ziconotide acetate: clinical use

Prescribing considerations

• Restrict initiation and management to clinicians experienced in intrathecal administration and pump systems.
• Complete neuropsychiatric assessment before treatment, after initiation, during treatment and promptly if depressive symptoms emerge.
• Consider infection risk, catheter placement, pump suitability and uncertainty surrounding long-term local spinal toxicity.
• Use caution in renal or hepatic impairment because these groups have not been formally studied.
• Assess cognitive, psychiatric and neurological adverse effects alongside other possible causes.

Contraindications and cautions

• Hypersensitivity to ziconotide or an excipient
• Concomitant intrathecal chemotherapy
• Pre-existing history of psychosis with ziconotide
• History of suicidal attempt or suicidal ideation with ziconotide
• Infection at the microinfusion site
• Uncontrolled bleeding diathesis
• Spinal canal obstruction impairing cerebrospinal-fluid circulation

Monitoring

• Pain response and treatment tolerability
• Mental state, cognition, mood and suicidal thinking
• Level of consciousness and neurological function
• Catheter or pump-site infection and symptoms of meningitis
• Creatine kinase, particularly if muscle symptoms or progressive elevation occur
• Pump function and intrathecal-system integrity

Clinical pharmacology

Ziconotide is a synthetic 25-amino-acid analogue of omega-conopeptide MVIIA. It blocks presynaptic N-type voltage-sensitive calcium channels in spinal nociceptive pathways, reducing neurotransmitter release. Systemic exposure after intrathecal administration is low; the peptide is degraded by widely distributed peptidases and cleared from cerebrospinal fluid largely with normal CSF turnover.

Formulation and product differences

• The selected product is a clear, colourless, single-use solution for intrathecal infusion.
• Aseptic dilution, when required, uses preservative-free sodium chloride solution.
• Only compatible, accurate infusion-pump systems should be used; oxygen exposure can degrade ziconotide.

Solution for infusion

Route: Intravenous

Strengths: 100 micrograms/mL