Vorapaxar: Difference between revisions

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[[Image:JPEG Vorapaxar.jpg|frame|right|Vorapaxar]]
{{DrugProjectFormSinglePage
|genericName=generic name
|aOrAn=a
|drugClass=Adrenergic receptor agonist
|indication=a list of indications, separated by commas.
|hasBlackBoxWarning=Yes
|adverseReactions=a list of adverse reactions, separated by commas.
|blackBoxWarningTitle=Warning Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult======Condition 1=====


{{SI}}
* Dosing Information


'''Editors-in-Chief:''' Sergio Leonardi, M.D., Duke Clinical Research Institute and [[C. Michael Gibson]], M.S., M.D.
:* (Dosage)


'''''Synonyms:''' '' TRA, thrombin receptor antagonist, SCH 530348
=====Condition 2=====


==Overview==
* Dosing Information
Vorapaxar is structurally similar to the natural product himbacine, but completely lacks the muscarinic M2 antagonist activity characteristic of himbacine.
This agent is an '''orally-active''', potent, reversible, and selective '''inhibitor''' of the '''PAR-1 receptor''' with a '''very long''' terminal '''half-life''', which ranges from 126 to 269 h. Although reversible, vorapaxar dissociates very slowly from the PAR-1 receptor, which is a critical requirement to compete effectively with the resident tethered ligand.


Vorapaxar is a '''direct acting drug''' (thus not a pro-drug) and is '''inactivated''' mainly '''via the CYP3A4 enzymatic system'''. Vorapaxar has '''no significant renal metabolism'''. The drug is currently not commercially available.
:* (Dosage)
|offLabelAdultGuideSupport======Condition 1=====


* Developed by: (Organisation)


==Phase II of Vorapaxar: the TRA-PCI and the Japanese study ==
* Class of Recommendation: (Class) (Link)


The key phase II study with vorapaxar was the '''TRA-PCI''', a large phase II study that tested the safety, tolerability, and preliminary efficacy of this agent in '''1,030''' '''patients''' with '''stable''' coronary artery disease ('''CAD''') '''presumed to be managed with PCI'''. The study showed '''similar bleeding incidence''' as measured by the TIMI scale (major or minor) between placebo and the 3 doses tested of vorapaxar (0.5, 1, and 2.5 mg). Also, exploratory analysis on efficacy showed a numerical reduction in the rate of myocardial infarction, mainly related to PCI.
* Strength of Evidence: (Category A/B/C) (Link)
A similarly designed study was conducted in Japan in patients with [[NSTEACS]] invasively managed. This additional phase II study in Japanese patients had similar results compared with TRA-PCI. Specifically, this study showed similar incidence of bleeding between placebo and vorapaxar and a reduction of MIs with vorapaxar.


==Phase III of Vorapaxar: TRA 2°P and TRA•CER==
* Dosing Information/Recommendation
Vorapaxar is currently tested in a large phase III program including approximately 39,000 patients. The program include 2 distinct studies, named TRA 2°P and TRA•CER, which will test the effectiveness of this compound in patient  with stable and unstable CAD respectively.


:* (Dosage)


==External Links==
=====Condition 2=====
* {{cite journal | author = Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators | title = Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. | journal = Lancet | volume = 373 | issue = 9667 | pages = 919-28 | year = 2009 | id = PMID 19286091}}


* {{cite journal | author = Goto S, Yamaguchi T, Ikeda Y, Kato K, Yamaguchi H, Jensen P. | title = Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. | journal = J Atheroscler Thromb | volume = 17 | issue = 2 | pages = 156-64 | year = 2010 | id = PMID 20124733}}
* Developed by: (Organisation)


* {{cite journal | author = Morrow DA, Scirica BM, Fox KA, Berman G, Strony J, Veltri E, Bonaca MP, Fish P, McCabe CH, Braunwald E; TRA 2(o)P-TIMI 50 Investigators | title = Evaluation of a novel antiplatelet agent for secondary prevention in patients with a history of atherosclerotic disease: design and rationale for the Thrombin-Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2 degrees P)-TIMI 50 trial. | journal = Am Heart J | volume = 158 | issue = 3 | pages = 335-341 | year = 2009 | id = PMID 19699854}}
* Class of Recommendation: (Class) (Link)


* {{cite journal | author = TRA*CER Executive and Steering Committees. | title = The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale. | journal = Am Heart J | volume = 158 | issue = 3 | pages = 327-334 | year = 2009 | id = PMID 19699853}}
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
|offLabelAdultNoGuideSupport======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 3=====
 
* Dosing Information
 
:* (Dosage)
|fdaLIADPed======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
|offLabelPedGuideSupport======Condition 1=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
 
=====Condition 2=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
|offLabelPedNoGuideSupport======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 3=====
 
* Dosing Information
 
:* (Dosage)
|contraindications=* Condition 1
* Condition 2
* Condition 3
* Condition 4
* Condition 5
|warnings======Conidition 1=====
 
(Description)
 
|clinicalTrials=======Central Nervous System======
 
: (list/description of adverse reactions)
 
======Cardiovascular======
 
: (list/description of adverse reactions)
 
======Respiratory======
 
: (list/description of adverse reactions)
 
======Gastrointestinal======
 
: (list/description of adverse reactions)
 
======Hypersensitive Reactions======
 
: (list/description of adverse reactions)
 
======Miscellaneous======
 
: (list/description of adverse reactions)
 
=====Condition 2=====
 
======Central Nervous System======
 
: (list/description of adverse reactions)
 
======Cardiovascular======
 
: (list/description of adverse reactions)
 
======Respiratory======
 
: (list/description of adverse reactions)
 
======Gastrointestinal======
 
: (list/description of adverse reactions)
 
======Hypersensitive Reactions======
 
: (list/description of adverse reactions)
 
======Miscellaneous======
 
: (list/description of adverse reactions)
|postmarketing=(Description)
|drugInteractions=* Drug 1
* Drug 2
* Drug 3
* Drug 4
* Drug 5
 
=====Drug 1=====
 
(Description)
 
=====Drug 2=====
 
(Description)
 
=====Drug 3=====
 
(Description)
 
=====Drug 4=====
 
(Description)
 
=====Drug 5=====
 
(Description)
|useInPregnancyFDA=(Description)
|useInPregnancyAUS=(Description)
|useInLaborDelivery=(Description)
|useInNursing=(Description)
|useInPed=(Description)
|useInGeri=(Description)
|useInGender=(Description)
|useInRace=(Description)
|useInRenalImpair=(Description)
|useInHepaticImpair=(Description)
|useInReproPotential=(Description)
|useInImmunocomp=(Description)
|othersTitle=Others
|useInOthers=(Description)
 
|administration=(Oral/Intravenous/etc)
|monitoring======Condition 1=====
 
(Description regarding monitoring, from ''Warnings'' section)
 
=====Condition 2=====
 
(Description regarding monitoring, from ''Warnings'' section)
 
=====Condition 3=====
 
(Description regarding monitoring, from ''Warnings'' section)
|IVCompat====Solution===
 
====Compatible====
 
* Solution 1
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* Solution 3
 
====Not Tested====
 
* Solution 1
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* Solution 3
 
====Variable====
 
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* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===Y-Site===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===Admixture===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===Syringe===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===TPN/TNA===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
(Description)
 
====Management====
 
(Description)
 
===Chronic Overdose===
 
====Signs and Symptoms====
 
(Description)
 
====Management====
 
(Description)
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|drugShortage=Drug Shortage
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Revision as of 17:10, 10 July 2014

Vorapaxar
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Vorapaxar is a Adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

  • Condition 1
  • Condition 2
  • Condition 3
  • Condition 4
  • Condition 5

Warnings

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Vorapaxar
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Vorapaxar Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Vorapaxar |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Vorapaxar |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Vorapaxar interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Vorapaxar Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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