Tasimelteon

Hetlioz LQ

4MG/ML suspensionVereinigte StaatenIm HandelZugelassen am 1. Dez. 2020

Inhalt auf Englisch

Anwendungsgebiete

HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 )

1.1Non-24-Hour Sleep-Wake Disorder (Non-24)

HETLIOZ capsules are indicated for the treatment of Non-24 in adults.

1.2Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older. HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.

Gegenanzeigen

None. None ( 4 )

Warnhinweise und Vorsichtsmaßnahmen

May cause somnolence: After taking HETLIOZ, patients should limit their activity to preparing for going to bed, because HETLIOZ can impair the performance of activities requiring complete mental alertness ( 5.1 )

5.1Somnolence

After taking HETLIOZ, patients should limit their activity to preparing for going to bed. HETLIOZ can potentially impair the performance of activities requiring complete mental alertness.

Anwendungsgebiete

1.1Non-24-Hour Sleep-Wake Disorder (Non-24)

HETLIOZ capsules are indicated for the treatment of Non-24 in adults.

1.2Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

Warnhinweise und Vorsichtsmaßnahmen

5.1Somnolence

After taking HETLIOZ, patients should limit their activity to preparing for going to bed. HETLIOZ can potentially impair the performance of activities requiring complete mental alertness.

Nebenwirkungen

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 ( 6.1 ) 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 .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. More than 2080 subjects have been treated with at least one dose of HETLIOZ, of which more than 380 have been treated for > 26 weeks and more than 170 have been treated for > 1 year.

Non-24-Hour Sleep-Wake Disorder (Non-24) A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated HETLIOZ (n=42) compared to placebo (n=42) in patients with Non-24. A randomized-withdrawal, placebo- controlled study of 8 weeks duration (Study 2) also evaluated HETLIOZ (n=10), compared to placebo (n=10), in patients with Non-24. In placebo-controlled studies, 6% of patients exposed to HETLIOZ discontinued treatment due to an adverse event, compared with 4% of patients who received placebo.

Table 2 shows the incidence of adverse reactions from Study 1. *Adverse reactions with an incidence > 5% and at least twice as high on HETLIOZ than on placebo are displayed. Table 2: Adverse Reactions in Study 1 HETLIOZ N=42 Placebo N=42 Headache 17 % 7 % Alanine aminotransferase increased 10 % 5 % Nightmare/abnormal dreams 10 % 0 % Upper respiratory tract infection 7 % 0 % Urinary tract infection 7 % 2 % Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) A 9-week, double-blind, randomized, placebo-controlled, two-period crossover study evaluated HETLIOZ (capsules and oral suspension; n=25) compared to placebo (n=26) in the treatment of nighttime sleep disturbances in patients with Smith-Magenis Syndrome.

Pediatric patients (n=11, age 3 to 15 years) received HETLIOZ LQ oral suspension, and patients ≥16 years of age (n=14) received HETLIOZ capsules. Adverse reactions were similar in patients treated for Non-24 and patients with Smith-Magenis syndrome treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ oral suspension, and patients ≥16 years of age who received HETLIOZ capsules.

Packung	Code	Status
TASIMELTEON 4MG/ML	NDA214517-002	Prescription
TASIMELTEON 4MG/ML	NDA214517-001	Prescription

Hetlioz LQ

Anwendungsgebiete

1.1Non-24-Hour Sleep-Wake Disorder (Non-24)

1.2Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1Somnolence

Zwei Arzneimittel in einer Frage?

Hetlioz LQ

Anwendungsgebiete

1.1Non-24-Hour Sleep-Wake Disorder (Non-24)

1.2Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1Somnolence

Zwei Arzneimittel in einer Frage?

Wechselwirkungen

7.1Strong CYP1A2 Inhibitors

7.2Strong CYP3A4 Inducers

7.3Beta-adrenergic Receptor Antagonists

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

Nebenwirkungen

6.1Clinical Trials Experience

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