Vorapaxar: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|genericName=generic name
|authorTag={{AL}}
|genericName=Vorapaxar
|aOrAn=a
|aOrAn=a
|drugClass=Adrenergic receptor agonist
|drugClass=[[platelet aggregation inhibitor]]
|indication=a list of indications, separated by commas.
|indicationType=prophylaxis
|indication=thrombotic cardiovascular events in patients with a history of [[myocardial infarction]] ([[MI]]) or with [[peripheral arterial disease]] ([[PAD]])
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=a list of adverse reactions, separated by commas.
|adverseReactions=[[bleeding]], [[anemia]]
|blackBoxWarningTitle=Warning Title
|blackBoxWarningTitle=WARNING: BLEEDING RISK
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Bleeding:</span></i> Do not use vorapaxar in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding.   
|fdaLIADAdult======Condition 1=====
Antiplatelet agents, including vorapaxar , increase the risk of bleeding, including ICH and fatal bleeding
|fdaLIADAdult======Patients with History of Myocardial Infarction (MI) or with Peripheral Arterial Disease (PAD)=====


* Dosing Information
* Dosing Information


:* (Dosage)
:* '''2.08 mg orally once daily''', with or without food.
|contraindications=====History of Stroke, Transient Ischemic Attack (TIA), or Intracranial Hemorrhage (ICH)====
*Vorapaxar is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population.
* Discontinue vorapaxar in patients who experience a stroke, TIA, or ICH.


=====Condition 2=====
====Active Pathologic Bleeding====
 
* Vorapaxar is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer
* Dosing Information
|warnings=====General Risk of Bleeding====
 
*Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding.
:* (Dosage)
*ZONTIVITY increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
|offLabelAdultGuideSupport======Condition 1=====
*Consider the underlying risk of bleeding before initiating ZONTIVITY. General risk factors for bleeding include older age, low body weight, reduced renal or hepatic function, history of bleeding disorders, and use of certain concomitant medications (e.g., anticoagulants, fibrinolytic therapy, chronic nonsteroidal anti-inflammatory drugs [NSAIDS], selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) increases the risk of bleeding
 
* Avoid concomitant use of warfarin or other anticoagulants.
* Developed by: (Organisation)
*Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or other surgical procedures.
 
*Withholding ZONTIVITY for a brief period will not be useful in managing an acute bleeding event because of its long half-life.
* Class of Recommendation: (Class) (Link)
*There is no known treatment to reverse the antiplatelet effect of ZONTIVITY.
 
*Significant inhibition of platelet aggregation remains 4 weeks after discontinuation.
* 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)
|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)


====Strong CYP3A Inhibitors or Inducers====
*Strong CYP3A inhibitors increase and inducers decrease ZONTIVITY exposure.
*Avoid concomitant use of ZONTIVITY with strong CYP3A inhibitors or inducers
|clinicalTrials=======Central Nervous System======
|clinicalTrials=======Central Nervous System======


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|othersTitle=Others
|othersTitle=Others
|useInOthers=(Description)
|useInOthers=(Description)
|administration=(Oral/Intravenous/etc)
|administration=(Oral/Intravenous/etc)
|monitoring======Condition 1=====
|monitoring======Condition 1=====
Line 440: Line 355:
|howSupplied=(Description)
|howSupplied=(Description)
|fdaPatientInfo=(Patient Counseling Information)
|fdaPatientInfo=(Patient Counseling Information)
|nlmPatientInfo=(Link to patient information page)
|alcohol=Alcohol-Vorapaxar interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|nlmPatientInfo=(Link to patient information page)
|drugShortage=Drug Shortage
|drugShortage=Drug Shortage
}}
}}

Revision as of 17:26, 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]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: BLEEDING RISK
See full prescribing information for complete Boxed Warning.
Bleeding: Do not use vorapaxar in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding. Antiplatelet agents, including vorapaxar , increase the risk of bleeding, including ICH and fatal bleeding

Overview

Vorapaxar is a platelet aggregation inhibitor that is FDA approved for the prophylaxis of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding, anemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Patients with History of Myocardial Infarction (MI) or with Peripheral Arterial Disease (PAD)
  • Dosing Information
  • 2.08 mg orally once daily, with or without food.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Vorapaxar FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

History of Stroke, Transient Ischemic Attack (TIA), or Intracranial Hemorrhage (ICH)

  • Vorapaxar is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population.
  • Discontinue vorapaxar in patients who experience a stroke, TIA, or ICH.

Active Pathologic Bleeding

  • Vorapaxar is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer

Warnings

WARNING: BLEEDING RISK
See full prescribing information for complete Boxed Warning.
Bleeding: Do not use vorapaxar in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding. Antiplatelet agents, including vorapaxar , increase the risk of bleeding, including ICH and fatal bleeding

General Risk of Bleeding

  • Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding.
  • ZONTIVITY increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
  • Consider the underlying risk of bleeding before initiating ZONTIVITY. General risk factors for bleeding include older age, low body weight, reduced renal or hepatic function, history of bleeding disorders, and use of certain concomitant medications (e.g., anticoagulants, fibrinolytic therapy, chronic nonsteroidal anti-inflammatory drugs [NSAIDS], selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) increases the risk of bleeding
  • Avoid concomitant use of warfarin or other anticoagulants.
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or other surgical procedures.
  • Withholding ZONTIVITY for a brief period will not be useful in managing an acute bleeding event because of its long half-life.
  • There is no known treatment to reverse the antiplatelet effect of ZONTIVITY.
  • Significant inhibition of platelet aggregation remains 4 weeks after discontinuation.

Strong CYP3A Inhibitors or Inducers

  • Strong CYP3A inhibitors increase and inducers decrease ZONTIVITY exposure.
  • Avoid concomitant use of ZONTIVITY with strong CYP3A inhibitors or inducers

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 about 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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