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Wakix Generic Name & Formulations
Legal Class
Rx
General Description
Pitolisant HCl 4.45mg, 17.8mg; tabs.
Pharmacological Class
H3 receptor antagonist/inverse agonist.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Wakix Indications
Indications
Excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
Wakix Dosage and Administration
Adult
Take in the AM upon awakening. Week 1: initially 8.9mg once daily; Week 2: increase to 17.8mg once daily; Week 3: may increase to max 35.6mg once daily. Adjust dose based on tolerability. Moderate hepatic impairment: initially 8.9mg once daily, may increase to max 17.8mg once daily after 14 days. Moderate to severe renal impairment: initially 8.9mg once daily, may increase to max 17.8mg once daily after 7 days. ESRD: not recommended. Concomitant strong CYP2D6 inhibitors: initially 8.9mg once daily, may increase to max 17.8mg once daily after 7 days; patients already stabilized on Wakix: reduce Wakix dose by ½. CYP2D6 poor metabolizers: initially 8.9mg once daily, may increase to max 17.8mg once daily after 7 days. Concomitant strong CYP3A4 inducers: double the original Wakix daily dose over 7 days; see full labeling.
Children
Not established.
Wakix Contraindications
Contraindications
Severe hepatic impairment.
Wakix Boxed Warnings
Not Applicable
Wakix Warnings/Precautions
Warnings/Precautions
Avoid in known QT prolongation, history of cardiac arrhythmias. Conditions that may increase risk of torsade de pointes or sudden death (eg, symptomatic bradycardia, hypokalemia, hypomagnesemia, congenital QT prolongation). Hepatic or renal impairment; monitor (See Adult dose). Elderly. Advise females of reproductive potential to use effective non-hormonal contraceptive during and for ≥21 days after the last dose. Pregnancy. Nursing mothers.
Wakix Pharmacokinetics
See Literature
Wakix Interactions
Interactions
Avoid concomitant other drugs known to prolong QT interval (eg, Class 1A & 3 antiarrhythmics, ziprasidone, chlorpromazine, thioridazine, moxifloxacin), centrally acting H1 receptor antagonists (eg, pheniramine maleate, diphenhydramine, promethazine, imipramine, clomipramine, mirtazapine). Potentiated by strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, bupropion); see Adult dose. Antagonized by strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin); see Adult dose. Antagonizes sensitive CYP3A4 substrates (eg, midazolam, cyclosporine, hormonal contraceptives).
Wakix Adverse Reactions
Adverse Reactions
Insomnia, nausea, anxiety; hypersensitivity reactions.
Wakix Clinical Trials
See Literature
Wakix Note
Not Applicable
Wakix Patient Counseling
See Literature
