Pitolisant (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: FILM COATED.
Brand Names
- PITOLISANT
Indications and Usage
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy.
Contraindications
WAKIX is contraindicated in patients with: known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported in patients treated with WAKIX [see Adverse Reactions (6.2)]. severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate hepatic impairment [see Use in Specific Populations (8.6)].
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)]
Mechanism of Action
The mechanism of action of pitolisant in excessive daytime sleepiness (EDS) or cataplexy in patients 6 years and older with narcolepsy is unclear. However, its efficacy could be mediated through its activity as an antagonist/inverse agonist at histamine-3 (H3) receptors.