Package Insert: Information for the User

Fyremadel0.25 mg/0.5 ml injectable solution in pre-filled syringe EFG

Ganirelix

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Fyremadelcontains the active ingredient ganirelix andbelongs to a group of medications called “gonadotropin-releasing hormone antagonists“that acts against the action of the endogenous 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. FSH is necessary in women for the growth and development of follicles in the ovaries. Follicles are small rounded vesicles that contain the oocytes. LH is necessary for the mature oocytes to be released from the follicles of the ovaries (i.e., ovulation).Fyremadelinhibits the action of GnRH, which causes the suppression of the release especially of LH.

How it is usedFyremadel

In women undergoing assisted reproductive techniques, such as in vitro fertilization (IVF) and other methods, premature ovulation may occasionally occur, which causes a significant reduction in the probability of becoming pregnant.Fyremadelis used to prevent the premature release of LH, which may cause premature ovulation.

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

Do not useFyremadel

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useFyremadel:

• If you have an active allergy, inform your doctor. Your doctor will decide, depending on the severity, if additional controls are needed during treatment. Cases of allergic reactions, even after the first dose, have been observed
• Allergic reactions, both general and local, have been reported, including hives (urticaria), facial swelling, lips, tongue, and/or throat swelling that may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If you have an allergic reaction, stop using Fyremadel and seek medical assistance immediately.
• Natural rubber latex allergy: the needle shield contains dried natural rubber latex, which may cause allergic reactions upon contact with the needle.
• During or after ovarian hormone stimulation, ovarian hyperstimulation syndrome may develop. This syndrome is related to the gonadotropin stimulation procedure. We recommend that you read the prospectus of the gonadotropin medication that you have been prescribed
• 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., age of the woman, semen characteristics) and the higher incidence of multiple pregnancies recorded after the use of assisted reproduction techniques withFyremadel. The incidence of congenital malformations after the use of assisted reproduction techniques withFyremadelis not different from the incidence with the use of other GnRH analogs in assisted reproduction techniques
• There is a slight increase in the risk of an ectopic pregnancy in women with damaged fallopian tubes
• The efficacy and safety ofFyremadelhave not been established in women weighing less than 50 kg or more than 90 kg. Consult your doctor for more information.

Children and adolescents

The use ofFyremadelis not appropriate in children or adolescents.

Use ofFyremadelwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Fyremadelshould be used during controlled ovarian stimulation for assisted reproduction techniques (ART). Do not useFyremadelduring pregnancy and breastfeeding.

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The effects on the ability to drive and operate machinery have not been studied.

Fyremadelcontains sodium

This medicationcontains less than 1 mmol of sodium (23 mg) per injection, which is essentially "sodium-free".

Fyremadelis used as part of the treatment in assisted reproductive techniques (ART), including in vitro fertilization (IVF).

You will administer the injections yourself, so your doctor must explain how to do it. Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Phase 1

Ovarian stimulation with follicle-stimulating hormone (FSH) or corifolitropin may start on the second or third day of your menstruation.

Phase 2

You must inject the contents of the Fyremadel syringe (0.25 mg) once a day 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.

Fyremadel and FSH should be administered approximately at the same time. However, these medications should not be mixed and should be injected in different locations.

Daily treatment with Fyremadel should continue until there are enough follicles of adequate size.

Phase 3

The final maturation of the oocytes in the follicles can be induced by administering human chorionic gonadotropin (hCG). The time elapsed between two injections of Fyremadel and between the last injection of Fyremadel and the hCG injection should not exceed 30 hours, otherwise, premature ovulation (i.e., release of the oocytes) may occur. Therefore, if the Fyremadel injection is in the morning, treatment with Fyremadel should be maintained throughout the gonadotropin treatment period, including the day when ovulation is induced. If the Fyremadel injection is in the afternoon, the last Fyremadel injection should be administered the evening before the day when ovulation is induced.

Instructions for use

Injection site

Fyremadel is presented in pre-filled syringes containing a dose. The contents of the syringe 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. If you administer the injections yourself or your partner, follow the instructions carefully that appear below. Do not mix Fyremadel with other medications.

Preparation of the injection site

Wash your hands thoroughly with water and soap. The injection site should be cleaned with a disinfectant (e.g. alcohol) to eliminate bacteria from the surface. Clean a 5 cm area around the point where you will puncture and let the disinfectant dry for at least one minute before injecting.

Insertion of the needle

Remove the needle cap. Pinch a large area of skin between your index and middle fingers. Insert the needle into the base of the area where you have pinched the skin at an angle of 45° with respect to the skin surface. The injection site should be varied for each injection.

Checking the correct position of the needle

Withdraw the plunger slowly to check if the needle is in the correct position. If blood enters the syringe, it means that the needle tip has penetrated a blood vessel. If this occurs, do not inject Fyremadel, but rather remove the syringe, cover the injection site with a disinfectant pad, 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.

Injection of the solution

Once the needle is correctly positioned, press the plunger slowly and constantly to inject the solution correctly and not to damage the skin tissues.

Extraction of the syringe

Withdraw the syringe quickly and press on the injection site with a disinfectant pad.

Use the pre-filled syringe only once.

If you use more Fyremadel than you should

Consult your doctor. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Fyremadel

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

Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Fyremadel

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

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very common (may affect up to 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
• Discomfort (general feeling of being unwell, feeling unwell).

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

• Severe allergic reactions have been observed, even after the first dose, including:
• Rash
• Facial swelling
• Difficulty breathing (dyspnea)
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)
• Hives (urticaria).

In addition, adverse effects related to controlled ovarian hyperstimulation have been observed, for example:

• Abdominal pain,
• Ovarian hyperstimulation syndrome (OHSS),(OHSS occurs when the ovaries react excessively to fertility medications being taken)
• Ectopic pregnancy (when the embryo develops outside the uterus)
• Abortion (see the prospectus of the FSH medication being used).

After the first dose ofFyremadel, the worsening of an existing eczema has been reported in a patient.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after ‘CAD’. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.in case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofFyremadel

• The active principle is ganirelix. Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml of aqueous solution.
• The other components are glacial acetic acid (E260), mannitol (E421) and water for injection preparations. The pH (acidity measurement) may have been adjusted with sodium hydroxide and glacial acetic acid.

Appearance of the product and contents of the pack

Fyremadelis a transparent and colourless injectable aqueous solution. The solution is ready for use, administered subcutaneously.The needle guard contains dry natural rubber/latex, which is in contact with the needle.

Fyremadelis presented in packs of 1 or 5 pre-filled syringes with injection needles (27 G).

Only some pack sizes may be marketed.

Holder of the marketing authorisation and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

FERRING S.A.U.

C/Arquitecto Sánchez Arcas nº 3 1º28040,Madrid-Spain

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Austria:Fyremadel0.25mg/0.5ml Injektionslösung in einer Fertigspritze

Denmark:Fyremadel0.25mg/0.5ml injektionsvæske, opløsning ifyldt injektionssprøjte

Spain:Fyremadel0.25 mg/0.5 ml solución inyectable en jeringa precargada EFG

Finland:Fyremadel0.25mg/0.5ml injektioneste, liuos esitäytetty ruisku

France:Fyremadel0.25mg/0.5ml solution injectable en seringue pré-remplie

Germany:Fyremadel0.25mg/0.5ml Injektionslösung in einer Fertigspritze

Italy:Fyremadel0.25mg/0.5ml soluzione iniettabile in siringa preriempita

Netherlands:Fyremadel0.25mg/0.5ml oplossing voor injectie in voorgevulde spuit

Norway:Fyremadel0.25mg/0.5ml injeksjonsvæske, oppløsning, i ferdigfylt sprøyte

Sweden:Fyremadel0.25mg/0.5ml injektionsvätska, lösning, förfylld spruta

United Kingdom:Fyremadel0.25mg/0.5ml solution for injection in pre-filled syringe

Last date of revision of this leaflet:April 2020

The detailed and updated information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.