What are the precautions for Pitolisant-wakix?

Pitolisant (Pitolisant)-wakix was the first drug approved to treat narcolepsy but is not classified as a controlled substance. It works by increasing the synthesis and release of histamine, a neurotransmitter in the brain that promotes wakefulness. In clinical studies of tilolixen tablets, warnings and precautions such as QT interval prolongation and embryo-fetal toxicity have emerged.

1. QT interval prolongation: Tilolixen tablets will prolong the QT interval. Patients with known prolongation of the QT interval should avoid use of tilolixen tablets or concomitant use with other drugs known to prolong the QT interval. Patients with a history of cardiac arrhythmias and other conditions that may increase the risk of torsade de pointes or sudden death (including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital QT prolongation) should also avoid use of tilolixan. Patients with hepatic or renal impairment may be at greater risk of QT prolongation due to higher concentrations of Pitolisant. Monitor patients with hepatic or renal impairment for increases in QTc.

2. Embryonic-Fetal Toxicity:In animal reproduction studies, administration of pituitary metabolites during organogenesis resulted in maternal and embryotoxicity in rats and rabbits at doses ≥13 and >4 times the maximum recommended human dose (MRHD) of 35.6 mg based on mg/m2 body surface area, respectively. Oral administration of pituitary metabolites to female rats during pregnancy and lactation can adversely affect maternal and fetal health and produce developmental delays at doses ≥13 times the MRHD (based on mg/m2 body surface area) and increase the incidence of major malformations at doses 22 times the MRHD. Tilolisen tablets may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal method of contraception during treatment with tilolixen tablets and for at least21 days after stopping treatment.