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 done by a doctor who has experience in this type of treatment of fertility problems.
Cetrodite is administered in 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 begins on day 5 or 6 from ovarian stimulation and continues throughout the ovarian stimulation period until the evening before or in the morning of the day in which the induction of ovulation (release of eggs) is expected;
- Cetrotide 3 mg is administered as a single dose on day 7 of ovarian stimulation. If further treatment is required, Cetrotide 0.25 mg daily injections can be started four days later.
Cetrotide is given by injection under the skin in the lower quadrants of the abdomen (belly). In view 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 instructed on the signs of an allergic reaction and what to do if it is. 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 during the menstrual cycle it induces ovulation. During infertility therapy, ovarian stimulation is normally used to induce the ovaries to produce more eggs. Cetrotide, by blocking the "effect of" LHRH, stops the production of LH and thus prevents premature ovulation, which can result in the release of eggs that are immature and unsuitable in techniques such as fertilization. in vitro (IVF).
How has Cetrotide been studied?
The ability of Cetrotide 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 LH secretion, but they work. 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 comparator treatments in preventing a spike in LH production. 95-97% of patients treated with Cetrotide had no LH surge compared to 98% for buserelin and 97% for triptorelin. After completion of the assisted reproductive procedure, 23% of patients treated with Cetrotide experienced pregnancy, compared with 32% in the comparator groups.
What are the risks associated with Cetrotide?
The most common side effects seen with Cetrotide (seen in 1 to 10 out of 100 patients) are mild to moderate ovarian hyperstimulation (which may 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 side effects reported with Cetrotide, see the package leaflet.
Cetrotide must 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 gonadotropin-releasing hormone, or to extrinsic peptide hormones (medicines based on hormones similar to Cetrotide ). Cetrotide should not be used in pregnant or breastfeeding women, in women who have passed the menopause, or in patients with moderate to severe kidney or liver disease. For the complete list of restrictions on use. , see the package leaflet.
Why has Cetrotide been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Cetrotide represents 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 controlled ovarian stimulation, followed by egg retrieval and assisted reproductive techniques. The Committee recommended that it be licensed. on placing on the market for Cetrotide.
Other information about Cetrotide:
On 13 April 1999, the European Commission issued a "Marketing Authorization" for Cetrotide, valid throughout the European Union. The holder of the "Marketing Authorization" is Merck Serono Europe Limited. "placing on the market was renewed on April 13, 2004 and April 13, 2009.
For the full version of Cetrotide's EPAR, click here.
Last update of this summary: 09-2009.
The information on Cetrotide - cetrorelix published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
