DIQTA 1.0: Drug-Induced QT Prolongation Atlas

PITOLISANT HYDROCHLORIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIQT concern

Severity Score:3.0

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

WARNINGS AND PRECAUTIONS
QT Interval Prolongation
WAKIX prolongs the QT interval. The use of WAKIX should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval [see Drug Interactions (7.1)]. WAKIX should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval [see Clinical Pharmacology (12.2)]. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant. Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment [see Dosage and Administration (2.2, 2.3)]. WAKIX is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. WAKIX is not recommended in patients with end-stage renal disease (ESRD) [see Dosage and Administration (2.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
DRUG INTERACTIONS
ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
QT Interval Prolongation [see Warnings and Precautions (5.1)]
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
WAKIX at the highest recommended dosage (i.e., 35.6 mg daily) led to a QTc increase of 4.2 msec. Exposures 3.8-fold higher than achieved at the highest recommended dose increase QTc 16 msec (mean) [see Warnings and Precautions (5.1)].
PATIENT COUNSELING INFORMATION
Prolongation of the QT Interval
Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see Warnings and Precautions (5.1)]. Advise patients to inform their healthcare provider that they are taking WAKIX before any new drug is taken.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24091

Other ADRs

1224

38380363

Odds Ratio = 1.302

Drug Property Information

ATC Code(s):

N07XX11 - pitolisant hydrochloride

N07XX - Other nervous system drugs
N07X - OTHER NERVOUS SYSTEM DRUGS
N07 - OTHER NERVOUS SYSTEM DRUGS
N - NERVOUS SYSTEM

Active Ingredient:PITOLISANT HYDROCHLORIDE

Active Ingredient UNII:YV33CH63HI

Drugbank ID:DB11642

PubChem Compound:N/ADIR Classification

CTD ID:C516975

PharmGKB:

CAS Number:362665-56-3

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

18.0 mg/day N07XX11

Chemical Structure:

SMILE Code:
ClC1=CC=C(CCCOCCCN2CCCCC2)C=C1

Reference

N/A