ORGALUTRAN SOLUTION FOR INJECTION 0.25 MG/0.5 ML [SIN12165P]

Product Info

ORGALUTRAN SOLUTION FOR INJECTION 0.25 MG/0.5 ML

[SIN12165P]

4.1 Therapeutic indications

The prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

In clinical trials Orgalutran was used with recombinant follicle stimulating hormone (FSH).

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 patients undergoing COH. Controlled ovarian hyperstimulation with FSH may start at day 2 or 3 of menses. Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting in general on day 6 of FSH administration. In high responders an early LH rise may be prevented by starting Orgalutran treatment on day 5. The start of Orgalutran may be delayed in absence of follicular growth.

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 Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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). 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 hrs, 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 patients undergoing multiple treatment cycles.

Luteal phase support should be given according to the reproductive medical center's practice.

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.

4.3 Contraindications

♦ Hypersensitivity to the active substance or to any components (section 6.1 List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

♦ Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue

♦ Moderate or severe impairment of renal or hepatic function

♦ Pregnancy or lactation