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MIFEPRISTONE
DIR Classification
Classification:Moderate-DIQT concern
Severity Score:2.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Interval Prolongation
- Mifepristone and its metabolites block IKr. KORLYM prolongs the QTc interval in a dose-related manner. There is little or no experience with high exposure, concomitant dosing with other QT-prolonging drugs, or potassium channel variants resulting in a long QT interval. [See Warnings & Precautions (5.6)] To minimize risk, the lowest effective dose should always be used.
- [MEDICATION GUIDE]
- KORLYM can cause serious side effects including:
- problems with the electrical system of your heart (QT interval prolongation).
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
2
24090
Other ADRs
18484
38363103
Odds Ratio = 0.173
Drug Property Information
ATC Code(s):
- G03XB01 - mifepristone
- G03XB - Antiprogestogens
- G03X - OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- G03 - SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
- G - GENITO URINARY SYSTEM AND SEX HORMONES
Active Ingredient:MIFEPRISTONE
Active Ingredient UNII:320T6RNW1F
Drugbank ID:DB00834
PubChem Compound:55245
CTD ID:D015735
PharmGKB:PA450500
CAS Number:84371-65-3
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 200.0 mg/day G03XB01
Chemical Structure: 
SMILE Code:
[H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](C1=CC=C(C=C1)N(C)C)C1=C3CCC(=O)C=C3CC[C@@]21[H]
[H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](C1=CC=C(C=C1)N(C)C)C1=C3CCC(=O)C=C3CC[C@@]21[H]
Reference
1: Assessment of the cardiac safety and pharmacokinetics of a short course, twice daily dose of orally-administered mifepristone in healthy male subjects.
[Darpo Borje,Bullingham Roy,Combs Daniel L,Ferber Georg,Hafez Karen]Cardiol J,2013;20(2):152-60. PMID: 23558873
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