LUVERIS

What it is

LUVERIS contains lutropin alfa, a recombinant human luteinising hormone (r-hLH) derived from a Chinese Hamster Ovary cell line that has been modified by the addition of human genes encoding the LH α- and β-chains. Each vial contains 75 IU of lutropin alfa as lyophilised powder. LUVERIS is intended for co-administration with follitropin alfa as subcutaneous injection after reconstitution with sterile water for injections.

Approved indications

— Stimulation of follicular development in women with severe LH and FSH deficiency, in association with a recombinant follicle stimulating hormone (FSH) preparation.

Dosing overview

A recommended regimen commences at 75 IU of LUVERIS daily with 75–150 IU FSH. The minimum effective dose of LUVERIS is 37.5 IU; however, dose titration is recommended according to individual patient response. Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response. Clinical studies have employed doses of up to 225 IU of lutropin alfa and 150 IU follitropin alfa per day to induce follicular development. LUVERIS should be given as a course of daily injections concomitantly with FSH and is intended for daily subcutaneous administration.

Key safety warnings

Mild to moderate ovarian hyperstimulation syndrome (OHSS) is a common adverse effect of ovulation induction with gonadotrophins. Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotrophins, high absolute or rapidly rising serum oestradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in assisted reproductive technology cycles. Adherence to recommended LUVERIS and FSH dosage and regimen of administration, and monitoring of stimulation cycles by ultrasound scans and oestradiol measurements, is recommended to minimise the risk of ovarian hyperstimulation and identify risk factors early. As OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event, patients should be followed for at least two weeks after hCG administration. In patients undergoing induction of ovulation, the incidence of multiple pregnancy is increased compared with natural conception. The patient should be advised of the potential risk of multiple births before starting treatment. In women with recent or ongoing thromboembolic disease or women with recognised risk factors for thromboembolic events, treatment with gonadotrophins may further increase the risk. In these women, the benefits of gonadotrophin administration need to be weighed against the risks.

Contraindications

LUVERIS is contraindicated in patients with hypersensitivity to gonadotrophins or to any of the excipients, ovarian, uterine or mammary carcinoma, active untreated tumours of the hypothalamus or pituitary gland, ovarian enlargement or cyst of unknown aetiology, gynaecological haemorrhages of unknown origin, and pregnancy and lactation.

PBS listing

LUVERIS powder for injection 75 I.U. with solvent is listed on the PBS as one item with streamlined restriction at an ex-manufacturer price of A$93.34.

Regulatory history

LUVERIS was first registered on the Australian Register of Therapeutic Goods on 24 March 2003 (ARTG 95042). In March 2016, the PBAC recommended amending the maximum PBS quantities for the current Section 100 listings of follitropin alfa + lutropin alfa and lutropin alfa from seven to 14, consistent with the maximum PBS quantities available for other drugs used for ovarian stimulation.