Prialt (ziconotide) for Pain Management and Relief

What is Prialt, and how does it work?

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

What are the side effects of Prialt?

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.

Common side effects of Prialt 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, or
• loss of balance or coordination

What is the dosage for Prialt?

General Information

• Prialt is intended for administration by or under the direction of a physician experienced in the technique of intrathecal administration and who is familiar with the drug and device labeling.
• Prialt is not intended for intravenous administration.
• Prialt is intended for intrathecal delivery using the Medtronic SynchroMed II
  Infusion System and CADD-Micro Ambulatory Infusion Pump. Refer to the manufacturer's manual for specific instructions and precautions for programming the microinfusion device and/or refilling the reservoir.
• Prialt may be used for therapy undiluted (25 mcg/mL in 20 mL vial) or diluted (100 mcg/mL in 1 or 5 mL vials). The 100 mcg/mL formulation may be administered undiluted once an appropriate dose has been established.
• Dilute Prialt with 0.9% Sodium Chloride Injection, USP (preservative free) using aseptic procedures to the desired concentration prior to placement in the microinfusion pump.
  • Saline solutions containing preservatives are not appropriate for intrathecal drug administration and should not be used due to risk of neurotoxicity.
  • Refrigerate but do not freeze all Prialt solutions after preparation and begin infusion within 24 hours.
• Inspect vials of Prialt visually for particulate matter and discoloration prior to administration whenever solution and container permit. Discard any
  Prialt solution with observed particulate matter or discoloration and any unused portion left in the vial.

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. Dose increases in increments of less than 2.4 mcg/day (0.1 mcg/hr) and less frequently than 2 to 3 times per week may be used. For each dose titration, assess the dosing requirements and adjust the pump infusion flow rate as required to achieve the new dosing.
• The maximum recommended dose is 19.2 mcg/day (0.8 mcg/hr).
• Adjust the dose of intrathecal Prialt according to the severity of pain, the patient's response to therapy, and the 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
  for performing a reservoir rinse, initial filling, refilling the reservoir, and
  programming.

Naive Pump Priming (i.e., first time use with Prialt)

• Use only the undiluted 25 mcg/mL formulation for naive pump priming. Rinse the internal surfaces of the pump with 2 mL of
  Prialt at 25 mcg/mL. Repeat twice for a total of three rinses.

Initial Pump Fill

• Use only the undiluted 25 mcg/mL formulation for the initial pump fill.
• Fill the naive pump after priming with the appropriate volume of Prialt 25 mcg/mL.
• Begin dosing at a delivery rate no higher than 2.4 mcg/day (0.1 mcg/hr).
• In a naive pump, Prialt is lost due to two factors that do not occur upon subsequent refills: adsorption on internal device surfaces, such as titanium, and by dilution in the residual space of the device.
• Consequently, the pump reservoir should be refilled with Prialt within 14 days of the initial fill to ensure appropriate dose administration.

Pump Refills

• For subsequent pump refills, fill the pump at least every 40 days if
  Prialt is used diluted. For undiluted Prialt, fill the pump at least every 84 days. To ensure aseptic transfer of
  Prialt into the device, use the Medtronic refill kit. Empty the pump contents prior to refill with
  Prialt.
• If the internal infusion system must be surgically replaced while the person is
  receiving Prialt, rinse the replacement pump with Prialt according to Naïve
  Pump Priming, and replace the initial fill solution within 14 days according to
  Initial Pump Fill.

Instructions For Use In The CADD-Micro Ambulatory Infusion Pump

• Refer to the manufacturer's manuals for specific instructions and precautions for performing the initial filling, refilling of the reservoir or replacement of the drug cartridge, and operation.
• 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 for the external microinfusion is 0.02 mL/hr
  to deliver the initial dose rate of 2.4 mcg/day (0.1 mcg/hr) of Prialt. Changes
  in dose rate are made by adjusting the flow rate of the infusion system and/or
  the concentration of Prialt solution.

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

What drugs interact with Prialt?

• Formal PK drug-drug interaction studies have not been performed with
  Prialt.
• As ziconotide is a peptide, it is expected to be completely degraded by endopeptidases and exopeptidases (Phase I hydrolytic enzymes) widely located throughout the body, and not by other Phase I biotransformation processes (including the cytochrome P450 system) or by Phase II conjugation reactions.
• Thus, intrathecal administration, low plasma ziconotide concentrations, and metabolism by ubiquitous peptidases make metabolic interactions of other drugs with ziconotide unlikely.
• Further, as ziconotide is not highly bound in plasma (approximately 50%) and has low plasma exposure following intrathecal administration, clinically relevant plasma protein displacement reactions involving ziconotide and co-administered medications are unlikely.
• Over 90% of patients treated with intrathecal Prialt used systemic opiates and in the slow titration study, 98% of patients received opioids.
• The combination of Prialt with intrathecal opiates has not been studied in placebo-controlled clinical trials and is not recommended.

Interaction With CNS Depressants

• Almost all patients in the Prialt clinical trials received concomitant
  non-intrathecal medication.
• Most patients received several concomitant drugs,
  including
  • antidepressants (66%),
  •  anxiolytics (52%),
  • antiepileptics (47%),
  • neuroleptics (46%), and
  • sedatives (34%).
• The use of drugs with CNS-depressant
  activities may be associated with an increased incidence of CNS adverse
  reactions such as dizziness and confusion.

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Is Prialt safe to use while pregnant or breastfeeding?

• No adequate and well-controlled studies have been conducted in pregnant women.
• Because animal studies are not always predictive of human response,
  Prialt should be used during pregnancy only if the potential benefit justifies risk to the fetus.
• The effect of Prialt on labor and delivery in humans is not known.
• It is not known whether Prialt is excreted in human breast milk.
• Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from
  Prialt, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.