NAVIGATOR Reimbursement and Access Program™ is an enhanced program that may help give more of your patients access to PRIALT® (ziconotide) intrathecal infusion–while simplifying the delivery and payment process for your practice.
Download these forms to enroll your practice and patients in this new program:
For more information, contact your Jazz Pharmaceuticals sales representative or call 1.855.PRIALT1 (774.2581).
INDICATION STATEMENT
PRIALT® (ziconotide) intrathecal infusion is indicated for the management of severe chronic pain in adult 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.
IMPORTANT SAFETY INFORMATION
WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS
PRIALT is contraindicated in patients with a pre-existing history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.
PRIALT is contraindicated in patients with:
- A known hypersensitivity to ziconotide or any of its formulation components
- Any other concomitant treatment or medical condition that would render IT administration hazardous, such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of cerebrospinal fluid (CSF)
- A pre-existing history of psychosis
The following medical conditions have been observed in patients on PRIALT: cognitive and neuropsychiatric adverse reactions, meningitis and other infections, reduced level of consciousness, and elevation of serum creatine kinase.
The most frequently reported adverse reactions (≥25%) in clinical trials (n=1254 PRIALT-treated patients) were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.
PRIALT should be administered intrathecally (IT) by or under the direction of a physician. PRIALT is not intended for intravenous (IV) administration. See full Prescribing Information for dosing and administration instructions.
PRIALT is for use only in the Medtronic SynchroMed® II Infusion System and the CADD-Micro Ambulatory Infusion Pump.
Please see full Prescribing Information, including BOXED Warning, for additional important safety information.