Dosing and uses of Prialt (ziconotide)
Adult dosage forms and strengths
intrathecal injection
- 25mcg/mL
- 100mcg/mL
Chronic Pain
2.4 mcg/day intrathecal (IT), (0.1 mcg/hour)
Titrate up by 2.4 mcg/day at intervals 2-3 times per week or less if necessary; no more than 19.2 mcg/day (0.8 mcg/hour) by Day 21
Administration
Use in only the Medtronic SynchroMed® EL or SynchroMed® II Infusion System or Simms Deltec Micro® External Microinfusion Device & Catheter
Medtronic Devices: Only the 25 mcg/mL undiluted solution is used for naive pump priming & initial pump filL
Simms Deltec Device: use 5 mcg/mL Prialt diluted in Ns
See manufacturer's package inserts for details
Monitor
Cognitive functions, mood alterations
Pediatric dosage forms and strengths
Safety/efficacy not established
Prialt (ziconotide) adverse (side) effects
>10%
Abnormal gait (14%)
Abnormal vision (12%)
Anorexia (10%)
Asthenia (22%)
Ataxia (14%)
Confusion (15%)
Diarrhea (18%)
Headache (13%)
Hypertonia (11%)
Memory impairment (12%)
Nausea (40%)
Somnolence (17%)
Vomiting (16%)
Frequency not defined
Anxiety
Aphasia
Dysesthesia
Fever
Hallucinations
Nervousness
Nystagmus
Paresthesia
Speech disorder
Vertigo
Warnings
Black box warnings
Severe psychiatric symptoms and neurologic impairment may occur during treatment with ziconotide. Patients with a preexisting history of psychosis should not be treated with ziconotide.
All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Ziconotide therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurologic or psychiatric signs or symptoms.
Contraindications
Hypersensitivity
History of psychosis
IV administration
IT administration to patients with uncontrolled bleeding, infection at the injection site, spinal obstruction that impairs CSF circulation
Cautions
IT administration only
Possibility of severe psychiatric & neurological complications
- Risk of severe or worsening depression w/ suicide risk in susceptible pts
- Monitor for cognitive impairment, hallucinations & mood swings
- Can be interrupted or discontinued abruptly without withdrawal effects
Possibility of meningitis & other infections
Levels of serum creatinine kinase may increase
Pregnancy, lactation
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion into breast milk unknown; discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Prialt (ziconotide)
Mechanism of action
Putative calcium channel blocker, synthetic conopeptide; binds to N-type voltage sensitive calcium channels located in nociceptive afferent nerves of the dorsal horn in the spinal cord
Not an opioid and does not bind to opioid receptors
Distribution
Protein Bound: 50%
Vd: 140 mL
Metabolism
Metabolism: by peptidases outside of CSF
Metabolites: small peptides/amino acids
Elimination
Half-life: 1-1.6hr in plasma (IV); 2.9-6.5hr in CSF (IT)
Excretion: Urine (<1%)
