ORGALUTRAN

What it is

ORGALUTRAN contains ganirelix acetate, a synthetic decapeptide with high antagonistic activity to gonadotropin releasing hormone (GnRH). Each prefilled syringe contains 250 µg ganirelix (as acetate) in 0.5 mL. ORGALUTRAN is presented as a sterile, ready-to-use, clear and colourless aqueous solution intended for subcutaneous administration.

Approved indications

— Prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.

Dosing overview

ORGALUTRAN 0.25 mg should be injected subcutaneously once daily, starting from day 5 or day 6 of FSH administration depending on the level of ovarian response. ORGALUTRAN should not be mixed with FSH but both preparations should be administered approximately at the same time. Daily treatment with ORGALUTRAN should be continued up to the day that sufficient follicles of adequate size are present. Because of the half-life of ganirelix, the time between two ORGALUTRAN injections and between the last ORGALUTRAN injection and the hCG injection should not exceed 30 hours, as otherwise a premature LH surge may occur.

Key safety warnings

Cases of hypersensitivity reactions (both generalised and local) have been reported with ORGALUTRAN, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema, and urticaria. Special care should be taken in women with signs and symptoms of active allergic conditions. Administration of ORGALUTRAN is not advised to patients with currently severe allergic symptoms. Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important. Ganirelix acetate may cause a skin reaction (in 10–15 per cent of patients moderate or severe redness with or without swelling was reported) at the site of injection, which normally disappears within 4 hours after administration.

Contraindications

ORGALUTRAN is contraindicated in patients with hypersensitivity to the active substance or to any of the components, hypersensitivity to GnRH or any other GnRH analogue, pregnancy or lactation, and moderate to severe renal impairment and hepatic impairment.

Regulatory history

ORGALUTRAN ganirelix 250 microgram per 0.5 mL (as acetate) injection prefilled syringe was first listed on the ARTG on 19 March 2001.