Prialt (ziconotide)

Prialt (ziconotide) is a non-narcotic pain reliever for severe chronic pain in people who cannot use or do not respond to standard medications.

Side effects of Prialt

NEUROPSYCHIATRIC ADVERSE REACTIONS

Prialt is contraindicated in patients with preexisting psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment. Monitor all patients for:

• Cognitive impairment
• Hallucinations
• Changes in mood or consciousness

Discontinue Prialt therapy in the event of serious neurological or psychiatric signs or symptoms.

Common side effects include:

• Dizziness
• Spinning sensation
• Drowsiness
• Nausea
• Headache
• Weakness
• Joint pain
• Sleep problems
• Unusual dreams
• Stomach pain
• Diarrhea
• Constipation
• Loss of appetite
• Urinating less than usual
• Loss of balance or coordination

Prialt dosage

General Information

• Prialt is administered by or under the direction of a physician experienced in intrathecal administration.
• Prialt is not intended for intravenous use.
• Prialt is administered using the Medtronic SynchroMed II Infusion System and CADD-Micro Ambulatory Infusion Pump.
• Prialt may be used undiluted or diluted.
• Dilute Prialt using 0.9% Sodium Chloride Injection, USP (preservative free) prior to placement in the microinfusion pump.

Dosing

Dose Initiation

• Initiate dosing with Prialt via intrathecal device at no more than 2.4 mcg/day (0.1 mcg/hr).

Dose Titration

• Titrate doses by up to 2.4 mcg/day (0.1 mcg/hr) at intervals of no more than 2 to 3 times per week based on analgesic response and adverse events.
• Maximum recommended dose is 19.2 mcg/day (0.8 mcg/hr).
• Adjust the dose of Prialt according to the severity of pain, response to therapy, and occurrence of adverse reactions.

Instructions For Use With The Medtronic SynchroMed II Infusion System

• Refer to the manufacturer’s manuals for specific instructions and precautions.

Naive Pump Priming

• Use undiluted Prialt for naive pump priming. Rinse the pump with Prialt at 25 mcg/mL.

Initial Pump Fill

• Use undiluted Prialt for the initial pump fill.
• Fill the naive pump after priming with the appropriate volume of Prialt 25 mcg/mL.
• Refill the pump within 14 days of the initial fill to ensure appropriate dose administration.

Pump Refills

• For subsequent pump refills, fill the pump every 40 days if Prialt is used diluted, or every 84 days if undiluted.
• Use the Medtronic refill kit for aseptic transfer of Prialt into the device.

Instructions For Use In The CADD-Micro Ambulatory Infusion Pump

• Refer to the manufacturer’s manuals for specific instructions and precautions.
• The CADD-Micro Ambulatory Infusion Pump is filled for the first time with Prialt solution at a concentration of 5 mcg/mL.
• This solution is prepared by diluting Prialt with 0.9% Sodium Chloride, USP (preservative free).
• The recommended initial flow rate is 0.02 mL/hr to deliver the initial dose rate of 2.4 mcg/day (0.1 mcg/hr) of Prialt.

Drug Interactions

• Formal PK drug-drug interaction studies have not been performed.
• Metabolic interactions with other drugs are unlikely due to ziconotide’s degradation by endopeptidases.
• Plasma protein displacement reactions involving ziconotide are unlikely.
• Combination of Prialt with intrathecal opiates is not recommended.

Interaction With CNS Depressants

• Patients in the Prialt trials received concomitant non-intrathecal medication.
• Most patients received antidepressants, anxiolytics, antiepileptics, neuroleptics, and sedatives.

Prialt during pregnancy or breastfeeding

• No adequate studies have been conducted in pregnant women.
• Use during pregnancy only if benefit justifies risk to the fetus.
• Effect on labor, delivery, and breastfeeding is not known.
• Discontinue nursing or the drug considering the importance of the drug to the mother.

Summary

Prialt (ziconotide) is a non-narcotic pain reliever for severe chronic pain in people who cannot use or do not respond to standard medications. Prialt is contraindicated in patients with preexisting psychosis. Common side effects include dizziness, spinning sensation, drowsiness, nausea, headache, weakness, joint pain, and sleep problems.