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Identification
- Summary
Protein C is a medication used to treat protein C deficiency leading to purpura fulminans or coumarin-induced skin necrosis.
- Brand Names
- Balfaxar, Beriplex, Ceprotin, Kcentra, Octaplex
- Generic Name
- Protein C
- DrugBank Accession Number
- DB11312
- Background
Protein C is an endogenously occurring plasma protein that plays a key role within the coagulation cascade. Protein C is a zymogen, or enzyme precursor, of a vitamin K-dependent anticoagulant glycoprotein (serine protease) that is synthesized in the liver. It is converted by the thrombin/thrombomodulin-complex on the endothelial cell surface to Activated Protein C (APC). Once in its activated form, APC functions as a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by inactivating essential components of the coagulation cascade (specifically factors V and VIII), which leads to a decrease in thrombin formation, and therefore a reduction in clot formation.
The Protein C pathway provides a natural mechanism for control of the coagulation system and prevention of excessive procoagulant responses to activating stimuli. A lack of protein C in the body would lead to unchecked coagulation activation, resulting in thrombin generation and intravascular clot formation.
Protein C is available in concentrated form as the product Ceprotin, which is indicated for use in pediatric and adult patients with severe congenital protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Structure
- Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- autoprothrombin IIA
- blood coagulation factor XIV
- Human protein C
- Protein C (coagulation inhibitor)
- Protein C concentrate
- Protein C concentrate (human)
- Protein C concentrate human
- Protein C human
Pharmacology
- Indication
Protein C concentrate is indicated for pediatric and adult patients with severe congenital protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.2 It is also found as a component of some prothrombin complex concentrate (i.e. Factor IX Complex (Human)) formulations, such as Kcentra.3
Along with other blood coagulation factors, it is used to reverse acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with a need for an urgent surgery/invasive procedure.4
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 Purpura fulminans •••••••••••• •••••• •••••••••• ••••••• • •••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• Treatment of Purpura fulminans •••••••••••• •••••• •••••••••• ••••••• • •••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• Prevention of Thrombosis, venous •••••••••••• •••••• •••••••••• ••••••• • •••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• Treatment of Thrombosis, venous •••••••••••• •••••• •••••••••• ••••••• • •••••••••• •••••••••• ••••••• •••••••••••• ••• •••••••• - Contraindications & Blackbox Warnings
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In clinical studies, the intravenous administration of Protein C Concentrate demonstrated a temporary increase, within approximately half an hour of administration, in plasma levels of APC. Replacement of protein C in protein C-deficient patients is expected to control or, if given prophylactically, to prevent thrombotic complications.2
- Mechanism of action
Protein C is an endogenously occurring plasma protein that plays a key role within the coagulation cascade. Also known as blood coagulation factor XIV, Protein C is a zymogen, or enzyme precursor, of a vitamin K-dependent anticoagulant glycoprotein (serine protease) that is synthesized in the liver. It is converted by the thrombin/thrombomodulin-complex on the endothelial cell surface to Activated Protein C (APC). Once in its activated form, APC functions as a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by inactivating essential components of the coagulation cascade (specifically factors V and VIII), which leads to a decrease in thrombin formation, and therefore a reduction in clot formation.
Target Actions Organism ACoagulation factor V inactivatorHumans ACoagulation factor VIII inactivatorHumans - Absorption
Cmax = 110 IU/dL Tmax = 0.50 hr
- Volume of distribution
Volume of distribution at steady state = 0.74 dL/kg
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Initial half life = 7.8 hr Terminal half life = 9.9 hr
- Clearance
CL = 0.0533 dL/kg/h
- Adverse Effects
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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 risk or severity of bleeding can be increased when Abciximab is combined with Protein C. Aceclofenac The risk or severity of bleeding and hemorrhage can be increased when Aceclofenac is combined with Protein C. Acemetacin The risk or severity of bleeding and hemorrhage can be increased when Protein C is combined with Acemetacin. Acenocoumarol The risk or severity of bleeding can be increased when Acenocoumarol is combined with Protein C. Acetylsalicylic acid Acetylsalicylic acid may increase the anticoagulant activities of Protein C. - Food Interactions
- Avoid herbs and supplements with anticoagulant/antiplatelet activity. Examples include garlic, ginger, bilberry, danshen, piracetam, and ginkgo biloba.
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.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Ceprotin Injection, powder, lyophilized, for solution; Kit 500 [iU]/5mL Intravenous Takeda Pharmaceuticals America, Inc. 2010-08-09 Not applicable US 
Ceprotin Injection, powder, for solution 500 IU Intravenous Takeda Manufacturing Austria Ag 2016-09-08 Not applicable EU 
Ceprotin Kit 100 [iU]/1mL Intravenous Baxalta Us Inc 2010-08-09 2018-11-30 US Ceprotin Injection, powder, lyophilized, for solution; Kit 1000 [iU]/10mL Intravenous Takeda Pharmaceuticals America, Inc. 2010-08-09 Not applicable US Ceprotin Injection, powder, for solution 1000 IU Intravenous Takeda Manufacturing Austria Ag 2016-09-08 Not applicable EU - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Balfaxar Protein C (22 [iU]/1mL) + Coagulation Factor IX Human (25.5 [iU]/1mL) + Coagulation factor VII human (16.5 [iU]/1mL) + Coagulation factor X human (24 [iU]/1mL) + Protein S human (22 [iU]/1mL) + Prothrombin (26 [iU]/1mL) Powder, for solution Intravenous Octapharma USA Inc 2023-11-30 Not applicable US Beriplex P/n 1000 Protein C (1640 unit) + Coagulation Factor IX Human (1240 unit) + Coagulation factor VII human (1000 unit) + Coagulation factor X human (2040 unit) + Protein S human (1360 unit) + Prothrombin (1600 unit) Powder, for solution Intravenous Csl Behring 2013-11-21 Not applicable Canada 
Beriplex P/N 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Protein C (1200 I.E.) + Coagulation Factor IX Human (1020 IE) + Coagulation factor VII human (700 IE) + Coagulation factor X human (1640 IE) + Protein S human (1000 IE) + Prothrombin (1360 IE) Injection, powder, for solution Parenteral Csl Behring 2013-04-16 Not applicable Austria 
Beriplex P/N 250 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Protein C (300 IE) + Coagulation Factor IX Human (255 IE) + Coagulation factor VII human (175 IE) + Coagulation factor X human (410 IE) + Protein S human (250 IE) + Prothrombin (340 I.E.) Injection, powder, for solution Parenteral Csl Behring 2008-02-27 Not applicable Austria Beriplex P/n 500 Protein C (820 unit) + Coagulation Factor IX Human (620 unit) + Coagulation factor VII human (500 unit) + Coagulation factor X human (1020 unit) + Protein S human (680 unit) + Prothrombin (800 unit) Powder, for solution Intravenous Csl Behring 2011-07-28 Not applicable Canada
Categories
- ATC Codes
- B01AD12 — Protein c
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Anticoagulants
- Biological Factors
- Blood and Blood Forming Organs
- Blood Coagulation Factor Inhibitors
- Blood Proteins
- Cardiovascular Agents
- Decreased Coagulation Factor Activity
- Enzyme Precursors
- Enzymes
- Enzymes and Coenzymes
- Fibrin Modulating Agents
- Fibrinolytic Agents
- Glycoconjugates
- Glycoproteins
- Hematologic Agents
- Protein Precursors
- Proteins
- 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
- Y2RU654EXB
- CAS number
- Not Available
References
- General References
- Esmon CT, Vigano-D'Angelo S, D'Angelo A, Comp PC: Anticoagulation proteins C and S. Adv Exp Med Biol. 1987;214:47-54. [Article]
- FDA Approved Drug Products: Ceprotin (protein C concentration [human]) powder for solution [Link]
- FDA Approved Drug Products: KCENTRA (Prothrombin Complex Concentrate (Human)) For Intravenous Use, Lyophilized Powder for Reconstitution [Link]
- FDA Approved Drug Products: BALFAXAR (prothrombin complex concentrate, human-lans) lyophilized powder for solution, for intravenous use (July 2023) [Link]
- External Links
- KEGG Drug
- D08796
- PubChem Substance
- 347911185
- 723868
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Protein_C
- FDA label
- Download (674 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data4 Completed Treatment Bleeding / Blood Loss During Surgery / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates 1 somestatus stop reason just information to hide 4 Recruiting Treatment Coagulation Disorder / Massive Hemorrhage / Traumatic haemorrhage 1 somestatus stop reason just information to hide 4 Withdrawn Treatment Postpartum Haemorrhage (PPH) 1 somestatus stop reason just information to hide 3 Completed Treatment Acute Major Bleeding / Coagulation Disorder 1 somestatus stop reason just information to hide 3 Completed Treatment Bleeding Cardiac Surgery Patients 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Powder, for solution Intravenous Injection, powder, for solution Parenteral Injection, powder, for solution Intravenous Injection, powder, for solution Intravenous 1000 IU Injection, powder, for solution Intravenous 500 IU Injection, powder, for solution Intravenous; Subcutaneous 1000 IU Injection, powder, for solution Intravenous; Subcutaneous 500 IU Injection, powder, lyophilized, for solution; kit Intravenous 1000 [iU]/10mL Injection, powder, lyophilized, for solution; kit Intravenous 500 [iU]/5mL Kit Intravenous 100 [iU]/1mL Injection, solution Intravenous 500 iu Injection Intravenous Injection, powder, lyophilized, for solution; kit Intravenous Kit; powder, for solution Intravenous Injection, powder, for solution Intravenous drip 520 IU/vial - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Inactivator
- General Function
- Central regulator of hemostasis. It serves as a critical cofactor for the prothrombinase activity of factor Xa that results in the activation of prothrombin to thrombin
- Specific Function
- Copper ion binding
- Gene Name
- F5
- Uniprot ID
- P12259
- Uniprot Name
- Coagulation factor V
- Molecular Weight
- 251701.245 Da
References
- FDA Approved Drug Products: Ceprotin (protein C concentration [human]) powder for solution [Link]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Inactivator
- 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
- FDA Approved Drug Products: Ceprotin (protein C concentration [human]) powder for solution [Link]
Drug created at December 03, 2015 16:52 / Updated at April 22, 2024 18:19