PERGOVERIS

What it is

Pergoveris contains follitropin alfa (recombinant human follicle stimulating hormone) and lutropin alfa (recombinant human luteinising hormone) produced by genetically engineered Chinese Hamster Ovary cells. Pergoveris is presented as a sterile solution for injection in a cartridge, pre-assembled in a disposable pen.

Approved indications

— Stimulation of follicular development in women with severe LH and FSH deficiency.

Dosing overview

A treatment regimen commences with the recommended dose of Pergoveris containing 150 IU recombinant human follicle stimulating hormone and 75 IU recombinant human luteinising hormone once daily. Pergoveris is intended for daily subcutaneous administration. Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response. Dose titration is recommended according to individual patient response. When an optimal response is obtained, a single injection of 250 microgram of recombinant hCG or 5,000 IU to 10,000 IU hCG should be administered 24 to 48 hours after the last Pergoveris injection.

Key safety warnings

Ovarian Hyperstimulation Syndrome (OHSS) is a condition that can manifest itself with various degrees of severity, comprising marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal cavity, pleural, and rarely, in the pericardial cavities. Mild to moderate OHSS is a common adverse effect of ovulation induction with gonadotrophins; the risk should be considered and discussed with women prior to treatment. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction. Adherence to recommended Pergoveris and FSH dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of OHSS; monitoring of stimulation cycles by ultrasound scans, as well as oestradiol measurements, is recommended to identify risk factors early. In patients undergoing induction of ovulation, the incidence of multiple pregnancy is increased compared with natural conception; multiple pregnancies, especially higher order, carry an increased risk of adverse maternal and perinatal outcomes, and 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 generally recognised risk factors for thromboembolic events, treatment with gonadotrophins may further increase the risk for aggravation or occurrence of such events, and in these women, the benefits of gonadotrophin administration need to be weighed against the risks.

Contraindications

Pergoveris is contraindicated in patients with hypersensitivity to gonadotrophins or to any of the excipients, ovarian, uterine or mammary carcinoma, 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

Pergoveris is listed on the PBS for stimulation of follicular development under Section 100 (IVF program) with Authority Required (streamlined) restriction. Pergoveris is available in three strengths: 300 IU follitropin alfa and 150 IU lutropin alfa in 0.48 mL solution; 450 IU follitropin alfa and 225 IU lutropin alfa in 0.72 mL solution; and 900 IU follitropin alfa and 450 IU lutropin alfa in 1.44 mL solution.

Regulatory history

A powder formulation of Pergoveris was first listed on the ARTG on 19 November 2009. The solution for injection formulation was first registered on 29 June 2018, with three strengths listed simultaneously. The PBAC recommended Pergoveris in November 2018 for stimulation of follicular development as a new form listing under Section 100 (IVF program) with streamlined authority required restriction. In November 2024, the PBAC recommended increasing the maximum quantity from 2 to 4 pens per prescription and removing the requirement for dose titration.