FEMVI

What it is

FEMVI contains cetrorelix (as acetate), with each vial containing 250 micrograms of cetrorelix. FEMVI is a lyophilised powder for injection. FEMVI is for subcutaneous injection into the lower abdominal wall.

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 FEMVI are to be administered once daily, at 24-hour intervals, either in the morning or in the evening. For morning administration, treatment with FEMVI 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. For evening administration, treatment with FEMVI 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, 210 micrograms of cetrorelix can be administered from each vial.

Key safety warnings

During or following ovarian stimulation, ovarian hyperstimulation syndrome (OHSS) can occur as an intrinsic risk of the stimulation procedure with gonadotrophins. 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. Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. The treatment with FEMVI is not advised in women with severe allergic conditions. There is limited experience with the administration of FEMVI during a repeated ovarian stimulation procedure. Therefore, FEMVI should be used in repeated cycles only after a careful risk/benefit evaluation.

Contraindications

FEMVI 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.

Regulatory history

FEMVI was first approved on 19 December 2000. FEMVI Cetrorelix 250 micrograms/mL Solution for Injection Prefilled Syringe (ARTG 444616) was first listed on 5 March 2025.