Product Information
Registration Status: ActiveSIN15814P
IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2000IU/VIAL is approved to be sold in Singapore with effective from 2019-09-19. It is marketed by CSL BEHRING PTE LTD, with the registration number of SIN15814P.
This product contains Albutrepenonacog Alfa 2000IU/Vial in the form of INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by CSL Behring GmbH (Powder) 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
Albutrepenonacog alfa (rIX-RFP) is a recombinant fusion protein that links a recombinant coagulation factor IX (rFIX) with a recombinant human albumin (rAlbumin).[A32547] It was developed by CSL Behring Canada, Inc and approved by Health Canada on April 26, 2017. It was also approved by FDA and EMA in 2016. It is currently marketed in the forms of 250, 500, 1000 and 2000 IU/vial.[L2305]
Indication
Under the EMA and FDA, rIX-RFP is indicated in the treatment of hemophilia B.[L2306] For Health Canada, rIX-FRP is also indicated to prevent or reduce bleeding episodes.[L2305] Hemophilia B is the second most common type of hemophilia. It is a rare inherited bleeding disorder caused by reduced or absent levels of factor IX (FIX). The FIX is a vitamin K-dependent plasma protease that when activated is involved in the blood coagulation cascade.[A32551] The hemophilia B is caused by mutations in the _FIX_ gene which can cause different phenotypes. The severe form is characterized by the presence of spontaneous and recurring bleeds into the joints and muscles and excessive bleeding after trauma or surgery.[A32552]
Mechanism of Action
The current therapies against hemophilia B are hampered by the short half-life of the replacement FIX therapy.[A32547] Thus, to solve this problem, in rIX-RFP there is the fusion of rFIX with rAlbumin which presents a much longer half-life and it does not present interactions with the immune system.[A32547] The administration of rIX-RFP increases the plasma concentration of FIX, thus addressing the coagulation deficiency of the patient. rIX-RFP is able to circulate in the plasma as an intact zymogen thanks to the pH-dependent binding to FcRn which is a normal protection pathway from lysosomal degradation of albumin. When the FIX is needed, rAlbumin is cleaved by the same proteases that activate the FIX.[A32547]
Pharmacokinetics
- Absorption
- rIX-RFP absorption is very rapid as it is directly administered intravenously. In clinical trials, the maximum plasma concentration, area under the curve and mean residence time are reported to be approximately 55 IU/dL, 5500 IU.h/dL and 125 hours respectively.[A32547]
- Distribution
- The reported volume of distribution for rIX-RFP according to phase I/II and III clinical trials is 95 ml/kg.[A32556]
- Metabolism
- The metabolism of rIX-RFP is not relevant as it is a recombinant protein and it is thought to be metabolized to peptides and amino acids.[L2313]
- Elimination
Clearance
In clinical trials, the weight-adjusted clearance in children and adults is reported to be 1.1 and 0.9 ml/h/kg.[A32547]
Toxicity
rIX-RFP is very well tolerated.[A32547]Mutaginicity trials were performed and they confirmed an absent mutagenic potential.[L2305]Fertility studies have not been performed. Developmental studies are not of major importance as there is a very low rate of incidence of hemophilia B in females.
Active Ingredient/Synonyms
Coagulation factor IX (recombinant), albumin fusion protein | Albutrepenonacog alfa |
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.