DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

ZICONOTIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIR concern

Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
Elevation of Serum Creatine Kinase
In clinical studies, 40% of PRIALT-treated patients had serum creatine kinase (CK) levels above the upper limit of normal (ULN), and 11% had CK levels that were greater than three times the ULN. In cases where CK was fractionated, only the muscle isoenzyme (MM) was elevated. The time to occurrence was sporadic, but the greatest incidence of CK elevation was during the first two months of treatment. One case of symptomatic myopathy with EMG findings, and two cases of acute renal failure associated with rhabdomyolysis and extreme CK elevations (17,000–27,000 IU/L) have been reported in PRIALT-treated patients.
Therefore, monitor serum CK in patients undergoing treatment with PRIALT periodically (e.g., every other week for the first month and monthly as appropriate thereafter). Evaluate patients clinically and obtain CK measurements in the setting of new neuromuscular symptoms (e.g., myalgias, myasthenia, muscle cramps, asthenia) or a reduction in physical activity. If these symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue the use of PRIALT.
ADVERSE REACTIONS
Clinical Trials Experience
The following medically important adverse reactions occurred in less than 2% of patients were assessed by the clinical investigators as related to PRIALT: acute renal failure, atrial fibrillation, cerebrovascular accident, sepsis, meningitis, psychotic disorder, suicidal ideation, respiratory distress, rhabdomyolysis, electrocardiogram abnormal, stupor, loss of consciousness, clonic convulsion and grand mal convulsion. Fatal aspiration pneumonia and suicide attempt were reported in less than 1% of patients.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42894

Other ADRs

1555

14115724

Odds Ratio = 3.81

Drug Property Information

ATC Code(s):

N02BG08 - ziconotide

N02BG - Other analgesics and antipyretics
N02B - OTHER ANALGESICS AND ANTIPYRETICS
N02 - ANALGESICS
N - NERVOUS SYSTEM

Active Ingredient:ziconotide acetate

Active Ingredient UNII:T2I226K69M

Drugbank ID:DB06283

PubChem Compound:N/A

CAS Number:107452-89-1

Dosage Form(s):injection, solution

Route(s) Of Administrator:intrathecal

Daily Dose:

0.012 mg/day N02BG08

Chemical Structure:

SMILE Code:
-

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Acute rhabdomyolysis in a patient with long-term exposure to intrathecal ziconotide: a case report.

[Horazeck Christian,Huh Albert S,Huh Billy K]
Pain Pract.2015 Mar;15(3):E34-9. doi: 10.1111/papr.12273. Epub 2015 Jan 7. PMID: 25565390

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