leuprorelin acetate: clinical use

Prescribing considerations

• Confirm that the product matches the indication and patient group.
• Account for the initial sex-hormone flare, particularly where vertebral metastases, spinal-cord compression or urinary obstruction could worsen.
• Assess bone-health, metabolic, cardiovascular, depression, seizure and QT-prolongation risks.
• Ensure staff are familiar with the exact depot device.

Contraindications and cautions

• Hypersensitivity to leuprorelin, another GnRH analogue or a formulation excipient.
• For Prostap SR: pregnancy or possible pregnancy, breastfeeding and undiagnosed abnormal vaginal bleeding.
• For Staladex: women, children, previous orchidectomy, or sole treatment where prostate cancer has caused spinal-cord compression or spinal metastases.

Monitoring

• Clinical response, PSA and testosterone in prostate cancer; confirm testosterone suppression if response is suboptimal or absorption is questioned.
• Mood, depressive symptoms, neurological symptoms and signs of idiopathic intracranial hypertension.
• Glucose control, metabolic and cardiovascular risk factors.
• Bone-health risk and bone mineral density where clinically indicated.
• QT risk in susceptible patients or with other QT-prolonging medicines.
• For central precocious puberty, growth, pubertal development and unexpected persistent vaginal bleeding.

Clinical pharmacology

Leuprorelin is a synthetic GnRH agonist. Initial pituitary stimulation is followed by receptor down-regulation, reduced gonadotrophin secretion and suppression of testicular or ovarian steroid production.

Formulation and product differences

• Prostap SR is a powder-and-solvent prolonged-release suspension in a dual-chamber pre-filled syringe and may be given under the skin or into a muscle.
• Staladex is a preformed biodegradable solid implant in a pre-filled syringe, administered under the abdominal skin.
• The products have different licensed populations, indications and handling instructions and are not operationally interchangeable.

Implant

Route: Implant

Strengths: 11.25 mg