Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Cetrotide 0.25 mg powder and solvent for solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cetrorelix acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Cetrotide is Cetrotide contains a medicine called 'cetrorelix'. This medicine stops your body from releasing an egg from your ovary (ovulation) during your menstrual cycle. Cetrotide belongs to a group of medicines called 'anti-gonadotropin-releasing hormones'. What Cetrotide is used for Cetrotide 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 Cetrotide works Cetrotide 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 Cetrotide 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 take it
e 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 hormones).
• •
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 not sure, talk to your doctor before using this medicine. Warnings and precautions Allergies Tell your doctor before using Cetrotide if you have an active allergy 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 you receive these medicines, you may develop 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 Cetrotide during more than one cycle Experience of using Cetrotide during more than one cycle is small. Your doctor will carefully look at the benefits and risks for you, if you need to have Cetrotide during more than one cycle. Liver disease Tell your doctor before using Cetrotide if you have a liver disease. Cetrotide has not been investigated in patients with hepatic disease. Kidney disease Tell your doctor before using Cetrotide if you have a kidney disease. Cetrotide has not been investigated in patients with kidney disease. Children and adolescents Cetrotide is not indicated for the 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 if you are breast-feeding. Driving and using machines Cetrotide is not expected to affect your ability to drive and use machines. 3.
How to take it
Cetrotide
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 at the end of this leaflet called 'How to mix and inject Cetrotide'. You start by using another medicine on day 1 of your treatment cycle. You then start using Cetrotide a few days later. (See next section 'How much to use').
How much to use Inject the contents of one Cetrotide vial 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). OR •
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 Cetrotide than you should Side effects are not expected if you accidentally inject more of this medicine than you should. The effect of the medicine will last for longer. No specific measures are usually required. If you forget to use Cetrotide • 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. 4.
Possible side effects
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 Cetrotide 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
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 refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze or place next to the freezer compartment or a freezer pack. Store 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 30°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 powder in the vial has changed in appearance. Do not use the prepared solution in the vial if it 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. 6.
Contents of the pack and other information
What Cetrotide contains The active substance is cetrorelix. Each vial contains 0.25 mg cetrorelix (as acetate). The other ingredients are:
• •
In the powder: mannitol. In the solvent: water for injections.
What Cetrotide looks like and contents of the pack Cetrotide is a powder and solvent for solution for injection. The white powder comes in a glass vial with a rubber stopper. The solvent is a clear and colourless solution in a pre-filled syringe. The powder vial contains 0.25 mg cetrorelix and the pre-filled syringe contains 1 ml solvent. It is available in packs of 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes (not all pack sizes may be marketed). For each vial, the pack also contains: one needle with a yellow mark – for injecting the sterile water into the vial and drawing the made up medicine out from the vial one needle with a grey mark – for injecting the medicine into your belly Marketing Authorisation Holder Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK Manufacturer Merck Healthcare KGaA, Frankfurter Straße 250, D-64293 Darmstadt, Germany This leaflet was last revised in April 2026
HOW TO MIX AND INJECT CETROTIDE • • • •
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.
Before you start 1.
This medicine must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use.
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: • one vial of powder • one pre-filled syringe with sterile water (solvent) • one needle with a yellow mark – for injecting the sterile water into the vial and drawing the made-up medicine out from the vial • one needle with a grey mark – for injecting the medicine into your belly • two alcohol swabs (not provided in the pack).
Mixing the powder and water to make up your medicine 1.
Remove the cap from the vial • There will be a rubber stopper underneath – keep this in the vial. • Wipe the rubber stopper and metal ring with an alcohol swab.
2.
Adding the water from the pre-filled syringe to the powder in the vial • Unwrap the needle with the yellow mark on it. • Remove the cap from the pre-filled syringe and screw the yellow needle onto it. Remove the cap from the needle. • Push the yellow needle through the centre of the rubber stopper of the vial. • Slowly push in the plunger of the syringe to inject the water into the vial. Do not use any other sort of water. • Leave the syringe in the rubber stopper.
3.
Mixing the powder and water in the vial • While carefully holding the syringe and vial, swirl gently to mix the powder and 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.
4.
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 out the yellow 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 your medicine from the vial.
•
Put the cap back on the yellow needle. Unscrew the yellow needle from the syringe and lay down the syringe.
Preparing the injection site and injecting your medicine 1.
Removing air bubbles • Unwrap the needle with the grey mark on it. Screw the grey needle onto the syringe and remove the cap from the grey needle. • Hold the syringe with the grey 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. • Do not touch the grey needle and do not let the needle touch any surface.
2.
Clean the injection site • Choose an injection site on your belly. It should be preferably around, but at least 5 cm away from your 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.
3.
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 grey needle completely into your skin at an angle of about 45 degrees – then let go of your skin.
4.
Injecting your medicine • Gently pull back the plunger of the syringe. If blood appears, follow Step 5 below. • If no blood appears, slowly push the plunger in to inject your medicine. • When the syringe is empty, take out the grey needle slowly at the same angle. • Use your second alcohol swab to gently apply pressure where you have just injected.
5.
If blood appears • Take out the grey 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 pre-filled syringe.
6.
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.
Frequently asked questions about Cetrotide 0.25 mg powder and solvent for solution for injection
How do I take Cetrotide 0.25 mg powder and solvent for solution for injection?
Cetrotide 0.25 mg powder and solvent for solution for injection comes as injection containing 0.25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Cetrotide 0.25 mg powder and solvent for solution for injection?
The active substance in Cetrotide 0.25 mg powder and solvent for solution for injection is cetrorelix acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cetrotide 0.25 mg powder and solvent for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Cetrotide 0.25 mg powder and solvent for solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: cetrorelix acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.
4.2. Posology and method of administration
Cetrotide should only be prescribed by a specialist experienced in this field.
Posology
The first administration of Cetrotide should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life‑threatening anaphylaxis) is immediately available. The following injections may be self‑administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
The contents of 1 vial are to be administered once daily, at 24 h intervals, either in the morning or in the evening. Each vial contains 0.25 mg of cetrorelix; however, due to losses during reconstitution and administration, only 0.21 mg can be administered (see section 6.6). Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Elderly
There is no relevant use of Cetrotide in the geriatric population.
Paediatric population
There is no relevant use of Cetrotide in the paediatric population.
Method of administration
Cetrotide is for subcutaneous injection into the lower abdominal wall.
The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the medicinal product in a slow rate to facilitate the progressive absorption of the medicinal product.
Administration in the morning
Treatment with Cetrotide should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
The starting day of Cetrotide is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.
Administration in the evening
Treatment with Cetrotide should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
The starting day of Cetrotide is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Cetrorelix is not to be used in the presence of any of the conditions listed below:
• Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipients listed in section 6.1.
• During pregnancy and lactation.
• Patients with severe renal impairment.
4.4. Special warnings and precautions for use
Allergic conditions
Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported (see section 4.8).
Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with Cetrotide is not advised in women with severe allergic conditions.
Ovarian Hyperstimulation Syndrome (OHSS)
During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur. This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins
An OHSS should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.
Luteal phase support should be given according to the reproductive medical centre´s practice.
Repeated ovarian stimulation procedure
There is limited experience up to now with the administration of cetrorelix during a repeated ovarian stimulation procedure. Therefore, cetrorelix should be used in repeated cycles only after a careful benefit/risk evaluation.
Congenital anomalies
The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures. Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offsprings.
Hepatic impairment
Cetrorelix has not been studied in patients with hepatic impairment and caution is therefore warranted.
Renal impairment
Cetrorelix has not been studied in patients with renal impairment and caution is therefore warranted.
Cetrorelix is contraindicated in patients with severe renal impairment (see section 4.3).
4.5. Interaction with other medicinal products and other forms of interaction
No formal drug-drug interaction studies have been performed with cetrorelix. In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way. However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.
4.6. Fertility, pregnancy and lactation
Pregnancy and breast-feeding
Cetrotide is not intended to be used during pregnancy and lactation (see section 4.3).
Fertility
Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy. No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.
4.7. Effects on ability to drive and use machines
Cetrotide has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of Cetrotide 0.25 mg.
Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Inversely, severe OHSS remains uncommon.
Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported.
List of adverse reactions
The adverse reactions reported below are classified according to frequency of occurrence as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Immune system disorders
Uncommon:
Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis.
Nervous system disorders
Uncommon:
Headache
Gastrointestinal disorders
Uncommon:
Nausea
Reproductive system and breast disorders
Common:
Mild to moderate OHSS (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure (see section 4.4).
Uncommon:
Severe OHSS (WHO grade III)
General disorders and administration site conditions
Common:
Local reactions at the injection site (e.g. erythema, swelling and pruritus).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
In acute toxicity studies in rodents non-specific toxic symptoms were observed after intraperitoneal administration of cetrorelix doses more than 200 times higher than the pharmacologically effective dose after subcutaneous administration.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- CETROTIDE 0,25 mg prescriptionCETRORELIXUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- CetrotideCetrorelixum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Cetrotide 0.25 mg powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.