Rapamycin for Cats Sirolimus Delayed- Release Tablets

Important Safety Information

• Do not use in cats with diabetes mellitus. Discontinue treatment immediately if diabetes mellitus is diagnosed during therapy.

• Do not administer in cats with pre-existing liver disease.

• Concomitant use with drugs that inhibit cytochrome P-450 3A4 or P-glycoprotein (such as calcium channel blockers, amiodarone, azoles, or cyclosporine) may increase the risk of toxicity.

• Use caution in cats with the MDR1 mutation or when used together with other P-gp substrates.

• Treatment may reduce the cat’s ability to mount an adequate immune response to vaccinations.

Use Limitations

• Safety has not been evaluated in cats with viral diseases (e.g., feline viral rhinotracheitis), other cardiomyopathy phenotypes, kidney disease, hyperthyroidism, or other systemic illnesses.

• Safety and effectiveness in sexually intact cats have not been determined. Do not use in animals intended for breeding.

• Safety has not been studied in cats receiving beta blockers or corticosteroids.

Monitoring and Laboratory Testing

• Treatment has been associated with elevations of liver enzymes (ALT, AST).

• Bloodwork should be repeated 1–2 months after initiating therapy, and every 6–12 months thereafter.

• Discontinue treatment if transaminase values exceed 2× the upper limit of normal, if other liver enzymes are elevated, or if clinical signs of liver dysfunction appear.

Adverse Reactions

• The most frequently reported adverse effects were cardiovascular in nature, including arrhythmia, congestive heart failure, syncope, and pericardial effusion.

• Other adverse events may include lethargy, vomiting, diarrhea, and inappetence.

Indication

• For use only in otherwise healthy cats with subclinical hypertrophic cardiomyopathy (HCM) in the absence of other causes of myocardial hypertrophy (e.g., systemic hypertension), current or historical symptoms of congestive heart failure, arterial thromboembolism, or severe left ventricular outflow tract obstruction.

Precautions

• Not for human use. Keep out of reach of children. Seek medical attention immediately in case of accidental ingestion.

• Pregnant and breastfeeding women should avoid handling.

• People with known hypersensitivity to sirolimus should take precautions when administering.

• Store securely out of reach of animals to prevent accidental ingestion or overdose.