Felycin^®-CA1

23% of cats with subclinical hypertrophic cardiomyopathy (HCM) suffer cardiovascular mortality within 5 years of diagnosis.^1,2 Now, you can give them more time with the first-ever FDA conditionally approved drug for cats with HCM from PRN Pharmacal.

Felycin-CA1 (sirolimus delayed-release tablets) is a first-in-class, once-weekly drug for the management of ventricular hypertrophy in cats with subclinical HCM.

Sirolimus, also known as rapamycin, is a macrolide that has been used to help prevent organ rejection in human allograft patients for more than 25 years. It was developed as a treatment for feline HCM due to these findings:

• Human transplant patients: Reduces left ventricle (LV) hypertrophy and improves cardiac function
• Rodent models of HCM: Reduces hypertrophy and restores function in failing hearts

RAPACAT Study ³

The RAPACAT study provided the first evidence that cats with subclinical HCM can be successfully treated.

Objective: Evaluate the effects of once-weekly Felycin-CA1 over six months in cats with subclinical HCM.

Animals: Forty-three client-owned cats with subclinical HCM ranging from 1 to 12 years of age. Thirty-six cats completed the study after 180 days.

Methods: Cats enrolled in a double-blind, multi-centered, randomized, placebo-controlled clinical trial were given Felycin-CA1 at the label dose, high dose, or a placebo once a week for six months.

Results

Efficacy: At Day 180, maximum LV myocardial wall thickness was significantly lower in the label dose Felycin-CA1 group compared to the placebo group.

Safety: Oral Felycin-CA1 was well tolerated with no significant differences in adverse events between groups.

Clinical relevance: Felycin-CA1 was well tolerated and may prevent or delay progressive LV hypertrophy in cats with subclinical HCM.

Conclusion: Cats treated with Felycin-CA1 had a reduction in LV maximal wall thickness.

Thirty-six client-owned cats with subclinical HCM were administered Felycin-CA1 or placebo. At day 180, cats treated with the recommended label dose of Felycin-CA1 had a significantly lower maximal wall thickness, showing an average reduction of 0.17 mm in comparison with a 0.94 mm increase for cats receiving placebo.

Felycin-CA1 is available in three different strengths. Weight-band dosing guidelines ensure accurate administration for maximum therapeutic efficacy for patients 2.5 kg and over.

Our competitive price point allows your clinic to maintain ample stock while remaining affordable for pet owners, enabling them to leave appointments with the solution already in hand.

Cats receiving Felycin-CA1 should have their liver enzymes evaluated 1-2 months after starting treatment and every 6-12 months thereafter. Discontinue use of medication if alanine aminotransferase and/or aspartate aminotransferase levels become greater than 2x upper limit of normal.​

The impact of concurrent administration of Felcyin-CA1 on vaccination for FHV-1, FCV, FPV, and FeLV has not been evaluated.

Felycin-CA1 underwent extensive safety studies.

• Pilot Study: Felycin-CA1 dosed at 0, 1.5, 4.5, and 7.5 times the label dose (divided over 3 doses per week) for 4 weeks. No significant safety concerns.
• Pivotal Study: Felycin-CA1 dosed at 0, 1.3, 3.8, 6.3 times label dose for 6 months. Asymptomatic increases in liver enzyme values in some cats. No effects on glucose metabolism.
• Vaccine Response Study: Rabies vaccine administered after 4 weeks of 3X Felycin-CA1. Vaccine response assessed after 8 weeks. All Felycin-CA1 dosed cats had a normal response to vaccination.

Takeaways

1. Felcyin-CA1’s once-weekly dosing regimen demonstrated a favorable safety profile.
2. Regular monitoring of liver function is essential for patient management.
3. Felycin-CA1 does not impact a cat’s ability to mount an immune response to rabies vaccine administration.

A higher incidence has been observed in certain breeds, including Maine Coon, Ragdoll, British Shorthair, Persian, Bengal, Sphynx, Norwegian Forest and Birman cats. ¹ There are higher incidence and genetic mutations found in Maine Coon and Ragdoll breeds. ²

HCM often develops silently, with little to no signs. Many cats remain symptom-free until complications suddenly emerge including congestive heart failure (CHF), aortic thromboembolism (ATE), and sudden death. ^1,2

A | Cat is predisposed to cardiomyopathy but has no clinical evidence of heart disease.

B | Cat presents with suspected cardiomyopathy but does NOT have clinical signs ​like a heart murmur, gallop or arrhythmia ausculted.

B1 | Low risk of imminent CHF or ATE based on minimal LA enlargement.

B2 | Increased risk of imminent CHF or ATE based on more severe LA enlargement (LA:Ao ≥1.8, LA diameter >20 mm) or presence of other risk factors.

C | HCM has developed into CHF, ATE or sudden death.

D | Cats with end-stage disease with clinical signs of CHF,​ refractory to standard therapy, or recurrent ATEs​.