ORGALUTRAN Solution for injection Ref.[9568] Active ingredients: Ganirelix

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.

Overdose in humans may result in a prolonged duration of action.

No data on acute toxicity of Orgalutran in humans are available. Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic adverse reactions. In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/kg, respectively.

In case of overdose, Orgalutran treatment should be (temporarily) discontinued.

Shelf life: 3 years.

Do not freeze.

Store in the original package in order to protect from light.

Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, aqueous solution closed with a rubber piston that does not contain latex. Each pre-filled syringe is affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into contact with the needle. (See section 4.4.)

Supplied in cartons containing 1 or 5 pre-filled syringes.

Not all pack sizes may be marketed.

Inspect the syringe before use. Use only syringes with clear, particle-free solutions and from undamaged containers.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.