Eliglustat: Difference between revisions

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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult===Indications==
|fdaLIADAdult===Indications==
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
* CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.


Limitations of Use:
'''Limitations of Use''':


Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect .
* Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect .
A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).
A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).


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:* CYP2D6 EMs and IMs taking strong or moderate CYP2D6 inhibitors
:* CYP2D6 EMs and IMs taking strong or moderate CYP2D6 inhibitors
:* CYP2D6 EMs taking strong or moderate CYP3A inhibitors
:* CYP2D6 EMs taking strong or moderate CYP3A inhibitors
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


==DOSAGE FORMS AND STRENGTHS==


* CERDELGA is supplied as 84 mg hard gelatin capsules, with a pearl blue-green opaque cap and pearl white opaque body imprinted with "GZ02" in black. Each capsule contains 100 mg eliglustat tartrate, which is equivalent to 84 mg of eliglustat.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport======Condition1=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
 
|offLabelPedGuideSupport=
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
 
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|contraindications=* CERDELGA is contraindicated in the following patients due to the risk of significantly increased eliglustat plasma concentrations which may result in prolongation of the PR, QTc, and/or QRS cardiac intervals that could result in cardiac arrhythmias. See TABLE 3 and TABLE 4 for examples of drugs in each of the categories described:


 
EMs or IMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor.
|warnings=
IMs or PMs taking a strong CYP3A inhibitor.
 
 
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


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<!--Drug Interactions-->
<!--Drug Interactions-->
|useInPregnancyFDA=*  
|useInPregnancyFDA=*
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


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|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|administration=* Oral
|administration=* Oral


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<!--IV Compatibility-->
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


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<!--Drug box 2-->
<!--Drug box 2-->
|structure=
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|howSupplied=*
|howSupplied=*
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
|brandNames=*
 
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Revision as of 16:47, 18 February 2015

Eliglustat
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]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Eliglustat is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

Limitations of Use:

  • Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect .

A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).

Dosage

Patient Selection

  • Select patients with Gaucher disease type 1 based on their CYP2D6 metabolizer status. It is recommended patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype.

Recommended Adult Dosage

  • The recommended dosage of CERDELGA is 84 mg twice daily in CYP2D6 EMs and IMs. The recommended dosage in CYP2D6 PMs is 84 mg once daily; appropriate adverse event monitoring is recommended. The predicted exposures with 84 mg once daily in patients who are CYP2D6 PMs are expected to be similar to exposures observed with 84 mg twice daily in CYP2D6 IMs.
  • Some inhibitors of CYP2D6 and CYP3A are contraindicated with CERDELGA depending on the patient's metabolizer status [see CONTRAINDICATIONS (4)]. Co-administration of CERDELGA with other CYP2D6 and CYP3A inhibitors may require dosage adjustment depending on the patient's CYP2D6 metabolizer status to reduce the risk of potentially significant adverse reactions.
  • Reduce the dosage of CERDELGA to 84 mg once daily for:
  • CYP2D6 EMs and IMs taking strong or moderate CYP2D6 inhibitors
  • CYP2D6 EMs taking strong or moderate CYP3A inhibitors

DOSAGE FORMS AND STRENGTHS

  • CERDELGA is supplied as 84 mg hard gelatin capsules, with a pearl blue-green opaque cap and pearl white opaque body imprinted with "GZ02" in black. Each capsule contains 100 mg eliglustat tartrate, which is equivalent to 84 mg of eliglustat.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Condition1

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • CERDELGA is contraindicated in the following patients due to the risk of significantly increased eliglustat plasma concentrations which may result in prolongation of the PR, QTc, and/or QRS cardiac intervals that could result in cardiac arrhythmias. See TABLE 3 and TABLE 4 for examples of drugs in each of the categories described:

EMs or IMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor. IMs or PMs taking a strong CYP3A inhibitor.

Warnings

There is limited information regarding Eliglustat Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Eliglustat in the drug label.




Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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



Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

There is limited information regarding Eliglustat Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

There is limited information regarding Eliglustat Mechanism of Action in the drug label.

Structure

There is limited information regarding Eliglustat Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Eliglustat 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.

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