Factor IX Complex (Human)

Identification

Name
Factor IX Complex (Human)
Accession Number
DB11330
Description

Factor IX Complex is a sterile, lyophilized concentrate composed of a number of Vitamin K-dependent clotting factors found in functioning human plasma. Also known as prothrombin complex concentrate, products containing this complex often include Factor IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower Factor), and low levels of Factor VII (proconvertin) derived from human plasma. Many commercially available products also contain low levels of other antithrombotic proteins. For example, Kcentra (FDA) also contains the antithrombotic proteins C and S, while Bebulin VH (FDA) contains heparin. Coagulation factors are purified from pooled human plasma and subsequently sterilized and treated.

Although Factor IX Complex products contain many different coagulation components, Factor IX is the lead component for potency and efficacy, particularly when used for the treatment of bleeding associated with Hemophilia B (Factor IX deficiency). As the product Kcentra, Factor IX Complex is also indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients experiencing acute major bleeding or requiring rapid reversal of therapy.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • 4F-PCC
  • APCC
  • Coagulation factor IX complex human
  • Coagulation factor IX, II, VII and X in combination
  • Factor IX Complex
  • Factor IX Complex (Human)
  • Factor IX complex human
  • Factor IX complex,human
  • Factor IX Fraction
  • PCC
  • Plasma Concentrate Factor IX
  • Prothrombin complex concentrate
  • Prothrombin complex concentrate (human)

Pharmacology

Indication

Factor IX Complex is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients. It is also indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or who require rapid reversal of therapy.

Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
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Pharmacodynamics
Not Available
Mechanism of action

Factor IX Complex is a sterile, lyophilized concentrate composed of a number of Vitamin K-dependent clotting factors found in functioning human plasma. Also known as prothrombin complex concentrate, products containing this complex often include Factor IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower Factor), and low levels of Factor VII (proconvertin) derived from human plasma. Many commercially available products also contain low levels of other antithrombotic proteins. For example, Kcentra(FDA) also contains the antithrombotic proteins C and S, while Bebulin VH (FDA) contains heparin.

This complex of coagulation factors helps replenish clotting factors that may have been lost through warfarin therapy or through a congenital abnormality such as Hemophilia B.

Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
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Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbciximabThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Acenocoumarol.
Acetylsalicylic acidThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Acetylsalicylic acid.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Factor IX Complex (Human).
AlteplaseThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Alteplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Factor IX Complex (Human).
AncrodThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Ancrod.
AnistreplaseThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Anistreplase.
Antithrombin AlfaThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Antithrombin Alfa.
Antithrombin III humanThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Antithrombin III human.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Alphanine Pws Inj 1500unit/vialPowder, for solutionIntravenousAlpha Therapeutic Corporation1992-12-312001-07-31Canada flag
Bebulin Vh 500unit/vialPowderIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1988-12-311998-08-13Canada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Bebulin Vh Inj 1000unit/vialFactor IX Complex (Human) (1000 unit) + Water (20 ml)Powder, for solutionIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1990-12-311998-08-13Canada flag
Feiba Vh Immuno Anti InhibitorFactor IX Complex (Human) + Antihemophilic factor human (4 unit) + Coagulation factor VII human + Coagulation factor X human + ProthrombinPowder, for solutionIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1986-12-311998-08-13Canada flag
ProfilnineFactor IX Complex (Human) (150 [iU]/1mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1981-07-202020-03-31US flag
ProfilnineFactor IX Complex (Human) (500 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUS flag
ProfilnineFactor IX Complex (Human) (100 [iU]/1mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUS flag
ProfilnineFactor IX Complex (Human) (500 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1981-07-202019-10-31US flag
ProfilnineFactor IX Complex (Human) (150 [iU]/1mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUS flag
ProfilnineFactor IX Complex (Human) (100 [iU]/1mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1981-07-202020-03-31US flag

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Chemical Identifiers

UNII
FW411QXD5M
CAS number
37224-63-8

References

General References
  1. Hedges A, Coons JC, Saul M, Smith RE: Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates. J Thromb Thrombolysis. 2016 Jul;42(1):6-10. doi: 10.1007/s11239-015-1321-4. [PubMed:26685667]
  2. Sin JH, Berger K, Lesch CA: Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation. J Crit Care. 2016 Jul 5;36:166-172. doi: 10.1016/j.jcrc.2016.06.024. [PubMed:27546767]
  3. Chai-Adisaksopha C, Hillis C, Siegal DM, Movilla R, Heddle N, Iorio A, Crowther M: Prothrombin complex concentrates versus fresh frozen plasma for warfarin reversal. A systematic review and meta-analysis. Thromb Haemost. 2016 Aug 4;116(4). [PubMed:27488143]
PubChem Substance
347911188
RxNav
1670383
ChEMBL
CHEMBL2109098
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Prothrombin_complex_concentrate
FDA label
Download (8.68 MB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentAcute Bleeding on Long-Term Anticoagulation Therapy / Hemorrhage / Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time) / Urgent Reversal of Vitamin K Antagonist (VKA) Anticoagulation1
4CompletedTreatmentHereditary Factor VIII Deficiency Disease With Inhibitor1
4CompletedTreatmentIntracranial Hemorrhages1
4CompletedTreatmentProthrombin Complex Factor Deficiency1
4Enrolling by InvitationTreatmentBleeding / Blood Loss,Surgical / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates1
4Not Yet RecruitingTreatmentCardiac Surgical Procedures1
4Not Yet RecruitingTreatmentCoagulation Disorders / Massive Hemorrhage / Traumatic haemorrhage1
4RecruitingTreatmentIntracranial Hemorrhages1
4Unknown StatusTreatmentAnticoagulation / Anticoagulation Reversal1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Powder, for solutionIntravenous
PowderIntravenous
Powder, for solutionIntravenous
Injection, powder, for solutionParenteral250 iu
Injection, powder, for solutionParenteral500 iu
Injection, powder, for solutionIntravenous1000 IU
Injection, powder, for solutionIntravenous500 IU
Injection, powder, for solutionIntravenous1000 U
Injection, powder, for solutionIntravenous250 U
Injection, powder, for solutionIntravenous500 U
Powder, for solutionParenteral1000 IU/20ml
Powder, for solutionParenteral500 IU/20ml
Injection
Injection, powder, for solution
Injection, powder, lyophilized, for solutionIntravenous500 IU
KitIntravenous
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on December 03, 2015 09:52 / Updated on June 12, 2020 10:53

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