Beroctocog alfa

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

Identification

Name
Beroctocog alfa
Accession Number
DB14473
Description
Not Available
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Factor VIII
  • Human antihemophilic factor/von willebrand factor complex
  • Human coagulation factor VIII/von willebrand factor complex
  • Octanate

Pharmacology

Indication

Beroctocog alfa is indicated for the prevention and control of bleeding in patients with hemophilia A or acquired Factor VIII (FVIII) deficiency.1 It is also indicated for surgical/invasive procedures in adult and pediatric patients with von Willebrand Disease in who desmopression is either ineffective or contraindicated.1 It is not indicated for patients with severe (i.e. type 3) von Willebrand Disease whom are undergoing major surgery.1

Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics
Not Available
Mechanism of action
Not Available
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
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Toxicity
Not Available
Affected organisms
Not Available
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.
DrugInteraction
AbciximabThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Acenocoumarol.
Acetylsalicylic acidThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Acetylsalicylic acid.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Beroctocog alfa.
AlteplaseThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Alteplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Beroctocog alfa.
AncrodThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Ancrod.
AnistreplaseThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Anistreplase.
Antithrombin AlfaThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Antithrombin Alfa.
Antithrombin III humanThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Antithrombin III human.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

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Food Interactions
Not Available

Products

Active Moieties
NameKindUNIICASInChI Key
Antihemophilic factor humanunknown839MOZ74GKNot AvailableNot applicable
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Humate-PKit80 [iU]/1mLIntravenousCSL Behring GmbH1986-05-01Not applicableUS flag
Humate-PKit80 [iU]/1mLIntravenousCSL Behring GmbH1986-05-01Not applicableUS flag
Humate-PKit80 [iU]/1mLIntravenousCSL Behring GmbH1986-05-01Not applicableUS flag
Humate-PKit80 [iU]/1mLIntravenousCSL BEHRING LLC1986-05-012009-01-06US flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
AlphanateBeroctocog alfa (250 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-152019-10-31US flag
AlphanateBeroctocog alfa (2000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC2014-06-262019-10-31US flag
AlphanateBeroctocog alfa (1000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-152019-10-31US flag
AlphanateBeroctocog alfa (2000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC2014-06-26Not applicableUS flag
AlphanateBeroctocog alfa (500 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-15Not applicableUS flag
AlphanateBeroctocog alfa (500 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-152019-10-31US flag
AlphanateBeroctocog alfa (1500 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-15Not applicableUS flag
AlphanateBeroctocog alfa (250 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-15Not applicableUS flag
AlphanateBeroctocog alfa (1500 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-152020-03-31US flag
AlphanateBeroctocog alfa (1000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-15Not applicableUS 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

Chemical Identifiers

UNII
5T6B772R4Q
CAS number
9001-27-8

References

General References
  1. FDA Approved Drug Products: Alphanate (antihemophilic factor/von Willebrand factor complex) powder for intravenous injection [Link]
RxNav
4257

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentSevere Hemophilia A1
4Active Not RecruitingTreatmentVon Willebrand's Disease1
4CompletedBasic ScienceHemophilia A1
4CompletedTreatmentBlood Platelet Disorders / Disorders, Blood Coagulation / Hematologic Diseases / Von Willebrand's Disease1
4CompletedTreatmentCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors1
4CompletedTreatmentSevere Haemophilia A1
4RecruitingTreatmentHemophilia A With Inhibitors1
3CompletedNot AvailableHemophilia A1
3CompletedDiagnosticHemophilia A1
3CompletedPreventionSevere Hemophilia A1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
KitIntravenous
Injection, powder, lyophilized, for solutionIntravenous1000 IU
KitIntravenous80 [iU]/1mL
Injection, powder, lyophilized, for solutionIntravenous1000 iu/10ml
Injection, powder, lyophilized, for solutionIntravenous250 iu/5ml
Injection, powder, lyophilized, for solutionIntravenous500 iu/5ml
PowderIntravenous500 IU
Injection, powder, lyophilized, for solutionIntravenous500 IU
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on July 05, 2018 16:41 / Updated on June 12, 2020 10:53

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