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Vonicog alfa

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Identification

Summary

Vonicog alfa is a recombinant human von Willebrand factor used to treat and prevent bleeding and surgical bleeding in adults with von Willebrand disease.

Generic Name
Vonicog alfa
DrugBank Accession Number
DB12872
Background

Vonicog alfa is a recombinant human von Willebrand factor (rVWF) produced from Chinese hamster ovary cells.4 Used to treat von Willebrand Disease, it mimics the biological actions of endogenous VWF.5

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Protein Structure
Protein Chemical Formula
Not Available
Protein Average Weight
20000000.0 Da (Contains all multimers and ultra-large multimers)
Sequences
Not Available
Synonyms
  • (618-THREONINE,709-ASPARTIC ACID)VON WILLEBRAND FACTOR HOMO SAPIENS (1381A>T,1472H>D VARIANT) BLOOD COAGULATION FACTOR
  • Von willebrand factor (recombinant)
  • Von willebrand factor, recombinant, human
  • Vonicog alfa
External IDs
  • BAX 111
  • BAX-111
  • BAX111
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Pharmacology

Indication

Vonicog alfa is indicated for the prevention and treatment of hemorrhage or surgical bleeding in adults with von Willebrand disease (VWD) when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.5

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Management ofBleeding••••••••••••••••••••••••••••• •• •••••••••••••••
Management ofBleeding••••••••••••••••••••••••••••• •• •••••••••••
Prevention ofBleeding••••••••••••••••••••••••••••• •• •••••••••••••••
Prevention ofBleeding••••••••••••••••••••••••••••• •• •••••••••••
Management ofSurgical bleeding••••••••••••••••••••••••••••• •• •••••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

Vonicog alfa works to restore hemostatic abnormalities in von Willebrand factor deficiency. It induces a quick-onset hemostasis and reduces bleeding time. It also causes a rise in FVIII:C levels.5

Mechanism of action

Vonicog alfa mimics the biological actions of endogenous von Willebrand factor (vWF). It promotes platelet adhesion to the vascular sub-endothelium at the site of vascular damage by binding to the vascular sub-endothelium matrix and the platelet membrane. Vonicog alfa also binds to and stabilizes endogenous factor VIII, attenuating its degradation and restoring the FVIII:C level to normal.5

TargetActionsOrganism
ACoagulation factor VIII
stabilization
Humans
ACollagen alpha-1(I) chain
binder
Humans
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

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]

Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

There is no information regarding the acute toxicity (LD50) of vonicog alfa. No symptoms of overdose with von Willebrand factor have been reported. Thromboembolic events may occur in case of a major overdose.5

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
VeyvondiInjection, powder, for solution1300 IUIntravenousBaxalta Innovations Gmb H2021-02-10Not applicableEU flag
VeyvondiInjection, powder, for solution650 IUIntravenousBaxalta Innovations Gmb H2021-02-10Not applicableEU flag
VonvendiPowder, for solution1300 unit / vialIntravenousTakedaNot applicableNot applicableCanada flag
VonvendiPowder, for solution650 unit / vialIntravenousTakedaNot applicableNot applicableCanada flag

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
5PKM8P0G5I
CAS number
Not Available

References

General References
  1. Tran T, Arnall J, Moore DC, Ward L, Palkimas S, Man L: Vonicog alfa for the management of von Willebrand disease: a comprehensive review and single-center experience. J Thromb Thrombolysis. 2020 Apr;49(3):431-440. doi: 10.1007/s11239-019-02018-1. [Article]
  2. Leebeek FWG, Peyvandi F, Escobar M, Tiede A, Castaman G, Wang M, Wynn T, Baptista J, Wang Y, Zhang J, Mellgard B, Ozen G: Recombinant von Willebrand factor prophylaxis in patients with severe von Willebrand disease: phase 3 study results. Blood. 2022 Jul 14;140(2):89-98. doi: 10.1182/blood.2021014810. [Article]
  3. Singal M, Kouides PA: Recombinant von Willebrand factor: a first-of-its-kind product for von Willebrand disease. Drugs Today (Barc). 2016 Dec;52(12):653-664. doi: 10.1358/dot.2016.52.12.2570978. [Article]
  4. Gritsch H, Schrenk G, Weinhappl N, Mellgard B, Ewenstein B, Turecek PL: Structure and Function of Recombinant versus Plasma-Derived von Willebrand Factor and Impact on Multimer Pharmacokinetics in von Willebrand Disease. J Blood Med. 2022 Nov 14;13:649-662. doi: 10.2147/JBM.S377126. eCollection 2022. [Article]
  5. EMA Approved Drug Products: Veyvondi (vonicog alfa) Intravenous Injection [Link]
PubChem Substance
347911400
RxNav
1812589
Wikipedia
Vonicog_alfa

Clinical Trials

Clinical Trials
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PhaseStatusPurposeConditionsCountStart DateWhy Stopped100+ additional columns
Unlock 175K+ rows when you subscribe.View sample data
Not AvailableAvailableNot AvailableVon Willebrand's Disease1somestatusstop reasonjust information to hide
3CompletedPreventionVon Willebrand's Disease1somestatusstop reasonjust information to hide
3CompletedTreatmentVon Willebrand's Disease1somestatusstop reasonjust information to hide
3Not Yet RecruitingTreatmentVon Willebrand's Disease1somestatusstop reasonjust information to hide
3RecruitingPreventionVon Willebrand's Disease1somestatusstop reasonjust information to hide

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, for solutionIntravenous130 UI
Injection, powder, for solutionIntravenous1300 IU
Injection, powder, for solutionIntravenous650 IU
Injection, powder, for solutionIntravenous650 UI
Powder, for solutionIntravenous1300 unit / vial
Powder, for solutionIntravenous650 unit / vial
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

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Details1. Coagulation factor VIII
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Stabilization
General Function
Factor VIII, along with calcium and phospholipid, acts as a cofactor for F9/factor IXa when it converts F10/factor X to the activated form, factor Xa
Specific Function
copper ion binding
Gene Name
F8
Uniprot ID
P00451
Uniprot Name
Coagulation factor VIII
Molecular Weight
267007.42 Da
References
  1. Brown R: Recombinant von Willebrand factor for severe gastrointestinal bleeding unresponsive to other treatments in a patient with type 2A von Willebrand disease: a case report. Blood Coagul Fibrinolysis. 2017 Oct;28(7):570-575. doi: 10.1097/MBC.0000000000000632. [Article]
  2. Gill JC, Castaman G, Windyga J, Kouides P, Ragni M, Leebeek FW, Obermann-Slupetzky O, Chapman M, Fritsch S, Pavlova BG, Presch I, Ewenstein B: Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease. Blood. 2015 Oct 22;126(17):2038-46. doi: 10.1182/blood-2015-02-629873. Epub 2015 Aug 3. [Article]
Details2. Collagen alpha-1(I) chain
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Binder
General Function
Type I collagen is a member of group I collagen (fibrillar forming collagen)
Specific Function
extracellular matrix structural constituent conferring tensile strength
Gene Name
COL1A1
Uniprot ID
P02452
Uniprot Name
Collagen alpha-1(I) chain
Molecular Weight
138911.075 Da
References
  1. Brown R: Recombinant von Willebrand factor for severe gastrointestinal bleeding unresponsive to other treatments in a patient with type 2A von Willebrand disease: a case report. Blood Coagul Fibrinolysis. 2017 Oct;28(7):570-575. doi: 10.1097/MBC.0000000000000632. [Article]
  2. Gill JC, Castaman G, Windyga J, Kouides P, Ragni M, Leebeek FW, Obermann-Slupetzky O, Chapman M, Fritsch S, Pavlova BG, Presch I, Ewenstein B: Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease. Blood. 2015 Oct 22;126(17):2038-46. doi: 10.1182/blood-2015-02-629873. Epub 2015 Aug 3. [Article]

Enzymes

Details1. A disintegrin and metalloproteinase with thrombospondin motifs 13
Kind
Protein
Organism
Humans
Pharmacological action
No
Actions
Substrate
General Function
Cleaves the vWF multimers in plasma into smaller forms thereby controlling vWF-mediated platelet thrombus formation
Specific Function
calcium ion binding
Gene Name
ADAMTS13
Uniprot ID
Q76LX8
Uniprot Name
A disintegrin and metalloproteinase with thrombospondin motifs 13
Molecular Weight
153603.05 Da
References
  1. Chung MC, Popova TG, Jorgensen SC, Dong L, Chandhoke V, Bailey CL, Popov SG: Degradation of circulating von Willebrand factor and its regulator ADAMTS13 implicates secreted Bacillus anthracis metalloproteases in anthrax consumptive coagulopathy. J Biol Chem. 2008 Apr 11;283(15):9531-42. doi: 10.1074/jbc.M705871200. Epub 2008 Feb 8. [Article]

Drug created at October 21, 2016 00:56 / Updated at October 04, 2024 01:08