Dacomitinib and Pitolisant: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Dacomitinib
Pitolisant
How we grade severity & evidence
Severity levels
- Contraindicated: These should generally not be used together.
- Major: Potentially serious — often needs a change or close monitoring.
- Moderate: Can be significant — usually manageable with monitoring.
- Minor: Usually limited clinical impact.
Evidence grades
- Established: Well documented — supported by controlled studies or strong clinical data.
- Probable: Good supporting evidence, though not definitively proven.
- Suspected: Some evidence suggests this interaction, but it is not well established.
- Possible: Limited or conflicting evidence; the interaction may occur.
- Theoretical: Predicted from the drugs' pharmacology; not yet confirmed in people.
Ratings come from the documented interaction literature and are reviewed by a pharmacist. They describe the documented risk of the combination, not what will necessarily happen to you — your dose, timing, and health picture all matter.
What happens
Increased pitolisant exposure
Interaction Deep Dive
Pitolisant is primarily metabolized by CYP2D6 and coadministration with the strong CYP2D6 inhibitor PARoxetine increased pitolisant exposure by 2.2-fold in a pharmacokinetic study. For patients on a stable dose of pitolisant, reduce the pitolisant dose by half when initiating a strong CYP2D6 inhibitor. If used concomitantly in patients currently receiving a strong CYP2D6 inhibitor, initiate pitolisant at 8.9 mg once daily and increase after 7 days to a maximum dosage of 17.8 mg once daily. For pediatric patients (6 years and older) weighing less than 40 kg, initiate pitolisant at 4.45 mg once daily and increase after 7 days to a maximum recommended dosage of 8.9 mg once daily. For pediatric patients (6 years and older) weighing more than or equal to 40 kg, initiate pitolisant at 4.45 mg once daily and increase after 7 days to a maximum recommended dosage of 8.9 mg once daily. May increase after another 7 days to a maximum recommended dosage of 17.8 mg once daily1.
Why it happens (mechanism)
Inhibition of CYP2D6-mediated metabolism of pitolisant
Literature reports
1 report — tap to read
a) In a drug interaction study, coadministration of pitolisant with PARoxetine (strong CYP2D6 inhibitors) may increase pitolisant Cmax and AUC by 1.47-fold and 2.21-fold, respectively 1.
Common questions
Can I take Dacomitinib and Pitolisant together?
Increased pitolisant exposure Always confirm with your pharmacist or prescriber before making any change.
How serious is the Dacomitinib and Pitolisant interaction?
It is rated major. Potentially serious — often needs a change or close monitoring.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How strong is the evidence for this interaction?
The evidence is graded "theoretical". Predicted from the drugs' pharmacology; not yet confirmed in people.
Questions for your pharmacist
- Does my dose of Dacomitinib or Pitolisant need adjusting while I take them together?
- What symptoms should prompt me to call you or my prescriber right away?
- Does the timing of my doses matter for this combination?
- Is there a safer alternative to one of these medications for me?
References (1)
- Product Information: WAKIX® oral tablets, pitolisant oral tablets. Harmony Biosciences LLC (per FDA), Plymouth Meeting, PA, 2026. DailyMed
Keep reading about Dacomitinib
Keep reading about Pitolisant
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