Factor IX Complex (Human)

Identification

Name
Factor IX Complex (Human)
Accession Number
DB11330  (DB09058, DB14047)
Type
Biotech
Groups
Approved, Investigational
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 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)
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Alphanine Pws Inj 1500unit/vialPowder, for solution1500 unitIntravenousAlpha Therapeutic Corporation1992-12-312001-07-31Canada
Bebulin Vh 500unit/vialPowder500 unitIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1988-12-311998-08-13Canada
ProfilnineKit500 [iU]/5mLIntravenousGrifols1981-07-20Not applicableUs
ProfilnineKit100 [iU]/1mLIntravenousGrifols1981-07-20Not applicableUs
ProfilnineKit500 [iU]/5mLIntravenousGrifols1981-07-20Not applicableUs
ProfilnineKit150 [iU]/1mLIntravenousGrifols1981-07-20Not applicableUs
ProfilnineKit100 [iU]/1mLIntravenousGrifols1981-07-20Not applicableUs
ProfilnineKit150 [iU]/1mLIntravenousGrifols1981-07-20Not applicableUs
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
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
Categories
UNII
FW411QXD5M
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.

Associated Conditions
Associated Therapies
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
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).
AnagrelideThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Anagrelide.
ArgatrobanThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Argatroban.
BivalirudinThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Bivalirudin.
DipyridamoleThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Dipyridamole.
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
PubChem Substance
347911188
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
1Active Not RecruitingTreatmentCardiovascular Disease (CVD)1
1CompletedTreatmentHealthy Volunteers1
1TerminatedTreatmentIntracranial Hemorrhages1
1, 2Unknown StatusPreventionFlu caused by Influenza1
2RecruitingTreatmentDrug Action Reversal1
3Active Not RecruitingTreatmentHemophilia A1
3CompletedTreatmentAcquired Coagulation Factor Deficiency1
3CompletedTreatmentAcute Major Bleeding / Reversal of Coagulopathy1
3Not Yet RecruitingTreatmentHeart Disease End Stage / Heart Failureļ¼ŒCongestive1
3Not Yet RecruitingTreatmentHemophilia A or B With Inhibitors1
3RecruitingTreatmentShock, 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
FormRouteStrength
Powder, for solutionIntravenous1500 unit
PowderIntravenous500 unit
Powder, for solutionIntravenous
KitIntravenous100 [iU]/1mL
KitIntravenous150 [iU]/1mL
KitIntravenous500 [iU]/5mL
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 August 02, 2018 06:23