CARDAMYST (etripamil)

After one 70 mg dose of etripamil, mean (%CV) area under the concentration-time curve (AUC) is approximately 5461 (51.6%) ng*min/mL and the C max is approximately 99 (64.6%) ng/mL. After a second 70 mg dose of etripamil administered 10 minutes after the first dose, mean (%CV) AUC is approximately 7721 (50.3%) ng*min/mL and the C max is approximately 132 (59.1%) ng/mL.

AbsorptionEtripamil median (range) time to C max (T max ) is 7 minutes (3 to 20 minutes) following a single intranasal administr...

The RAPID study (NCT #03464019) was a randomized, double-blind, placebo-controlled, multicenter, event-driven, phase 3 study designed to evaluate the efficacy and safety of CARDAMYST in patients with a history of symptomatic PSVT. Six hundred ninety-two (692) patients were randomized 1:1 to CARDAMYST 70 mg or placebo. Patients with an episode of perceived PSVT were to self-administer the study drug intranasally in a medically unsupervised setting and self-administer a second dose of the study drug if symptoms persisted at 10 minutes after the first dose. Continuously obtained electrocardiograp...

The following clinically significant adverse reactions are described elsewhere in the labeling: Risk of syncope [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence > 5%) are nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Milestone Pharmaceuticals USA, INC. at toll-free phone 1-877-207-4764 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because cl...

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) M...

Syncope: May cause dizziness and/or syncope, especially in patients with a history of syncope. Administer in a sitting position ( 5.1 ). 5.1 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...