Orgalutran - ganirelix

What is Orgalutran?

Orgalutran is a pre-filled syringe containing a solution for injection. Each Orgalutran syringe contains 0.25 mg of the active substance 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, before induction into the ovary). ovulation) The medicine can only be obtained with a prescription.

How is Orgalutran used?

Orgalutran treatment should be supervised by a physician experienced in this type of treatment of fertility problems. Orgalutran is administered in a dose of 0.25 mg once daily. Treatment should begin on the sixth day of ovarian stimulation, ie six days after the start of FSH (follicle stimulating hormone) administration. Daily treatment with Orgalutran should be continued until there is a sufficient number of follicles (bags containing ova) of large size.
Orgalutran is given by injection under the skin (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 with the possibility of obtaining advice from an expert. For more information on using 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 usually used to induce the ovaries to produce more than one egg. After a few days, a hormone such as hCG (human chorionic gonadotropin) is administered to trigger ovulation; then the eggs are taken for use in techniques such as fertilization in vitro. Orgalutran, by blocking the effect of GnRH, stops the production of LH and thus prevents premature ovulation, ie the release from an ovary of eggs that may be immature and not suitable for fertilization.

How has Orgalutran been studied?

The efficacy of Orgalutran as a treatment to prevent premature ovulation was studied in 1,335 women involved in three main studies. Orgalutran was compared with buserelin, leuprorelin and triptorelin (these are GnRH agonist drugs: they act on the secretion of LH, stimulating the production of GnRH to the point that the body stops producing LH). The main criteria of effectiveness were the number of eggs that can be collected and the rate of ongoing pregnancies.

What benefit has Orgalutran shown during the studies?

After treatment with Orgalutran, the number of ova retrievable was between 7.9 and 11.6 while the ongoing pregnancy rate per attempt was between 20.3% and 31%. The values ​​for the comparator 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, mainly redness with or without edema (seen in 12% of patients 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 are hypersensitive (allergic) to ganirelix, to any of the other substances in Orgalutran, to GnRH or to GnRH agonists. It should also not be used in pregnant or breastfeeding women and in women with moderate to severe kidney or liver problems. For the complete list of limitations, see the package insert. The ovary may over-respond to treatment (ovarian hyperstimulation syndrome) and both the doctor and the patient should be aware of this possibility.

Why has Orgalutran been approved?

The Committee for Medicinal Products for Human Use (CHMP) considered that Orgaluran has demonstrated 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 reproductive techniques, she recommended the granting of a marketing authorization for Orgalutran.

Other information about Orgalutran:

On May 17, 2000, the European Commission issued the N.V. Organon a "Marketing Authorization" for Orgalutran, valid throughout the European Union. This authorization was renewed on May 17, 2005.
For the full version of the Orgalutran evaluation (EPAR), click here.

Last update of this summary: 06-2006.

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