Anti-inhibitor coagulant complex

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)

Hemophilia A and B

FEIBA NF (Anti-Inhibitor Coagulant Complex) is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and hemophilia B patients with inhibitors.

Clinical experience suggests that patients with a Factor VIII inhibitor titer of less than 5 B.U. may be successfully treated with Antihemophilic Factor. Patients with titers ranging between 5 and 10 B.U. may either be treated with Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor.

This image is provided by the National Library of Medicine.

Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function3-5 that were present before treatment with FEIBA NF, nanofiltered and vapor-heated.

Dosing Information

Treatment should be initiated and supervised by a physician experienced in the management of hemophilia.

Clinical trials demonstrated that the response to treatment with FEIBA may differ from patient to patient with no correlation to the patient’s inhibitor titer. Response may also vary between different types of hemorrhage (e.g. joint hemorrhage vs. CNS hemorrhage). As a general guideline, a dosage range of 50 to 100 Units of FEIBA NF, per kg of body weight is recommended. However, care should be taken to distinguish between the following four indications:

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

Intravenous

Reconstitution

FEIBA NF contains no preservatives. Aseptic technique should be used throughout the entire reconstitution process and the solution should then be used immediately.

Allow the unopened vials of FEIBA NF (concentrate) and Sterile Water for Injection (diluent) to reach room temperature (not above 37°C, 98°F).
Remove caps from the concentrate and diluent vials to expose central portions of the rubber stoppers.
Disinfect the rubber stoppers of both vials using a germicidal solution. Place the vials on an even surface and allow them to dry.
Open the package of BAXJECT device by peeling away the lid without touching the inside (Fig. A).
Do not remove the device from the package. Turn the package over and insert the plastic spike through diluent stopper. (Fig. B).
Grip the package at its edge and pull the package off the device (Fig. B).
Turn the system over, so that the vial is on top. Quickly insert the other plastic spike into the FEIBA NF stopper (Fig. C). The vacuum will draw the diluent into the FEIBA NF vial. Please make sure that the connection of the two vials should be done expeditiously to close the open fluid pathway created by the first insertion of the spike to the diluent vial.
Swirl gently until FEIBA NF is completely dissolved. Make sure that FEIBA NF has been dissolved completely; otherwise, active material will not pass through the device filter.

Do not refrigerate after reconstitution!
After complete reconstitution of FEIBA NF its injection or infusion should be commenced as promptly as practicable, but must be completed within three hours following reconstitution. The solution must be given by intravenous injection or intravenous drip infusion.
Rate of Administration:

The maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. For a patient with a body weight of 75 kg, this corresponds to an infusion rate of 2.5 - 7.5 mL per minute depending on the number of units per vial (see label on vial).

Intravenous Injection or Infusion:

Inspect for particulate matter and discoloration after reconstituting the concentrate as described under Reconstitution prior to administration. The appearance of the solution should be colorless to slightly yellowish and essentially free of visible particles. Do not use solutions that are cloudy or have deposits.
Mixing of FEIBA NF with other products or substances must be avoided. It is advisable to flush venous access lines with isotonic saline prior to and after infusion of FEIBA NF.
If devices other than those supplied with FEIBA NF are used, ensure use of an adequate filter.
Plastic Luer lock syringes are recommended for use with this product since protein such as FEIBA NF tends to stick to the surface of all-glass syringes.
Turn the BAXJECT device handle down towards the FEIBA NF concentrate vial and remove the cap attached to the syringe connection of the BAXJECT device (Fig. D).
Draw air into the syringe, connect the syringe to the BAXJECT device, inject air into the concentrate vial (Fig. E).
While keeping the syringe plunger in place, turn the system upside down (concentrate vial now on top). Draw the concentrate into the syringe by pulling the plunger back slowly (Fig. F).
Turn the BAXJECT handle to its original position (facing side way).
Disconnect the syringe, attach a suitable needle and inject or infuse intravenously as instructed under Rate of Administration.

Monitoring

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

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

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

FEIBA NF is available in single-dose vials in the following nominal dosage strengths:

Blue - 500 Units per vial (NDC 64193-223-02)

Green - 1000 Units per vial (NDC 64193-224-02)

Purple - 2500 Units per vial (NDC 64193-225-02)

The number of Units of Factor VIII inhibitor bypassing activity is stated on the label of each vial.

FEIBA NF is packaged with a suitable volume (20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT Needleless Transfer Device, and one Package Insert.

The 50 mL SWFI stoppers are not latex-free and may contain Dry Natural Rubber Latex.

Storage

Store at room temperature, not to exceed 25°C (77°F).

Avoid freezing, which may damage the diluent vial.

Store in the original package in order to protect from light.

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

Feiba NF®^[1]

Look-Alike Drug Names

N/A^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

↑ "FEIBA NF (anti-inhibitor coagulant complex) kit".
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[1] "FEIBA NF (anti-inhibitor coagulant complex) kit".

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]