Albutrepenonacog alfa 500unit powder and solvent for solution for injection vials
Requires a prescription from a doctor or prescriber
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Albutrepenonacog alfa
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Albutrepenonacog alfa on the MHRA register
Idelvion 500unit powder and solvent for solution for injection vials
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(1)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary.
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 8 · Randomised trials: 15 · 1998–2024
Showing the 50 most relevant studies, sorted by most relevant.
E. Van Cutsem, M. Tempero, D. Sigal, et al.
Journal of Clinical Oncology, 2020
H. Gisslinger, C. Klade, P. Georgiev, et al.
The Lancet. Haematology, 2020
B. Escudier, A. Płużańska, P. Koralewski, et al.
Lancet, 2007
U. Platzbecker, M. D. Della Porta, V. Santini, et al.
Lancet, 2023
M. Haynes, R. Giovanelli, B. Kent, et al.
The Astrophysical Journal, 2018
H. Wedemeyer, C. Yurdaydın, S. Hardtke, et al.
The Lancet. Infectious diseases, 2019
U. Platzbecker, A. Symeonidis, E. Olíva, et al.
Leukemia, 2017
J. Díaz-Manera, P. Kishnani, H. Kushlaf, et al.
The Lancet. Neurology, 2021
Charlie J. Nederpelt, L. Naar, P. Krijnen, et al.
Critical Care Medicine, 2021
J. M. Kirkwood, M. H. Strawderman, M. Ernstoff, et al.
Journal of Clinical Oncology, 2023
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
92 hours
Mechanism
The current therapies against hemophilia B are hampered by the short half-life of the replacement FIX therapy.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
125 hours
Half-life
92 hours
Protein binding
Volume of distribution
95 ml
[A32556]
Metabolism
[L2313]
Elimination
240 hours
Clearance
0.9 ml
[A32547]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[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]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 815 interactions
[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.
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]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A32547]
[A32547]
[A32556]
[L2313]
[L2313]
[A32547]
Proteins and enzymes this drug interacts with in the body
PMID:22409427
Factor Xa activates pro-inflammatory signaling pathways in a protease-activated receptor (PAR)-dependent manner .
PMID:24041930 PMID:30568593 PMID:34831181 PMID:18202198
Up-regulates expression of protease-activated receptors (PARs) F2R, F2RL1 and F2RL2 in dermal microvascular endothelial cells .
PMID:35738824
Triggers the production of pro-inflammatory cytokines, such as MCP-1/CCL2 and IL6, in cardiac fibroblasts and umbilical vein endothelial cells in PAR-1/F2R-dependent manner .
PMID:30568593 PMID:34831181
Triggers the production of pro-inflammatory cytokines, such as MCP-1/CCL2, IL6, TNF-alpha/TNF, IL-1beta/IL1B, IL8/CXCL8 and IL18, in endothelial cells and atrial tissues .
PMID:24041930 PMID:35738824 PMID:9780208
Induces expression of adhesion molecules, such as ICAM1, VCAM1 and SELE, in endothelial cells and atrial tissues .
PMID:24041930 PMID:35738824 PMID:9780208
Increases expression of phosphorylated ERK1/2 in dermal microvascular endothelial cells and atrial tissues .
PMID:24041930 PMID:35738824
Triggers activation of the transcription factor NF-kappa-B in dermal microvascular endothelial cells and atrial tissues .
PMID:24041930 PMID:35738824
Activates pro-inflammatory and pro-fibrotic responses in dermal fibroblasts and enhances wound healing probably via PAR-2/F2RL1-dependent mechanism .
PMID:18202198
Activates barrier protective signaling responses in endothelial cells in PAR-2/F2RL1-dependent manner; the activity depends on the cleavage of PAR-2/F2RL1 by factor Xa .
PMID:22409427
Up-regulates expression of plasminogen activator inhibitor 1 (SERPINE1) in atrial tissues PMID:24041930
Enzymes involved in drug metabolism — important for understanding drug interactions
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Albutrepenonacog alfa
Additional database identifiers
Drugs Product Database (DPD)
22683
Drugs Product Database (DPD)
22684
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3528
GenAtlas
F10
GeneCards
F10
GenBank Gene Database
K03194
GenBank Protein Database
182841
Guide to Pharmacology
2359
UniProt Accession
FA10_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3546
GenAtlas
F8
GeneCards
F8
GenBank Gene Database
M14113
GenBank Protein Database
182818
UniProt Accession
FA8_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: