Product Information
Registration Status: ActiveSIN15577P
HEMLIBRA SOLUTION FOR INJECTION 30MG/ML is approved to be sold in Singapore with effective from 2018-11-09. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN15577P.
This product contains Emicizumab 30mg/ml in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Chugai Pharma Manufacturing Co. in KOREA, Ltd. (CPMC) (Bulk Manufacturing and Primary Packager) in REPUBLIC OF, andSamsung Biologics Co. in JAPAN.
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
Emicizumab is a humanized recombinant monoclonal antibody that mimics the function of the coagulation Factor VIII and it has the capacity to bind simultaneously to activated Factor IX and Factor X. The ability of Emicizumab to bind to all these three different factors allows it to overcome immunogenicity and unstable hemostatic efficacy produced by previous Factor VII agents. Emicizumab was originated as an improved form of hBS23 and it was approved on November 16, 2017, for the treatment of hemophilia A with factor VIII inhibitors.[A31279, L1016] It was created by Chugai Pharmaceuticals Co. Ltd. and co-developed with Roche and Genentech.[L1015]
Indication
The main function of Emicizumab is the prevention of bleeding episodes. Thus, Emicizumab is approved for the routine prophylaxis of patients with hemophilia A that present Factor VIII inhibitors. Hemophilia A is a deficiency of coagulation Factor VIII which causes a serious bleeding disorder. The standard treatment is done with the administration of recombinant or serum-deriver Factor VIII which induces the formation of anti-factor VIII alloantibodies (Factor VIII inhibitors) and renders the standard treatment ineffective.[A31286]
Mechanism of Action
Emicizumab exerts its action by performing the function of the coagulation Factor VIII without presenting a structural homology.[L1017] It presents a dual specificity which allows it to bind to both the Factor IXa and the Factor X, performing the required bridgning activity for the launch of the coagulation cascade.[A31286]
Pharmacokinetics
- Absorption
- Subcutaneous administration of Emicizumab presents a very high bioavailability ranging from 80.4% to 93.1% when administered subcutaneously in a dose of 1 mg/kg.[FDA label] In clinical trials, at the same dose, Emicizumab presented a linear exposure which concentration peaked 1-2 weeks after administration and presented a profile framed by a Cmax of 5.92 mcg/ml and a AUC of 304 mcg day/ml.[A31279]
- Distribution
- The apparent volume of distribution is 11.4L and there are reports indicating that this value can increased with increasing body weight.[FDA label]
- Metabolism
- No information available
- Elimination
Clearance
The apparent clearance is 0.24 L/day and there are reports indicating that this value can increased with increasing body weight.[FDA label]
Toxicity
The administration of Emicizumab has reported cases of microangiopathy and thrombotic events with concomitant use of activated prothrombin complex concentrate at doses higher of 100 U/kg/24 hours. There are also reports of injection site reaction, headaches and arthralgia.[L1018]
Active Ingredient/Synonyms
emicizumab-kxwh | Emicizumab |
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.