Protein C

Identification

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Name
Protein C
Accession Number
DB11312
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Blood factors
Description

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.

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 with thrombosis.

Protein C is available in concentrated form as the product Ceptrotin, which is indicated foruse in pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.

Protein structure
Db11312
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
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
CeprotinInjection, powder, for solution1000 IUIntravenousBaxter Ag2001-07-16Not applicableEu
CeprotinInjection, powder, for solution500 IUIntravenousBaxter Ag2001-07-16Not applicableEu
CeprotinKit1000 [iU]/10mLIntravenousBaxalta US Inc.2010-08-09Not applicableUs
CeprotinKit500 [iU]/5mLIntravenousBaxalta US Inc.2010-08-09Not applicableUs
CeprotinKit100 [iU]/1mLIntravenousBaxalta Us Inc2010-08-092018-11-30Us
Additional Data Available
  • Application Number
    Application Number

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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 End
Beriplex P/n 1000Protein 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 solutionIntravenousCsl Behring2013-11-21Not applicableCanada
Beriplex P/n 500Protein 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 solutionIntravenousCsl Behring2011-07-28Not applicableCanada
KcentraProtein C (1240 U/40mL) + Coagulation Factor IX Human (1020 U/40mL) + Coagulation factor VII human (700 U/40mL) + Coagulation factor X human (1520 U/40mL) + Protein S human (920 U/40mL) + Prothrombin (1180 U/40mL)KitIntravenousCSL Behring GmbH2013-12-13Not applicableUs
KcentraProtein C (620 U/20mL) + Coagulation Factor IX Human (510 U/20mL) + Coagulation factor VII human (350 U/20mL) + Coagulation factor X human (760 U/20mL) + Protein S human (460 U/20mL) + Prothrombin (590 U/20mL)KitIntravenousCSL Behring GmbH2013-04-29Not applicableUs
OctaplexProtein C (1240 unit) + Coagulation Factor IX Human (1000 unit) + Coagulation factor VII human (960 unit) + Coagulation factor X human (1200 unit) + Protein S human (1280 unit) + Prothrombin (1520 unit)Kit; Powder, for solutionIntravenousOctapharma Pharmazeutika Produktionsges M B H2015-08-11Not applicableCanada
OctaplexProtein C (620 unit) + Coagulation Factor IX Human (500 unit) + Coagulation factor VII human (480 unit) + Coagulation factor X human (600 unit) + Protein S human (640 unit) + Prothrombin (760 unit)Kit; Powder, for solutionIntravenousOctapharma Pharmazeutika Produktionsges M B H2008-07-08Not applicableCanada
Categories
UNII
Y2RU654EXB
CAS number
Not Available

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.

Pharmacodynamics

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 Label.

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.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

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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

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
(1,2,6,7-3H)Testosterone(1,2,6,7-3H)Testosterone may increase the anticoagulant activities of Protein C.
(R)-warfarinThe risk or severity of bleeding can be increased when Protein C is combined with (R)-warfarin.
(S)-WarfarinThe risk or severity of bleeding can be increased when Protein C is combined with (S)-Warfarin.
1-Testosterone1-Testosterone may increase the anticoagulant activities of Protein C.
18-methyl-19-nortestosterone18-methyl-19-nortestosterone may increase the anticoagulant activities of Protein C.
3,5-Diiodotyrosine3,5-Diiodotyrosine may increase the anticoagulant activities of Protein C.
4-hydroxycoumarinThe risk or severity of bleeding can be increased when Protein C is combined with 4-hydroxycoumarin.
4-Hydroxytestosterone4-Hydroxytestosterone may increase the anticoagulant activities of Protein C.
5beta-dihydrotestosterone5beta-dihydrotestosterone may increase the anticoagulant activities of Protein C.
7,8-Dichloro-1,2,3,4-tetrahydroisoquinolineThe risk or severity of bleeding and hemorrhage can be increased when 7,8-Dichloro-1,2,3,4-tetrahydroisoquinoline is combined with Protein C.
Additional Data Available
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  • Severity
    Severity

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Food Interactions
Not Available

References

General References
  1. Esmon CT, Vigano-D'Angelo S, D'Angelo A, Comp PC: Anticoagulation proteins C and S. Adv Exp Med Biol. 1987;214:47-54. [PubMed:2959034]
External Links
KEGG Drug
D08796
PubChem Substance
347911185
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Protein_C
ATC Codes
B01AD12 — Protein c
FDA label
Download (674 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentHealthy Volunteers1
1CompletedTreatmentThrombotic events1
2CompletedTreatmentSepsis / Shock, Septic1
2CompletedTreatmentStroke, Ischemic1
2Not Yet RecruitingTreatmentTrauma Injury1
2RecruitingOtherBleeding in Cardiac Surgery1
2, 3CompletedTreatmentHypercoagulability1
3CompletedTreatmentAcute Major Bleeding / Disorders, Blood Coagulation1
3CompletedTreatmentReversal of Anticoagulant Treatment1
3CompletedTreatmentReversal of Coagulopathy1
3RecruitingTreatmentCongestive Heart Failure / Heart Disease End Stage1
3RecruitingTreatmentSignificant Bleeding Risk1
3TerminatedTreatmentSepsis1
4Enrolling by InvitationTreatmentBleeding / Blood Loss,Surgical / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1
Not AvailableCompletedNot AvailableHemorrhage1
Not AvailableCompletedNot AvailableHypercoagulability1
Not AvailableCompletedNot AvailableHypercoagulability / Severe Congenital Protein C Deficiency1
Not AvailableRecruitingNot AvailableHemorrhage1
Not AvailableWithdrawnTreatmentIntracranial Hemorrhage, Spontaneous / Intracranial Hemorrhage, Traumatic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Powder, for solutionIntravenous
Injection, powder, for solutionIntravenous1000 IU
Injection, powder, for solutionIntravenous500 IU
KitIntravenous100 [iU]/1mL
KitIntravenous1000 [iU]/10mL
KitIntravenous500 [iU]/5mL
KitIntravenous
Kit; powder, for solutionIntravenous
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

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

Drug created on December 03, 2015 09:52 / Updated on November 02, 2019 02:43