Cardamyst (etripamil)

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Etripamil is a cytochrome P-450 (CYP) 3A4 and CYP3A5 substrate. Etripamil inhibits CYP2D6, CYP3A4, and CYP2C9 but does not inhibit CYP2B6 or CYP2C8. Etripamil does not induce CYP1A2, CYP2B6, or CYP3A4.

Etripamil is a substrate of P-glycoprotein (P-gp) and organic anion transporting polypeptide (OATP) 1B1, but not OATP1B3, breast cancer resistance protein (BCRP), organic cation transporter (OCT) 1, OCT2, organic anion transporter (OAT) 1, OAT3, multidrug and toxin extrusion transporter (MATE) 1, and MATE2K. Etripamil inhibits P-gp and MATE1, but not BCRP, bile salt export pump (BSEP), MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Hypersensitivity to etripamil 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 ECG.

*Sick sinus syndrome (except in patients with a permanent pacemaker).

*Second degree atrioventricular (AV) Mobitz 2 block or higher degree of AV block.

• Complete atrioventricular block
• Second degree atrioventricular heart block
• Wolff-parkinson-white pattern

• Chronic heart failure
• Sick sinus syndrome

• Syncope due to bradycardia

The most common adverse reactions (>5%) reported with etripamil nasal spray in clinical studies were nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis.

There are no severe adverse reactions for this drug.

More Frequent

• Epistaxis
• Nasal congestion
• Nasal pain
• Pharyngitis
• Rhinorrhea

Rare or Very Rare

• Hypotension

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The safety and effectiveness of etripamil have not been established in pediatric patients.

Etripamil is structurally similar to another drug in the same pharmacologic class that has been associated with a high risk of potentially irreversible electromechanical dissociation or cardiovascular collapse in pediatric patients <1 year of age, including neonates.

There are no adequate data regarding use of etripamil in pregnant women.

Reproductive studies conducted with IV administration of etripamil in pregnant rats and rabbits during organogenesis did not show any evidence of fetal harm or malformations in rats at exposures up to approximately 3 times the maximum concentration and 0.4 times the AUC at the maximum recommended human dose (MRHD) and in rabbits at exposures approximately equivalent to the maximum concentration and 10 times the AUC at the MRHD, at which maternal toxicities were observed.

It is not known whether etripamil is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. The structurally related compound, verapamil, is known to be present in human milk. Because the presence of etripamil in breastmilk has not been characterized, and there is a potential for adverse reactions in the breastfed infant including hypotension and bradycardia, interrupt breastfeeding and pump and discard milk for 12 hours (approximately 5 terminal half-lives) after treatment with etripamil.

Among patients in clinical trials of etripamil, 41% (681/1662) were >=60 years of age, and 14% (238/1662) were >=70 years of age. No meaningful differences in safety or effectiveness were observed between these patients and younger patients.