POOLED SAFETY DATA
The safety of CARDAMYST was evaluated using pooled data from 321 patients across double-blind, randomized, placebo-controlled studies1-3
Most Frequent (≥5.0%) Adverse Reactions Observed in Randomized Controlled Studies*
| CARDAMYST 70 mg n=235 % | CARDAMYST 2x70 mg† n=86 % | Placebo n=223 % | |
|---|---|---|---|
| Nasal discomfort | 28 | 23 | 6 |
| Nasal congestion | 14 | 12 | 1 |
| Rhinorrhea | 12 | 10 | 2 |
| Throat irritation | 7 | 6 | 1 |
| Epistaxis | 6 | 7 | 1 |
Similar rates of adverse reactions were seen in patients who self-administered 1 or 2 doses of CARDAMYST2
1.6% of patients discontinued CARDAMYST due to treatment-related adverse reactions4
Adverse reactions that occurred within 24 hours of study drug administration for perceived PSVT in the double-blind, placebo-controlled studies, NODE-1, NODE-301 Part 1, NODE-301 Part 2 (RAPID), and NODE-301 Part 3 (RAPID Extension) that had an overall incidence of 5% or greater and where the incidence in the pooled CARDAMYST group is at least 1% greater than that of the pooled placebo group.
†2x70 mg: first administration of 70-mg CARDAMYST followed by a repeat dose of 70-mg CARDAMYST 10 minutes later if symptoms persisted.
In phase 2 & 3 clinical studies (N=1642)4:
Within 24 hours of CARDAMYST (etripamil) nasal spray administration
0.4% of patients experienced hypotension
0.2% of patients experienced syncope
0.1% of patients had Mobitz I second-degree AV block
0 cases of Mobitz II second-degree or third-degree AV block
How to use CARDAMYST
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Additional clinical data
See repeat use data from the open-label NODE-303 study.
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