CETRORELIX ACETATE 0.25 MG POWDER FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Patient leaflet - CETRORELIX ACETATE 0.25 MG POWDER FOR SOLUTION FOR INJECTION

1. what cetrorelix injection is and what it is used for

What Cetrorelix injection is

Cetrorelix injection contains a medicine called ‘cetrorelix acetate’. This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle. Cetrorelix injection belongs to a group of medicines called ‘anti-gonadotropin-releasing hormones’.

What Cetrorelix injection is used for

Cetrorelix injection is one of the medicines used during ‘assisted reproductive techniques’ to help you get pregnant. It stops eggs being released straight away. This is because if the eggs are released too early (premature ovulation) it may not be possible for your doctor to collect them.

How Cetrorelix injection works

Cetrorelix injection blocks a natural hormone in your body called LHRH (‘luteinising hormone releasing hormone’).

LHRH controls another hormone, called LH (‘luteinising hormone’).
LH stimulates ovulation during your menstrual cycle.

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

2. what you need to know before you use cetrorelix injection

Do not use Cetrorelix injection:

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

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before using this medicine.

Warnings and precautions

Allergies

Tell your doctor before using Cetrorelix injection if you have an active allergy or have had allergies in the past.

Ovarian Hyperstimulation Syndrome (OHSS) Cetrorelix injection is used together with other medicines that stimulate your ovaries to develop more eggs ready to be released. During or after you receive these medicines, you may develop Ovarian Hyperstimulation Syndrome (OHSS). This is when your follicles develop too much and become large cysts.

For possible signs to look out for and what to do if this happens see section 4 ‘Possible side effects’.

Using Cetrorelix injection during more than one cycle

Experience of using Cetrorelix injection during more than one cycle is small. Your doctor will carefully look at the benefits and risks for you, if you need to have Cetrorelix injection during more than one cycle.

Liver disease

Tell your doctor before using Cetrorelix injection if you have a liver disease. Cetrorelix injection has not been investigated in patients with hepatic disease.

Kidney disease

Tell your doctor before using Cetrorelix injection if you have a kidney disease. Cetrorelix injection has not been investigated in patients with kidney disease.

Children and adolescents

Cetrorelix injection is not indicated for the use in children and adolescents.

Other medicines and Cetrorelix injection

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

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

Driving and using machines

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

3. HOW TO USE CETRORELIX INJECTION

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Using this medicine

This medicine is only for injection just under the skin of your belly (subcutaneous). To reduce skin irritation, select a different part of your belly each day.

Your doctor must supervise your first injection. Your doctor or nurse will show you how to prepare and inject the medicine.
You can carry out the following injections yourself as long as your doctor has made you aware of the symptoms that may indicate allergy and of the possibly serious or life threatening consequences that would need immediate treatment (see section 4 ‘Possible side effects’).
Please carefully read and follow the instructions mentioned in section called ‘How to mix and inject Cetrorelix injection’.
You start by using another medicine on day 1 of your treatment cycle. You then start using Cetrorelix injection a few days later. (See next section ‘How much to use’).

How much to use

Inject the contents of one vial (0.25 mg Cetrorelix injection) once each 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 every morning or every evening.

If you are injecting every morning: Start your injections on day 5 or 6 of the treatment cycle. Based on your ovarian response, your doctor may decide to start on another day. Your doctor will tell you the exact date and time. You will keep using this medicine up until and including the morning that your eggs are collected (ovulation induction).

If you are injecting every evening: Start your injections on day 5 of the treatment cycle. Based on your ovarian response, your doctor may decide to start on another day. Your doctor will tell you the exact date and time. You will keep using this medicine up until and including the evening before your eggs are collected (ovulation induction).

If you use more Cetrorelix injection than you should

Bad effects are not expected if you accidentally inject more cetrorelix or more frequently than you should, but the effect of the medicine will last for longer. No specific measures are usually required. Speak to your doctor about when to inject your next dose.

If you forget to use Cetrorelix injection

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

HOW TO MIX AND INJECT CETRORELIX INJECTION The doctor or nurse will demonstrate how to use this medicine first.

This section tells you how to mix the powder and the sterile water (solvent) together and then how to inject your medicine.
Before starting to use this medicine, please read these instructions the whole way through first.
This medicine is only for you – do not let anyone else use it.
Use each needle, vial and syringe only once.
The following solvent and devices are required for each injection/vial of drug product for self-administration. The items supplied to you may be in different sizes or types, and may be used differently to the following instructions. You will be shown how to use these first.
– 1 ml sterile water for injections (solvent), taken from a suitably sized single use container e.g vial or ampoule
– 1 injection syringe (suggested sizes: 1 ml, 2 ml or 2.5 ml, graduated)
– 1 injection needle (20 gauge, or appropriate fitting)
– 1 hypodermic injection needle (27 gauge, or appropriate fitting)
– 2 alcohol swabs

Before you start

1. This medicine must be at room temperature prior to injection. Remove from the refrigerator at least 30 minutes before preparing the injection.
2. Wash your hands
It is important that your hands and the things you use are as clean as possible.
3. Lay out everything you need on a clean surface:

You may be provided with items in different sizes or types to the one described below.

one vial of cetrorelix powder
one container of sterile water for injections (vial or ampoule)
one syringe
one injection needle (20 gauge – yellow hub, or alternative)
one hypodermic injection needle (27 gauge -grey hub, or alternative)
two alcohol swabs.

Preparation of injection

If you have been given a vial of sterile water, go to section 4.

If you have been given an ampoule of sterile water, go to section 5.

4. Using a vial of sterile water for injections to make up your medicine. If you have been given an ampoule of sterile water, go to next section.

Only use the sterile water for injections you have received. Do not use any other water.

4a. Remove the caps from the vial of powder

There will be a rubber stopper underneath – keep this on for both vials.
Wipe the rubber stopper of both vials with an alcohol swab.

4b. Filling of syringe with 1 ml sterile water

Unwrap the needle with the yellow hub on it.
Fix the needle onto syringe.

Remove the cap from the needle.

	Artwork No.	–				Colours Used
	Customer	Accord (Lambda)			■	Pantone Black
	Description	Cetrorelix acetate Inj
	Market	UK

	Language	English
	Size	170 × 550 mm (PIL)
advertising & communication services ltd.	Min. Font Size	9
	Version No.	11 (Page 2 of 2)
	Date	03_01_22 (Cetrorelix acetate Inj (LAM-UK) PIL)
Prepared By Regulatory Affairs			Checked By Regulatory Affairs	Approved By Quality Assurance

Turn vial of sterile water upside down, and insert needle into the vial (make sure needle tip stays under sterile water to avoid bubbles). Gently pull back plunger to draw up 1ml sterile water from

the vial into the syringe. Take care not to pull the plunger out completely (if this happens, discard the dose as sterility will be lost, and prepare a new dose by restarting from step1). Some sterile water may be left in the vial – this is normal, and should be discarded.

Now go to section 6.

5. Using an ampoule of sterile water for injections to make up your medicine 5a. Handling of ampoule of ................

sterile water

Hold the ampoule upright and tap ’ the top of the chamber quickly i / and lightly until all fluid flows to 7 the bottom of the chamber.

If no blood appears, slowly push the plunger in to inject your medicine.
When the syringe is empty, take out the needle slowly at the same angle.
Use your second alcohol swab to gently apply pressure where you have just injected.

9e. If blood appears

take out the needle slowly at the same angle.
use your second alcohol swab to gently apply pressure where you have just pierced your skin.
empty your medicine into a sink and follow Step 6 below.
wash your hands and start again with a new vial and syringe.

9f. Disposal

Use each needle, vial and syringe only once.
Put the cap back on the needles so that they are safe to be thrown away.
Ask your pharmacist how to safely dispose of used needles, vial and syringe.

5b. Cleaning of ampoule and filling of syringe with 1 ml sterile water

Clean the neck of the ampoule with an alcohol swab. Allow it to dry.

4. POSSIBLE SIDE EFFECTS

Grasp the neck of the ampoule and quickly snap the top off directing away from you. Place

on a flat surface.

Unwrap the needle with the yellow hub on it.

Fix the needle onto syringe. Remove the cap from the needle.

Tilting the ampoule gently, place the tip of the needle inside the ampoule to withdraw the content into the syringe.

Now go to section 6.

6. Removing air bubbles

Hold the syringe with the needle pointing upwards and check for any air bubbles.
To remove air bubbles, gently flick the syringe until all the air collects at the top – then slowly

push the plunger in until the air bubbles are gone and the liquid is just starting to come out of the needle.

7. Adding the sterile water from the syringe to

the powder in the vial

Push the needle through the centre of the rubber stopper of the vial.
Slowly push in the plunger of the syringe to inject the sterile water into the vial.

Leave the syringe in the rubber stopper.

8. Mixing the powder and sterile water to make up your medicine

8a. Mixing the powder and sterile water in the vial

While carefully holding the syringe and vial, swirl gently to mix the powder and Sterile water together. When it is mixed, it will look clear and have no particles in it.
Do not shake or you will create bubbles in your medicine.

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

Allergic reactions

Warm, red skin, itching (often in your groin or armpits), red, itchy, raised areas (hives), runny nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing or serious difficulty breathing, or dizziness. You may be having a possible serious, life-threatening allergic reaction to the medicine. This is uncommon (may affect up to 1 in 100 women).

If you notice any of the side effects above, stop using Cetrorelix injection and contact your doctor immediately.

Ovarian Hyperstimulation Syndrome (OHSS) This may occur due to the other medicines that you are using to stimulate your ovaries.

Lower abdominal pain together with feeling sick (nausea) or being sick (vomiting) may be the symptoms of Ovarian Hyperstimulation Syndrome (OHSS). This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed. This event is common (may affect up to 1 in 10 women).
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing or fluid in your stomach or chest. This event is uncommon (may affect up to 1 in 100 women).

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

Other side effects

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

Mild and short lasting skin irritation may occur at the injection site like redness, itching or swelling.

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

Feeling sick (nausea)
Headache.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: or search for MHRA Yellow Card in the Goodle Play or Apple Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CETRORELIX INJECTION

8b. Re-filling the syringe with the medicine from the vial

Turn the vial upside down. Then, gently pull back the plunger, in order to draw the medicine from the vial into the syringe. Take care not to pull out completely the plunger with the attached plunger

stopper. In case you pulled out the plunger with the plunger stopper by mistake, make sure to discard the dose as sterility will be lost, and prepare a new dose (and restart from step 1).

If any medicine is left in the vial, pull back the needle until the end of the needle is just inside the rubber stopper. If you look from the side through the gap in the rubber stopper, you can control the movement of the needle and the liquid.
Make sure that you collect all of the liquid from the vial.
Put the cap back on the needle. Remove the needle from the syringe and lay down the syringe.

9. Preparing the injection site and injecting your medicine

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 vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C); in the original package in order to protect from light.

The unopened product may be stored in the original package at room temperature (not above 25°C) for up to three months.

The solution should be used immediately after preparation.

Do not use this medicine if you notice that the white lyophilized cake or powder in the vial has changed in appearance. Do not use it if the prepared solution in the vial is not clear and colourless or if it has particles in it.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

9a. Clean the injection site

Choose an injection site on your belly. It is best around the belly button (navel). To reduce skin irritation, select a different part of your belly each day.
Clean the skin at your chosen injection site with your second alcohol swab – use a circular motion.
Unwrap the needle with grey hub on it. Fix the needle onto the syringe and remove the cap from the needle.
Hold the syringe with the needle

6. CONTENTS OF THE PACK AND OTHER INFORMATION

pointing upwards and check for any air bubbles.

To remove air bubbles, gently flick the syringe until all the air collects at the top – then slowly push the plunger in until the air bubbles are gone and the liquid is just starting to come out of the needle.
Do not touch the needle and do not let the needle touch any surface.

9c. Piercing your skin

Hold the syringe in one hand -like you would hold a pencil.
Gently pinch up the skin around where you are going to inject and hold this firmly with your other hand.

Slowly push the needle completely into your skin at an angle of about 45 to 90 degrees -then let go of your skin.

9d. Injecting your medicine

Gently pull back the plunger of the syringe. If blood appears, follow Step 5 below.

What Cetrorelix injection contains

– The active ingredient is Cetrorelix (as acetate).

Each vial contains 0.25 mg Cetrorelix (as acetate).

– The other ingredient is mannitol (E421) & glacial acetic acid.

What Cetrorelix injection looks like and contents of the pack

Cetrorelix injection is a white lyophilized cake or powder for solution for injection in a glass vial with a rubber stopper and flip-off aluminium cap.

It is available in packs of one or seven vials (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Lambda Therapeutic Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Manufacturer:

Accord Healthcare Limited,