ORGALUTRAN 0.25 MG 0.5ML

Orgalutran 25 mg 5 ml

Product Description:

• Prevention of premature luteinizing hormone (LH) elevation in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive technologies (ART).
• In clinical trials, Orgalutran was used in combination with recombinant follicle-stimulating hormone (FSH).

Dosage/direction for use:

• Orgalutran should only be prescribed by a specialist experienced in treating infertility.
• Posology: Orgalutran is used to prevent premature LH surges in patients undergoing COH.
• Controlled ovarian stimulation with FSH may begin on the second or third day of menstruation.
• Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 6 of FSH administration. In elevated responders, an early rise in LH can be prevented by initiating treatment with Orgalutran on day 5.
• Initiation of Orgalutran may be delayed in the absence of follicular growth.
• Orgalutran and FSH should be administered at approximately the same time.
• However, preparations should not be mixed and different injection sites should be used.
• FSH dose adjustments should be based on the number and size of the developing follicles, not on the amount of oestradiol circulating (see Pharmacology: Pharmacodynamics under Procedures).
• Daily treatment with Orgalutran should be continued until the day that there are sufficient follicles of adequate size.
• The final maturation of the follicles can be induced by the administration of human chorionic gonadotropin (hCG).
• Because of the half-life of ganirelix, the time between two injections of Orgalutran as well as the time between the last injection of Orgalutran and one injection of hCG should not exceed 30 hours, otherwise premature LH influx may occur.
• Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued for the entire course of treatment including the day ovulation begins.
• Orgalutran has been shown to be safe and effective in patients undergoing multiple treatment cycles.
• Luteal phase support should be provided in accordance with Reproductive Medicine Center practices.

How to take:

• Orgalutran should be administered subcutaneously, preferably in the upper leg.
• The injection site should be varied to prevent fat atrophy. The patient or her partner may administer the Orgalutran injection themselves, provided they are adequately instructed and have access to expert advice.
• Air bubble(s) can be seen in the prefilled syringe. This is expected, and there is no need to remove the air bubble(s).