| Pharmaceutical Information |
| Drug Name |
Factor ix complex |
| Drug ID |
BADD_D00866 |
| 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. |
| Indications and Usage |
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. |
| Marketing Status |
approved; investigational |
| ATC Code |
B02BD04 |
| DrugBank ID |
DB11330
|
| KEGG ID |
Not Available
|
| MeSH ID |
D005164
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
Not Available
|
| NDC Product Code |
68516-3212; 68516-3209; 68516-3210; 68516-3207; 68516-3208; 68516-3211 |
| UNII |
FW411QXD5M
|
| Synonyms |
Factor IX | Factor Nine | Autoprothrombin II | Christmas Factor | Factor IX Fraction | Plasma Thromboplastin Component | Blood Coagulation Factor IX | Factor IX Complex | Factor 9 | Coagulation Factor IX | Factor IX, Coagulation |
|
| Chemical Information |
| Molecular Formula |
Not Available |
| CAS Registry Number |
37224-63-8 |
| SMILES |
Not Available |
| Chemical Structure |
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| ADRs Induced by Drug |
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*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
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| ADR Term |
ADReCS ID |
ADR Frequency (FAERS)
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ADR Severity Grade (FAERS)
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ADR Severity Grade (CTCAE)
|
| Chills | 15.05.03.016; 08.01.09.001 | - | - | | | Flushing | 24.03.01.002; 23.06.05.003; 08.01.03.025 | - | - | | | Headache | 17.14.01.001 | - | - | | | Lethargy | 08.01.01.008; 19.04.04.004; 17.02.04.003 | - | - | | | Nausea | 07.01.07.001 | - | - | | | Paraesthesia | 23.03.03.094; 17.02.06.005 | - | - | | | Pyrexia | 08.05.02.003 | - | - | | | Somnolence | 19.02.05.003; 17.02.04.006 | - | - | | | Urticaria | 23.04.02.001; 10.01.06.001 | - | - | | | Vomiting | 07.01.07.003 | - | - | |
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