Tasimelteon: Difference between revisions

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Created page with "{{DrugProjectFormSinglePage |aOrAn=a |indicationType=treatment |hasBlackBoxWarning=Yes |adverseReactions=<!--Black Box Warning--> |blackBoxWarningTitle=<span style="color:#FF0..."
 
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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|genericName=tasimelteon
|aOrAn=a
|aOrAn=a
|drugClass=central nervous system agent
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=non-24-hour sleep-wake disorder
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[[headache]], [[urinary tract infection]], [[upper respiratory tract infection]], abnormal dreams, increased liver enzymes
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


Line 12: Line 13:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).


:* Dosage
==Dosage==


=====Condition2=====
* The recommended dosage of HETLIOZ is 20 mg per day taken before bedtime, at the same time every night.


* Dosing Information
* Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.


:* Dosage
==DOSAGE FORMS AND STRENGTHS==


=====Condition3=====
* Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.


* Dosing Information


:* Dosage
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


=====Condition4=====


* Dosing Information
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


:* Dosage


<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->
|fdaLIADPed=* There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelAdultGuideSupport======Condition1=====


* Developed by:


* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 




=====Skin and Hypersensitivy Reactions=====
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.




|contraindications=* None
|warnings='''Somnolence'''


=====Special Senses=====
* 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.
|clinicalTrials=* 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.


* A total of 1346 subjects were treated with at least one dose of HETLIOZ, of which 139 were treated for > 26 weeks and 93 were treated for > 1 year.


* 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.


=====Urogenital=====
* 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 1 shows the incidence of adverse reactions from Study 1.


[[File:Tasimelteon table1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


=====Miscellaneous=====


|drugInteractions='''Strong CYP1A2 Inhibitors (e.g., fluvoxamine)'''


* Avoid use of HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions [see Clinical Pharmacology (12.3)].


<!--Drug Interactions-->
'''Strong CYP3A4 Inducers (e.g., rifampin)'''
|drugInteractions=* Drug
:* Description


<!--Use in Specific Populations-->
* Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy.
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''

Revision as of 14:36, 24 April 2015

Tasimelteon
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Overview

Tasimelteon is a central nervous system agent that is FDA approved for the treatment of non-24-hour sleep-wake disorder. Common adverse reactions include headache, urinary tract infection, upper respiratory tract infection, abnormal dreams, increased liver enzymes.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Dosage

  • The recommended dosage of HETLIOZ is 20 mg per day taken before bedtime, at the same time every night.
  • Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.

DOSAGE FORMS AND STRENGTHS

  • Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Tasimelteon in adult patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Tasimelteon in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • There is limited information regarding FDA-Labeled Use of Tasimelteon in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Tasimelteon in pediatric patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Tasimelteon in pediatric patients.

Contraindications

  • None

Warnings

Somnolence

  • 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.

Adverse Reactions

Clinical 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.
  • A total of 1346 subjects were treated with at least one dose of HETLIOZ, of which 139 were treated for > 26 weeks and 93 were treated for > 1 year.
  • 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 1 shows the incidence of adverse reactions from Study 1.
This image is provided by the National Library of Medicine.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Tasimelteon in the drug label.

Drug Interactions

Strong CYP1A2 Inhibitors (e.g., fluvoxamine)

  • Avoid use of HETLIOZ in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions [see Clinical Pharmacology (12.3)].

Strong CYP3A4 Inducers (e.g., rifampin)

  • Avoid use of HETLIOZ in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tasimelteon in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tasimelteon during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tasimelteon with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Tasimelteon with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tasimelteon with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Tasimelteon with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tasimelteon with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tasimelteon in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tasimelteon in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tasimelteon in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tasimelteon in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Tasimelteon in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Tasimelteon in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Tasimelteon in the drug label.

Pharmacology

There is limited information regarding Tasimelteon Pharmacology in the drug label.

Mechanism of Action

Structure

File:Tasimelteon01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tasimelteon in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tasimelteon in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tasimelteon in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tasimelteon in the drug label.

How Supplied

Storage

There is limited information regarding Tasimelteon Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Tasimelteon |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Tasimelteon |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tasimelteon in the drug label.

Precautions with Alcohol

  • Alcohol-Tasimelteon interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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