Evaluated in more than 1,200 patients¹

• Administered as a continuous IT infusion in 1,254 patients in clinical trials including three double-blind, placebo-controlled multicenter studies and four open-label, long-term studies
• The most frequently reported adverse events (>25%) in clinical trials were dizziness, nausea, confusional state, and nystagmus (N=1,254)
• Serious adverse events and discontinuation were reported to be less frequent when the drug was slowly titrated
• Duration of treatment has ranged from a one-hour IT infusion to treatment lasting more than 7.5 years

Important Safety Information

Contraindications:

PRIALT is contraindicated in patients with a known hypersensitivity to ziconotide or any of its formulation components and in patients with any other concomitant treatment or medical condition that would render IT administration hazardous.

Patients with a pre-existing history of psychosis should not be treated with ziconotide. Contraindications to the use of IT analgesia include conditions such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of CSF.

WARNINGS: Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Patients with a pre-existing history of psychosis should not be treated with PRIALT. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.

Precautions:

Meningitis and Other Infections: Meningitis can occur due to inadvertent contamination of the microinfusion device and other means. Patients, caregivers, and healthcare providers must be particularly vigilant for the signs and symptoms of meningitis.

Cognitive and Neuropsychiatric Adverse Events: Use of PRIALT has been associated with CNS-related adverse events, including psychiatric symptoms, cognitive impairment, and decreased alertness/unresponsiveness. The PRIALT dose should be reduced or discontinued if signs or symptoms of cognitive impairment develop, but other contributing causes should also be considered.

Reduced Level of Consciousness: Patients have become unresponsive or stuporous while receiving PRIALT. PRIALT should be discontinued until the event resolves, and other etiologies should be considered.

Elevation of Serum Creatine Kinase (CK-MM): In clinical studies (mostly open label), 40% of patients had serum creatine kinase (CK) levels above the upper limit of normal (ULN), and 11% had CK levels that were > 3 times the ULN. Most patients who experienced elevations in CK, even for prolonged periods of time, did not have limiting side effects. It is recommended that physicians monitor serum CK in patients undergoing treatment with PRIALT periodically.

Adverse Reactions:

Please see accompanying full prescribing information including boxed WARNING and important safety information.

Reference: 1. PRIALT^® (ziconotide intrathecal infusion) Prescribing Information.