What is Cetrotide?
Cetrotide consists of a powder and a solvent for the preparation of a solution for injection. Cetrotide contains the active substance cetrorelix.
What is Cetrotide used for?
Cetrotide is given to women undergoing ovarian stimulation (infertility therapy in which the ovaries are stimulated to produce more than one egg). It is used to prevent premature ovulation (premature release of eggs from the ovary).
The medicine can only be obtained with a prescription .
How is Cetrotide used?
Treatment with Cetrotide should be performed by a doctor experienced in this type of treatment for fertility problems.
Cetrodite is administered at doses of 0.25 mg or 3 mg:
- Cetrotide 0.25 mg is taken once a day, in the morning or evening at 24-hour intervals. Treatment starts on day 5 or 6 of ovarian stimulation and continues throughout the ovarian stimulation period until the evening before or in the morning of the day when ovulation is expected (egg release);
- Cetrotide 3 mg is given as a single dose on day 7 of ovarian stimulation. If further treatment is required, daily injections of Cetrotide 0.25 mg may be started four days later.
Cetrotide is given by injection under the skin at the lower quadrants of the abdomen (belly). In consideration of the risk of allergic reactions, which can be dangerous, the first injection must be supervised by a doctor and the patient must be monitored for the next 30 minutes. Subsequent injections can be self-administered, provided that the patient is adequately trained on the signs of an allergic reaction and what to do in that case. The medicine should be injected slowly each day at different points in the abdomen to reduce injection reactions.
How does Cetrotide work?
The active substance in Cetrotide, cetrorelix, blocks the effects of a natural hormone called luteinizing hormone-releasing hormone (LHRH). LHRH regulates the production and secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During infertility therapy, ovarian stimulation is normally used to induce the ovaries to produce more eggs. Cetrotide, by blocking the effect of LHRH, interrupts the production of LH and therefore prevents premature ovulation, which can lead to the release of eggs that are immature and unsuitable in techniques such as in vitro fertilization (IVF).
What studies have been performed on Cetrotide?
Cetrotide's ability to prevent premature ovulation was studied in three main studies involving 814 women. Cetrotide was compared with buserelin nasal spray and triptorelin depot injections. These are medicines that also act on the secretion of LH, but they work by overstimulating the production of LHRH to the point that the body stops producing 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 comparative treatments in preventing a peak in LH production. 95-97% of the patients treated with Cetrotide did not observe any LH peak compared to 98% for buserelin and 97% for triptorelin. Once the assisted reproduction procedure was completed, a pregnancy occurred in 23% of patients treated with Cetrotide, compared to 32% in comparison groups.
What are the risks associated with Cetrotide?
The most common side effects with Cetrotide (seen in between 1 and 10 patients in 100) are mild to moderate ovarian hyperstimulation (which may manifest as an undesirable effect of the ovarian stimulation procedure itself) and local reactions at the site of inoculation, 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 substances, to any hormone similar in structure to the gonadotropin-releasing hormone, or to extrinsic peptide hormones (medicines based on hormones similar to Cetrotide ). Cetrotide should not be used in women who are pregnant or breast-feeding, in women who have passed the menopause, or in patients with moderate to severe renal or hepatic disorders. For the full list of usage restrictions, see the package leaflet.
Why has Cetrotide been approved?
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 the benefits of Cetrotide outweigh its risks for the prevention of premature ovulation in patients undergoing controlled ovarian stimulation, followed by egg retrieval and assisted reproduction techniques. The Committee recommended the granting of a marketing authorization for Cetrotide.
Other information on Cetrotide:
On 13 April 1999 the European Commission issued a marketing authorization for Cetrotide, valid throughout the European Union. The marketing authorization holder is Merck Serono Europe Limited. The marketing authorization was renewed on 13 April 2004 and 13 April 2009.
For the full EPAR version of Cetrotide, click here.
Last update of this summary: 09-2009.
