Firemadel

Package Leaflet: Information for the User

Fyremadel, 0.25 mg/0.5 ml, solution for injection in a pre-filled syringe
Ganirelix

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Fyremadel and what is it used for
• 2. Important information 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 is Fyremadel and what is it used for

Fyremadel contains the active substance ganirelix and belongs to a group of medicines called "gonadotropin-releasing hormone antagonists". It works by blocking the action of the natural hormone 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. The follicles contain egg cells. LH is necessary for the release of mature egg cells from the follicles in the ovaries (ovulation). Fyremadel inhibits the action of GnRH, which leads to the inhibition of hormone release, mainly LH.

Use of Fyremadel

In women participating in assisted reproduction programs, including in vitro fertilization (IVF) and other methods, ovulation may sometimes occur too early, which significantly reduces the chances of pregnancy. Fyremadel is used to prevent premature increase in luteinizing hormone (LH) levels, which can cause too early release of the egg cell.

In clinical trials, ganirelix was used with recombinant follicle-stimulating hormone (FSH) or follitropin alpha, a long-acting ovarian stimulant.

2. Important information before using Fyremadel

When not to use Fyremadel

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

Warnings and precautions

Before starting treatment with Fyremadel, discuss with your doctor or pharmacist:

• if you have an active allergic condition, inform your doctor. The doctor will decide, depending on the severity of this condition, whether additional monitoring is necessary during treatment. Allergic reactions have been reported after the first dose of the medicine.
• both generalized and localized allergic reactions, including hives, facial swelling, lip swelling, tongue swelling, and/or throat swelling, which can cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If an allergic reaction occurs, discontinue use of Fyremadel and seek medical attention immediately.
• if you are allergic to latex. The needle shield contains dry, natural rubber/latex, which comes into contact with the needle and may cause allergic reactions.
• during or after hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome (OHSS) may occur. This syndrome is associated with gonadotropin stimulation procedures. More information can be found in the package leaflet for the gonadotropin product.
• after assisted reproduction techniques (ART), the frequency of congenital malformations may be slightly higher than after natural conception. This is likely related to other characteristics of the patients (e.g., the woman's age, semen parameters) and multiple pregnancy. The frequency of congenital malformations after assisted reproduction techniques using Fyremadel does not differ from that after using 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 a body weight less than 50 kg or more than 90 kg. For further information, consult your doctor.

Children and adolescents

Use of Fyremadel in children and adolescents is not recommended.

Fyremadel and other medicines

Tell your doctor or pharmacist about all medicines you are 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 reproduction programs (ART). Do not use Fyremadel during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effects of Fyremadel on the ability to drive and use machines.

Fyremadel contains sodium

Fyremadel contains less than 1 mmol of sodium (23 mg) per injection, which means the medicine is considered "sodium-free".

3. How to use Fyremadel

Fyremadel is used as part of the treatment in assisted reproduction programs, including in vitro fertilization.

Your doctor will explain how to perform the injection, as you will be doing it yourself.

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Step 1

Ovarian stimulation with follicle-stimulating hormone (FSH) or follitropin alpha may start on the 2nd or 3rd day of menstrual bleeding.

Step 2

Fyremadel (0.25 mg) should be injected subcutaneously once a day, starting on the 5th or 6th day of stimulation. Based on the response to treatment from the ovaries, your doctor may decide to start administration of the medicine on a different day.

Fyremadel and FSH should be administered at approximately the same time. However, the products should not be mixed, and injections should be performed at different sites.

Continue daily administration of Fyremadel until the day when a sufficient number of follicles of adequate size are present.

Step 3

Final maturation of the egg cells in the follicles can be triggered by administration of human chorionic gonadotropin (hCG). The time between two injections of Fyremadel, as well as the time between the last injection of Fyremadel and the injection of hCG, should not exceed 30 hours, as premature ovulation (i.e., release of the egg cell) may occur. Therefore, if Fyremadel is injected in the morning, administration of the medicine should be continued throughout the treatment with gonadotropins, including the day of ovulation triggering. If Fyremadel is injected in the afternoon, the last dose of Fyremadel should be administered in the afternoon on the day before the day of ovulation triggering.

Instructions for use

Injection site

Fyremadel is supplied in pre-filled syringes containing one dose. The contents should be injected slowly, subcutaneously, preferably into the thigh. Inspect the solution before administration. Do not use the medicine if the solution contains particles or is not clear. If injections are performed by yourself or your partner, follow the instructions below carefully. Do not mix Fyremadel with other medicines.

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 skin surface. Clean the skin over an area of about 5 cm around the injection site and wait at least one minute for the disinfectant to dry.

Inserting the needle

Remove the needle shield. Hold the skin fold between your fingers. Insert the needle at an angle of 45 degrees to the skin surface. Change the injection site each time.

Checking the correct position of the needle

Gently pull back the plunger to check if the needle is inserted correctly. If any blood is drawn into the syringe, it means the needle is in a blood vessel. If this happens, do not inject Fyremadel. Withdraw the syringe with the needle, cover the injection site with a swab soaked in a disinfectant, and press; the site will stop bleeding after about one minute. Do not use this syringe again and dispose of it properly. Try again with a new syringe.

Injecting the solution

If the needle is inserted correctly, push the plunger slowly and evenly to inject the solution properly without damaging the surrounding tissue.

Removing the syringe

Withdraw the syringe quickly and press the injection site with a swab soaked in a disinfectant.

The pre-filled syringe is for single use only.

Using more Fyremadel than recommended

Contact your doctor.

Missing a dose of Fyremadel

If you forget to take a dose, take it as soon as possible.

Do not take a double dose to make up for a missed dose.

If more than 6 hours have passed since the scheduled time of the missed dose (so that the time between two injections is longer than 30 hours), take the dose as soon as possible and contact your doctor.

Stopping use of Fyremadel

Unless your doctor tells you to, do not stop using Fyremadel, as this may affect the outcome of the treatment.

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

4. Possible side effects

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

Very common (may affect more than 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• -headache
• nausea
• general malaise

Rare (may affect up to 1 in 10,000 people)

• allergic reactions reported after the first dose of the medicine
• rash
• facial swelling
• difficulty breathing (dyspnea)
• facial swelling, lip swelling, tongue swelling, and/or throat swelling, which can cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• hives

Other side effects associated with controlled ovarian hyperstimulation treatment have also been reported, such as:

• abdominal pain
• ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when the ovaries overreact to fertility treatment)
• ectopic pregnancy (when the embryo develops outside the uterus)
• miscarriage (refer to the package leaflet for the FSH medicine)

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fyremadel

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 "Expiry date (EXP)". The expiry date refers to the last day of the month.

No special precautions for storage are necessary.

Inspect the pre-filled syringe before use. Only use pre-filled syringes containing a clear solution without particles, from an undamaged pack.

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

What Fyremadel contains

• The active substance is ganirelix. Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml of aqueous solution.
• The other ingredients are: acetic acid, mannitol, and water for injections. The pH (a measure of acidity) is adjusted with sodium hydroxide and acetic acid.

What Fyremadel looks like and contents of the pack

Fyremadel is a clear, colorless aqueous solution for injection. The solution is ready for use and is administered subcutaneously. The needle shield contains dry, natural rubber/latex, which comes into contact with the needle.

Fyremadel is available in packs containing 1 or 5 pre-filled syringes with needles for injection (27G).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For further information and inquiries

Ferring Pharmaceuticals Poland Sp. z o. o.

ul. Szamocka 8

01-748 Warsaw

This medicinal product is authorized 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

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

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

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

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

Date of last revision of the package leaflet: