Anti-inhibitor coagulant complex: Difference between revisions

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human antihemophilic factor
human antihemophilic factor


|indication=
|indication=
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|adverseReactions=
|adverseReactions=


high antibody titer
high [[antibody]] titer


<!--Black Box Warning-->
<!--Black Box Warning-->


|blackBoxWarningTitle=
|blackBoxWarningTitle=
Title
WARNING


|blackBoxWarningBody=
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors.


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

Revision as of 00:37, 14 July 2014

Anti-inhibitor coagulant complex
Black Box Warning
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: Gerald Chi

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
* Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors.

Overview

Anti-inhibitor coagulant complex is a human antihemophilic factor that is FDA approved for the {{{indicationType}}} of spontaneous bleeding episodes or in hemophilia A and hemophilia B patients with inhibitors. There is a Black Box Warning for this drug as shown here. Common adverse reactions include high antibody titer.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

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 Anti-inhibitor coagulant complex in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Anti-inhibitor coagulant complex 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 Anti-inhibitor coagulant complex 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 Anti-inhibitor coagulant complex in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Anti-inhibitor coagulant complex in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
* Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Anti-inhibitor coagulant complex 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 Anti-inhibitor coagulant complex 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 Anti-inhibitor coagulant complex in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Anti-inhibitor coagulant complex during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Anti-inhibitor coagulant complex with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Anti-inhibitor coagulant complex with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Anti-inhibitor coagulant complex with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Anti-inhibitor coagulant complex with respect to specific gender populations.

Race

There is no FDA guidance on the use of Anti-inhibitor coagulant complex with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Anti-inhibitor coagulant complex in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Anti-inhibitor coagulant complex in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Anti-inhibitor coagulant complex in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Anti-inhibitor coagulant complex in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Anti-inhibitor coagulant complex in the drug label.

Condition1
  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Anti-inhibitor coagulant complex in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Anti-inhibitor coagulant complex in the drug label.

Pharmacology

There is limited information regarding Anti-inhibitor coagulant complex Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Anti-inhibitor coagulant complex in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Anti-inhibitor coagulant complex in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Anti-inhibitor coagulant complex in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Anti-inhibitor coagulant complex in the drug label.

Condition1
  • Description

How Supplied

Storage

There is limited information regarding Anti-inhibitor coagulant complex 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 Anti-inhibitor coagulant complex in the drug label.

Precautions with Alcohol

  • Alcohol-Anti-inhibitor coagulant complex 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. "FEIBA NF (anti-inhibitor coagulant complex) kit".
  2. "http://www.ismp.org". External link in |title= (help)


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