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
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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Bleeding •••••••••••• •••••••••• ••••••• ••• •••••••• Treatment of Bleeding •••••••••••• •••••••••• ••••••• ••• •••••••• Management of Bleeding •••••••••••• •••••• ••••••••• ••• •••••••••• •• ••••••• •••• •• •••••••••••• •• ••••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• Management of Bleeding •••••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• Management of Bleeding •••••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Beroctocog alfa. Alteplase The therapeutic efficacy of Beroctocog alfa can be decreased when used in combination with Alteplase. Aminocaproic acid The risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Beroctocog alfa. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Active Moieties
Name Kind UNII CAS InChI Key Antihemophilic factor human unknown 839MOZ74GK Not Available Not applicable - Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Humate-P Kit 80 [iU]/1mL Intravenous CSL Behring GmbH 1986-05-01 Not applicable US 
Humate-P Kit 80 [iU]/1mL Intravenous CSL Behring GmbH 1986-05-01 Not applicable US Humate-P Kit 80 [iU]/1mL Intravenous CSL BEHRING LLC 1986-05-01 2009-01-06 US Humate-P Kit 80 [iU]/1mL Intravenous CSL Behring GmbH 1986-05-01 Not applicable US Truemed Group LLC Injection, powder, for suspension 500 U/1 Intramuscular Truemed Group LLC 2022-09-17 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Alphanate Beroctocog alfa (1000 [iU]/10mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1978-08-15 2019-10-31 US Alphanate Beroctocog alfa (2000 [iU]/10mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 2014-06-26 Not applicable US Alphanate Beroctocog alfa (500 [iU]/5mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1978-08-15 Not applicable US Alphanate Beroctocog alfa (1000 [iU]/10mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 1978-08-15 Not applicable US Alphanate Beroctocog alfa (2000 [iU]/10mL) + Water (1 mL/1mL) Kit Intravenous GRIFOLS USA, LLC 2014-02-26 2019-10-31 US
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
- 17RNR4H479
- CAS number
- 9001-27-8
References
- General References
- FDA Approved Drug Products: Alphanate (antihemophilic factor/von Willebrand factor complex) powder for intravenous injection [Link]
- External Links
- 4257
- Wikipedia
- Factor_VIII_(medication)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Treatment Von Willebrand's Disease 1 4 Completed Basic Science Hemophilia A 1 4 Completed Treatment Congenital Hematological Disorder / Hemophilia A With Inhibitors / Hemophilia B With Inhibitors 1 4 Completed Treatment Severe Hemophilia A 2 4 Terminated Treatment Hemophilia A 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Kit Intravenous Injection, powder, for solution 500 iu/1vial Injection, powder, lyophilized, for solution Intravenous 500 IU Injection, powder, for solution Intravenous; Parenteral 500 IU/10ML Injection, powder, for solution Intravenous; Parenteral 1000 IU/10ML Injection, powder, lyophilized, for solution Intravenous Solution Parenteral Injection, powder, for solution Intravenous 100 IU/ML Injection, powder, for solution Intravenous 200 IU/ML Injection, powder, for solution Intravenous 50 IU/ML Solution Parenteral 500 UI Injection, powder, for solution 1000 iu/1vial Kit Intravenous 80 [iU]/1mL Injection, powder, lyophilized, for solution Intravenous 1000 iu/10ml Injection, powder, lyophilized, for solution Intravenous 500 iu/5ml Solution Intravenous 250 UI Injection, powder, for solution Intravenous; Parenteral 100 UI/ML Injection, powder, for solution Intravenous; Parenteral 100 IU/ML Injection, powder, for solution Intravenous; Parenteral 200 UI/ML Injection, powder, for solution Intravenous 100 iu/ml Solution 250 UI Injection, powder, for solution Intravenous Injection, powder, for suspension Intramuscular 500 U/1 Solution Intravenous Powder 250 iu Powder 500 iu Injection, powder, for solution 1000 iu Injection, powder, for solution 500 iu Injection, powder, for solution 250 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 July 18, 2023 22:57