1. Prothrombin complex concentrate

2. Description : Indication : Pharmacodynamics : Mechanism of action :
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 :
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

3. Brands : Feiba Nf
Company : Baxter Healthcare Corporation .
Description : FEIBA (Anti-Inhibitor Coagulant Complex) is a freeze-dried sterile human plasma fraction with factor VIII inhibitor bypassing activity to be reconstituted for intravenous administration. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One unit of activity is defined as that amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value.
Form : Freeze-dried fraction
Route of administration : Intravenous
Dosage : Do not exceed a single dose of 100 units per kg body weight and a daily dose of 200 units per kg body Contraindication : Known anaphylactic or severe hypersensitivity reactions to FEIBA or any if its components, including factors of the kinin generating system. Disseminated intravascular coagulation (DIC). Acute thrombosis or embolism (including myocardial infarction). Side effects : The most frequently reported adverse reactions observed in > 5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

4. Brands : Cofact
Company : Sanquin
Used for/Prescribed for : Co-fact©, prothrombin complex concentrate, is used for restoring the international normalized ratio (INR) in patients on vitamin K antagonists (VKA) presenting with acute bleeding.
Route of administration : Intravenous

5. Brands : Kcentra
Company: Csl Behring Ag
Description : 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 ). 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.
Used for/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.
Form : Nanofiltered and lyophilized non-activated four-factor Prothrombin Complex Concentrate
Route of administration : Intravenous
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 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.

6. Brands : Octaplex
Company: Octapharma
Used for/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.
Form : Powder and solvent for solution
Route of administration : Intravenous
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;

7. References : http://www. rxlist