A database of FDA approved therapeutic peptides and proteins
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1808 details |
Primary information | |
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ThPP ID | Th1200 |
Therapeutic Peptide/Protein Name | Prothrombin complex concentrate |
Sequence | NA view full sequnce in fasta |
Functional Classification | Ia |
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 |
Volume of Distribution | NA |
Clearance | NA |
Categories | NA |
Patents Number | NA |
Date of Issue | NA |
Date of Expiry | NA |
Drug Interaction | NA |
Target | NA |
Information of corresponding available drug in the market | |
Brand Name | Kcentra |
Company | Csl Behring Ag |
Brand Discription | Kcentra is a purified, heat-treated, nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate (Human) prepared from human U.S. Source Plasma (21 CFR 640.60). It contains the Vitamin K dependent Coagulation Factors II, VII, IX and X, and the antithrombotic Proteins C and S. Factor IX is the lead factor for the potency of the preparation as stated on the vial label. The excipients are human antithrombin III, heparin, human albumin, sodium chloride, and sodium citrate. Kcentra is sterile, pyrogen-free, and does not contain preservatives. |
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 |
Physcial Appearnce | 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 | http://www.rxlist.com/kcentra-drug.htm |
PubMed ID | 28124406, 27367551, 26677005, 26509839, 25705417, 25586208, 25485923, 25136597, 24934756 |
3-D Structure | N.A. |