Ziconotide

PRIALT

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Ziconotide ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Ziconotide ballicule

What it isIntrathecal N-type voltage-gated calcium-channel blocker; severe chronic pain refractory to other therapies.

Why this oneNonopioid analgesia without respiratory depression, tolerance, or withdrawal distinguishes it from intrathecal opioids.

What limits itA pump and slow titration are required; cognitive and psychiatric toxicity is dose-limiting, and prior psychosis is a contraindication.

Ziconotide molecular structure (skeletal formula) — Molecular structure: Ziconotide

FDA-approved for

refractory chronic pain (2004)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Severe psychiatric symptoms and neurological impairment may occur; contraindicated in preexisting psychosis; monitor frequently

FDA dosing	Population	Start	Target	Max
Severe chronic pain (intrathecal)	adult	≤2.4 mcg/day (0.1 mcg/hr)	titrate to response	19.2 mcg/day (0.8 mcg/hr)

Titration Increase by up to 2.4 mcg/day (0.1 mcg/hr) no more than 2-3 times per week

Renal Undefined

Hepatic Undefined

Recommended maximum 19.2 mcg/day (0.8 mcg/hr) reached by about Day 21

Instructions

Intrathecal only; not for IV administration
Administer via programmable implanted or external microinfusion device by/under a physician experienced in intrathecal administration
Do not use preservative-containing saline (neurotoxicity risk); refrigerate, do not freeze, begin infusion within 24 h of preparation
Do not abruptly withdraw opiates — taper over a few weeks and replace with equivalent oral opiates
Start elderly at low end of dosing range

Available strengths

inj 100 mcg/mL

Contraindications

Preexisting history of psychosis
Any concomitant treatment or medical condition rendering intrathecal administration hazardous (e.g., infection at injection site, uncontrolled bleeding diathesis, spinal canal obstruction impairing CSF circulation)

Cautions

Cognitive and neuropsychiatric reactions (hallucinations, depression/suicidality)
Meningitis and other infections (higher with external devices)
Reduced level of consciousness (unresponsiveness/stupor)
Elevation of serum creatine kinase; monitor periodically
Not an opiate — cannot prevent opiate withdrawal
Impaired alertness — avoid driving/machinery

Adverse reactions

Dizziness
Nausea
Confusional state
Nystagmus

Pregnancy Insufficient data to identify drug-associated risk

Lactation No milk data; monitor breastfed infants for sedation (respiratory depression/feeding problems)

Cost

Ziconotide (PRIALT)

Strength		#/mo	generic $/unit	CostPlus
100 mcg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Ziconotide is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entryNo US generic

⚠ BOXED WARNINGS

Severe psychiatric symptoms and neurologic impairment; monitor closely and discontinue for serious symptoms
Contraindicated in patients with a history of psychosis

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability2 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityUsually well tolerated at therapeutic doses; overdose toxicity varies by the specific non-opioid analgesic.

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