PRIALT is the only non-opioid intrathecal (IT) therapy approved for severe chronic pain.

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

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:
The most frequently reported adverse events (25%) in the 1,254 patients (662 patient years) in  clinical trials were dizziness, nausea, confusional state, and nystagmus. Serious adverse events and discontinuation of PRIALT for adverse events are less frequent when the drug is slowly titrated over 21 days than with a faster titration schedule.