Factor XIII concentrate

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Factor XIII concentrate
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]

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Overview

Factor XIII concentrate is a hemostatic that is FDA approved for the treatment of congenital Factor XIII deficiency. Common adverse reactions include joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Corifact is a Factor XIII concentrate indicated for adult and pediatric patients with congenital Factor XIII deficiency for:

Routine prophylactic treatment Peri-operative management of surgical bleeding

Dosage

40 International Units (IU) per kg body weight at a rate not to exceed 4 mL per minute Adjust dose ±5 IU per kg to maintain 5% to 20% trough level of FXIII activity as provided in the example below

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Corifact is a Factor XIII Concentrate indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.

Dosage

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 Factor XIII concentrate in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Factor XIII concentrate 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 Factor XIII concentrate 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 Factor XIII concentrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Factor XIII concentrate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Factor XIII concentrate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Factor XIII concentrate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Factor XIII concentrate with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

There is no FDA guidance on the use of Factor XIII concentrate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Factor XIII concentrate in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Factor XIII concentrate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Factor XIII concentrate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Factor XIII concentrate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Factor XIII concentrate in the drug label.

Pharmacology

There is limited information regarding Factor XIII concentrate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Factor XIII concentrate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Factor XIII concentrate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Factor XIII concentrate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Factor XIII concentrate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Factor XIII concentrate in the drug label.

How Supplied

Storage

There is limited information regarding Factor XIII concentrate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Factor XIII concentrate in the drug label.

Precautions with Alcohol

  • Alcohol-Factor XIII concentrate 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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