Orgalutran

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.

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. 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. 1). 3 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. 3). Hepatic impairment There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were excluded from clinical studies.

Summary of the safety profile The table below shows all adverse reactions in women treated with Orgalutran in clinical studies using recFSH for ovarian stimulation. The adverse reactions with Orgalutran using corifollitropin alfa for ovarian stimulation are expected to be similar.

Tabulated list of adverse reactions The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100). The frequency of hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance.

System organ class Frequency Adverse reaction Immune system disorders Very rare Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria)1 Worsening of a pre-existing eczema2 Nervous system disorders Uncommon Headache Gastrointestinal disorders Uncommon Nausea General disorders and administration site conditions Very common Local skin reaction at the site of injection (predominantly redness, with or without swelling)3 Uncommon Malaise 1 Cases have been reported, as early as with the first dose, among patients administered Orgalutran.

2 Reported in one subject after the first Orgalutran dose. 3 In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12 % in Orgalutran treated patients and 25 % in patients treated subcutaneously with a GnRH agonist.

The local reactions generally disappear within 4 hours after administration. 4), ectopic pregnancy and spontaneous abortion. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 6 professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Hypersensitivity reaction Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalised and local), have been reported with Orgalutran, as early as with the first dose, during post-marketing surveillance.

8). If a hypersensitivity 4 reaction is suspected, Orgalutran should be discontinued and appropriate treatment administered. In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.

Ovarian hyperstimulation syndrome (OHSS) Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.

Ectopic pregnancy Since infertile women undergoing assisted reproduction, and particularly in vitro fertilisation (IVF), often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

Congenital malformations The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.

In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.

2). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.

1. − Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue. − Moderate or severe impairment of renal or hepatic function. − Pregnancy or breast-feeding.