CETROTIDE 0.25 mg POWDER AND SOLVENT FOR INJECTION

Introduction

Package Leaflet: Information for the User

Cetrotide 0.25mg powder and solvent for solution for injection

cetrorelix

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Cetrotide is and what it is used for
2. What you need to know before you use Cetrotide
3. How to use Cetrotide
4. Possible side effects
5. Storage of Cetrotide
6. Contents of the pack and other information

How to mix and inject Cetrotide

1. What Cetrotide is and what it is used for

What Cetrotide is

Cetrotide contains a substance called “cetrorelix”. This substance prevents your body from releasing an egg from the ovary (ovulation) during your menstrual cycle. Cetrotide belongs to a group of medicines known as “gonadotropin-releasing hormone antagonists”.

What Cetrotide is used for

Cetrotide is one of the medicines used during “assisted reproduction techniques” to help you get pregnant. It works by immediately stopping the release of eggs. This is because if the eggs are released too early (premature ovulation), your doctor may not be able to collect them.

How Cetrotide works

Cetrotide blocks a natural hormone in your body, called LHRH (“luteinizing hormone-releasing hormone”).

• LHRH controls another hormone, called LH (“luteinizing hormone”).
• LH stimulates ovulation during the menstrual cycle.

This means that Cetrotide stops the chain of events that leads to the release of an egg from the ovary. When your eggs are ready to be collected, you will be given another medicine that will release them (induction of ovulation).

2. What you need to know before you use Cetrotide

Do not use Cetrotide

• if you are allergic to cetrorelix or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines similar to Cetrotide (any other peptide hormone).
• if you are pregnant or breast-feeding.
• if you have severe kidney disease.

Do not use Cetrotide if any of the above applies to you. If you are in doubt, consult your doctor before using this medicine.

Warnings and precautions

Allergies

Consult your doctor before using Cetrotide if you have an active allergic problem or have had allergies in the past.

Ovarian Hyperstimulation Syndrome (OHSS)

Cetrotide is used together with other medicines that stimulate your ovaries to develop more eggs ready to be released. During or after receiving these medicines, you may suffer from OHSS. This situation occurs when your follicles develop too much and become large cysts.

To learn about the possible signs to look out for and what to do if they occur, see section 4 “Possible side effects”.

Using Cetrotide for more than one cycle

Experience with the use of Cetrotide for more than one cycle is limited. Your doctor will carefully evaluate the benefits and risks for you if you need to use Cetrotide for more than one cycle.

Liver disease

Tell your doctor before using Cetrotide if you have any liver disease. Cetrotide has not been studied in patients with liver disease.

Kidney disease

Tell your doctor before using Cetrotide if you have any kidney disease. Cetrotide has not been studied in patients with kidney disease.

Children and adolescents

Cetrotide is not indicated for use in children and adolescents.

Other medicines and Cetrotide

Tell your doctor if you are using, have recently used, or might use any other medicines.

Pregnancy and breast-feeding

Do not use Cetrotide if you are pregnant, think you may be pregnant, or are breast-feeding.

Driving and using machines

Cetrotide is not expected to affect your ability to drive and use machines.

3. How to use Cetrotide

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are in doubt, consult your doctor again.

Using this medicine

This medicine is for subcutaneous injection only, just under the skin of your abdomen. To reduce skin irritation, choose a different part of your abdomen each day.

• Your doctor should supervise the first injection. Your doctor or nurse will teach you how to prepare and inject the medicine.
• You can put the following injections yourself, as long as your doctor has informed you about the symptoms that may indicate an allergy and the possible serious or life-threatening consequences that would require immediate treatment (see section 4 “Possible side effects”).
• Read and follow carefully the instructions at the end of this leaflet, titled “How to mix and inject Cetrotide”.
• You will start using another medicine on day 1 of your treatment cycle. Then, you will start using Cetrotide a few days later. (See the next section “How much to use”.)

How much to use

Inject the contents of one vial of Cetrotide once a day. It is best to use the medicine at the same time each day, leaving 24 hours between each dose.

You can choose to inject either every morning orevery evening.

• If you inject every morning: Start your injections on the fifth or sixth day of the treatment cycle. Depending on your ovarian response, your doctor may decide to start treatment on another day. Your doctor will tell you the exact date and time. You will continue using this medicine until the morning of egg collection, including that morning (induction of ovulation).

OR

• If you inject every evening: Start your injections on the fifth day of the treatment cycle. Depending on your ovarian response, your doctor may decide to start treatment on another day. Your doctor will tell you the exact date and time. You will continue using this medicine until the night before egg collection, including that night (induction of ovulation).

If you use more Cetrotide than you should

No side effects are expected if you accidentally inject more medicine than you should. The effect of the medicine will last longer. In general, no specific measures are necessary.

If you forget to use Cetrotide

• If you forget a dose, inject it as soon as you remember and consult your doctor.
• Do not inject a double dose to make up for forgotten doses.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions

• Redness and feeling of heat in the skin, itching (often in the groin or armpits), red, swollen, and itchy areas (hives), runny nose, rapid or irregular heartbeat, swelling of the tongue and throat, sneezing, whistling sound while breathing (wheezing), severe difficulty breathing or dizziness. You may be having a serious, potentially life-threatening allergic reaction to the medicine. This is uncommon (may affect up to 1 in 100 women).

If you notice any of the above side effects, stop using Cetrotide and consult your doctor immediately.

Ovarian Hyperstimulation Syndrome (OHSS)

This can occur due to the other medicines you are using to stimulate your ovaries.

• Pain in the lower abdomen, along with feeling sick or vomiting, can be symptoms of OHSS. This may indicate that your ovaries have overreacted to treatment and have developed large cysts. This effect is common (may affect up to 1 in 10 women).
• OHSS can become severe, with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing, or fluid accumulation in the stomach or chest. This effect is uncommon (may affect up to 1 in 100 women).

If you notice any of the above side effects, consult your doctor immediately.

Other side effects

Common (may affect up to 1 in 10 women):

• Mild and short-lasting skin reactions may occur at the injection site, such as redness, itching, or swelling.

Uncommon (may affect up to 1 in 100 women):

• Feeling sick.
• Headache.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetrotide

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

Do not use this medicine after the expiry date which is stated on the carton, vial, and pre-filled syringe after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze or place near the freezer compartment or next to a freezer pack.

Keep the container in the outer carton to protect from light.

The unopened product can be stored at room temperature (not above 30°C) for a maximum of three months.

The solution should be used immediately after preparation.

Do not use this medicine if you notice that the white powder in the vial has changed appearance. Do not use the prepared solution in the vial if it is no longer clear and colorless or contains particles.

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. Container Contents and Additional Information

Cetrotide Composition

• The active ingredient is cetrorelix. Each vial contains 0.25 mg of cetrorelix (as acetate).
• The other components are:

• In the powder: mannitol.
• In the solvent: water for injectable preparations.

Appearance of the Product and Container Contents

Cetrotide is a powder and solvent for injectable solution. The white powder comes in a glass vial with a rubber stopper. The solvent is a clear and colorless solution in a pre-filled syringe.

The vial with powder contains 0.25 mg of cetrorelix and the pre-filled syringe contains 1 ml of solvent.

It is available in packs of 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes (only certain pack sizes may be marketed).

For each vial, the packaging also contains:

• a needle with a yellowmark to inject sterile water into the vial and withdraw the prepared medication from the vial
• a needle with a graymark to inject the medication into your abdomen

Marketing Authorization Holder

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, Netherlands

Manufacturer

Merck Healthcare KGaA, Frankfurter Straße 250, D-64293, Darmstadt, Germany

Date of Last Revision of this Leaflet:10/2024

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

HOW TO MIX AND INJECT CETROTIDE

• This section explains how to mix the powder and sterile water (solvent) and then how to inject the medication.
• Before starting to use this medication, read these instructions completely first.
• This medication is for you only; do not allow anyone else to use it.
• Use each needle, vial, and syringe only once.

Before You Start

1. This medication should be at room temperature before injection. Remove it from the refrigerator approximately 30 minutes before use.

1. Wash your hands
   • It is essential that your hands and the objects you use are as clean as possible.

1. Place everything you need on a clean surface:
   • a vial of powder
   • a pre-filled syringe with sterile water (solvent)
   • a needle with a yellowmark to inject sterile water into the vial and withdraw the prepared medication from the vial
   • a needle with a graymark to inject the medication into your abdomen
   • two alcohol swabs (not provided in the packaging).

Mixing the Powder and Water to Prepare Your Medication

1. Remove the vial cap
   • You will find a rubber stopper underneath; keep it in the vial.
   • Clean the rubber stopper and the metal ring with an alcohol swab.

1. Add the water from the pre-filled syringe to the powder in the vial
   • Remove the needle cover from the needle with the yellowmark.
   • Remove the cap from the pre-filled syringe and screw on the yellow needle. Remove the needle cap.

1. Mix the powder and water in the vial
   • While carefully holding the syringe and vial, gently move to mix the powder and water. Once mixed, the solution will have a clear and particle-free appearance.
   • Do not shake the vial, as it will create bubbles in the medication.

1. Refill the syringe with the medication from the vial
   • Place the vial upside down. Then, gently pull the plunger to withdraw the medication from the vial into the syringe. Be careful not to completely separate the plunger from the plunger cap. If the plunger and cap have been separated by mistake, discard the dose, as sterility will be lost, and prepare a new dose (start again from step 1).
   • If medication remains in the vial, pull the yellow needle until the needle tip is just inside the rubber stopper. If you look sideways through the empty space in the rubber stopper, you can control the movement of the needle and liquid.
   • Make sure to withdraw all the medication from the vial.

• Put the cap back on the yellow needle. Unscrew the yellow needle from the syringe and discard the syringe.

Preparing the Injection Site and Injecting the Medication

1. Clean the injection site
   • Choose an injection site on your abdomen. The area around the navel is best. To reduce skin irritation, select a different part of your abdomen each day.
   • Clean the skin of the chosen injection site with the second alcohol swab, using a circular motion.

1. Puncture the skin
   • Hold the syringe with one hand, as if it were a pencil.
   • Gently take a skin fold around the injection site and hold it firmly with the other hand.
   • Slowly insert the gray needle completely into the skin at an angle of approximately 45 to 90 degrees. Then, release the skin.

1. Inject the medication
   • Gently pull the syringe plunger. If blood appears, continue as indicated in step 5.
   • If no blood appears, push the plunger gentlyto inject the medication.
   • When the syringe is empty, slowly withdraw the gray needle at the same angle.
   • Use the second alcohol swab to apply gentle pressure to the injection site.

1. If blood appears:
   • slowly withdraw the gray needle at the same angle
   • use the second alcohol swab to apply gentle pressure to the skin puncture site
   • discard the medication in a sink and continue as indicated in step 6 below
   • wash your hands and start again with a new vial and pre-filled syringe.

1. Disposal
   • Use each needle, vial, and syringe only once.
   • Put the caps back on the needles so that they can be disposed of safely.
   • Ask your pharmacist how to dispose of the used needles, vial, and syringe.