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|useInPregnancyFDA=
|useInPregnancyFDA=
* '''Pregnancy Category'''
* '''Pregnancy Category C'''
:* Animal reproduction studies have not been conducted with Profilnine. It is also not known whether Profilnine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Profilnine should be given to a pregnant woman only if clearly indicated.


|useInPregnancyAUS=
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|useInPed=
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
* Safety and effectiveness in pediatric patients below the age of 16 have not been established. However, across a well controlled half-life and recovery clinical trial in patients previously treated with factor IX concentrates for Hemophilia B, the two pediatric patients receiving Profilnine responded similarly when compared with the adult patients.
 
| useInGeri=
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.


Revision as of 00:19, 14 July 2014

Factor IX complex
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

Disclaimer

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Overview

Factor IX complex is a compelx of coagulation factors IX, II, and X and low levels of factor VII that is FDA approved for the {{{indicationType}}} of bleeding in patients with factor IX deficiency (hemophilia B). Common adverse reactions include flushing, nausea, fever, and shivering.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hemophilia B
  • Dosing Information
  • Each vial of Profilnine is labeled with total units expressed as international units (IU) according to the WHO International Standard. One unit approximates the activity in one mL of normal plasma.
  • A 1% increase in factor IX (0.01 units)/units administered/kg can be expected. The amount of Profilnine required to establish hemostasis will vary with each patient and depends on the circumstances. The following formula may be used as a guide in determining the number of units to be administered:
This image is provided by the National Library of Medicine.
  • In normal clinical practice there is variability among patients and their clinical condition. Therefore, the factor IX level of each patient should be monitored frequently during replacement therapy.
This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Coagulopathy of Chronic Liver Disease
  • Dosing Information
  • 20 mL of factor IX complex containing 2000 units of factors II, IX, and X[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Safety and effectiveness in pediatric patients below the age of 16 have not been established. However, across a well controlled half-life and recovery clinical trial in patients previously treated with factor IX concentrates for Hemophilia B, the two pediatric patients receiving Profilnine responded similarly when compared with the adult patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • None known.

Warnings

  • Because Profilnine is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma to the application of viral elimination/reduction steps such as DEAE chromatography, solvent detergent treatment and nanofiltration in the manufacturing process. Despite these measures, such products can potentially transmit disease: therefore the risk of infectious agents cannot be totally eliminated. The physician must weigh the risks and benefits of using this product and discuss these issues with the patient. Appropriate vaccination (hepatitis A and B) for patients in receipt of plasma derived factor IX complex concentrates is recommended.
  • The use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications and the use of such products may be potentially hazardous in patients undergoing surgery, in patients post surgery, in patients with known liver disease, and in patients with signs of fibrinolysis, thrombosis or disseminated intravascular coagulation (DIC)(6). For these patients, clinical surveillance for early signs of consumptive coagulopathy should be initiated with appropriate biological testing when administering this product. Profilnine should only be administered to patients when the beneficial effects of use outweigh the serious risk of potential hypercoagulation.

Precautions

  • Exercise caution when handling Profilnine due to the limited risk of exposure to viral infection.
  • Discard any unused Profilnine vial contents. Discard administration equipment after single use. Do not resterilize components. Do not reuse components.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Factor IX 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 Factor IX 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 C
  • Animal reproduction studies have not been conducted with Profilnine. It is also not known whether Profilnine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Profilnine should be given to a pregnant woman only if clearly indicated.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Factor IX complex in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Factor IX complex during labor and delivery.

Nursing Mothers

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

Pediatric Use

  • Safety and effectiveness in pediatric patients below the age of 16 have not been established. However, across a well controlled half-life and recovery clinical trial in patients previously treated with factor IX concentrates for Hemophilia B, the two pediatric patients receiving Profilnine responded similarly when compared with the adult patients.

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Intravenous

Monitoring

  • After repeated treatment with Profilnine, patients should be monitored for the development of neutralizing antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.

IV Compatibility

There is limited information regarding IV Compatibility of Factor IX complex in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Factor IX complex in the drug label.

Pharmacology

There is limited information regarding Factor IX complex Pharmacology in the drug label.

Mechanism of Action

Structure

File:Factor IX complex01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Factor IX complex in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Factor IX complex in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Factor IX complex in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Factor IX complex in the drug label.

Condition1
  • Description

How Supplied

  • Profilnine is supplied in sterile lyophilized form in single dose vials accompanied by a suitable volume of diluent (Sterile Water for Injection, USP), according to factor IX potency. Each vial is labeled with the factor IX potency expressed in International Units which is referenced to the WHO International Standard. Profilnine is packaged with a Mix2Vial filter transfer set for use in administration.
  • It is available in the following potencies, and the product is also color coded based upon assay on the carton and vial label as follows:
This image is provided by the National Library of Medicine.

Storage

There is limited information regarding Factor IX complex Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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

Patient Counseling Information

  • After repeated treatment with Profilnine, patients should be monitored for the development of neutralizing antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
  • Hypersensitivity and allergic type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX complex concentrate products. Patients must be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia and anaphylaxis. Patients must be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care if these symptoms occur.

Precautions with Alcohol

  • Alcohol-Factor IX complex interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Profilnine®[2]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Gazzard, B. G. (1975-08). "The use of fresh frozen plasma or a concentrate of factor IX as replacement therapy before liver biopsy". Gut. 16 (8): 621–625. ISSN 0017-5749. PMC 1411020. PMID 1102399. Unknown parameter |coauthors= ignored (help); Check date values in: |date= (help)
  2. ↑ "PROFILNINE (factor ix complex) kit".
  3. ↑ "http://www.ismp.org". External link in |title= (help)


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