Overview
Albutrepenonacog alfa (rIX-RFP) is a recombinant fusion protein that links a recombinant coagulation factor IX (rFIX) with a recombinant human albumin (rAlbumin). 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.
Indication
Under the EMA and FDA, rIX-RFP is indicated in the treatment of hemophilia B. For Health Canada, rIX-FRP is also indicated to prevent or reduce bleeding episodes. 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. 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.
Associated Conditions
- Perioperative Blood Loss
- Bleeding episodes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/11/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000IU/VIAL | SIN15813P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1000IU/Vial | 9/19/2019 | |
| IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/VIAL | SIN15811P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250IU/vial | 9/19/2019 | |
| IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500IU/VIAL | SIN15812P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500IU/vial | 9/19/2019 | |
| IDELVION POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2000IU/VIAL | SIN15814P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2000IU/vial | 9/19/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| IDELVION | csl behring canada inc | 02451336 | Powder For Solution
,
Kit - Intravenous | 250 UNIT / VIAL | N/A |
| IDELVION | csl behring canada inc | 02451352 | Powder For Solution
,
Kit - Intravenous | 1000 UNIT / VIAL | 7/4/2019 |
| IDELVION | csl behring canada inc | 02451344 | Powder For Solution
,
Kit - Intravenous | 500 UNIT / VIAL | N/A |
| IDELVION | csl behring canada inc | 02451360 | Kit
,
Powder For Solution - Intravenous | 2000 UNIT / VIAL | N/A |
| IDELVION | csl behring canada inc | 02489627 | Kit
,
Powder For Solution - Intravenous | 3500 UNIT / VIAL | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IDELVION 250 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1161095001 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| IDELVION 2000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1161095004 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| IDELVION 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1161095002 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| IDELVION 1000 UI polvo y disolvente para solucion inyectable | 1161095003 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| IDELVION 3.500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1161095009 | POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.