ganirelix acetate: clinical use

Prescribing considerations

• Specialist prescribing is required within a controlled ovarian-stimulation programme.
• Assess active allergic disease; treatment is not advised with severe allergic conditions because clinical experience is lacking.
• Safety and efficacy have not been established below 50 kg or above 90 kg.
• Consider risks from the overall assisted-reproduction programme, including OHSS and ectopic pregnancy.

Contraindications and cautions

• Hypersensitivity to ganirelix or an excipient
• Hypersensitivity to GnRH or another GnRH analogue
• Moderate or severe renal impairment
• Moderate or severe hepatic impairment
• Pregnancy
• Breastfeeding

Monitoring

• Monitor ovarian response according to the specialist protocol, particularly follicle number and size.
• Remain alert for premature LH rises, hypersensitivity and OHSS.
• Arrange early ultrasound confirmation of an intrauterine pregnancy because ectopic pregnancy risk may be increased in the treated population.

Clinical pharmacology

A synthetic peptide GnRH antagonist producing rapid, reversible suppression of pituitary gonadotrophins. It is rapidly absorbed after subcutaneous injection and eliminated mainly through faeces, with a smaller urinary contribution.

Formulation and product differences

• The Ovamex product is a clear, colourless, ready-to-use aqueous solution in a single-use glass pre-filled syringe with an attached needle.
• It contains mannitol, water for injections and acetic acid, with sodium hydroxide or acetic acid for pH adjustment; it is essentially sodium-free.
• It requires no special storage conditions and must not be mixed with other medicines.

Injection

Route: Parenteral

Strengths: 0.25 mg/0.5 mL