Product Information
Registration Status: ActiveSIN14933P
OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU is approved to be sold in Singapore with effective from 2016-01-28. It is marketed by WELLCHEM PHARMACEUTICALS PTE LTD, with the registration number of SIN14933P.
This product contains Factor II 280 - 760 IU/vial,Factor IX 500 IU/vial,Factor VII 180 - 480 IU/vial,Factor X 360 - 600 IU/vial,Protein C 260 - 620 IU/vial, and Protein S 240 - 640 IU/vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS DRIP use.
This product is manufactured by Octapharma Pharmazeutika Produktionsges m.b.H.(Powder) in FRANCE,Octapharma S.A.S. (Powder) in AUSTRIA, andSolupharm Pharmazeutische Erzeugnisse GmbH (Solvent) in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Active Ingredient/Synonyms
5-Methoxybenzimidazole vitamin B12 | 5-Methoxybenzimidazolylcobalamin | Cyano-5-methoxybenzimidazolylcobamide | Vitamin B 12 factor IIIm | Factor IIIm |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication
For treatment of hemophilia (Christmas disease).
Mechanism of Action
Coagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. It is located within the blood plasma as a zymogen, an antecedent to enzymatic function, in its inactivated state. Factor IX is dependent on the presence of Vitamin K, and is activated to a serine protease by the function of Coagulation Factor XIa. Factor XIa cleaves the peptide bond associated with protein activation in Factor IX, leaving Factor IX with two exposed chains, a light chain and a heavy chain. These two chains are held together by several disulfide bonds that reinforce the structure of Factor IX's activated form. After being activated, Factor IX forms a complex with calcium ions, membrane phospholipids and Coagulation Factor VIII to activate Coagulation Factor X. The activation of Factor X then performs a similarly integral step in the blood coagulation cascade. The ultimate result of phenotypically normal coagulation factors is the creation of platelets for normal blood clotting.
Clearance
8.62 ± 1.7
Active Ingredient/Synonyms
Coagulation factor IX (recombinant) | Coagulation factor IX recombinant human | Factor IX (Recombinant) | nonacog alfa | nonacog gamma | Recombinant factor IX | Coagulation Factor IX (Recombinant) |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Human recombinant antihemophilic factor (AHF) or Factor VIII, 2332 residues, glycosylated, produced by CHO cells
Indication
For the treatment of hemophilia A, von Willebrand disease and Factor XIII deficiency.
Mechanism of Action
Antihemophilic factor (AHF) is a protein found in normal plasma which is necessary for clot formation. The administration of AHF provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect of patients with hemophilia A (classical hemophilia).
Clearance
* 4.1 mL/h•kg [Previously treated pediatric patients]
Active Ingredient/Synonyms
Antihemophilic factor (recombinant) | Antihemophilic factor recombinant | Antihemophilic factor, human recombinant | Antihemophilic factor, recombinant | Factor VIII (rDNA) | Factor VIII (Recombinant) | Factor VIII recombin | Factor VIII, recombinant | Human Factor VIII (Recombinant) | Human factor VIII recombinant | Octocog alfa | rAHF | Recombinant antihemophilic factor VIII | Antihemophilic factor, human recombinant |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits [FDA Label]. For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and prevention of bleeding episodes. Also known as Fibrin Stabilizing Factor (FSF), Factor XIII is an endogenously available coagulation factor and the final enzyme within the blood coagulation cascade. Within the body, FXIII circulates as a heterotetramer composed of 2 catalytic A-subunits and 2 non-catalytic B-subunits (FXIII-A2B2) [A32363]. When activated by thrombin at the site of injury, the FXIII A2B2 pro-enzyme is cleaved resulting in activation of the catalytic A-subunit and dissociation from its carrier B-subunit. As a result, the active transglutaminase from subunit A cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot. This contributes to enhanced platelet and clot adhesion to injured tissue, thereby improving blood coagulation and maintenance of hemostasis [A18581]. When supplied as the recombinant form, Coagulation Factor XIII A-Subunit (Recombinant) binds to free human FXIII B-subunit resulting in a heterotetramer (rA2B2) with a similar activity profile and half-life as the endogenously available form. In patients with congenital factor XIII A-subunit deficiency, this product (marketed as Tretten) is indicated for the routine prophylaxis of bleeding. In these patients, activated rFXIII has been shown to increase the mechanical strength of fibrin clots, slow down fibrinolysis, and to enhance platelet adhesion to the site of injury. As the half-life of endogenous Factor XIII is long (5-11 days), prophylactic therapy with the replacement of FXIII can be given every 4-6 to maintain hemostasis[A32363]. Other drug products with similar structure and function to Coagulation Factor XIII A-Subunit (Recombinant) include [DB12909], which is a purified endogenous (human) form of coagulation factor XIII. Compared to Coagulation Factor XIII A-Subunit (Recombinant), which is produced through recombinant DNA technology where the target protein is grown in yeast and then isolated, the human form is isolated from pooled human plasma. Coagulation Factor XIII A-Subunit (Recombinant) is available in the US as the commmercially available product Tretten, and in the EU as NovoThirteen. Tretten is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography [FDA Label].
Indication
For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.
Pharmacokinetics
- Absorption
- Following intravenous administration, the maximum concentration (Cmax) was found to be 0.48 IU/mL [FDA Label].
- Distribution
- Metabolism
- Elimination
Clearance
0.41 mL/h/kg
Toxicity
The most common adverse reactions reported in clinical trials (≥1%), were headache, pain in the extremities, injection site pain, and increase in fibrin D dimer levels. Due to the anti-clotting activity of this medication, thromboembolic complications may occur with its usage.
Active Ingredient/Synonyms
Blood Coagulation Factor XIII (Synthetic Human A-Chain Precursor) | Catridecacog | Factor XIII A-Subunit (Recombinant) | HUMAN FACTOR XIII (A2) HOMODIMER (ALLELE F13A*1B), RECOMBINANT DNA ORIGIN | Recombinant Coagulation Factor XIII | Coagulation Factor XIII A-Subunit (Recombinant) |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Protein C is an endogenously occurring plasma protein that plays a key role within the coagulation cascade. Also known as blood coagulation factor XIV, Protein C is a zymogen, or enzyme precursor, of a vitamin K-dependent anticoagulant glycoprotein (serine protease) that is synthesized in the liver. It is converted by the thrombin/thrombomodulin-complex on the endothelial cell surface to Activated Protein C (APC). Once in its activated form, APC functions as a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by inactivating essential components of the coagulation cascade (specifically factors V and VIII), which leads to a decrease in thrombin formation, and therefore a reduction in clot formation. The Protein C pathway provides a natural mechanism for control of the coagulation system and prevention of excessive procoagulant responses to activating stimuli. A lack of Protein C in the body would lead to unchecked coagulation activation, resulting in thrombin generation and intravascular clot formation with thrombosis. Protein C is available in concentrated form as the product Ceptrotin, which is indicated foruse in pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.
Indication
Protein C Concentrate is indicated for pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.
Mechanism of Action
Protein C is an endogenously occurring plasma protein that plays a key role within the coagulation cascade. Also known as blood coagulation factor XIV, Protein C is a zymogen, or enzyme precursor, of a vitamin K-dependent anticoagulant glycoprotein (serine protease) that is synthesized in the liver. It is converted by the thrombin/thrombomodulin-complex on the endothelial cell surface to Activated Protein C (APC). Once in its activated form, APC functions as a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by inactivating essential components of the coagulation cascade (specifically factors V and VIII), which leads to a decrease in thrombin formation, and therefore a reduction in clot formation.
Pharmacokinetics
- Absorption
- Cmax = 110 IU/dL Tmax = 0.50 hr
- Distribution
- Volume of distribution at steady state = 0.74 dL/kg
- Metabolism
- Elimination
Clearance
CL = 0.0533 dL/kg/h
Active Ingredient/Synonyms
autoprothrombin IIA | blood coagulation factor XIV | Human protein C | Protein C (coagulation inhibitor) | Protein C concentrate | Protein C concentrate (human) | Protein C concentrate human | Protein C human | Protein C |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.
Description
Protein S human is a vitamin K-dependent plasma glycoprotein which has antcoagulant properties [A19561]. It serves as a negative feedback mechanism in the coagulation cascade.
Indication
For use in the emergency reversal of coagulation factor deficiency in patients recieving vitamin K antagonist therapy [FDA Label]. Protein S is administered as part of a cocktail containing several other coagulation factors.
Mechanism of Action
Thrombin converts protein C to activated protein C (APC) [A19561]. Protein S functions as a cofactor for APC and together they proteolytically cleave factor Va and VIIIa [A19561] [A19562]. This inhibits the activities of the prothrombinase and tenase complexes respectively and leads to a reduction in thrombin generation. The reduction in thrombin generation suppresses the coagulation cascade preventing additional clotting from occuring. Protein S is suggested to inhibit factors Va and Xa through protein-protein interactions [A19565] [A19561]. Protein S is also suggested to inhibit production of factor Xa by the tenase complex by competing for binding to phospholipids via its gamma-carboxyglutamic acid domain. Protein S is thought to exert an anti-inflammatory effect in addition to its anticoagulant properties. The protein S-C4b-binding protein complex is believed to bind to phosphotidylserines on the cell membranes of apoptotic cells and interact with macrophages, signalling them to phagocytose the cell before it can rupture [A19564].
Active Ingredient/Synonyms
Protein S | Protein S (human) | Vitamin K-dependent protein S | Protein S human |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.