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Pharmacokinetics & Drug Interactions
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Pharmacokinetic (PK) and Drug Interaction Information for WAKIX

The PK profile of WAKIX supports once-daily dosing

  • Median t1/2 ~20 hours (7.5 to 24.2 hours) after a single 35.6-mg dose
  • Median Tmax 3.5 hours (2 to 5 hours)
  • No clinically significant PK differences were observed following administration with a high-fat meal

t1/2, half-life; Tmax, time to maximum concentration.

WAKIX had no clinically important PK interactions with modafinil or sodium oxybate

  • In a clinical PK study to evaluate the concomitant use of WAKIX with modafinil or sodium oxybate, WAKIX had no effect on the PK of modafinil or sodium oxybate, and these agents had no clinically relevant effect on the PK of WAKIX

Effect of WAKIX on modafinil

WAKIX had no effect on the PK of modafinil

Effect of modafinil on WAKIX

Modafinil had no clinically relevant effect on the PK of WAKIX

*Seventeen healthy male subjects received treatment with a single dose of 35.6 mg WAKIX on Day 1, modafinil 200 mg/day from Day 5 to Day 25, and a single dose of 35.6 mg WAKIX plus 200 mg modafinil on Day 26.1

*Seventeen healthy male subjects received treatment with a single dose of 35.6 mg WAKIX on Day 1, modafinil 200 mg/day from Day 5 to Day 25, and a single dose of 35.6 mg WAKIX plus 200 mg modafinil on Day 26.1

Some medications have clinically important drug interactions with WAKIX
Effect of Other Drugs on WAKIX
Strong CYP2D6 Inhibitors
  • Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold
Strong CYP3A4 Inducers
  • Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%
Histamine 1 (H1) Receptor Antagonists
  • WAKIX increases the levels of histamine in the brain; therefore, H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX
Drugs Known to Prolong QT Interval
  • Concomitant use of drugs that prolong the QT interval may add to the QT effects of WAKIX and increase the risk of cardiac arrhythmia
Effect of WAKIX on Other Drugs
Sensitive CYP3A4 Substrates
  • WAKIX is a borderline/weak inducer of CYP3A4; therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX
  • The effectiveness of hormonal contraceptives (e.g., ethinyl estradiol) may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy

See Full Prescribing Information for prevention or management of drug interactions.

Dosing WAKIX with other medications

Some medications have clinically important drug interactions with
WAKIX. Identify drug interactions and recommendations for dosing
WAKIX with other medications.

See points to discuss with patients»Start prescribing»

Reference

  1. Data on file. Harmony Biosciences.