CETROTIDE

What it is

CETROTIDE contains cetrorelix (as acetate), with each vial containing 250 microgram of cetrorelix. CETROTIDE is a lyophilised powder for injection. CETROTIDE is for subcutaneous injection into the lower abdominal wall. Cetrorelix is a LHRH antagonist. Cetrorelix competes with the binding of endogenous LHRH to pituitary receptors and controls the secretion of the gonadotrophins luteinising hormone (LH) and follicle stimulating hormone (FSH).

Approved indications

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

Dosing overview

The contents of 1 vial of CETROTIDE are to be administered once daily, at 24-hour intervals, either in the morning or in the evening. When administered in the morning, treatment with CETROTIDE should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotrophins and is to be continued throughout the gonadotrophin treatment period including the day of ovulation induction. When administered in the evening, treatment with CETROTIDE should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotrophins and is to be continued throughout the gonadotrophin treatment period until the evening prior to the day of ovulation induction. Due to losses during reconstitution and administration, only 210 microgram can be administered from each vial.

Key safety warnings

Ovarian hyperstimulation syndrome (OHSS) can occur during or following ovarian stimulation as an intrinsic risk of the stimulation procedure with gonadotrophins, and as OHSS can be life-threatening, the condition should be managed by a specialist experienced in the field. Caution is advised in patients with hypersensitivity to GnRH, and special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. The treatment with CETROTIDE is not advised in women with severe allergic conditions. There is limited experience with the administration of CETROTIDE during repeated ovarian stimulation procedures, and CETROTIDE should be used in repeated cycles only after a careful risk/benefit evaluation.

Contraindications

CETROTIDE is contraindicated in patients with hypersensitivity to cetrorelix acetate or any structural analogues of GnRH, extrinsic peptide hormones or mannitol; pregnancy and lactation; post-menopausal women; and patients with moderate and severe renal and hepatic impairment.

PBS listing

CETROTIDE powder for injection 250 micrograms (as acetate) with diluent is listed on the PBS as 1 item with streamlined restriction, at an ex-manufacturer price of A$39.40.

Regulatory history

CETROTIDE was first registered on the ARTG on 19 December 2000.