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| Primary information |
|---|
| ID | 10836 |
| Therapeutic ID | Th1200 |
| Protein Name | Prothrombin complex concentrate |
| Sequence | NA
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | Factor II - 48-60 hrs; factor VII - 1.5-6 hrs; factor IX - 20-24 hrs and factor X - 24 - 48 hrs. |
| Description | Anti-inhibitor coagulant complex, also known as activated prothrombin complex concentrate (APCC) is a preparation containing precursor and activated forms of blood coagulation factors II, VII, IX, and X derived from pooled human venous plasma. |
| Indication/Disease | For use in hemophilia A and B patients with inhibitors for: 1) control and prevention of bleeding episodes; 2) perioperative management; and 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
| Pharmacodynamics | The administration of human prothrombin complex provides an increase in plasma levels of the vitamin K dependent coagulation factors, and can temporarily correct the coagulation defect of patients with deficiency of one or several of these factors. |
| Mechanism of Action | They act by reversal of anticoagulants |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | NA |
| NA |
| Clearance | NA |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | Kcentra |
| Company | Csl Behring Ag |
| Brand Description | Csl Behring Ag |
| Prescribed For | Kcentra, (Prothrombin Complex Concentrate (Human)), is 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. |
| Chemical Name | NA |
| Formulation | NA |
| Physical Appearance | Nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate |
| Route of Administration | Intravenous |
| Recommended Dosage | Reconstitute Kcentra with 20 mL of diluent (Sterile Water for Injection, USP) provided with the kit. When reconstituted, the final concentration of drug product in Factor IX units will be in a range from 20-31 units/mL, depending on the actual potency, which is listed on the carton. |
| Contraindication | Patients with known anaphylactic or severe systemic reactions to Kcentra or any components in Kcentra including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and Human albumin. Patients with disseminated intravascular coagulation (DIC). Patients with known heparin-induced thrombocytopenia (HIT). Kcentra contains heparin |
| Side Effects | The most common adverse reactions (ARs) (frequency ≥ 2.8%) observed in subjects receiving Kcentra were headache, nausea/vomiting, arthralgia, and hypotension. The most serious ARs were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis. Other include Hypersensitivity Reactions; Arterial and venous thromboembolic complications; Possible Transmission of Infectious Agents. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |