PUREGON

What it is

PUREGON contains follitropin beta, a recombinant human follicle-stimulating hormone (recFSH). Follitropin beta is produced by recombinant-DNA technology in a Chinese hamster ovary cell line transfected with the human FSH subunit genes. PUREGON is a solution for injection presented as a clear, colourless solution. PUREGON is available in three strengths: cartridges containing 300 IU, 600 IU or 900 IU of follitropin beta. PUREGON solution for injection in cartridges has been developed for use in the PUREGON Pen and should be administered subcutaneously.

Approved indications

— Anovulatory infertility in women. — Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (for example, in vitro fertilisation and related procedures) in women. — Treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism in men.

Dosing overview

Treatment with PUREGON should be initiated under the supervision of a physician experienced in the treatment of fertility problems. In women with anovulation or defective follicle ripening, dosage should be adjusted individually depending on ovarian response, which requires ultrasound assessment of follicular development. A sequential treatment scheme is recommended starting with daily administration of 50 IU PUREGON, with the starting dose maintained for at least seven days. If there is no ovarian response, the daily dose is then gradually increased until follicle growth and/or plasma estradiol levels indicate an adequate response, with a daily ascent rate of 40–100% considered optimal. For controlled ovarian hyperstimulation in medically assisted reproduction, a starting dose of 100–225 IU is recommended for at least the first four days, after which the dose may be adjusted individually based on ovarian response. Stimulation of follicular growth is generally achieved by daily administration of 75–300 IU FSH. In men, 75 IU FSH injections are given daily or 2–3 times a week, combined with a simultaneous dose of 1000–2000 IU hCG, 2–3 times a week. Treatment should be continued for at least three months before any improvement in spermatogenesis can be expected.

Key safety warnings

Mild to moderate uncomplicated ovarian enlargement occurs in approximately 20% of those treated with PUREGON and hCG and generally regresses without treatment within two or three weeks. Ovarian Hyperstimulation Syndrome (OHSS) is a distinct medical event that may progress rapidly to become serious, characterised by a dramatic increase in vascular permeability which can result in rapid accumulation of fluid in the peritoneal cavity, thorax and potentially the pericardium. Severe OHSS may be life-threatening. Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration. Ovarian torsion has been reported after treatment with gonadotrophins, including PUREGON, and may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Multiple pregnancies and births have been reported for all gonadotrophin treatments, including PUREGON. Multiple gestations, especially high order, carry an increased risk of adverse maternal and perinatal outcomes. Thromboembolic events have been reported following treatment with gonadotrophins, including PUREGON. In women with generally recognised risk factors for thromboembolic events such as personal or family history, severe obesity or thrombophilia, treatment with gonadotrophins may further increase this risk.

Contraindications

PUREGON is contraindicated in the following situations: hypersensitivity to the active substance or any of the excipients; tumours of ovarium, breasts, uterus, testes, hypothalamus and pituitary gland; pregnancy; unexplained vaginal bleeding; ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease. PUREGON is also contraindicated when an effective response cannot be obtained, such as primary ovarian failure as indicated by high levels of FSH. Primary testicular failure is a contraindication in men. PUREGON should not be used in the elderly or in children.

PBS listing

PUREGON 900 IU solution for injection in 1.08 mL multi-dose cartridge is listed on the PBS with streamlined and restricted restriction types, at an ex-manufacturer price of A$265.09. PUREGON 600 IU solution for injection in 0.72 mL multi-dose cartridge is listed on the PBS with restricted and streamlined restriction types, at an ex-manufacturer price of A$178.32. PUREGON 300 IU solution for injection in 0.36 mL multi-dose cartridge is listed on the PBS with restricted and streamlined restriction types, at an ex-manufacturer price of A$91.38.

Regulatory history

PUREGON follitropin beta (rch) 600 IU and 300 IU solution for injection cartridges were first listed on the ARTG on 15 November 2001. PUREGON follitropin beta (rch) 900 IU solution for injection cartridge was first listed on the ARTG on 10 October 2005.