Cetrotide is a powder and solvent that are made up in a solution for injection. Cetrotide contains the active substance cetrorelix.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Cetrotide is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs). It is used to prevent premature ovulation (early release of eggs from the ovary).
The medicine can only be obtained with a prescription.
Treatment with Cetrotide should be carried out by a doctor who has experience in this type of fertility treatment.
Cetrotide is given at doses of either 0.25 mg or 3 mg:
- Cetrotide 0.25 mg is given once a day, either in the morning or in the evening at 24-hour intervals. 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;
- Cetrotide 3 mg is given as a single dose on day 7 of ovarian stimulation. If further treatment is needed, daily injections of Cetrotide 0.25 mg can be started four days later. Cetrotide is given by injection under the skin of the lower abdomen (tummy). Because of the risk of allergic reactions, which can be dangerous, the first injection should be supervised by a doctor, and the patient monitored for 30 minutes. The following 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, to reduce reactions to the injection.
The active substance in Cetrotide, cetrorelix, blocks the effects of a natural hormone called luteinising hormone releasing hormone (LHRH). LHRH controls the production and release of another hormone called luteinising hormone (LH), which causes ovulation during the menstrual cycle. During fertility treatment, ovarian stimulation is normally 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).
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 are medicines that also 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.
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.
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 local 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 should not be used in people who may be hypersensitive (allergic) to cetrorelix or any of the other ingredients, to any hormones that are similar in structure to gonadotropin-releasing hormone, or to extrinsic peptide hormones (hormone-based medicines similar to Cetrotide). It must not be used in women who are pregnant or breast-feeding, in women who have been through the menopause, or in patients with moderate or severe kidney or liver disease. For the full list of restrictions, see the Package Leaflet.
The Committee for Medicinal Products for Human Use (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 for the prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproduction techniques. The Committee recommended that Cetrotide be given marketing authorisation.