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Start your patients on the only non-opioid intrathecal option

When to prescribe PRIALT, the only FDA-approved non-opioid intrathecal treatment for severe chronic pain

According to the 2016 Polyanalgesic Consensus Conference (PACC) guidelines, intrathecal therapy now occupies the same line as spinal cord stimulation in the management of severe chronic pain, with important caveats regarding your patient’s condition1:

  • Before neurostimulation in cases of active cancer-related pain that is mechanical and likely to spread
  • At the same time as neurostimulation in adults with non-cancer pain
  • After neurostimulation for non-cancer pain if the pain is isolated and unlikely to spread1

PRIALT is recommended first-in-pump for cancer and non-cancer patients by the 2016 PACC guidelines.1

Escalation Diagram

Steps for starting your patient on PRIALT

Establish patient expectations of intrathecal therapy:

  • Explain that PRIALT is FDA-approved and PACC guideline-recommended for adults with severe chronic pain1,2
  • Discuss the goals of treatment and that it may take time to respond2
  • Educate patients on potential adverse reactions and monitor their response to treatment2
  • Recommend psychological evaluation of patients to monitor for issues1
  • Continually monitor their progress and assess their response to treatment, including improvements to pain severity2

Titration: start low and go slow

Studies show that tolerability improved when the patient’s PRIALT dose was started low and slowly titrated upward. Rapid titration schedules resulted in less tolerability and substantially more frequent adverse events. Slower titration may result in fewer serious adverse events and discontinuations for adverse reactions.1,2

Titration Diagram Titration Diagram

Initiate1,4

A starting dose for continuous intrathecal delivery of 0.5-1.2 mcg/day—consistent with the PRIALT Prescribing Information—is recommended in the PACC guidelines,*† but initial dosing should not exceed 2.4 mcg/day (0.1 mcg/hour).

Titrate2

Titrate gradually, by no more than 2.4 mcg/day and no more than 2 to 3 times per week. Lower and less frequent dose increases may be used. The daily dose should not exceed 19.2 mcg/day.1,2,3

Monitor2

Ongoing assessment is key to managing outcomes. Adjust the dosage according to your patient’s pain severity, response to the therapy, and the occurrence of potential adverse events. To help manage expectations, let patients know that reaching the appropriate therapeutic dose may take longer when starting low.2

*PACC, founded 2000, offers guidance on IT therapy to help improve efficacy and patient safety. PACC was initiated by the International Neuromodulation Society (INS) and was partially funded via an unrestricted grant from product sponsor. No corporate entities had any direct input into the contents of the manuscripts or the conclusions of the collaborators.1

†PRIALT is intended for IT delivery using the Medtronic SynchroMed™ II infusion system and CADD-Micro® Ambulatory Infusion Pump. The minimum flow rate of the Medtronic SynchroMed™ II pump is 0.048 mL/day. The lowest initial starting dose that can be delivered through the Medtronic SynchroMed® II pump without dilution is 1.2 mcg/day.2,4

CADD-Micro® is a registered trademark of SIMS Deltec, Inc.

SynchroMed™ is a trademark of Medtronic

REFERENCES:

  1. Deer TR, Pope JE, Hayek SM, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations on intrathecal drug infusion systems best practices and guidelines. Neuromodulation. 2017;20(2):3-31.
  2. PRIALT [package insert]. Lake Forest, IL; TerSera Therapeutics.
  3. Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):403-404.
  4. SynchroMed II Drug Infusion Pump. Medtronic website. Accessed July 9, 2018. https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/drug-infusion-systems/synchromed-ii.html

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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 Precaution

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.

Important Safety Information and Indication

Indication

PRIALT® (ziconotide) solution, 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.

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 Precaution

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.