Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Luveris (Serono)

vials containing 75 IU as powder for reconstitution

Approved indication: gonadotrophin deficiency

Australian Medicines Handbook section 10.6.1

Some women with infertility have a severe deficiency of follicle stimulating hormone (FSH) and luteinising hormone (LH). To induce ovulation they can be treated with these hormones, but the preparations may be derived from urine. Urinary human chorionic gonadotrophin (HCG) is often used to mimic LH as it has a similar structure and action.

Genetic engineering has now enabled the production of recombinant LH. A double-blind trial randomised 259 infertile women to receive either recombinant LH or urinary HCG for the induction of ovulation. There were no significant differences between the treatments in the number of oocytes retrieved or the number of subsequent pregnancies.1

Lutropin alfa is a recombinant form of LH. It is genetically engineered using Chinese hamster ovary cells. There are only slight differences in the structure of lutropin and the hormone derived from urine.

The recommended regimen for lutropin is designed to assist the development of one follicle, but HCG is still used to induce ovulation. Patients have daily subcutaneous injections of lutropin and FSH. The patient's response is assessed by oestrogen secretion and measuring the follicle size with ultrasound. When an optimal response is obtained HCG is given 24-48 hours after the previous injection of lutropin. Approximately 70% of the women taking a daily lutropin dose of 75 IU respond to this regimen.

The response has to be carefully monitored because of the risk of ovarian hyperstimulation syndrome. Other adverse effects include injection site reactions, abdominal or pelvic pain, breast pain and nausea.

Infertility due to gonadotrophin deficiency is rare, so lutropin has been studied in relatively few patients. It will initially be reserved for women with a severe deficiency (LH less than 1.2 IU/L) because those with a less severe deficiency may respond to FSH alone.

References

  1. European Recombinant LH Study Group. Recombinant human luteinizing hormone is as effective as, but safer than, urinary human chorionic gonadotropin in inducing final follicular maturation and ovulation in in vitro fertilization procedures: results of a multicenter double-blind study. J Clin Endocrinol Metab 2001;86:2607-18.