What is Orgalutran?
Orgalutran is a pre-filled syringe containing a solution for injection. Each Orgalutran syringe contains 0.25 mg of the active ingredient ganirelix in 0.5 ml of solution.
What is Orgalutran used for?
Orgalutran is given to women undergoing infertility therapy, whose ovaries are stimulated to produce more than one egg (ovarian stimulation). It is used to prevent premature ovulation (premature release of eggs from the ovary, prior to ovulation induction). The medicine can only be obtained with a prescription.
How is Orgalutran used?
Treatment with Orgalutran should be supervised by a doctor experienced in this type of treatment for fertility problems. Orgalutran is given as 0.25 mg once a day. Treatment should start on the sixth day of ovarian stimulation, ie six days after the start of administration of FSH (follicle stimulating hormone). The daily treatment with Orgalutran should be continued until the day when there is a sufficient number of large follicles (pouches containing eggs).
Orgalutran is given by subcutaneous injection (under the skin), preferably in the thigh. Orgalutran injections can be given by the patient or by another person as long as they are trained and can be consulted by an expert. For more information on the use of Orgalutran, see the package leaflet.
How does Orgalutran work?
The active substance in Orgalutran, ganirelix, blocks the effects of a natural hormone called gonadotropin-releasing hormone (GnRH). GnRH regulates the secretion of another hormone, called luteinizing hormone (LH), which during the menstrual cycle induces the release of the egg (ovulation). During infertility therapy, ovarian stimulation is normally used to induce the ovaries to produce more than one egg. After a few days, a hormone like hCG (human chorionic gonadotropin) is given to trigger ovulation; then the eggs are taken to be used in techniques such as in vitro fertilization. Orgalutran, by blocking the effect of GnRH, interrupts the production of LH and therefore prevents premature ovulation, that is the release by an ovary of ova that could be immature and not suitable for fertilization.
What studies have been carried out on Orgalutran?
The efficacy of Orgalutran as a treatment to prevent premature ovulation was studied in 1 335 women involved in three main studies. Orgalutran has been compared with buserelin, leuprorelin and triptorelin (these are GnRH agonist drugs: they act on LH secretion, stimulating the production of GnRH to the point that the body stops producing LH). The main efficacy criteria were the number of withdrawable eggs and the current pregnancy rate.
What benefit has Orgalutran shown during the studies?
After treatment with Orgalutran, the number of eggs that could be taken was between 7.9 and 11.6 while the ongoing pregnancy rate per attempt was between 20.3% and 31%. The values for the comparative treatments were slightly higher (buserelin: 9.7 and 25.7%, leuprorelin: 14.1 and 36.4%, triptorelin: 8.6 and 35.1%).
What are the risks associated with Orgalutran?
Orgalutran may cause a skin reaction at the injection site, especially redness with or without edema (observed in 12% of patients involved in the studies). The other side effects (seen in less than 1 in 100 patients) were nausea, headache and malaise.
Orgalutran should not be used in patients who may be hypersensitive (allergic) to ganirelix, to any of the other Orgalutran substances, to GnRH or to GnRH agonists. It must also not be used in women who are pregnant or breastfeeding and in women with moderate to severe kidney or liver problems. For the complete list of limitations, see the package leaflet. It may happen that the ovary responds to excessive treatment (ovarian hyperstimulation syndrome) and both the doctor and the patients must be aware of this possibility.
Why has Orgalutran been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Orgaluran has proved its efficacy and that the tendency to give lower results than GnRH agonists is acceptable. After concluding that the benefits of Orgalutran outweigh the risks for the prevention of early luteinizing hormone spikes in women undergoing controlled ovarian hyperstimulation in assisted reproduction techniques, recommended that Orgalutran be granted marketing authorization.
More information on Orgalutran:
On May 17, 2000, the European Commission issued a marketing authorization for Orgalutran to NV Organon, valid throughout the European Union. This authorization was renewed on 17 May 2005.
For the full version of the evaluation (EPAR) of Orgalutran, click here.
Last update of this summary: 06-2006.
