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The PRIALT Access & Support Program^™

The PRIALT Access & Support Program can help determine insurance coverage and explore eligibility of financial options for appropriate patients.

After determining if a patient is appropriate for PRIALT, your office may enroll the patient in the program using the PRIALT Enrollment and Patient Authorization Form.

The PRIALT Access & Support Program can:

Conduct benefits investigations and re-verifications and confirm coverage.
Provide prior authorization support.
Explore financial assistance options for eligible patients.

It starts with enrolling your patient. Enrollment in the PRIALT Access & Support Program does not guarantee coverage and individual results may vary. For more information, contact the PRIALT Access & Support Program at 1-855-PRIALT1 (1-855-774-2581).

PRIALT Access & Support Program resources

Patient Enrollment and Authorization forms

Important Safety Information

PRIALT may cause serious side effects including psychiatric (mental) symptoms and problems thinking (confusion, memory problems, speech difficulties). The doctor should be called immediately if, while taking PRIALT, you: are confused or disoriented, are less alert, see or hear things that are not real (hallucinations), have changes in mood or consciousness.

Your doctor may stop your treatment with PRIALT, give you other medicines, or require you to be hospitalized if you experience any of these symptoms.

You should not be given PRIALT if you:

are allergic to PRIALT or any of its ingredients
have a condition or are receiving a treatment that would cause an injection in your spinal fluid to be unsafe
have or had a mental illness called psychosis (a loss of contact with reality, usually including delusions (false beliefs about what is taking place or who one is) or hallucinations (seeing or hearing things that aren't real))

PRIALT may cause or worsen depression, which increases the risk of suicide. People 65 years of age and older have a higher risk for confusion with PRIALT. Taking certain other medicines along with PRIALT may raise the risk of having problems with thinking or alertness. Tell your doctor about all the medicines you are taking.

Meningitis (inflammation of the protective membranes covering the brain and spinal cord) or other infections can happen if the infusion device becomes contaminated. Tell your doctor right away if you have fever, headache, stiff neck, changes in mental status (feeling tired, confused, disoriented), nausea, vomiting, and/or seizures as these may be symptoms of developing meningitis.

PRIALT may cause unconsciousness or reduced mental alertness. Avoid activities where you need to be alert, awake, and have full control of your body (activities like operating machinery or driving a car) during treatment with PRIALT.

Tell the doctor if you experience new or worsening muscle pain, soreness, weakness or if your urine is dark in color as this could be a sign of rare but serious muscle side effects.

You should also tell the doctor if you are pregnant, plan to become pregnant or if you are breastfeeding.

The most common side effects of PRIALT include dizziness, nausea, confusion and uncontrolled eye movements. These are not all the possible side effects of PRIALT. Talk to your doctor about any side effects you may be experiencing.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information, including BOXED Warning, and discuss with your doctor.

PRIALT 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.

CONTRAINDICATIONS

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 intrathecal 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.

WARNINGS AND PRECAUTIONS

Cognitive and Neuropsychiatric Adverse Reactions

Severe psychiatric symptoms and neurological impairment may occur during treatment. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT may cause or worsen depression, with the risk of suicide in susceptible patients.

In clinical trials, 12% of patients reported hallucinations; other acute psychiatric events included paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%). Patients with pretreatment psychiatric disorders may be at an increased risk. Management of psychiatric complications may need to include discontinuation of PRIALT, treatment with psychotherapeutic agents and/or short-term hospitalization.

In clinical trials, cognitive adverse reactions included confusion (33%), memory impairment (22%), speech disorder (14%), aphasia (12%), thinking abnormal (8%), and amnesia (1%). Cognitive impairment may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop, but other contributing causes must also be considered. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation. The elderly (≥65 years) are at higher risk for confusion. Concomitant use of central nervous system (CNS) depressants with PRIALT may have additive effects.

Meningitis and Other Infections

Meningitis can occur due to inadvertent contamination of the microinfusion device and other means. In clinical trials, the rate of meningitis was 3% (40 cases) in the PRIALT group using either internal or external microinfusion devices and 1% (1 case) with placebo. In patients with external microinfusion devices and catheters, meningitis occurred in 38 out of 41 patients (93%), 37 of whom received PRIALT and one who received placebo.

Patients, caregivers, and healthcare providers must be particularly vigilant for the signs and symptoms of meningitis including, but not limited to, fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures.

Strict aseptic procedures must be used during the preparation of the PRIALT solution and refilling of the microinfusion device.

Reduced Level of Consciousness

In clinical trials, 2% of PRIALT-treated patients became unresponsive or stuporous. If reduced levels of consciousness occur, discontinue PRIALT until the event resolves, and other etiologies (e.g., meningitis) must be considered.

Elevation of Serum Creatine Kinase

In clinical trials, serum creatine kinase (CK) levels above the upper limit of normal (ULN) were reported in 40% of patients, with 11% of patients having CK levels >3 times ULN. Incidences were higher during the first 2 months of treatment. Serum CK should be monitored periodically. In the setting of new neuromuscular symptoms, evaluate patients, obtain CK measurements, and if symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue the use of PRIALT.

Withdrawal From Opiates

PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates. To avoid withdrawal syndrome when opiate withdrawal is necessary, do not abruptly reduce or withdraw opioid medications.

Driving and Operating Machinery

Use of PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. Caution patients against engaging in hazardous activities that require complete mental alertness or motor coordination.

MOST COMMON ADVERSE REACTIONS

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.

ADDITIONAL IMPORTANT INFORMATION

PRIALT is not intended for intravenous (IV) administration. 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.

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