic acid, mannitol (E 421), water for injections. The pH (a measure of acidity) may be adjusted with sodium hydroxide (see section 2 “Ganirelix Gedeon Richter contains sodium”).

Description of the appearance of Ganirelix Gedeon Richter and package contents
Ganirelix Gedeon Richter is a clear, colourless injectable solution (injection). The medicine
is contained in a glass syringe with a pre-attached stainless steel needle, sealed with a rubber cap and fitted with a plunger. The needle is protected by a rigid cap.
Ganirelix Gedeon Richter is available in pack sizes of 1, 5 or 6 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

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

Instructions for use
HOW TO PREPARE AND ADMINISTER GANIRELIX GEDEON RICHTER FROM A PRE-FILLED SYRINGE

Before administering this medicine, read these instructions and the entire package leaflet carefully and completely.
These instructions explain how to give an injection of Ganirelix Gedeon Richter. The injection may be given by yourself or by your partner. If you have any doubts about how to perform the injection or any questions, ask your doctor or pharmacist for help.
Do not mix Ganirelix Gedeon Richter with other medicinal products.
Administer the injection at the same time each day.
Each pre-filled syringe contains one single daily dose of ganirelix.

CONTENTS OF THE INSTRUCTIONS FOR USE

1. Preparation for injection
2. Preparation of the injection site
3. Administration of the medicine
4. After the injection

1. Preparation for injection

• Wash your hands thoroughly with soap and water. It is important that your hands and all items used are as clean as possible to avoid infection.
• Find a clean area for the items needed for the injection, such as a clean table or similar flat surface.
• Gather all the items you need and place them on the clean surface:
  • Antiseptic swabs (e.g. alcohol swabs)
  • 1 pre-filled syringe containing the medicine
  • Do not hold the syringe by the plunger, otherwise it may become disassembled.
  • Do not use this medicine after the expiry date stated on the label or the carton after Exp. The expiry date refers to the last day of that month.
  • A puncture-resistant sharps and cutting waste container (e.g. a plastic bottle with a sufficiently wide opening) for safe disposal of the used syringe.
• Inspect the solution before use.
• You may notice one or more air bubbles in the pre-filled syringe. This is expected and there is no need to remove these bubbles.
• Do not use the syringe if:
  • it is broken or damaged, or
  • the needle cap has been removed or is not securely attached, or
  • leakage of liquid is visible, or
  • the solution appears abnormal (contains particles or is not colourless). If any of these conditions occur, safely discard the syringe in the puncture-resistant container and use a new one.

2. Preparation of the injection site

• Select the injection site, preferably on the thigh. The injection site should be rotated with each injection to prevent damage to the subcutaneous tissue.

• Do not administer the injection in an area that is tender, damaged, or bruised. Always select an intact skin area for administration of the medicine.
• Do not inject through clothing.
• Administer Ganirelix Gedeon Richter and follicle-stimulating hormone (FSH) at approximately the same time. However, these medicines must not be mixed together and must be injected at different injection sites.
• Clean the selected injection site with a disinfectant (e.g., alcohol) to remove any bacteria present on the surface. Wipe an area of approximately 5 cm in diameter around the point where the needle will enter and allow the disinfectant to dry for about 1 minute before proceeding.
• Do not touch the injection site again or blow on it before the injection.

3. Medication Injection

• Ganirelix Gedeon Richter is supplied in pre-filled syringes with an integrated needle, ready for administration without further adjustments to the syringe.
• Holding the central part of the syringe body, remove 1 syringe from the packaging.
• To inject the medication, remove the needle cap from the syringe held horizontally and not directed toward the person. Do not twist the cap but pull it straight off.

• When handling the syringe, do not touch the tip of the syringe or the needle with your fingers to avoid any contamination.
• At the chosen and disinfected injection site, grasp a skin fold between the index finger and thumb.

• Administer Ganirelix Gedeon Richter by subcutaneous injection, i.e., into the fatty layer just beneath the skin.
• Hold the syringe with the other hand so that you can place your thumb on the plunger when needed. Insert the needle completely, with a quick and firm motion, into the center of the pinched skin at a 45° angle to the skin surface.

• Gently pull back the plunger to check whether the needle is correctly positioned.
• If blood appears in the syringe, this means the tip of the needle has entered a blood vessel. If this occurs, do not inject Ganirelix Gedeon Richter; instead, remove the syringe, cover the injection site with a disinfectant swab, and apply pressure; bleeding should stop within one or two minutes.
• Do not use this syringe; dispose of it properly and use a new syringe.
• Once the needle is correctly positioned, slowly and steadily push the plunger down with your thumb to ensure proper injection of the solution and to avoid damaging the skin tissue.
• Push the plunger down until the syringe is completely empty.

4. After the injection

• Wait 5 seconds (count slowly to 5), then release the skin that was being pinched.
• Remove the syringe quickly from the skin and apply pressure to the injection site with a swab containing disinfectant.

• Do not rub the skin after the injection.
• Use each pre-filled syringe only once.
• Do not re-cap the needle to avoid needle-stick injuries.
• Immediately and safely dispose of the used syringe into a puncture-resistant container and return it to the pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines you no longer use.