Coagulation factor XIII A-subunit: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
No edit summary
No edit summary
Line 1: Line 1:
{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|genericName=coagulation factor xiii a
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=prophylaxis
|hasBlackBoxWarning=Yes
|indication=bleeding in patients with congenital factor XIII A-subunit deficiency
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[[headache]], [[pain|pain in the extremities]], [[pain|injection site pain]], D dimer increase
|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>
Line 12: Line 14:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==
* For routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency.


* Dosing Information
==Dosage==
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information


:* Dosage
* Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders.


<!--Off-Label Use and Dosage (Adult)-->
* The dose for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay.


<!--Guideline-Supported Use (Adult)-->
* Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
* A pharmacokinetic study was conducted in the FXIII congenitally deficient population evaluating five dose cohorts (2, 7, 24, 60 and 89 IU/kg) with blood sampling at 0.5, 1, 4, 8, 24, 48, 72 hours, and 7, 14, and 28 days. Samples were tested for FXIII activity by a chromogenic assay and for FXIII A2B2 tetramer levels by an ELISA, as well as for other analytes. It was found that FXIII tetramer levels were proportional to the observed FXIII activity up to the point of replacement of 100% of normal FXIII activity, but there was no increase in FXIII tetramer levels at higher levels of FXIII activity. A dose of 35 IU/kg is sufficient to replace 100% of FXIII activity in this population, and higher doses may not increase the levels of tetrameric Factor XIII.


* Class of Recommendation:
==DOSAGE FORMS AND STRENGTHS==


* Strength of Evidence:
* TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is available as a white lyophilized powder in single-use vial containing nominally 2500 IU per vial (2000 – 3125 IU) of recombinant coagulation factor XIII A-subunit. The actual amount of TRETTEN in IU is stated on each carton and vial.


* Dosing Information
* After reconstitution with the provided Sterile Water for Injection, each vial contains 667-1042 IU/mL recombinant coagulation factor XIII A-subunit.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


:* Dosage
=====Condition2=====


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


<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====


* 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-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
Line 110: Line 81:


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* TRETTEN is contraindicated in patients who have known [[hypersensitivity]] to the active substance or to any of the excipients
 
<!--Warnings-->
|warnings=* Description
|warnings=* Description


Line 244: Line 213:


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|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 15:14, 29 April 2015

Coagulation factor XIII A-subunit
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

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

Coagulation factor XIII A-subunit is a {{{drugClass}}} that is FDA approved for the prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency. Common adverse reactions include headache, pain in the extremities, injection site pain, D dimer increase.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency.

Dosage

  • Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders.
  • The dose for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay.
  • Consider dose adjustment if adequate coverage is not achieved with the recommended 35 IU/kg dose.
  • A pharmacokinetic study was conducted in the FXIII congenitally deficient population evaluating five dose cohorts (2, 7, 24, 60 and 89 IU/kg) with blood sampling at 0.5, 1, 4, 8, 24, 48, 72 hours, and 7, 14, and 28 days. Samples were tested for FXIII activity by a chromogenic assay and for FXIII A2B2 tetramer levels by an ELISA, as well as for other analytes. It was found that FXIII tetramer levels were proportional to the observed FXIII activity up to the point of replacement of 100% of normal FXIII activity, but there was no increase in FXIII tetramer levels at higher levels of FXIII activity. A dose of 35 IU/kg is sufficient to replace 100% of FXIII activity in this population, and higher doses may not increase the levels of tetrameric Factor XIII.

DOSAGE FORMS AND STRENGTHS

  • TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is available as a white lyophilized powder in single-use vial containing nominally 2500 IU per vial (2000 – 3125 IU) of recombinant coagulation factor XIII A-subunit. The actual amount of TRETTEN in IU is stated on each carton and vial.
  • After reconstitution with the provided Sterile Water for Injection, each vial contains 667-1042 IU/mL recombinant coagulation factor XIII A-subunit.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Coagulation factor XIII A-subunit in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Coagulation factor XIII A-subunit in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Coagulation factor XIII A-subunit in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Coagulation factor XIII A-subunit in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Coagulation factor XIII A-subunit in pediatric patients.

Contraindications

  • TRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Coagulation factor XIII A-subunit 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 Coagulation factor XIII A-subunit 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

There is limited information regarding Coagulation factor XIII A-subunit Drug Interactions in the drug label.

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 Coagulation factor XIII A-subunit in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Coagulation factor XIII A-subunit during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Coagulation factor XIII A-subunit with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Coagulation factor XIII A-subunit with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Coagulation factor XIII A-subunit with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Coagulation factor XIII A-subunit with respect to specific gender populations.

Race

There is no FDA guidance on the use of Coagulation factor XIII A-subunit with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Coagulation factor XIII A-subunit in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Coagulation factor XIII A-subunit in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Coagulation factor XIII A-subunit in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Coagulation factor XIII A-subunit in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Coagulation factor XIII A-subunit in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Coagulation factor XIII A-subunit in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Coagulation factor XIII A-subunit in the drug label.

Pharmacology

There is limited information regarding Coagulation factor XIII A-subunit Pharmacology in the drug label.

Mechanism of Action

Structure

File:Coagulation factor XIII A-subunit01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Coagulation factor XIII A-subunit in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Coagulation factor XIII A-subunit in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Coagulation factor XIII A-subunit in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Coagulation factor XIII A-subunit in the drug label.

How Supplied

Storage

There is limited information regarding Coagulation factor XIII A-subunit Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Coagulation factor XIII A-subunit |?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::Coagulation factor XIII A-subunit |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Coagulation factor XIII A-subunit in the drug label.

Precautions with Alcohol

  • Alcohol-Coagulation factor XIII A-subunit 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)

{{#subobject: 

 |Page Name=Coagulation factor XIII A-subunit
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject: 

 |Label Page=Coagulation factor XIII A-subunit
 |Label Name=Coagulation factor XIII A-subunit11.png

}}

{{#subobject: 

 |Label Page=Coagulation factor XIII A-subunit
 |Label Name=Coagulation factor XIII A-subunit11.png

}}

Retrieved from "https://www.wikidoc.org/index.php?title=Coagulation_factor_XIII_A-subunit&oldid=1093066"