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Felycin®-CA1 (sirolimus delayed-release tablets)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal Law to use this product other than as directed in the labeling.

Felycin-CA1 (sirolimus delayed-release tablets) has been conditionally approved by FDA pending a full demonstration of effectiveness under application number NADA 141-604.

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 application number 141-604. See prescribing information for complete details regarding adverse events, warnings, and precautions.

PROIN ER™

IMPORTANT SAFETY INFORMATION: For oral use in dogs only. Not for human use. Keep out of reach of children. If accidentally ingested by humans, contact a physician immediately.

The most commonly reported side effects were vomiting, loss of appetite, diarrhea, excessive salivation, agitation, tiredness, vocalization, confusion, increased water consumption, weight loss, weakness, fever, panting, and reversible changes in skin color (flushing or bright pink). Abnormal gait, seizures or tremors, as well as liver enzyme elevations, kidney failure, blood in urine and urine retention have been reported. In some cases death, including euthanasia has been reported. Sudden death was sometimes preceded by vocalization or collapse.

Instances of dogs chewing through closed vials of PROIN® and eating the vial contents have been reported, in some cases resulting in overdose. Keep the product in a secured storage area out of the reach of pets in order to prevent accidental ingestion or overdose, as dogs may willingly consume more than the recommended dosage of PROIN® Chewable Tablets or PROIN ER™ tablets. Contact your veterinarian immediately if the dog ingests more tablets than prescribed or if other pets ingest PROIN Chewable tablets or PROIN ER tablets.

PROIN and PROIN ER may cause elevated blood pressure and should be used with caution in dogs with pre-existing heart disease, high blood pressure, liver disease, kidney insufficiency, diabetes, glaucoma, and other conditions associated with high blood pressure. Dogs may transition from PROIN Chewable Tablets to PROIN ER without a break in administration. However, do not alternate PROIN ER with PROIN Chewable Tablets because the effectiveness and safety of interchangeable use have not been evaluated.

The safe use of PROIN and PROIN ER in dogs used for breeding purposes, during pregnancy or in lactating bitches, has not been evaluated. Contact your veterinarian if you notice restlessness or irritability, loss of appetite, the incontinence persists or worsens, or any other unusual signs. See prescribing information for complete details regarding adverse events, warning and precautions.

Reconcile®

IMPORTANT SAFETY INFORMATION:

The most common adverse events reported in decreasing order of reported frequency are: decreased appetite, depression/lethargy, shaking/shivering/tremor, vomiting, restlessness and anxiety, seizures, aggression, diarrhea, mydriasis, vocalization, weight loss, panting, confusion, incoordination, and hypersalivation. Reconcile chewable tablets are contraindicated for dogs with a history of seizures or when used with MAOIs. For product label, including complete safety information, see package insert.

NADA#141-272

KBroVet®

IMPORTANT SAFETY INFORMATION:

KBroVet® (potassium bromide chewable tablets) is approved by FDA under application number 141-615. See prescribing information for complete details regarding adverse events, warnings, and precautions. Contraindicated in dogs with a history of hypersensitivity to bromide. Not for use in cats. Not for human use. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans. The most commonly reported side effects were increased appetite, weight gain, vomiting/regurgitation, sedation, and ataxia/weakness. Other reported side effects include increased thirst and urination, and lethargy. Reversible neurologic signs (sedation, ataxia, weakness) were generally associated with adjunctive potassium bromide treatment or high serum bromide concentrations. Animals with kidney disease may be predisposed to bromide toxicities. The safe use of KBroVet has not been evaluated in dogs that are intended for breeding, are pregnant or lactating, or less than 6 months of age. Use caution when changing diets, administering chloride-containing IV fluids, and administering concurrent medications. Careful monitoring is important in dogs that have a condition that may cause difficulty maintaining electrolyte balance.

WARNINGS:

Not for use in humans. Keep out of reach of children. Contact a physician in case of accidental ingestion by humans. Not for use in cats. Keep KBroVet-CA1 in a secured location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

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