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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{RB}}
|genericName=Galsulfase
|aOrAn=a
|aOrAn=a
|drugClass=glycosaminoglycan (GAG)-specific enzyme
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=Mucopolysaccharidosis VI
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea, infusion-related reactions
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|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>


* Content
 


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
* NAGLAZYME (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).  NAGLAZYME has been shown to improve walking and stair-climbing capacity.
* Dosing Information


:* Dosage
====Dosage====
Recommended Dose
The recommended dosage regimen of NAGLAZYME is 1 mg per kg of body weight administered once weekly as an intravenous infusion.


=====Condition2=====
Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion [see WARNINGS AND PRECAUTIONS (5.2)].


* Dosing Information
The total volume of the infusion should be delivered over a period of time of no less than 4 hours.  NAGLAZYME should be diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 250 mL and delivered by controlled intravenous infusion using an infusion pump.  The initial infusion rate should be 6 mL per hour for the first hour.  If the infusion is well tolerated, the rate of infusion may be increased to 80 mL per hour for the remaining 3 hours.  The infusion time can be extended up to 20 hours if infusion reactions occur.


:* Dosage
For patients 20 kg and under or those who are susceptible to fluid volume overload, physicians may consider diluting NAGLAZYME in a volume of 100 mL [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.3)]. The infusion rate (mL per hour) should be decreased so that the total infusion duration remains no less than 4 hours.


=====Condition3=====
Each vial of NAGLAZYME provides 5 mg of galsulfase (expressed as protein content) in 5 mL of solution and is intended for single use only.  Do not use the vial more than one time.  The concentrated solution for infusion must be diluted with 0.9% Sodium Chloride Injection, USP, using aseptic techniques.  Prepare Naglazyme using low-protein-binding containers and administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter. There is no information on the compatibility of diluted NAGLAZYME with glass containers.


* Dosing Information
2.2 Instructions for Use
Prepare and use NAGLAZYME according to the following steps. Use aseptic techniques.


:* Dosage
Determine the number of vials to be used based on the patient's weight and the recommended dose of 1 mg per kg:  


=====Condition4=====
Patient's weight (kg) x 1 mL/kg of NAGLAZYME = Total number of mL of NAGLAZYME


* Dosing Information
Total number of mL of NAGLAZYME ÷ 5 mL per vial = Total number of vials


:* Dosage
Round up to the next whole vial. Remove the required number of vials from the refrigerator to allow them to reach room temperature. Do not allow vials to remain at room temperature longer than 24 hours prior to dilution. Do not heat or microwave vials.


<!--Off-Label Use and Dosage (Adult)-->
Before withdrawing the NAGLAZYME solution from the vial, visually inspect each vial for particulate matter and discoloration.  The NAGLAZYME solution should be clear to slightly opalescent and colorless to pale yellow.  Some translucency may be present in the solution.  Do not use if the solution is discolored or if there is particulate matter in the solution.


<!--Guideline-Supported Use (Adult)-->
From a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP, withdraw and discard a volume equal to the volume of NAGLAZYME solution to be added. If using a 100 mL infusion bag, this step is not necessary.
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
Slowly withdraw the calculated volume of NAGLAZYME from the appropriate number of vials using caution to avoid excessive agitation.  Do not use a filter needle, as this may cause agitation.  Agitation may denature NAGLAZYME, rendering it biologically inactive.


* Class of Recommendation:
Slowly add the NAGLAZYME solution to the 0.9% Sodium Chloride Injection, USP, using care to avoid agitation of the solutions.  Do not use a filter needle.


* Strength of Evidence:
Gently rotate the infusion bag to ensure proper distribution of NAGLAZYME.  Do not shake the solution.


* Dosing Information
Administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter.
NAGLAZYME does not contain preservatives; therefore, after dilution with saline, the infusion bags should be used immediately.  If immediate use is not possible, the diluted solution must be stored refrigerated at 2°C to 8°C (36°F to 46°F) and administered within 48 hours from the time of dilution to completion of administration.  Other than during infusion, do not store the diluted NAGLAZYME solution at room temperature.  Any unused product or waste material must be discarded and disposed of in accordance with local requirements.


:* Dosage
NAGLAZYME must not be infused with other products in the infusion tubing.  The compatibility of NAGLAZYME in solution with other products has not been evaluated.


=====Condition2=====
3 DOSAGE FORMS AND STRENGTHS
 
Injection; 5 mL vials (5 mg per 5 mL).
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=====Indications====
* NAGLAZYME (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).  NAGLAZYME has been shown to improve walking and stair-climbing capacity.


* Dosing Information
====Dosage====
Recommended Dose
The recommended dosage regimen of NAGLAZYME is 1 mg per kg of body weight administered once weekly as an intravenous infusion.


:* Dosage
Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion [see WARNINGS AND PRECAUTIONS (5.2)].


=====Condition2=====
The total volume of the infusion should be delivered over a period of time of no less than 4 hours.  NAGLAZYME should be diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 250 mL and delivered by controlled intravenous infusion using an infusion pump.  The initial infusion rate should be 6 mL per hour for the first hour.  If the infusion is well tolerated, the rate of infusion may be increased to 80 mL per hour for the remaining 3 hours.  The infusion time can be extended up to 20 hours if infusion reactions occur.


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
For patients 20 kg and under or those who are susceptible to fluid volume overload, physicians may consider diluting NAGLAZYME in a volume of 100 mL [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.3)]. The infusion rate (mL per hour) should be decreased so that the total infusion duration remains no less than 4 hours.


<!--Off-Label Use and Dosage (Pediatric)-->
Each vial of NAGLAZYME provides 5 mg of galsulfase (expressed as protein content) in 5 mL of solution and is intended for single use only.  Do not use the vial more than one time.  The concentrated solution for infusion must be diluted with 0.9% Sodium Chloride Injection, USP, using aseptic techniques.  Prepare Naglazyme using low-protein-binding containers and administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter. There is no information on the compatibility of diluted NAGLAZYME with glass containers.


<!--Guideline-Supported Use (Pediatric)-->
2.2 Instructions for Use
|offLabelPedGuideSupport======Condition1=====
Prepare and use NAGLAZYME according to the following steps. Use aseptic techniques.


* Developed by:  
Determine the number of vials to be used based on the patient's weight and the recommended dose of 1 mg per kg:  


* Class of Recommendation:
Patient's weight (kg) x 1 mL/kg of NAGLAZYME = Total number of mL of NAGLAZYME


* Strength of Evidence:
Total number of mL of NAGLAZYME ÷ 5 mL per vial = Total number of vials


* Dosing Information
Round up to the next whole vial. Remove the required number of vials from the refrigerator to allow them to reach room temperature. Do not allow vials to remain at room temperature longer than 24 hours prior to dilution. Do not heat or microwave vials.


:* Dosage
Before withdrawing the NAGLAZYME solution from the vial, visually inspect each vial for particulate matter and discoloration.  The NAGLAZYME solution should be clear to slightly opalescent and colorless to pale yellow.  Some translucency may be present in the solution.  Do not use if the solution is discolored or if there is particulate matter in the solution.


=====Condition2=====
From a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP, withdraw and discard a volume equal to the volume of NAGLAZYME solution to be added. If using a 100 mL infusion bag, this step is not necessary.


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
Slowly withdraw the calculated volume of NAGLAZYME from the appropriate number of vials using caution to avoid excessive agitation.  Do not use a filter needle, as this may cause agitation.  Agitation may denature NAGLAZYME, rendering it biologically inactive.


<!--Non–Guideline-Supported Use (Pediatric)-->
Slowly add the NAGLAZYME solution to the 0.9% Sodium Chloride Injection, USP, using care to avoid agitation of the solutions.  Do not use a filter needle.
|offLabelPedNoGuideSupport======Condition1=====


* Dosing Information
Gently rotate the infusion bag to ensure proper distribution of NAGLAZYME.  Do not shake the solution.


:* Dosage
Administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter.
NAGLAZYME does not contain preservatives; therefore, after dilution with saline, the infusion bags should be used immediately.  If immediate use is not possible, the diluted solution must be stored refrigerated at 2°C to 8°C (36°F to 46°F) and administered within 48 hours from the time of dilution to completion of administration.  Other than during infusion, do not store the diluted NAGLAZYME solution at room temperature.  Any unused product or waste material must be discarded and disposed of in accordance with local requirements.


=====Condition2=====
NAGLAZYME must not be infused with other products in the infusion tubing.  The compatibility of NAGLAZYME in solution with other products has not been evaluated.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->

Revision as of 13:49, 17 April 2015

Galsulfase
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Galsulfase is a glycosaminoglycan (GAG)-specific enzyme that is FDA approved for the treatment of Mucopolysaccharidosis VI. Common adverse reactions include rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea, infusion-related reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • NAGLAZYME (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

Dosage

Recommended Dose The recommended dosage regimen of NAGLAZYME is 1 mg per kg of body weight administered once weekly as an intravenous infusion.

Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion [see WARNINGS AND PRECAUTIONS (5.2)].

The total volume of the infusion should be delivered over a period of time of no less than 4 hours. NAGLAZYME should be diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 250 mL and delivered by controlled intravenous infusion using an infusion pump. The initial infusion rate should be 6 mL per hour for the first hour. If the infusion is well tolerated, the rate of infusion may be increased to 80 mL per hour for the remaining 3 hours. The infusion time can be extended up to 20 hours if infusion reactions occur.

For patients 20 kg and under or those who are susceptible to fluid volume overload, physicians may consider diluting NAGLAZYME in a volume of 100 mL [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.3)]. The infusion rate (mL per hour) should be decreased so that the total infusion duration remains no less than 4 hours.

Each vial of NAGLAZYME provides 5 mg of galsulfase (expressed as protein content) in 5 mL of solution and is intended for single use only. Do not use the vial more than one time. The concentrated solution for infusion must be diluted with 0.9% Sodium Chloride Injection, USP, using aseptic techniques. Prepare Naglazyme using low-protein-binding containers and administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter. There is no information on the compatibility of diluted NAGLAZYME with glass containers.

2.2 Instructions for Use Prepare and use NAGLAZYME according to the following steps. Use aseptic techniques.

Determine the number of vials to be used based on the patient's weight and the recommended dose of 1 mg per kg:

Patient's weight (kg) x 1 mL/kg of NAGLAZYME = Total number of mL of NAGLAZYME

Total number of mL of NAGLAZYME ÷ 5 mL per vial = Total number of vials

Round up to the next whole vial. Remove the required number of vials from the refrigerator to allow them to reach room temperature. Do not allow vials to remain at room temperature longer than 24 hours prior to dilution. Do not heat or microwave vials.

Before withdrawing the NAGLAZYME solution from the vial, visually inspect each vial for particulate matter and discoloration. The NAGLAZYME solution should be clear to slightly opalescent and colorless to pale yellow. Some translucency may be present in the solution. Do not use if the solution is discolored or if there is particulate matter in the solution.

From a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP, withdraw and discard a volume equal to the volume of NAGLAZYME solution to be added. If using a 100 mL infusion bag, this step is not necessary.

Slowly withdraw the calculated volume of NAGLAZYME from the appropriate number of vials using caution to avoid excessive agitation. Do not use a filter needle, as this may cause agitation. Agitation may denature NAGLAZYME, rendering it biologically inactive.

Slowly add the NAGLAZYME solution to the 0.9% Sodium Chloride Injection, USP, using care to avoid agitation of the solutions. Do not use a filter needle.

Gently rotate the infusion bag to ensure proper distribution of NAGLAZYME. Do not shake the solution.

Administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter. NAGLAZYME does not contain preservatives; therefore, after dilution with saline, the infusion bags should be used immediately. If immediate use is not possible, the diluted solution must be stored refrigerated at 2°C to 8°C (36°F to 46°F) and administered within 48 hours from the time of dilution to completion of administration. Other than during infusion, do not store the diluted NAGLAZYME solution at room temperature. Any unused product or waste material must be discarded and disposed of in accordance with local requirements.

NAGLAZYME must not be infused with other products in the infusion tubing. The compatibility of NAGLAZYME in solution with other products has not been evaluated.

3 DOSAGE FORMS AND STRENGTHS Injection; 5 mL vials (5 mg per 5 mL).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • NAGLAZYME (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

Dosage

Recommended Dose The recommended dosage regimen of NAGLAZYME is 1 mg per kg of body weight administered once weekly as an intravenous infusion.

Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion [see WARNINGS AND PRECAUTIONS (5.2)].

The total volume of the infusion should be delivered over a period of time of no less than 4 hours. NAGLAZYME should be diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 250 mL and delivered by controlled intravenous infusion using an infusion pump. The initial infusion rate should be 6 mL per hour for the first hour. If the infusion is well tolerated, the rate of infusion may be increased to 80 mL per hour for the remaining 3 hours. The infusion time can be extended up to 20 hours if infusion reactions occur.

For patients 20 kg and under or those who are susceptible to fluid volume overload, physicians may consider diluting NAGLAZYME in a volume of 100 mL [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.3)]. The infusion rate (mL per hour) should be decreased so that the total infusion duration remains no less than 4 hours.

Each vial of NAGLAZYME provides 5 mg of galsulfase (expressed as protein content) in 5 mL of solution and is intended for single use only. Do not use the vial more than one time. The concentrated solution for infusion must be diluted with 0.9% Sodium Chloride Injection, USP, using aseptic techniques. Prepare Naglazyme using low-protein-binding containers and administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter. There is no information on the compatibility of diluted NAGLAZYME with glass containers.

2.2 Instructions for Use Prepare and use NAGLAZYME according to the following steps. Use aseptic techniques.

Determine the number of vials to be used based on the patient's weight and the recommended dose of 1 mg per kg:

Patient's weight (kg) x 1 mL/kg of NAGLAZYME = Total number of mL of NAGLAZYME

Total number of mL of NAGLAZYME ÷ 5 mL per vial = Total number of vials

Round up to the next whole vial. Remove the required number of vials from the refrigerator to allow them to reach room temperature. Do not allow vials to remain at room temperature longer than 24 hours prior to dilution. Do not heat or microwave vials.

Before withdrawing the NAGLAZYME solution from the vial, visually inspect each vial for particulate matter and discoloration. The NAGLAZYME solution should be clear to slightly opalescent and colorless to pale yellow. Some translucency may be present in the solution. Do not use if the solution is discolored or if there is particulate matter in the solution.

From a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP, withdraw and discard a volume equal to the volume of NAGLAZYME solution to be added. If using a 100 mL infusion bag, this step is not necessary.

Slowly withdraw the calculated volume of NAGLAZYME from the appropriate number of vials using caution to avoid excessive agitation. Do not use a filter needle, as this may cause agitation. Agitation may denature NAGLAZYME, rendering it biologically inactive.

Slowly add the NAGLAZYME solution to the 0.9% Sodium Chloride Injection, USP, using care to avoid agitation of the solutions. Do not use a filter needle.

Gently rotate the infusion bag to ensure proper distribution of NAGLAZYME. Do not shake the solution.

Administer the diluted NAGLAZYME solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 µm in-line filter. NAGLAZYME does not contain preservatives; therefore, after dilution with saline, the infusion bags should be used immediately. If immediate use is not possible, the diluted solution must be stored refrigerated at 2°C to 8°C (36°F to 46°F) and administered within 48 hours from the time of dilution to completion of administration. Other than during infusion, do not store the diluted NAGLAZYME solution at room temperature. Any unused product or waste material must be discarded and disposed of in accordance with local requirements.

NAGLAZYME must not be infused with other products in the infusion tubing. The compatibility of NAGLAZYME in solution with other products has not been evaluated.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Galsulfase 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

There is limited information regarding Postmarketing Experience of Galsulfase 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

Drug Interactions

  • Drug
  • Description

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 Galsulfase in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Galsulfase01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Galsulfase 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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Retrieved from "https://www.wikidoc.org/index.php?title=Galsulfase&oldid=1088643"