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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/337942/2016

EMEA/H/C/00233

EPAR summary for the public

Cetrotide

cetrorelix

This is a summary of the European public assessment report (EPAR) for Cetrotide. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cetrotide.

What is Cetrotide?

Cetrotide is a medicine that contains the active substance cetrorelix. It is available as a powder and solvent used to make a solution for injection.

What is Cetrotide used for?

Cetrotide is used to prevent premature ovulation (early release of eggs from the ovary). It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs).

The medicine can only be obtained with a prescription.

How is Cetrotide used?

Treatment with Cetrotide should be carried out by a doctor who has experience in this type of fertility treatment. Cetrotide is given by injection under the skin of the lower abdomen (belly). The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening. Treatment starts on day 5 or 6 of ovarian stimulation, and is continued throughout the ovarian stimulation period, until the evening before or the morning of the day when the induction of ovulation (the release of eggs) is planned.

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Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor, and the patient closely watched for 30 minutes. Further injections may be given by the patient herself, as long as she is made aware of the signs of allergic reaction and what to do if they appear. The medicine should be injected slowly at different places on the abdomen every day.

How does Cetrotide work?

The active substance in Cetrotide, cetrorelix, blocks the effects of luteinising-hormone-releasing hormone (LHRH) in the body. LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation. During fertility treatment, ovarian stimulation is used to make the ovaries produce more eggs. By blocking the effect of LHRH, Cetrotide stops the production of LH, and therefore prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable for use in techniques such as in vitro fertilisation (IVF).

How has Cetrotide been studied?

The ability of Cetrotide to prevent premature ovulation has been studied in three main studies involving 814 women. Cetrotide was compared with buserelin nasal spray and triptorelin depot injection. These medicines act on the secretion of LH, but work by overstimulating the production of LHRH so that the body stops making LH. The main measure of effectiveness was the prevention of premature LH production.

What benefit has Cetrotide shown during the studies?

Cetrotide was as effective as the comparator treatments in preventing a surge in the production of LH. Between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for buserelin and 97% for triptorelin. Once the assisted-reproduction procedure was completed, 23% of patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.

What is the risk associated with Cetrotide?

The most common side effects with Cetrotide (seen in between 1 and 10 patients in 100) are mild to moderate overstimulation of the ovaries (which can occur as a side effect of the ovarian stimulation procedure itself) and reactions at the injection site, such as redness, swelling and itching. For the full list of all side effects reported with Cetrotide, see the package leaflet.

Cetrotide must not be used in people who are hypersensitive (allergic) to cetrorelix or any of the other ingredients, to any hormones that are chemically similar to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone medicines similar to Cetrotide). It must not be used in women who are pregnant or breastfeeding, or in patients with severe kidney disease. For the full list of restrictions, see the package leaflet.

Why has Cetrotide been approved?

The CHMP concluded that Cetrotide is a safe and effective alternative to existing treatments for the prevention of premature ovulation. The CHMP decided that Cetrotide's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Cetrotide?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cetrotide have been included in the summary of product characteristics and the package leaflet.

Other information about Cetrotide

The European Commission granted a marketing authorisation valid throughout the European Union for Cetrotide on 13 April 1999.

The full EPAR for Cetrotide is available on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Cetrotide, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist..

This summary was last updated in 06-2016.

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Cetrotide

EMA/337942/2016