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warnings and cautions
5 WARNINGS AND PRECAUTIONS 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 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.
6 ADVERSE REACTIONS 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 clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CARDAMYST was evaluated using pooled data from double-blind, randomized, placebo-controlled trials including NODE-1, NODE-301 Part 1, RAPID, and RAPID Extension. A total of 321 patients were treated with CARDAMYST in randomized controlled studies. In the RAPID and RAPID Extension studies, in which patients had the option of self-administering a second dose of CARDAMYST for a perceived episode of PSVT, the majority of patients (65%) self-administered a second dose of CARDAMYST (2x70mg). In NODE-301 Part 1, RAPID, and RAPID Extension, to assess tolerability, a test dose(s) was given prior to randomization. A small percentage of patients failed the test dose due to hypotension (0.4%) [see Warnings and Precautions ( 5.1 )]. The majority of treatment-related adverse reactions reported in clinical studies with CARDAMYST have been related to local reactions to, at, or near the nasal administration site, including the nose, throat, and eyes. These local reactions included nasal discomfort, nasal congestion, throat irritation, oropharyngeal pain, lacrimation, rhinorrhea, bleeding from the nose, upper-airway cough syndrome, and sneezing. Table 1: Most frequent (≥5.0%) Adverse Reactions 1 Observed in Randomized Controlled Studies 1) Adverse reactions that occurred within 24 hours of study drug administration (TEAE24h) for perceived PSVT in the double-blind, placebo-controlled studies, NODE-1, NODE-301 Part 1, RAPID and RAPID Extension that had an overall incidence of 5% or greater and where the incidence is at least 1% greater than the placebo group. 2) 2x70 mg: first administration of etripamil 70 mg followed by a second dose of etripamil 70 mg 10 minutes later if symptoms persisted. Placebo N=223 % CARDAMYST 70 mg N=235 % CARDAMYST 2x70 mg 2 N=86 % Nasal Discomfort 6 28 23 Nasal Congestion 1 14 12 Rhinorrhea 2 12 10 Throat Irritation 1 7 6 Epistaxis 1 6 7
adverse reactions table
<table ID="t1" width="100%"><caption>Table 1: Most frequent (≥5.0%) Adverse Reactions<sup>1</sup> Observed in Randomized Controlled Studies </caption><col width="24.225%" align="left"/><col width="21.925%" align="left"/><col width="26.000%" align="left"/><col width="27.850%" align="left"/><tfoot><tr><td colspan="4" align="left" valign="top"><paragraph styleCode="footnote">1) Adverse reactions that occurred within 24 hours of study drug administration (TEAE24h) for perceived PSVT in the double-blind, placebo-controlled studies, NODE-1, NODE-301 Part 1, RAPID and RAPID Extension that had an overall incidence of 5% or greater and where the incidence is at least 1% greater than the placebo group. </paragraph></td></tr><tr><td colspan="4" align="left" valign="top"><paragraph styleCode="footnote">2) 2x70 mg: first administration of etripamil 70 mg followed by a second dose of etripamil 70 mg 10 minutes later if symptoms persisted. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"/><td align="center" valign="top" styleCode="Toprule Botrule Rrule">Placebo N=223 % </td><td align="center" valign="top" styleCode="Toprule Botrule Rrule">CARDAMYST 70 mg N=235 % </td><td align="center" valign="top" styleCode="Toprule Botrule Rrule">CARDAMYST 2x70 mg<sup>2</sup> N=86 % </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Nasal Discomfort </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">28 </td><td align="center" valign="top" styleCode="Botrule Rrule">23 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Nasal Congestion </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Rhinorrhea </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">10 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Throat Irritation </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Epistaxis </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td></tr></tbody></table>