Fyremadel

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Package leaflet: Information for the user

Fyremadel, 0.25 mg/0.5 ml, solution for injection in pre-filled pen
Ganirelix
Please read all of 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 further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to anyone else. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Fyremadel is and what it is used for

Fyremadel contains the active substance ganirelix and belongs to a group of medicines called "gonadotropin-releasing hormone (GnRH) antagonists". It acts as an antagonist to 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 ovarian follicles. Follicles contain the egg cells. LH is required for the release of mature egg cells from the follicles in the ovaries (ovulation). Fyremadel inhibits the action of GnRH, thereby suppressing the release of hormones, especially LH.

Use of Fyremadel
In women undergoing assisted reproductive technologies, including in vitro fertilization (IVF) and other methods, ovulation may sometimes occur too early, significantly reducing the chance of pregnancy. Fyremadel is used to prevent a premature rise in luteinizing hormone (LH) levels, which could cause premature release of the egg cell.
In clinical studies, ganirelix was used in combination with recombinant follicle-stimulating hormone (FSH) or with corifollitropin alfa, a long-acting ovarian follicle-stimulating agent.

2. Important information before using Fyremadel

When not to use Fyremadel

• if the patient is allergic to ganirelix or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to gonadotropin-releasing hormone (GnRH) or to GnRH analogues;
• if the patient has moderate or severe kidney or liver disease;
• if the patient is pregnant or breastfeeding.

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Warnings and precautions
Before starting treatment with Fyremadel, discuss the following with your doctor or pharmacist:

• if you have an active allergic condition, inform your doctor. Your doctor will decide, depending on the severity of the condition, whether additional monitoring is required during treatment. Allergic reactions have been reported after administration of the first dose of the medicine.
• both generalized and local allergic reactions have been reported, including urticaria, facial swelling, swelling of the lips, tongue and/or throat, which may cause difficulty in breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If an allergic reaction occurs, discontinue use of Fyremadel and seek immediate medical help.
• if you are allergic to latex. The needle cover contains dry natural rubber/latex which is in contact with the needle and may cause allergic reactions.
• ovarian hyperstimulation syndrome (OHSS) may occur during or after ovarian hormonal stimulation. This syndrome is associated with gonadotropin stimulation procedures. Further information is provided in the package leaflet of the gonadotropin product.
• following assisted reproductive techniques (ART), the frequency of congenital abnormalities may be slightly higher than after natural conception. This is likely related to other patient factors (e.g. maternal age, semen parameters) and multiple pregnancies. The frequency of congenital abnormalities following ART using Fyremadel does not differ from that observed with the use of GnRH analogues.
• women with damaged fallopian tubes have a slightly increased risk of ectopic pregnancy.
• the efficacy and safety of Fyremadel have not been established in women with body weight below 50 kg or above 90 kg. For further information, consult your doctor.

Children and adolescents
Fyremadel is not indicated for use in children and adolescents.
Other medicines and Fyremadel
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy, breastfeeding and fertility
Fyremadel should be used during controlled ovarian hyperstimulation in assisted reproductive technology (ART) programmes. Do not use Fyremadel during pregnancy or breastfeeding.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Driving and using machines
No studies on the effects of Fyremadel on the ability to drive and use machines have been conducted.
Fyremadel contains sodium
Fyremadel contains less than 1 mmol of sodium (23 mg) per injection, meaning the medicine is considered "sodium-free".

3. How to use Fyremadel

Fyremadel is used as part of fertility treatment programmes, including in vitro fertilisation (IVF).
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Your doctor will explain how to administer the injection, as you will be performing it yourself.
Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
please consult your doctor or pharmacist.

Stage 1
Ovarian stimulation with follitropin (FSH) or corifollitropin alfa may begin on day 2 or 3 of menstrual
bleeding.

Stage 2
Fyremadel (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or 6 of
stimulation. Based on the ovarian response to treatment, your doctor may decide to start
administration on a different day.
Fyremadel and FSH should be administered at approximately the same time. However, the
medicines must not be mixed, and injections should be given at different sites.
Daily administration of Fyremadel should continue until there are sufficient numbers of follicles of
appropriate size.

Stage 3
Final maturation of oocytes within the follicles can be triggered by administering human chorionic
gonadotropin (hCG). The interval between two Fyremadel injections, as well as the interval between
the last Fyremadel injection and the hCG injection, should not exceed 30 hours, as premature
ovulation (i.e. oocyte release) may otherwise occur. Therefore, if Fyremadel is injected in the
morning, administration should continue throughout gonadotropin treatment, including on the day
of ovulation trigger. If Fyremadel is injected in the afternoon, the last dose of Fyremadel should be
administered in the afternoon of the day before the ovulation trigger.

Instructions for use
Injection site
Fyremadel is supplied in pre-filled syringes containing a single dose. The contents should be injected
slowly and subcutaneously, preferably into the thigh. Inspect the solution before use. Do not use
the medicine if the solution contains particles or is not clear. If the injection is to be self-administered
by the patient or her partner, the instructions below must be strictly followed. Fyremadel must not be
mixed with other medicines.

Preparing the injection site
Wash hands thoroughly with soap and water. Cleanse the injection site with a disinfectant (e.g.
alcohol) to remove bacteria from the skin surface. Clean the skin in an area approximately 5 cm
around the site where the needle will be inserted, and wait at least one minute for the disinfectant to
dry.
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Inserting the needle
Remove the needle cap. With fingers, grasp a large fold of skin. Insert the needle at a 45-degree
angle to the skin surface. Always rotate injection sites.

Checking correct needle placement
Gently pull back the syringe plunger to check whether the needle has been correctly placed. If any
blood enters the syringe, this indicates that the needle is inside a blood vessel. If this occurs, do not
inject Fyremadel. Remove the syringe and needle, cover the injection site with a disinfectant-soaked
swab and apply pressure; bleeding will stop after about one minute. Do not reuse this syringe and
dispose of it properly. Try again using a new syringe.

Injecting the solution
If the needle is correctly placed, slowly and evenly press the syringe plunger to inject the solution
properly without damaging surrounding tissues.

Removing the syringe
Quickly withdraw the syringe and press a disinfectant-soaked swab firmly against the injection site.
The pre-filled syringe is for single use only.

Precautions for using the pre-filled syringe
This medicine is contained in a syringe with a fine needle. When removing the pre-filled syringe
from its packaging, hold it in the middle of the glass barrel to avoid bending or damaging the needle.
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Do not use the cartridge-syringe if the needle appears bent or abnormal: Carefully inspect the syringe and needle before use. If the needle seems bent or damaged, do not use the syringe. Contact your doctor or pharmacist.
Do not remove the needle cover and reattach it to the needle: After removing the needle cover, do not attempt to reattach it to the needle. This may potentially damage or bend the needle, leading to incorrect administration or injury.
Ensure the needle bevel is facing upward (not downward): When administering the injection, ensure the needle bevel is facing upward to avoid pain or needle bending. This positioning ensures smooth insertion and a safe injection process.

Use of a higher than recommended dose of Fyremadel
Contact a doctor.

Missed dose of Fyremadel
If the patient forgets to take a dose, she should take it as soon as possible.
Do not use a double dose to make up for a missed dose.
If more than 6 hours have passed since the correct time for administering the missed dose (so that the interval between two injections exceeds 30 hours), the dose should be taken as soon as possible and the patient should contact her doctor.

Stopping treatment with Fyremadel
Unless otherwise advised by the doctor, do not stop using Fyremadel, as this may affect the treatment outcome.

If you have any further questions regarding the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

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 resolve within 4 hours after administration.

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Not common (may affect no more than 1 in 100 women)

• Headache
• Nausea
• General malaise

Very rare (may affect no more than 1 in 10,000 women)

• Allergic reactions observed after administration of the first dose of the medicine
• Rash
• Facial swelling
• Breathing difficulties (dyspnoea)
• Swelling of the face, lips, tongue, and (or) throat, which may cause difficulty in breathing and (or) swallowing (angioedema and (or) anaphylaxis)
• Urticaria

Adverse reactions associated with controlled ovarian hyperstimulation treatment have also been reported, for example:

• Abdominal pain
• Ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when the ovaries over-respond to infertility therapy)
• Ectopic pregnancy (when the embryo develops outside the uterus)
• Miscarriage (please refer to the patient information leaflet included in the FSH medicine package)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fyremadel

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Inspect the prefilled syringe before use. Only use prefilled syringes that contain a clear solution free from solid particles and that come in undamaged packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Fyremadel contains

• The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg
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  of ganirelix (as acetate) in 0.5 ml of aqueous solution.

• The other components are: acetic acid, glacial, mannitol and water for injections. The appropriate pH (measure of acidity) has been adjusted with sodium hydroxide and glacial acetic acid.

What Fyremadel looks like and contents of the pack
Fyremadel is a clear, colourless aqueous solution for injection. The solution is ready
for use and administered subcutaneously. The needle cover contains dry natural rubber/latex which is in contact with the needle.
Fyremadel is available in packs containing 1 or 5 pre-filled syringes with injection needles (27G).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer/importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

For questions and to obtain information
Ferring Pharmaceuticals Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
Poland

This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Austria: Ganirelix Astro 0.25 mg/0.5 ml Injektionslösung in einer Fertigspritze
Belgium: Fyremadel, 0.25 mg/0.5 ml oplossing voor injectie in een voorgevulde spuit
Fyremadel 0.25 mg/0.5 mL, solution injectable en seringue pré-remplie
Fyremadel 0.25 mg/0.5 ml Injektionslösung in einer Fertigspritze
Czech Republic: Fyremadel 0.25 mg/0.5 ml injekční roztok v předplněné injekční stříkačce
Denmark: Fyremadel 0.25 mg/0.5 ml injektionsvæske, opløsning, i fyldt injektionssprøjte
Finland: Fyremadel 0.25 mg/0.5 ml injektioneste, liuos, esitäytetty ruisku
France: Fyremadel 0.25 mg/0.5 ml solution injectable en seringue pré-remplie
Greece: Fyremadel 0.25 mg/0.5 ml ενέσιμο διάλυμα σε προγεμισμένη σύριγγα
Germany: Fyremadel 0.25 mg/0.5 ml Injektionslösung in einer Fertigspritze
Italy: Fyremadel 0.25 mg/0.5 ml soluzione iniettabile in siringa preriempita
Poland: Fyremadel 0.25 mg/0.5 ml roztwór do wstrzykiwań w ampułko-strzykawce
Portugal: Fyremadel 0.25 mg/0.5 ml solução injetável em seringa pré-cheia
The Netherlands: Fyremadel 0.25 mg/0.5 ml oplossing voor injectie in voorgevulde spuit
Norway: Fyremadel 0.25 mg/0.5 ml injeksjonsvæske, oppløsning, i ferdigfylt sprøyte
Spain: Fyremadel 0.25 mg/0.5 ml solución inyectable en jeringa precargada EFG
Slovakia: Fyremadel 0.25 mg/0.5 ml injekčný roztok v naplnenej injekčnej striekačke
Sweden: Fyremadel 0.25 mg/0.5 ml injektionsvätska, lösning, förfylld spruta
United Kingdom: Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe