Felycin®-CA1
(sirolimus delayed-release tablets)
USES
Once-weekly tablets for cats indicated for the management of ventricular hypertrophy with subclinical hypertrophic cardiomyopathy (HCM). Conditionally-approved by FDA pending a full demonstration of effectiveness under application number 141-604.
Federal law restricts this drug to use by or on the order of a licensed veterinarian. See full prescribing information for complete dosing and administration instructions.
| Item # | Product Name | Supplied |
|---|---|---|
| 30091693 | Felycin-CA1 0.4mg | 12 ct. carton |
| 30091793 | Felycin-CA1 1.2mg | 12 ct. carton |
| 30091893 | Felycin-CA1 2.4mg | 12 ct. carton |
PRODUCT INFORMATION
Active Ingredient(s): Sirolimus
IMPORTANT SAFETY INFORMATION:
Do not use Felycin®-CA1 in cats with diabetes mellitus. Discontinue immediately if a cat receiving Felycin-CA1 is diagnosed with diabetes mellitus. Do not administer in cats with pre-existing liver disease. Administration of Felycin-CA1 with drugs that inhibit cytochrome P-450 3A4 or P-glycoprotein, such as calcium channel blockers, amiodarone, azoles, or cyclosporine, may increase risk for toxicity. Use caution when administering in cats with the MDR1 mutation or when administering concomitantly with another P-gp substrate. Treatment with Felycin-CA1 could impact the cat’s ability to mount an adequate immune response to vaccinations.
The use of Felycin-CA1 in cats with viral disease like feline viral rhinotracheitis has not been evaluated. The safety and effectiveness of Felycin-CA1 has not been evaluated in cats with other cardiomyopathy phenotypes, in cats receiving beta blockers or corticosteroids, in cats with kidney disease, hyperthyroidism, or other significant systemic disease. The effectiveness of Felycin-CA1 has not been evaluated in sexually intact cats, therefore, should not be used in animals intended for breeding.
Treatment with Felycin-CA1 has been associated with the elevation of the transaminase enzymes, which include alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Bloodwork should be repeated 1 to 2 months following initiation of treatment, and every 6-12 months thereafter. Discontinue treatment if transaminase values exceed 2X the upper limit of normal (ULN), if other liver enzymes besides ALT or AST are elevated, or if clinical signs of liver dysfunction are noted.
The most frequently observed adverse reactions in cats treated with Felycin-CA1 were cardiovascular in nature, relating to the progression of HCM, and included arrhythmia, congestive heart failure, syncope, and pericardial effusion. Other adverse reactions observed were lethargy, vomiting, diarrhea, and inappetence.
For use only in otherwise healthy cats with subclinical HCM in the absence of other causes of compensatory myocardial hypertrophy (e.g. systemic hypertension), current or historic symptoms of congestive heart failure, arterial thromboembolism, and severe LV outflow tract obstruction.
Not for human use. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans. Pregnant and breastfeeding women should avoid contact with Felycin-CA1. People with known hypersensitivity to sirolimus should administer Felycin-CA1 with caution.
Keep Felycin-CA1 in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.
Felycin-CA1 is conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-604. See prescribing information for complete details regarding adverse events, warnings, and precautions.
