Prescribing Information

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Compass Rose

As of May 20, 2013, access to PRIALT will only be available
through the NAVIGATOR Reimbursement and Access Program™.

Go to www.navigatorprogram.com »

This change is designed to simplify the payment and reimbursement process for practices while helping to reduce out-of-pocket expenses for a majority of their enrolled patients.*

The NAVIGATOR Program provides physicians with a single point of access for purchase and reimbursement of PRIALT. It also may help reduce out-of-pocket expenses for patients.

  • >90% of patients have PRIALT coverage1
    • Based on 1000+ patient insurance verifications
  • >90% of patients had $0 copay2
    • Based on 740 shipments
    • Copay amounts include patients receiving financial assistance
  • For certain commercially insured patients, practices have the
    option of Direct Billing or Buy and Bill (BnB)

To enroll, visit www.navigatorprogram.com or call 1.855.PRIALT1 (774.2581).

If you are a pharmacy, we thank you for your support of PRIALT patients. Please direct your customers to call 1.855.PRIALT1 (774.2581) between the hours of 8 am and 8 pm ET to speak with a customer service representative who can assist with enrollment.

* Insurance coverage and plans may vary. This is general information only and is not a guarantee of any coverage of reimbursement outcome. All treatment decisions rest solely with the treating physician or qualified healthcare professional.

  1. Data on file. Jazz Pharmaceuticals, Inc. (Based on 1048 patient insurance verifications completed from 10.3.12 through 3.7.13.)
  2. Data on file. Jazz Pharmaceuticals, Inc. (Based on 740 shipments from 10.8.12 through 3.19.13.)

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 preexisting 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 preexisting 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.