Posology : מינונים

4.2 Posology and method of administration
Orgalutran should only be prescribed by a specialist experienced in the treatment of infertility.
Posology
Orgalutran is used to prevent premature LH surges in women undergoing COH.
Controlled ovarian hyperstimulation with FSH or corifollitropin alfa may start at day 2 or 3 of menses. Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa. The starting day of Orgalutran is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol.The start of Orgalutran may be delayed in absence of follicular growth, although clinical experience is based on starting Orgalutran on day 5 or day 6 of stimulation.


Orgalutran and FSH should be administered approximately at the same time.
However, the preparations should not be mixed and different injection sites are to be used.
FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1). Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate size are present. Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).

Timing of last injection
Because of the half-life of ganirelix, the time between two Orgalutran injections as well as the time between the last Orgalutran injection and the hCG injection should not exceed 30 hours, as otherwise a premature LH surge may occur. Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation. When injecting Orgalutran in the afternoon the last Orgalutran injection should be given in the afternoon prior to the day of triggering ovulation.
Orgalutran has shown to be safe and effective in women undergoing multiple treatment cycles.
The need for luteal phase support in cycles using Orgalutran has not been studied. In clinical studies, luteal phase support was given according to study centres’ practice or according to the clinical protocol.


Special populations


Renal impairment
There is no experience on the use of Orgalutran in subjects with renal impairment, as they were excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe renal impairment (see section 4.3).


Hepatic impairment
There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were excluded from clinical studies. Therefore, the use of Orgalutran is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Paediatric population
There is no relevant use of Orgalutran in the paediatric population.


Method of administration
Orgalutran should be administered subcutaneously, preferably in the upper leg. The injection site should be varied to prevent lipoatrophy. The patient or her partner may perform the injections of Orgalutran themselves, provided that they are adequately instructed and have access to expert advice.
Air bubble(s) may be seen in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed.