Factor IX Complex (Human)

Identification

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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 solutionIntravenousAlpha Therapeutic Corporation1992-12-312001-07-31Canada
Bebulin Vh 500unit/vialPowderIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1988-12-311998-08-13Canada
ProfilnineKit100 [iU]/1mLIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUs
ProfilnineKit500 [iU]/5mLIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUs
ProfilnineKit150 [iU]/1mLIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUs
ProfilnineKit500 [iU]/5mLIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUs
ProfilnineKit150 [iU]/1mLIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUs
ProfilnineKit100 [iU]/1mLIntravenousGRIFOLS USA, LLC1981-07-20Not applicableUs
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 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
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
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.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

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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
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
(R)-warfarinThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with (R)-warfarin.
(S)-WarfarinThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with (S)-Warfarin.
4-hydroxycoumarinThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with 4-hydroxycoumarin.
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.
AmediplaseThe therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Amediplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic Acid is combined with Factor IX Complex (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

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
1CompletedOtherHealthy Volunteers1
1CompletedTreatmentHealthy Volunteers2
1CompletedTreatmentThrombotic events1
1TerminatedTreatmentIntracranial Hemorrhages1
2Not Yet RecruitingTreatmentCoagulation Disorders / Hemorrhage1
2Not Yet RecruitingTreatmentTrauma Injury1
2RecruitingOtherBleeding / General Surgery / Transfusions1
2RecruitingTreatmentDrug Action Reversal1
2Unknown StatusTreatmentIntracerebral Hemorrhage1
3Active Not RecruitingTreatmentHemophilia A1
3CompletedTreatmentAcquired Coagulation Factor Deficiency1
3CompletedTreatmentAcute Major Bleeding / Reversal of Coagulopathy1
3CompletedTreatmentReversal of Anticoagulant Treatment1
3RecruitingTreatmentHeart Disease End Stage / Heart Failureļ¼ŒCongestive1
3RecruitingTreatmentSignificant Bleeding Risk1
3TerminatedTreatmentMajor Trauma1
4CompletedTreatmentAcute Bleeding on Long-Term Anticoagulation Therapy / Acute Bleeding While on 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
4RecruitingTreatmentAnticoagulation / Anticoagulation Reversal1
4RecruitingTreatmentIntracranial Hemorrhages1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1
Not AvailableCompletedNot AvailableBlood Loss,Surgical / Coagulation Protein Disorders / Perioperative Care1
Not AvailableCompletedNot AvailableCardiopulmonary Bypass1
Not AvailableCompletedNot AvailableHemorrhage1
Not AvailableNot Yet RecruitingNot AvailableHemophilia A1
Not AvailableRecruitingNot AvailableHemorrhage1
Not AvailableUnknown StatusNot AvailableAcquired Haemophilia1
Not AvailableWithdrawnTreatmentIntracranial Hemorrhage, Spontaneous / Intracranial Hemorrhage, Traumatic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Powder, for solutionIntravenous
PowderIntravenous
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 September 02, 2019 19:22