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Pitolisant Dosage

Medically reviewed by Drugs.com. Last updated on Dec 15, 2020.

Applies to the following strengths: 4.45 mg; 17.8 mg

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
Maintenance dose: 17.8 to 35.6 mg/day
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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.