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INDICATIONS AND USAGE

CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

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IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil)

CONTRAINDICATIONS

CARDAMYST is contraindicated in patients with:

Hypersensitivity to CARDAMYST or any of its components.
Heart failure - New York Heart Association (NYHA) Class II to IV.
Wolff-Parkinson-White (WPW), Lown-Ganong-Levine (LGL) syndromes, or manifest pre-excitation (delta wave) on a 12-lead electrocardiogram (ECG).
Sick sinus syndrome without a permanent pacemaker.
Second degree atrioventricular (AV) Mobitz 2 block or higher degree of AV block.

WARNINGS AND PRECAUTIONS

Syncope Related to Hemodynamic Effects

Because of effects on blood pressure, heart rate, and cardiac conduction, CARDAMYST may cause dizziness and/or syncope, especially in patients with a history of syncope and high-grade AV block or sinus node dysfunction, or those with a history of syncope during an episode of PSVT.
In clinical trials, a small percentage of patients (0.4%) experienced clinically significant hypotension during test dosing prior to randomization, which precluded further participation in the study. Patients with a history of hypotensive episodes or those at increased risk for hemodynamic instability should be monitored appropriately when initiating CARDAMYST.
If syncope occurs, patients should be placed in the recumbent position and treated supportively.
Patients should be cautioned about these possible adverse effects and advised to administer CARDAMYST in a sitting position, and in a location where the risk of fall is minimal.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 5%) observed in randomized controlled studies are nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis.

Lactation: A lactating woman should pump and discard breastmilk for 12 hours after CARDAMYST administration in order to minimize exposure to a breastfed infant.

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