MENOPUR

What it is

Menopur is human menopausal gonadotrophin (hMG) powder and solvent for injection. Highly purified hMG originates from the urine of postmenopausal women and contains follicle stimulating hormone (FSH), luteinising hormone (LH) and human chorionic gonadotrophin (hCG), providing FSH bioactivity and LH bioactivity in a 1:1 ratio. Menopur is available as powder for injection with solvent in 600 IU and 1200 IU strengths, and also as pre-filled multidose pens. Menopur is intended for subcutaneous injection after reconstitution with the solvent provided.

Approved indications

— Anovulatory infertility, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with clomiphene citrate. — Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).

Dosing overview

There are great inter-individual variations in the response of the ovaries to exogenous gonadotrophins, making it impossible to set a uniform dosage scheme. Therefore, the dosage should be adjusted individually depending on the ovarian response. Treatment with Menopur should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The first injection of Menopur should be performed under direct medical supervision.

Key safety warnings

The active ingredient in Menopur is extracted from human urine. Therefore, the risk of transmission of a pathogen (known or unknown) cannot be completely excluded. Ovarian Hyperstimulation Syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement and a syndrome that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities. Severe cases of OHSS may present with abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea. OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after the hCG administration. Women with polycystic ovarian syndrome (PCOS) are at higher risk of developing OHSS. Multiple pregnancy, especially high order, carries an increased risk of adverse maternal and perinatal outcomes. In patients undergoing ovulation induction with gonadotrophins, the incidence of multiple pregnancies is increased compared with natural conception. Women with generally recognised risk factors for thromboembolic events, such as personal or family history, severe obesity (Body Mass Index > 30 kg/m²) or thrombophilia may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotrophins.

Contraindications

Menopur is contraindicated in pregnancy and lactation. Menopur is contraindicated in patients with hypersensitivity to the active substance or any of the excipients used in the formulation. Menopur is contraindicated in women who have tumours of the pituitary gland or hypothalamus, ovarian, uterine or mammary carcinoma, gynaecological haemorrhage of unknown aetiology, or ovarian cysts or enlarged ovaries not due to polycystic ovarian disease.

PBS listing

Menopur powder for injection is listed on the PBS in two strengths: 600 IU with solvent and 1200 IU with solvent. Both items have streamlined restrictions, with ex-manufacturer prices of A$239.69 and A$479.39 respectively.

Regulatory history

Menopur 600 IU and 1200 IU powder for injection with solvent were first registered on the ARTG on 13 September 2011. An AusPAR was issued on 25 July 2011, and the TGA approved Menopur for the treatment of anovulatory infertility and for controlled ovarian hyperstimulation in assisted reproductive technologies. Pre-filled multidose pens in 600 IU and 1200 IU strengths were registered on the ARTG on 24 January 2022. In July 2022, the PBAC recommended Menopur for Assisted Reproductive Technology, and in July 2024 extended this recommendation for an additional 12 months.