Ziconotide

What it is used for

PRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.

Who should not take it

• PRIALT is contraindicated in patients with a known hypersensitivity to ziconotide or any of its formulation components.
• PRIALT is contraindicated in patients with any other concomitant treatment or medical condition that would render intrathecal administration hazardous. Contraindications to the use of intrathecal analgesia include the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of CSF.
• PRIALT is contraindicated in patients with a pre-existing history of psychosis.

Other medicines and interactions

Formal PK drug-drug interaction studies have not been performed with PRIALT. As ziconotide is a peptide, it is expected to be completely degraded by endopeptidases and exopeptidases (Phase I hydrolytic enzymes) widely located throughout the body, and not by other Phase I biotransformation processes (including the cytochrome P450 system) or by Phase II conjugation reactions. Thus, intrathecal administration, low plasma ziconotide concentrations, and metabolism by ubiquitous peptidases make metabolic interactions of other drugs with ziconotide unlikely. Further, as ziconotide is not highly bound in plasma (approximately 50%) and has low plasma exposure following intrathecal administration, clinically relevant plasma protein displacement reactions involving ziconotide and co-administered medications are unlikely.

Over 90% of patients treated with intrathecal PRIALT used systemic opiates and in the slow titration study, 98% of patients received opioids.

The combination of PRIALT with intrathecal opiates has not been studied in placebo-controlled clinical trials and is not recommended.

Storing it

• Refrigerate PRIALT during transit.
• Store PRIALT at 2°C to 8°C (36°F to 46°F).
• PRIALT, once diluted aseptically with saline, may be stored at 2°C to 8°C for 24 hours.
• Do NOT freeze PRIALT.
• Protect from light.