Fyremadel

Package leaflet: Information for the user

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

ganirelix
Generic medicine
Please read all of this leaflet carefully before you use 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this 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 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 egg cells. LH is required to release
mature egg cells from the follicles and ovaries (i.e., ovulation). Fyremadel inhibits the action of GnRH,
resulting in suppression of the release of LH, in particular.
Fyremadel is used
In women undergoing assisted reproductive techniques, including in vitro fertilization (IVF) and
other methods, ovulation may occasionally occur too early, causing a significant reduction in the
chances of becoming pregnant. Fyremadel is used to prevent the premature release of LH, which
could otherwise trigger premature release of egg cells.
In clinical studies, Fyremadel has been used in combination with recombinant follicle-stimulating
hormone (FSH) or corifollitropin alfa, a long-acting follicle-stimulating agent.

2. What you should know before using Fyremadel

Do not use Fyremadel

• 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 or pharmacist before using Fyremadel

• if you currently have an allergic condition, inform your doctor. The doctor will decide, depending on the severity, whether additional monitoring during treatment is necessary. Allergic reactions have been reported, even after the first dose.
• ovarian hyperstimulation syndrome (OHSS) may occur during or following hormonal ovarian stimulation. This syndrome is related to the gonadotropin stimulation procedure. Please read the package leaflet of the gonadotropin-containing medicine prescribed to you.
• 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 (e.g. maternal age, sperm characteristics) and the higher rate of multiple pregnancies associated with assisted reproductive techniques. The incidence of congenital malformations following assisted reproductive techniques using Fyremadel is not different from that observed with other GnRH analogues used in assisted reproductive techniques.
• there is a slightly increased risk of ectopic pregnancy in women with tubal damage.
• the efficacy and safety of Fyremadel have not been established in women weighing less than 50 kg or more than 90 kg. Consult your doctor for further information.
  For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
Fyremadel should not be used in children or adolescents.
Other medicines and Fyremadel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Fyremadel is intended for use during controlled ovarian stimulation in assisted reproductive techniques (ART). Do not use Fyremadel during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No studies on the ability to drive vehicles or use machines have been conducted.
Fyremadel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per injection, i.e. essentially ‘sodium-free’.

3. How to use Fyremadel

Fyremadel is used as part of treatment for assisted reproductive techniques (ART),
including in vitro fertilization (IVF).
You will need to administer the injections yourself; therefore, your doctor will explain what you need to do. Always use this
medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Phase 1
Ovarian stimulation with follicle-stimulating hormone (FSH) or corifollitropin may begin on day 2 or 3 of the cycle.
Phase 2
The contents of the Fyremadel syringe (0.25 mg) must be injected just under 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.
Fyremadel and FSH should be administered at approximately the same time. However, the preparations must not be mixed, and the injections must be given at different sites.
Daily treatment with Fyremadel must continue until a sufficient number of follicles of adequate size are present.
Phase 3
Final maturation of the oocytes within the follicles can be induced by administration of
human chorionic gonadotropin (hCG). The time interval between two Fyremadel injections, and between
the last Fyremadel injection and the hCG injection, must not exceed 30 hours; otherwise, premature ovulation (i.e., release of oocytes) may occur. Therefore, if Fyremadel is administered in the morning, you must administer Fyremadel on the day you receive hCG treatment for ovulation induction. If Fyremadel is administered in the afternoon, the last Fyremadel injection must be given the afternoon before the day of ovulation induction.
Instructions for use
Injection site
Fyremadel is supplied in pre-filled syringes containing a single dose. The contents 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. If you are administering the injections yourself or if your partner is doing so, carefully follow the instructions below. Do not mix Fyremadel 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 spot 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 the base of the pinched skin between the two fingers, at a 45° angle to the skin surface. The injection site should be rotated with each administration.

Checking correct needle placement
Gently pull back the plunger of the syringe 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 Fyremadel. Remove the syringe, cover the injection site with a disinfectant-soaked swab, and apply pressure; the bleeding will stop within one or two minutes. Do not reuse the syringe—discard it properly. 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.
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 Fyremadel than you should
Contact your doctor.
If you forget to use Fyremadel
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 a forgotten 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 injection as soon as possible and consult your doctor for further advice.
If you stop using Fyremadel
Do not stop treatment with Fyremadel unless advised by your doctor, as this may affect the outcome of treatment.
If you have any questions about the use of 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.
Common (may affect up to 1 in 10 people)

• 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 people)

• Headache
• Nausea
• Malaise (general feeling of being unwell).

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

• More widespread reactions of probable allergic nature, even after the first dose.

In addition, undesirable effects related to the treatment for controlled ovarian hyperstimulation have also been reported, for example:

• Abdominal pain
• Ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when your ovaries over-respond to the fertility medicines you are taking)
• Ectopic pregnancy (when the embryo develops outside the uterus)
• And miscarriage (see the package leaflet of the FSH-containing preparation you are being treated with).

In one case, after the first dose of Fyremadel, worsening of a pre-existing skin rash (eczema) was reported.
Reporting of side effects
If you experience any side effects, 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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, following "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Check the syringe before use. Only use syringes containing clear solutions free from particles and with intact packaging.
Do not dispose of any medicine 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 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 components are glacial acetic acid (E260), mannitol (E421), water for injections. The pH (measure of acidity) may be adjusted with sodium hydroxide and glacial acetic acid.

Description of the appearance of Fyremadel and contents of the pack
Fyremadel is a clear, colourless, aqueous injectable solution. The solution is ready for use and
intended for subcutaneous administration.
Fyremadel is available in packs of 1 or 5 pre-filled syringes with injection needles (27 G).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Legal Representative in Italy:
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1
20143 Milano

Selling Agent
FERRING S.p.A.
Via C. Imbonati 18
20159 Milano
Tel: +39 02 640 00 11

This medicinal product is authorised in the European Economic Area countries 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