Pitolisant Disease Interactions

The use of CNS stimulants can cause psychotic symptoms, suicidal ideation, and aggression, and can exacerbate symptoms of behavior disturbance and thought disorder; CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders. All patients (particularly those with psychotic or bipolar disorders) should be monitored closely, especially during treatment initiation and at times of dose changes. Extreme caution should be exercised when CNS stimulants are given to patients with a history of psychosis, depression, mania, or bipolar disorder. Prior to initiating therapy, all patients should be screened for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or family history of suicide, bipolar disease, or depression). If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. Some CNS stimulants are contraindicated in patients with marked agitation or anxiety.

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Pitolisant is contraindicated in patients with severe hepatic impairment. Pitolisant is extensively metabolized by the liver. Care should be exercised when using pitolisant in patients with moderate hepatic impairment. It is recommended to monitor patients with mild and moderate hepatic impairment and to adjust the dosage of pitolisant in patients with moderate hepatic impairment as appropriate. No dosage adjustment is recommended in patients with mild hepatic impairment.

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Pitolisant prolongs the QT interval. The use of pitolisant should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. The use of pitolisant should also be avoided 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. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant. It is recommended to monitor patients with hepatic or renal impairment for increased QTc. Exercise care when using this agent in patients with these conditions.

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The pharmacokinetics of pitolisant in patients with end-stage renal disease (ESRD) (eGFR of <15 mL/minute/1.73 m2) is unknown. Pitolisant is not recommended in patients with ESRD. It is recommended to adjust the dosage of pitolisant when using this agent in patients with moderate (eGFR 30 to 59 mL/minute/1.73 m2) and severe (eGFR 15 to 29 mL/minute/1.73 m2) renal impairment.

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