Product Information
Registration Status: ActiveSIN13191P
OPTIVATE is approved to be sold in Singapore with effective from 2006-03-16. It is marketed by EURO ASIA MEDICO PTE LTD, with the registration number of SIN13191P.
This product contains Factor Viii 100 iu/ml, and Von Willebrand Factor 260 iu/ml in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by Bio Products Laboratory in UNITED KINGDOM, andPharma Hameln GmbH (Diluent) 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}}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
von Willebrand Factor (vWF) is a multimeric glycoprotein that consists of disulfide-bridge linked dimers. It is usually circulating in plasma as a stable complex with the coagulation factor VIII. The human vWF, as a drug product, is a complex that also contains the coagulation factor VIII.[A32268] This complex was developed by Octapharma Pharmazeutika Produktionsges and FDA approved on August 21, 2015.[L1878]
Indication
The vWF and Factor VIII complex is indicated for the prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease patients. It is also indicated for the on-demand treatment and control of bleeding episodes.[L1880] The von Willebrand disease is an inherited disorder characterized by the deficiency or misfunction of the von Willebrand factor (vWF). Due to this deficiency, the blood cannot clot properly and the patients that present this disease are prone to prolonged or excessive bleeding. There are three types of this disease, and type 3 is an autosomal recessive inherited disorder marked by very low or absent levels of vWF.[L1867]
Mechanism of Action
The vWF is involved in primary and secondary homeostasis and it is also a carrier and stabilizing protein that protects the coagulation factor VIII from proteolysis and clearance.[A32268] vWF also presents an adhesive function in which it mediates the binding between platelets and subendothelial tissues.[A32289] The external human vWF acts as the endogenous vWF and thus, it presents all the functions abovementioned.[L1880]
Pharmacokinetics
- Absorption
- According to clinical trials in patients with von Willebrand disease, the AUC, Cmax and mean residence time was approximately 1119 h.IU/dL, 76 IU/dL and 20.6 hours, respectively.[A32270]
- Distribution
- The volume of distribution of the human concentrate vWF is 69.7 ml/kg.[A32270]
- Metabolism
- The endogenous regulator of the vWF is ADAMTS13. The interaction between these two proteins results in the proteolysis of vWF. This proteolysis occurs primarily in the cleavage site at the domain A2 which is a target domain for ADAMTS13.[A32290]
- Elimination
Clearance
The clearance rate of the human concentrate vWF is 3.9 ml.h/kg.[A32270]
Toxicity
The administration of human vWF seems to be very well accepted.
Active Ingredient/Synonyms
Human von willebrand factor | Von willebrand factor | Von willebrand factor (human) | Von willebrand factor complex (human) | von Willebrand factor, human | Von willebrand's factor | Von Willebrand Factor 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.