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A PAR-1 antagonist for the reduction of thrombotic cardiovascular events in patients with a history of MI or with PAD1

ZONTIVITY® (vorapaxar) has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization.1

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MI, myocardial infarction; PAD, peripheral arterial disease; PAR-1, protease-activated receptor-1.

Indications and Usage

ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).

Important Safety Information
WARNING: BLEEDING RISK
  • Do not use ZONTIVITY in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH), or with active pathological bleeding
  • Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding

 

CONTRAINDICATIONS:

  • ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population. Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH.
  • ZONTIVITY is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer.

 

WARNINGS AND PRECAUTIONS:

  • ZONTIVITY increases the risk of bleeding (which may include ICH and fatal 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, and history of bleeding disorders.
  • Use of certain concomitant medications (eg, anticoagulants, fibrinolytic therapy, chronic nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) also increases the risk of bleeding.
  • Avoid concomitant use of warfarin or other anticoagulants due to the risk of bleeding. Avoid concomitant use of strong CYP3A inhibitors or inducers due to their effect on ZONTIVITY exposure.
  • Withholding ZONTIVITY for a brief period will not be useful in managing an acute bleeding event due to its long half-life. There is no known treatment to reverse the antiplatelet effect of ZONTIVITY.
  • ZONTIVITY is not recommended in patients with severe hepatic impairment.

 

ADVERSE REACTIONS:

  • Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction with ZONTIVITY.
  • Any GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) bleeding (severe/moderate/mild) occurred in 27.7% of patients taking ZONTIVITY and in 19.8% of patients taking placebo (HR 1.52: 95% CI [1.43-1.61])
  • GUSTO moderate or severe bleeding, 3.7% vs 2.4%, HR 1.55 (1.30-1.86)
  • GUSTO severe bleeding, 1.3% vs 1.0%, HR 1.24 (0.92-1.66)
  • Clinically significant bleeding (bleeding requiring medical attention including ICH, or overt signs of hemorrhage with a drop in Hgb =3 g/dL or when Hgb is not available, an absolute drop in Hct =9%) over 3 years occurred in 15.5% of patients taking ZONTIVITY and in 10.9% of patients taking placebo (HR 1.47: 95% CI [1.35-1.60])
  • Other adverse reactions (> 2%) include anemia (5%); depression (2.4%); and rashes, eruptions, and exanthemas (2.2%).

To report SUSPECTED ADVERSE EVENTS, contact WraSer Pharmaceuticals at 1-800-988-6115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information, including Boxed Warning, and Medication Guide.

Reference: 1. Zontivity Prescribing Information. Parsippany, WraSer Pharmaceuticals.; 2022.

READ LESS
Indications and Usage

ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization (UCR).

READ MORE
READ LESS
Important Safety Information
WARNING: BLEEDING RISK
  • Do not use ZONTIVITY in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH), or with active pathological bleeding
  • Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding

 

CONTRAINDICATIONS:

  • ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population. Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH.
  • ZONTIVITY is contraindicated in patients with active pathological bleeding such as ICH or peptic ulcer.

 

WARNINGS AND PRECAUTIONS:

  • ZONTIVITY increases the risk of bleeding (which may include ICH and fatal 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, and history of bleeding disorders.
  • Use of certain concomitant medications (eg, anticoagulants, fibrinolytic therapy, chronic nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) also increases the risk of bleeding.
  • Avoid concomitant use of warfarin or other anticoagulants due to the risk of bleeding. Avoid concomitant use of strong CYP3A inhibitors or inducers due to their effect on ZONTIVITY exposure.
  • Withholding ZONTIVITY for a brief period will not be useful in managing an acute bleeding event due to its long half-life. There is no known treatment to reverse the antiplatelet effect of ZONTIVITY.
  • ZONTIVITY is not recommended in patients with severe hepatic impairment.

 

ADVERSE REACTIONS:

  • Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction with ZONTIVITY.
  • Any GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) bleeding (severe/moderate/mild) occurred in 27.7% of patients taking ZONTIVITY and in 19.8% of patients taking placebo (HR 1.52: 95% CI [1.43-1.61])
  • GUSTO moderate or severe bleeding, 3.7% vs 2.4%, HR 1.55 (1.30-1.86)
  • GUSTO severe bleeding, 1.3% vs 1.0%, HR 1.24 (0.92-1.66)
  • Clinically significant bleeding (bleeding requiring medical attention including ICH, or overt signs of hemorrhage with a drop in Hgb =3 g/dL or when Hgb is not available, an absolute drop in Hct =9%) over 3 years occurred in 15.5% of patients taking ZONTIVITY and in 10.9% of patients taking placebo (HR 1.47: 95% CI [1.35-1.60])
  • Other adverse reactions (> 2%) include anemia (5%); depression (2.4%); and rashes, eruptions, and exanthemas (2.2%).
READ MORE

To report SUSPECTED ADVERSE EVENTS, contact Aralez Pharmaceuticals at 1-866-207-6592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information, including Boxed Warning.

Reference: 1. Zontivity Prescribing Information. Parsippany, WraSer Pharmaceuticals.; 2022.