Package Insert: Information for the User

Astarté 0.25 mg/ 0.5 ml Injectable Solution in Preloaded 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 read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Astarté contains the active ingredient ganirelix and belongs 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). This medication inhibits the action of GnRH, which causes the suppression of the release especially of LH.

What is ganirelix used for

In women undergoing assisted reproduction 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. This medication is used to prevent the premature release of LH, which can cause premature ovulation.

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

Do not use Astarté

• if you are allergic to ganirelix or any of the other ingredients 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 use this medication

• 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, lip, 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 this medication and seek medical assistance immediately.
• during or after hormonal stimulation of the ovaries, 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 (birth defects) 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., the woman's age, semen characteristics) and the higher incidence of multiple pregnancies (pregnancy with more than one baby at a time) recorded after the use of assisted reproduction techniques. The incidence of birth defects after the use of this medication in assisted reproduction techniques is 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 of this medication have not been established in women weighing less than 50 kg or more than 90 kg. Consult your doctor for more information.

Children and adolescents

This medication is not suitable for use in children or adolescents

Other medications and Astarté

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

Pregnancy, lactation, and fertility

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

This medication should be used during controlled ovarian stimulation for assisted reproduction techniques (ART).

Do not use this medication during pregnancy and lactation.

Driving and operating machines

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

This medication contains sodium

This medication contains less than 1mmol of sodium (23 mg) per injection; this is essentially "sodium-free".

This medicationis used as part of the treatment in assisted reproduction 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 syringe ofthis medication(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 another day.

This medicationand FSH must be administered approximately at the same time. However, these medications should not be mixed and should be injected in different places.

Daily treatment withthis medicationmust continue until there are sufficient 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 ofthis medicationand between the last injection ofthis medicationand the hCG injection should not exceed 30 hours, otherwise, premature ovulation (i.e., release of the oocytes) may occur. Therefore,if the injection ofthis medicationis in the morning, treatment withthis medicationmust be maintained throughout the treatment period with gonadotropin, including the day when ovulation is induced.If the injection ofthis medicationis in the afternoon, the last injection ofthis medicationmust be administered in the evening before the day when ovulation is induced.

Instructions for use

• Injection site

This medicationis presented in pre-filled syringes containing a dose. The contents of the syringe must 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. You may notice air bubbles in the pre-filled syringe. This is expected to happen and is not necessary to remove the air bubbles. If you administer the injections yourself or your partner, follow the instructions below carefully. Do not mix this medication with other medications.

• Preparation of the injection site

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

• Insertion of the needle
• Take 1 syringe from the package by its body. Do not take the syringe by the plunger.

1. Hold the syringe in positionverticallyand remove the needle cap without pressing or rotating the syringe.
2. Pinch a large area of skin between your index and middle fingers.
3. 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.

In each injection, the injection site must be varied.

• Verification of the correct position of the needle

Withdraw the plunger gently to check if the needle is in the correct position.

If blood enters the syringe, it means that the tip of the needle has penetrated a blood vessel. If this occurs, do not inject this medication. 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 in the correct position, press the plunger slowly and constantly to inject the solution correctly and not to damage the skin tissues.

• Removal of the syringe

Remove the syringe quickly.

Press the injection site with a disinfectant pad. Use the pre-filled syringe only once.

If you use more Astarté than you should

Consult your doctor.

If you forgot to use Astarté

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 andconsult your doctor for advice.

If you interrupt treatment with Astarté

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

If you have any other questions about the use of thismedication, ask your doctor,pharmacistor nurse.

Like all medications, this medication may produce adverse effects, although not all people may 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). The local reaction usually disappears within 4 hours after administration.

Uncommon (may affect up to 1 in 100 women)

• Headache
• Nausea (feeling sick)
• Discomfort (general feeling of being unwell, feeling unwell)

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

• Allergic reactions have been observed, even after the first dose
• 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 of ganirelix, 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 theSpanish System for Pharmacovigilance of Medications for Human Use: www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label and the boxafter 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 container is not damaged.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacisthow to dispose ofthecontainers and themedications you no longerneed.By doing so, you will help protect the environment.

Composition of Astarté

• The active principle is ganirelix. Each preloaded syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml of aqueous solution.
• The other components are glacial acetic acid, mannitol, 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 packaging

This medication is a transparent and colorless injectable aqueous solution. The solution is ready to use, administered subcutaneously.

This medication is presented in packaging of 1 or 5 preloaded syringes with injection needles (27 G), as specified below:

• 1 preloaded syringe
• 5 preloaded syringes

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

GP-Pharm, S.A.

Pol. Ind. Els Vinyets – Els Fogars Sector 2

Carretera comarcal 244, km22

08777 Sant Quintí de Mediona, Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Portugal: Astarté

Spain: Astarté 0.25 mg/ 0.5 ml injectable solution in preloaded syringe EFG

Last review date of this prospectus: 08/2023

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