GANIRELIX-AFT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.25 MG/0.5 ML [SIN17558P]

Product Info

GANIRELIX-AFT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.25 MG/0.5 ML

[SIN17558P]

Indication

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, ganirelix injection was used with recombinant follicle stimulating hormone (FSH).

Dosing

4.2 DOSE AND METHOD OF ADMINISTRATION

Ganirelix-AFT should only be prescribed by a specialist experienced in the treatment of infertility.

Posology

Ganirelix-AFT 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. Ganirelix-AFT (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 Ganirelix-AFT treatment on day 5. The start of Ganirelix-AFT may be delayed in absence of follicular growth.

Ganirelix-AFT 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 Ganirelix-AFT 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 Ganirelix-AFT injections as well as the time between the last Ganirelix-AFT injection and the hCG injection should not exceed 30 hrs, as otherwise a premature LH surge may occur. Therefore, when injecting Ganirelix-AFT in the morning, treatment with Ganirelix-AFT should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.

When injecting Ganirelix-AFT in the afternoon the last Ganirelix-AFT injection should be given in the afternoon prior to the day of triggering ovulation.

Ganirelix injection 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

Ganirelix-AFT 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 Ganirelix-AFT 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.

Contraindications

4.3 CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the components including elastomer or rubber (see Section 6.1 List of Excipients and Section 6.5 Nature and Contents of Container – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Hypersensitivity to GnRH or any other GnRH analogue

• Pregnancy or lactation

• Moderate to severe renal impairment or hepatic impairment