| Entry 3 |
| (3) Primary information |
|---|
| ID | 1808 |
| 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 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 | http://www.rxlist.com/kcentra-drug.htm |
| PubMed ID | 28124406, 27367551, 26677005, 26509839, 25705417, 25586208, 25485923, 25136597, 24934756 |
| 3-D Structure | N.A. |
| Entry 4 |
| (4) Primary information |
|---|
| ID | 1809 |
| 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 | Octaplex |
| Company | Octapharma |
| Brand Discription | NA |
| Prescribed for | Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. Treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available. |
| Chemical Name | NA |
| Formulation | NA |
| Physcial Appearance | Powder and solvent for solution |
| Route of Administration | Intravenous |
| Recommended Dosage | The dose will depend on the INR before treatment and the targeted INR. In the following table approximate doses (ml/kg body weight of the reconstituted product) required for normalisation of INR (≤ 1.2 within 1 hour) at different initial INR levels are given |
| Contraindication | In patients with acquired deficiency of the vitamin K dependent coagulation factors (e.g. as induced by treatment with vitamin K antagonists), Octaplex should only be used when rapid correction of prothrombin complex levels is necessary, such as major bleeding or emergency surgery. In other cases, reduction of the dose of the vitamin K antagonist and/or administration of vitamin K is usually sufficient. Patients receiving a vitamin K antagonist may have an underlying hypercoaguable state and infusion of prothrombin complex concentrate may exacerbate this. In congenital deficiency of any of the vitamin K dependent factors, specific coagulation factor product should be used when available. If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately. In case of shock, standard medical treatment for shock should be implemented. |
| Side Effects | Immune system disorders; General disorders and administration site conditions; Vascular disorders; Nervous system disorders; |
| Useful Link | https://www.medicines.org.uk/emc/medicine/21897 |
| PubMed ID | 28124406, 27367551, 26677005, 26509839, 25705417, 25586208, 25485923, 25136597, 24934756 |
| 3-D Structure | N.A. |