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 ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH and in patients with active pathological bleeding. Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH. 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.

Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction with ZONTIVITY. 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 ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH and in patients with active pathological bleeding.

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Discontinue ZONTIVITY in patients who experience a stroke, TIA, or ICH. 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.