Taliglucerase alfa: Difference between revisions

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


* Dosing Information
* ELELYSO is indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.


:* Dosage
==Dosage==


=====Condition2=====
'''Recommended Dosage'''


* Dosing Information
* Treatment-naïve patients: The recommended dosage for treatment-naïve adult and pediatric patients 4 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion.


:* Dosage
* Patients switching from imiglucerase: Patients currently being treated with imiglucerase for Type 1 Gaucher disease can be switched to ELELYSO. Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage when they switch from imiglucerase to ELELYSO Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.


=====Condition3=====
* ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information


:* Dosage
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* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
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=====Metabolic and Nutritional=====
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=====Urogenital=====
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|useInPregnancyFDA=* '''Pregnancy Category'''
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|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''

Revision as of 15:27, 20 February 2015

Taliglucerase alfa
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]

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Overview

Taliglucerase alfa 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

  • ELELYSO is indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

Dosage

Recommended Dosage

  • Treatment-naïve patients: The recommended dosage for treatment-naïve adult and pediatric patients 4 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion.
  • Patients switching from imiglucerase: Patients currently being treated with imiglucerase for Type 1 Gaucher disease can be switched to ELELYSO. Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage when they switch from imiglucerase to ELELYSO Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
  • ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Warnings

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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 Taliglucerase alfa in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Taliglucerase alfa Pharmacology in the drug label.

Mechanism of Action

Structure

File:Taliglucerase alfa01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Taliglucerase alfa Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Taliglucerase alfa 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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