Ovamex

Package leaflet: Information for the user

Ovamex
0.25 mg/0.5 ml, solution for injection in prefilled syringe
Ganirelix
Please read all of this leaflet carefully before use, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Ovamex is and what it is used for

Ovamex contains the active substance ganirelix and belongs to a group of medicines called “antagonistic gonadotrophin-releasing hormone (GnRH) antagonists”. GnRH is a naturally occurring hormone that regulates the release of gonadotrophins [luteinising hormone (LH) and recombinant human follicle-stimulating hormone (FSH)]. Gonadotrophins 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 oocytes (eggs). LH is necessary for the release of mature oocytes from the follicles and ovaries (i.e. ovulation). Ovamex inhibits the action of GnRH, thereby suppressing the release of hormones, particularly LH.

Ovamex is used
In women undergoing assisted reproductive technologies, including in vitro fertilisation (IVF) and related techniques, spontaneous ovulation may occasionally occur too early, significantly reducing the chances of successful pregnancy. Ovamex is used to prevent a premature rise in LH levels, which could trigger premature release of oocytes.

In clinical studies, ganirelix has been 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 Ovamex

When not to use Ovamex

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

Warnings and precautions
Before starting treatment with Ovamex, discuss this with your doctor, pharmacist, or nurse.

• if the patient has an active allergic condition, inform the doctor. The doctor will decide, depending on the severity of the condition, whether additional monitoring is required during treatment. Cases of allergic reactions have been reported after administration of the first dose;
• 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 Ovamex immediately and seek urgent medical help;
• ovarian hyperstimulation syndrome (OHSS) may occur during or after hormonal stimulation of the ovaries. This syndrome is associated with gonadotropin stimulation procedures. Please refer to the patient leaflet included with the prescribed gonadotropin-containing medications;
• the frequency of congenital abnormalities following assisted reproductive techniques may be slightly higher than after natural conception. This is likely related to underlying patient characteristics (e.g. maternal age, semen parameters) and the higher incidence of multiple pregnancies following assisted reproductive techniques. The frequency of congenital abnormalities following assisted reproductive techniques using Ovamex does not differ from that observed with other GnRH analogues used in assisted reproductive techniques;
• women with damaged fallopian tubes have a slightly increased risk of ectopic pregnancy;
• The efficacy and safety of Ovamex 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
Ovamex must not be used in children and adolescents.
Other medicines and Ovamex
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Ovamex is to be used during controlled ovarian stimulation as part of assisted reproductive technology (ART).
Do not use Ovamex during pregnancy or breastfeeding.
Driving and operating machinery
The effect of Ovamex on the ability to drive and operate machinery has not been studied.
Ovamex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. it is considered "sodium-free".

3. How to use Ovamex

This medicine is used as part of assisted reproductive technology (ART) programmes, including
in vitro fertilisation (IVF).
The injections will be self-administered by the patient, so the doctor will explain what needs to be
done. This medicine should always be used exactly as directed by the doctor or pharmacist. If the
patient does not understand the instructions, she should consult her doctor or pharmacist.

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

Stage 2
The contents of the Ovamex pre-filled pen (0.25 mg) should be injected subcutaneously once daily,
starting on day 5 or 6 of stimulation. Depending on the ovarian response, the doctor may decide
to start treatment on a different day.

Ovamex and FSH should be administered at approximately the same time each day. However,
the medicines should not be mixed and the injections must be given at different sites.
Daily administration of Ovamex should be continued until the follicles have reached appropriate
size.

Stage 3
Final maturation of oocytes within the follicles can be triggered by administration of human
chorionic gonadotropin (hCG). The interval between two Ovamex injections, as well as the time
between the last Ovamex injection and the hCG injection, should not exceed 30 hours, because
otherwise premature ovulation (i.e. release of oocytes) may occur. Therefore, if Ovamex was injected in the morning, Ovamex should also be administered on the day when hCG is given to trigger ovulation.
If Ovamex was injected in the afternoon, the last Ovamex injection should be given in the
afternoon prior to the day of ovulation trigger.

Instructions for use

• Injection site
  Ovamex is supplied in pre-filled syringes containing a single dose. The solution should be injected slowly and directly under the skin, preferably in the thigh. Check the solution before use. Do not use if the solution contains particles or is not clear. Small air bubbles may be visible in the pre-filled syringe. This is normal, and there is no need to remove the air bubble(s). When performing the injection yourself or when your partner administers the injection, carefully follow the instructions below. Do not mix Ovamex medicinal product with other medicines.

• Preparing the injection site
  Wash hands thoroughly with soap and water. Clean the injection site with a disinfectant (e.g. alcohol) to remove bacteria from the skin surface. Wipe an area of about 5 cm (two inches) around the injection site and allow the disinfectant to dry for at least one minute before injecting.

• Inserting the needle
  Remove the needle cap. Gently pinch a clean area of skin to create a skin fold. Insert the needle at the base of the skin fold at a 45° angle to the skin surface.

Always rotate injection sites.

• Checking correct needle placement
  Gently pull back on the syringe plunger to check whether the needle is correctly positioned. If blood enters the syringe, this means the needle tip has punctured a blood vessel. In this case, do not continue injecting Ovamex. Remove the syringe, cover the injection site with a disinfectant-soaked swab and apply pressure; bleeding should stop within about one minute. Do not reuse the same syringe; dispose of it properly. Try again using a new syringe.

• Injecting the solution
  Once the needle is correctly placed, press the syringe plunger slowly and evenly to inject the solution properly without damaging skin tissue.

• Removing the syringe
  Quickly withdraw the syringe. Cover the injection site with a disinfectant-soaked swab. Use the pre-filled syringe only once.

Use of more than the recommended dose of Ovamex
Contact your doctor immediately.

Missed dose of Ovamex
If the patient remembers a missed dose, she should take it as soon as possible.
Do not use a double dose to make up for a missed dose.
If the delay exceeds 6 hours (so that the interval between two injections exceeds 30 hours), the dose should be administered as soon as possible and the patient should contact her doctor for advice.

Stopping use of Ovamex
Do not stop using Ovamex unless instructed by the doctor, as this may affect treatment outcomes.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

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

• 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 patients)

• headache
• nausea
• malaise.

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

• Allergic reactions have been observed after the first dose.
• 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.

Additionally, adverse reactions have been reported which are known to occur during controlled ovarian hyperstimulation, such as:

• abdominal pain;
• ovarian hyperstimulation syndrome (OHSS). (OHSS occurs when the ovaries over-respond to fertility medications.)
• ectopic pregnancy (when the embryo develops outside the uterus)
• miscarriage (see the patient information leaflet of the FSH-containing medicine used).

In one patient, worsening of pre-existing rash (eczema) was observed after the first dose of ganirelix.

Reporting of adverse reactions

If any adverse reactions occur in patients, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store Ovamex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
No special precautions for storage conditions are required.
Inspect the ampoule-syringe before use. Only use ampoule-syringes containing a clear solution free from particles and with 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 help protect the environment.

6. Contents of the packaging and other information

What Ovamex 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: glacial acetic acid, mannitol, and water for injections. The appropriate pH (acidity measurement) has been adjusted using sodium hydroxide and glacial acetic acid.

What Ovamex looks like and contents of the pack
Ovamex is a clear, colourless aqueous solution for injection. The solution is ready for use
and intended for subcutaneous administration.
Ovamex is available in packs containing 1 or 5 pre-filled syringes with injection needles (27 G), as specified below:

• 1 pre-filled syringe
• 5 pre-filled syringes

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Theramex Ireland Limited
3 Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland
Manufacturer
GP-PHARM, S.A.
Polígono Industrial Els Vinyets-Els Fogars, Sector 2,
Carretera Comarcal C-244, Km 22,
08777 Sant Quintí de Mediona, Spain
This medicinal product is authorised in the European Economic Area member states under the following names:
Portugal:
Belgium:
Poland:
Greece:
Czech Republic:
Italy:
Information on this medicine is available by calling the telephone number: +48 22 307 71 66