Dosage adjustments may be required (see full prescribing information). Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%.Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold.Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%).WAKIX is not recommended in patients with end-stage renal disease (ESRD). Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment (see full prescribing information). The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant monitor these patients for increased QTc.Avoid use 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. WAKIX prolongs the QT interval avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval.WAKIX is also contraindicated in patients with severe hepatic impairment. WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation.
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