Drug Detail:Pitolisant (Pitolisant [ pi-tol-i-sant ])
Drug Class: CNS stimulants
Usual Adult Dose for Narcolepsy
Initial Up Titration: 8.9 mg orally once a day for 1 week, then 17.8 mg orally once a day for 1 week, then may increase to 36 mg orally once a day
- Adjust dose based on patient response and tolerability
Maximum dose: 35.6 mg/day
Comments:
- Total dose should be administered as a single dose in the morning during breakfast.
- It may take up to 8 weeks for some patients to achieve a clinical response.
Use: For the treatment of excessive daytime sleepiness in patients with narcolepsy.
Renal Dose Adjustments
Moderate to severe renal impairment: Initial dose: 8.9 mg orally once a day for 1 week; then increase to 17.8 mg orally once a day; maximum dose: 17.8 mg/day
ESRD (CrCl less than 15 mL/min/1.73 m2): Use is not recommended
Liver Dose Adjustments
Mild Liver Dysfunction (Child-Pugh A): No adjustment recommended
Moderate Liver Dysfunction (Child-Pugh B): Initial dose: 8.9 mg orally once a day for 1 week; then increase to 17.8 mg orally once a day; maximum dose: 17.8 mg/day
Severe Liver Dysfunction (Child-Pugh C): Contraindicated
Dose Adjustments
CYP450 2D6 Poor Metabolizers:
- Initial dose: 8.9 mg orally once a day; titrate to 17.8 mg orally once a day after 7 days; maximum dose: 17.8 mg/day
Coadministration with Strong CYP450 2D6 Inhibitors:
- For patients on a strong CYP450 2D6: Initiate pitolisant at 8.9 mg orally once a day, increase after 7 days to a maximum dosage of 17.8 mg/day
- For patients initiating a strong CYP450 2D6 inhibitor while on a stable dose of pitolisant; reduce pitolisant dose by one-half
Coadministration with Strong CYP450 3A4 Inducers:
- Assess for loss of efficacy of pitolisant after initiation of a strong CYP450 3A4 inducer
- For patients on a stable pitolisant dose of 8.9 mg or 17.8 mg once a day, double the dose over 7 days
- If a strong CYP450 3A4 inducer is discontinued, decrease pitolisant dose by one-half
Precautions
CONTRAINDICATIONS:
- Severe hepatic impairment
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day in the morning during breakfast
Monitoring:
- Monitor QTc prolongation especially in patients with risk factors
Patient advice:
- Patients should be instructed to read approved patient labeling.
- Patients should be instructed to notify their healthcare professional immediately if they feel faint, lose consciousness, or have heart palpitations.
- Patients should be instructed to inform their healthcare provider regarding all medications they are taking as there are possible drug interactions with this product.
- Women of childbearing potential should be advised to use effective non-hormonal contraception during use and for 21-days after discontinuing therapy; this drug may reduce the efficacy of hormonal contraception.
Frequently asked questions
- How does Wakix work for narcolepsy?
- Is Wakix a controlled substance?
