These highlights do not include all the information needed to use WAKIX® safely and effectively. See full prescribing information for WAKIX.
WAKIX® (pitolisant) tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy (1)
DOSAGE AND ADMINISTRATION
Administer once daily in the morning upon wakening.
The recommended dosage range is 17.8 mg to 35.6 mg daily. Titrate dosage as follows:
Week 1: Initiate with 8.9 mg once daily
Week 2: Increase dosage to 17.8 mg once daily
Week 3: May increase to the maximum recommended dosage of 35.6 mg once daily (2.1)
Hepatic impairment (2.2, 8.6, 12.3):
Moderate hepatic impairment: Initial dosage is 8.9 mg once daily. Titrate to a maximum dosage of 17.8 mg once daily after 14 days
Renal impairment (2.3, 8.7, 12.3):
Moderate and severe impairment: Initial dosage is 8.9 mg once daily. Titrate to maximum dosage of 17.8 mg once daily after 7 days
End-stage renal disease (ESRD): Not recommended
Poor Metabolizers of CYP2D6: Maximum recommended dosage is 17.8 mg once daily (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 4.45 mg and 17.8 mg (3)
CONTRAINDICATIONS
WAKIX is contraindicated in patients with severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
QT Interval Prolongation: Increases in QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. Monitor patients with hepatic or renal impairment for increased QTc (5.1)
ADVERSE REACTIONS
The most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia, nausea, and anxiety (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Harmony Biosciences at 1-800-833-7460 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP2D6 Inhibitors: Maximum recommended dosage is 17.8 mg once daily (2.4, 7.1)
Strong CYP3A4 Inducers: Decreased exposure of WAKIX; consider dosage adjustment (2.4, 7.1)
Sensitive CYP3A4 Substrates (including hormonal contraceptives): WAKIX may reduce effectiveness of sensitive CYP3A4 substrates. Use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuation of treatment (7.1, 8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 11/2019