Factor IX Complex (Human)

Identification

Name
Factor IX Complex (Human)
Accession Number
DB11330  (DB09058)
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Blood factors
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.

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
  • 4F-PCC
  • APCC
  • Coagulation factor IX, II, VII and X in combination
  • Factor IX Complex (Human)
  • Factor IX Fraction
  • PCC
  • Plasma Concentrate Factor IX
  • Prothrombin complex concentrate
  • Prothrombin complex concentrate (human)
Categories
UNII
Not Available
CAS number
37224-63-8

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.

Structured Indications
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
Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
Not Available
Food Interactions
Not Available

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]
External Links
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
1CompletedTreatmentHealthy Volunteers1
1RecruitingTreatmentCardiovascular Disease (CVD)1
1TerminatedTreatmentIntracranial Hemorrhages1
1, 2Unknown StatusPreventionFlu caused by Influenza1
2RecruitingTreatmentDrug Action Reversal1
3CompletedTreatmentAcquired Coagulation Factor Deficiency1
3CompletedTreatmentAcute Major Bleeding / Reversal of Coagulopathy1
3Not Yet RecruitingTreatmentHemophilia A or B With Inhibitors1
3Not Yet RecruitingTreatmentShock, Hemorrhagic1
4CompletedTreatmentHemophilia A1
4CompletedTreatmentProthrombin Complex Factor Deficiency1
4Enrolling by InvitationTreatmentBlood Loss,Surgical / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Haemorrhage / Prothrombin Complex Concentrates1
4RecruitingTreatmentIntracranial Hemorrhages1
4Unknown StatusTreatmentPostpartum Hemorrhage1
Not AvailableCompletedNot AvailableBlood Loss,Surgical / Coagulation Protein Disorders / Perioperative Care1
Not AvailableCompletedNot AvailableCardiopulmonary Bypass1
Not AvailableCompletedNot AvailableCongenital FVII Deficiency / Congenital Hematological Disorder1
Not AvailableRecruitingNot AvailableHemorrhage1
Not AvailableUnknown StatusNot AvailableAcquired Haemophilia1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
Not Available
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

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

Drug created on December 03, 2015 09:52 / Updated on November 18, 2016 14:25