Identification
- Summary
Factor IX Complex (Human) is a Factor IX complex used to prevent and treat bleeding episodes in hemophilia B or vitamin K antagonist therapy.
- Brand Names
- Profilnine
- Generic Name
- Factor IX Complex (Human)
- DrugBank Accession Number
- DB11330
- Background
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.
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- Associated Therapies
- Contraindications & Blackbox Warnings
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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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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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Factor IX Complex (Human). Alteplase The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Alteplase. Aminocaproic acid The risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Factor IX Complex (Human). Ancrod The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Ancrod. Anistreplase The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Anistreplase. Antithrombin Alfa The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Antithrombin Alfa. Antithrombin III human The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Antithrombin III human. Apixaban The therapeutic efficacy of Factor IX Complex (Human) can be decreased when used in combination with Apixaban. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Alphanine Pws Inj 1500unit/vial Powder, for solution 1500 unit / vial Intravenous Alpha Therapeutic Corporation 1992-12-31 2001-07-31 Canada 
Bebulin Vh 500unit/vial Powder 500 unit / 10 mL Intravenous Osterreichisches Institut Fur Haemoderivate Ges M.B.H. 1988-12-31 1998-08-13 Canada - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Bebulin Vh Inj 1000unit/vial Factor IX Complex (Human) (1000 unit / vial) + Water (20 mL / vial) Powder, for solution Intravenous Osterreichisches Institut Fur Haemoderivate Ges M.B.H. 1990-12-31 1998-08-13 Canada Feiba Vh Immuno Anti Inhibitor Factor IX Complex (Human) + Antihemophilic factor human (4 unit) + Coagulation factor VII human + Coagulation factor X human + Prothrombin Powder, for solution Intravenous Osterreichisches Institut Fur Haemoderivate Ges M.B.H. 1986-12-31 1998-08-13 Canada Profilnine Factor IX Complex (Human) (100 [iU]/1mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 Not applicable US 
Profilnine Factor IX Complex (Human) (500 [iU]/5mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 Not applicable US Profilnine Factor IX Complex (Human) (500 [iU]/5mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 2019-10-31 US Profilnine Factor IX Complex (Human) (150 [iU]/1mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 Not applicable US Profilnine Factor IX Complex (Human) (100 [iU]/1mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 2020-03-31 US Profilnine Factor IX Complex (Human) (1500 [iU]/10mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 Not applicable US Profilnine Factor IX Complex (Human) (150 [iU]/1mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 2020-03-31 US Profilnine Factor IX Complex (Human) (500 [iU]/5mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1981-07-20 Not applicable US
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
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- FW411QXD5M
- CAS number
- 37224-63-8
References
- General References
- 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. [Article]
- 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. [Article]
- 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). [Article]
- External Links
- PubChem Substance
- 347911188
- 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
Phase Status Purpose Conditions Count 4 Completed Treatment Acute Bleeding on Long-Term Anticoagulation Therapy / Hemorrhage / Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time) / Urgent Reversal of Vitamin K Antagonist (VKA) Anticoagulation 1 4 Completed Treatment Bleeding / Blood Loss During Surgery / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates 1 4 Completed Treatment Hereditary Factor VIII Deficiency Disease With Inhibitor 1 4 Completed Treatment Intracranial Hemorrhages 1 4 Completed Treatment Prothrombin Complex Factor Deficiency 1 4 Not Yet Recruiting Treatment Cardiac Surgical Procedures (D006348) 1 4 Not Yet Recruiting Treatment Cardiac Valve Disease 1 4 Not Yet Recruiting Treatment Knee Disease / Osteoarthritis in the Hip Joint / Prostate Cancer / Spine, Open 1 4 Not Yet Recruiting Treatment Liver Disease 1 4 Recruiting Treatment Anticoagulation / Anticoagulation Reversal 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Parenteral 500 IU Powder, for solution Intravenous 1500 unit / vial Powder Intravenous 500 unit / 10 mL Injection, powder, for solution Parenteral Injection, powder, for solution Intravenous 1000 IU Injection, powder, for solution Intravenous 500 IU Injection, powder, for solution Intravenous 1000 U Injection, powder, for solution Intravenous 250 U Injection, powder, for solution Intravenous 500 U Powder, for solution Parenteral 1000 IU/20ml Powder, for solution Parenteral 500 IU/20ml Powder, for solution Intravenous Injection Parenteral 1000 IU Injection, powder, for solution Injection, powder, lyophilized, for solution Intravenous 500 IU Kit Intravenous Injection, solution, concentrate Intravenous 1000 IU/10mL Injection, solution, concentrate Intravenous 500 IU/5mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at December 03, 2015 16:52 / Updated at May 21, 2021 10:21