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

Identification

Brand Names
Alphanate
Generic Name
Beroctocog alfa
DrugBank Accession Number
DB14473
Background

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

Pharmacology
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Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Contraindications
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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
Adverseeffects
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Toxicity

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.
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.
ApixabanThe therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Apixaban.
Interactions
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Food Interactions
No interactions found.

Products

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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 LLC1986-05-012009-01-06US flag
Humate-PKit80 [iU]/1mLIntravenousCSL Behring GmbH1986-05-01Not applicableUS flag
Humate-PKit80 [iU]/1mLIntravenousCSL Behring GmbH1986-05-01Not applicableUS flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
AlphanateBeroctocog alfa (500 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-152019-10-31US flag
AlphanateBeroctocog alfa (500 [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 (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, LLC1978-08-152019-10-31US flag
AlphanateBeroctocog alfa (250 [iU]/5mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-15Not applicableUS flag
AlphanateBeroctocog alfa (1000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-152019-10-31US flag
AlphanateBeroctocog alfa (1000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC1978-08-15Not applicableUS flag
AlphanateBeroctocog alfa (2000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC2014-06-262019-10-31US flag
AlphanateBeroctocog alfa (2000 [iU]/10mL) + Water (1 mL/1mL)KitIntravenousGRIFOLS USA, LLC2014-06-26Not 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
Affected organisms
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
Wikipedia
Factor_VIII_(medication)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentSevere Hemophilia A1
4Active Not RecruitingTreatmentVon Willebrand's Disease1
4CompletedBasic ScienceHemophilia As1
4CompletedTreatmentCongenital Hematological Disorder / Hemophilia A With Inhibitors / Hemophilia B With Inhibitors1
4CompletedTreatmentSevere Hemophilia A1
4TerminatedTreatmentHemophilia As1
3Active Not RecruitingTreatmentHemophilia As1
3Active Not RecruitingTreatmentVon Willebrand's Disease1
3CompletedPreventionSevere Hemophilia A1
3CompletedTreatmentHemophilia A, Congenital1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
KitIntravenous
Injection, powder, for solutionIntravenous1000 IU
Injection, powder, for solutionIntravenous250 IU
Injection, powder, for solutionIntravenous500 IU
Injection, powder, for solution500 iu/1vial
Injection, powder, for solutionIntravenous; Parenteral500 IU/10ML
Injection, powder, for solutionIntravenous; Parenteral1000 IU/10ML
Injection, powder, lyophilized, for solutionIntravenous500 IU
Injection, powder, lyophilized, for solutionIntravenous
Injection, powder, for solutionIntravenous100 IU/ML
Injection, powder, for solutionIntravenous200 IU/ML
Injection, powder, for solutionIntravenous50 IU/ML
Injection, powder, for solution1000 iu/1vial
KitIntravenous80 [iU]/1mL
Injection, powder, for solutionIntravenous; Parenteral100 UI/ML
Injection, powder, for solutionIntravenous; Parenteral100 IU/ML
Injection, powder, for solutionIntravenous; Parenteral200 UI/ML
Injection, powder, for solutionIntravenous100 iu/ml
Injection, powder, for solutionIntravenous
Powder250 iu
Powder500 iu
Injection, powder, for solution1000 iu
Injection, powder, for solution500 iu
Injection, powder, for solution250 iu
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created at July 05, 2018 22:41 / Updated at August 17, 2021 04:16