follitropin alfa: clinical use

Prescribing considerations

• Initiate and supervise within specialist fertility services with appropriate monitoring facilities.
• Assess infertility causes and contraindications to pregnancy before treatment.
• Monitor for poor or excessive response.
• Record brand and batch number for traceability.
• Discuss risks including OHSS, multiple pregnancy, pregnancy loss and ectopic pregnancy.

Contraindications and cautions

• Hypersensitivity to follitropin alfa, FSH or a formulation ingredient
• Hypothalamic or pituitary tumour
• Unexplained ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease
• Unexplained gynaecological bleeding
• Ovarian, uterine or breast carcinoma
• Primary ovarian failure, reproductive-organ malformation or uterine fibroids incompatible with pregnancy
• Primary testicular insufficiency

Monitoring

• Ovarian follicle number and size by ultrasound, preferably with serum estradiol
• Clinical features and risk factors for OHSS and thromboembolism
• Relevant endocrine abnormalities before ovarian stimulation
• Semen analysis when assessing response in men

Clinical pharmacology

Recombinant human FSH binds FSH receptors and promotes ovarian follicular development. In men with gonadotrophin deficiency, concomitant hCG enables stimulation of spermatogenesis.

Formulation and product differences

• Ovaleap is a multidose cartridge for the dedicated Ovaleap Pen.
• Bemfola is a single-use pre-filled pen that is discarded after injection.
• Storage, handling and device instructions differ by brand; pens and cartridges are not interchangeable.