Cardamyst (etripamil) is filed as calcium channel blocker. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. CARDAMYST is a calcium channel blocker indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults ( 1 ).
12.1 Mechanism of Action Etripamil is an L-type calcium influx inhibitor (slow channel blocker or calcium ion antagonist). Etripamil exerts its pharmacologic effect by modulating the influx of ionic calcium across the cell membrane of the AV nodal cells as well as arterial smooth muscles and contractile myocardial cells. By interrupting reentry at the AV node, etripamil can restore sinus rhythm in patients with PSVT.
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.
4 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. Hypersensitivity to CARDAMYST or any of its components ( 4 ). Heart failure - New York Heart Association (NYHA) Class II to IV ( 4 ). Wolff-Parkinson-White (WPW), Lown-Ganong-Levine (LGL) syndromes, or manifest pre-excitation (delta wave) on a 12-lead ECG ( 4 ). Sick sinus syndrome (except in patients with a permanent pacemaker) ( 4 ) Second degree atrioventricular (AV) Mobitz 2 block or higher degree of AV block ( 4 )
Nasal discomfort (>5%); Nasal congestion (>5%); Rhinorrhea (>5%); Throat irritation (>5%); Epistaxis (>5%)
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
2 DOSAGE AND ADMINISTRATION For intranasal use only ( 2.1 ). Initial dosage: A dose of 70 mg is administered as two nasal sprays, one spray into each nostril. Each nasal spray device delivers two sprays. The two sprays together contain a total of 70 mg etripamil ( 2.1 ). Repeat dosage (if needed): Should symptoms persist for 10 minutes after administration of CARDAMYST, take a second dose of 70 mg administered as two nasal sprays, one spray into each nostril. Do not exceed 140 mg in a 24-hour period ( 2.1 ). 2.1 Recommended Dosage Administer as soon as possible after PSVT symptom onset. Administer CARDAMYST by the nasal route only. Each CARDAMYST device delivers two sprays for a total of 70 mg. Recommended Dosage: Using one nasal spray device, administer one spray into each nostril for a total initial dose of 70 mg. If symptoms persist after 10 minutes, use the second nasal spray device to administer a second dose of one spray into each nostril (70 mg total). Patients and caregivers should call their healthcare provider or seek emergency medical help if symptoms do not improve within 20 minutes after a second dose. Do not exceed 140 mg in a 24-hour period. See Instructions for Use for proper nasal spray technique. If a full initial dose (i.e., 2 sprays, one in each nostril) is not administered due to device malfunction or misuse, the patient should wait at least 10 minutes before self-administering a second dose, if needed.
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Important Treatment Instructions Instruct patients and caregivers on PSVT symptoms and the timing of administration in relation to the onset of the episode of PSVT. Instruct patients and caregivers on what to observe following administration, and what would constitute an outcome requiring medical attention. Instruct patients and caregivers to call their healthcare provider or seek emergency medical help if symptoms do not improve within 20 minutes after a second dose. Administration Information Instruct patients and caregivers not to test or prime before use. Instruct patients and caregivers to discard the CARDAMYST device after use. Lactation Advise lactating women to pump and discard breastmilk for 12 hours after CARDAMYST administration in order to minimize exposure to a breastfed infant [see Use in Specific Populations ( 8.2 )] . Manufactured for: Milestone Pharmaceuticals USA, Inc. 6210 Ardrey Kell Road, Suite 650, Charlotte, NC, 28277
According to its FDA label, Cardamyst (etripamil) is approved for: 1 INDICATIONS AND USAGE CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. CARDAMYST is a calcium channel blocker indicated for the conversion of acute symptomatic episodes of paroxy… For medical advice, please talk to your prescriber or pharmacist.
Cardamyst (etripamil) belongs to the calcium channel blocker class of medications.
The FDA label lists Cardamyst (etripamil) as: 3 DOSAGE FORMS AND STRENGTHS Nasal Spray: Clear colorless to yellow solution. 70 mg of etripamil per device. Nasal spray: 70 mg etripamil per device ( 3 ).; nasal route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Cardamyst. Availability changes as patents expire.
Our ingest of the FDA label for Cardamyst (etripamil) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Cardamyst (etripamil) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Cardamyst (etripamil) as 2025-12-12.
The FDA label lists Milestone Pharmaceuticals USA, Inc. as a labeler/manufacturer of Cardamyst (etripamil). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling Store at 20°C to 25°C (68°F to 77°F), with excursions permitted from 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Do not test spray, prime or press the plunger before use. Disca…" Follow the packaging insert for the authoritative guidance.
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