Registration

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Healthcare Provider Important Safety Information

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.

Indication

HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQTM oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.

Important Safety Information

  • HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness.
  • The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.Adverse reactions were similar in patients treated for Non-24 and patients with SMS treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQTM oral suspension, and patients ≥16 years of age who received HETLIOZ capsules
  • Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.
  • There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. Caution should be exercised when HETLIOZ® is administered to a nursing woman.
  • HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
  • The safety and effectiveness of HETLIOZ® for the treatment of Non-24 in pediatric patients have not been established. The safety and effectiveness of HETLIOZ LQTM oral suspension for the treatment of nighttime sleep disturbances in SMS have been established in pediatric patients 3 years and older.
  • To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full US Prescribing Information.