Vorapaxar

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]

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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)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vorapaxar in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vorapaxar in adult patients.

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)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vorapaxar in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vorapaxar in pediatric patients.

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 vorapaxar, increase the risk of bleeding, including ICH and fatal bleeding.
• vorapaxar increases the risk of bleeding in proportion to the patient's underlying bleeding risk.
• Consider the underlying risk of bleeding before initiating vorapaxar. 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 vorapaxar 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 vorapaxar.
• Significant inhibition of platelet aggregation remains 4 weeks after discontinuation.

Strong CYP3A Inhibitors or Inducers

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

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Condition 2

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Cardiovascular

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Respiratory

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Gastrointestinal

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Hypersensitive Reactions

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Miscellaneous

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Postmarketing Experience

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Drug Interactions

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Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Race

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Renal Impairment

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

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Monitoring

Condition 1

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Condition 2

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Condition 3

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IV Compatibility

Solution

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Not Tested

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Variable

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Incompatible

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Y-Site

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

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Chronic Overdose

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Management

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Pharmacology

Vorapaxar
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Mechanism of Action

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Structure

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Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

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Clinical Studies

Condition 1

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How Supplied

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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.