Atopica® for Cats

ATOPICA^® for Cats (cyclosporine oral solution) USP MODIFIED is indicated for the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs in body weight.

Do not use in cats with a history or suspicion of malignant disorders, feline leukemia virus (FeLV) or feline immunodeficiency virus (FIV) infection, or hypersensitivity to cyclosporine. Atopica^® is a systemic immunosuppressant that may increase susceptibility to infection, development of neoplasia, and decrease response to vaccination. Persistent, progressive weight loss may result in hepatic lipidosis; monitoring of body weight is recommended. For use only in cats. Wash hands after administration. People with known hypersensitivity should avoid contact with Atopica^®. Do not use with other immunosuppressive agents. It is important for cats to avoid exposure to Toxoplasma gondii during treatment. Use with caution in cats with diabetes mellitus or renal insufficiency, and with drugs that affect the P-450 enzyme system. The most common adverse events were vomiting, weight loss, diarrhea or loss of appetite. Please speak with your veterinarian for advice. Please see Product Label for full prescribing information.

This product contains a chemical on the Proposition 65 List.

Cats

Cyclosporine (Modified)

Immunosuppressant

The manufacturer does not specify the exact flavor of this product.

Atopica for Cats (cyclosporine oral solution) USP MODIFIED is supplied in glass amber bottles of 5 and 17 mL at 100 mg/mL. A dispensing system is included (see Product Insert for additional information).

Please ensure the selected product and quantity are appropriate for your pet, as recommended by your veterinarian. For current availability, please refer to the product selection above.

Atopica for Cats oral solution should be administered as directed by your veterinarian. Wash hands after administration. Please consult your veterinarian before making any changes or discontinuing the prescribed dosing schedule. If you have questions about your pet’s prescribed dosing schedule (e.g., timing, interval), please contact your veterinarian.

The initial dose of Atopica for Cats is 3.2 mg/lb/day (7mg/kg/day) as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dose of Atopica for Cats may be tapered by decreasing the frequency of dosing to every other day or twice weekly to maintain the therapeutic effect.

Atopica for Cats should be administered directly on a small amount of food or orally just after feeding. Whenever possible, Atopica for Cats should be administered on a consistent schedule with regard to meals and time of day. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.

The dispensing system includes an oral dosing syringe graduated in 1 lb increments. Do not rinse or clean the oral dosing syringe between uses.

Atopica for Cats should only be dispensed in the original container and stored at controlled room temperature between 59 and 77°F. Once opened, use contents within two months for the 5 mL container and 11 weeks for the 17 mL container. Keep this and all other medications in a secure location out of the reach of children and animals.

Exposure to extreme temperatures, light, or moisture can affect the integrity and effectiveness of medications. Always store this medication properly (e.g., away from the bathroom, kitchen sink, or other damp places), as outlined on the Product Label.

The most common side effects reported for this medication are vomiting, weight loss, diarrhea, or loss of appetite.

Atopica for Cats (cyclosporine) is a systemic immunosuppressant that may increase susceptibility to infection and development of neoplasia (cancer or other abnormal tissue growth).

Contact your veterinarian immediately if your pet has swelling/overgrowth of the gums; complete loss of appetite; persistent, progressive weight loss; or if you notice any signs of serious illness or infection (e.g., fever, chills, frequent or painful urination).

The information provided above may not encompass all possible side effects. Please notify your veterinarian if your pet experiences any side effects, including those listed above, or if you notice anything unusual.

For use only in cats. Not for human use. Keep this and all drugs out of reach of children and animals.

Do not eat, drink, smoke, or use smokeless tobacco while handling Atopica for Cats. Wash hands after administration. In case of accidental ingestion, seek medical advice immediately and provide the package insert or the label to the physician.

People with known hypersensitivity to cyclosporine should avoid contact with Atopica for Cats.

The safety and effectiveness of Atopica for Cats has not been established in cats less than 6 months of age or less than 3 lbs (1.4 kg) body weight.

Atopica for Cats is not for use in breeding cats, pregnant, or lactating queens.

This medication should be used with caution in cats with diabetes mellitus or renal insufficiency.

Do not administer this medication to animals with a known or suspected allergy/hypersensitivity to it (cyclosporine) or any of its ingredients. Allergic reactions to medications may occur. Please inform Vetsource and your veterinarian if your pet has any known sensitivities or allergies, especially to medications and supplements.

If your pet displays symptoms of an allergic reaction, discontinue therapy and call your veterinarian immediately or seek emergency veterinary attention. Symptoms may include (but are not limited to): swollen lips, tongue, face, or airways; difficulty breathing; agitation; profuse salivation; and widespread hives or itching.

This medication is classified as hazardous due to potential exposure risks in humans. Proper use of personal protective equipment (PPE), such as gloves, may be recommended when handling this medication to minimize the risk of exposure. Wash hands thoroughly with soap and water after administration (even if gloves are worn).

Do not use Atopica for Cats with other immunosuppressive agents.

Atopica for Cats should be used with caution with drugs that affect the P-450 enzyme system. Simultaneous administration with drugs that suppress the P-450 enzyme system, such as azoles (e.g., ketoconazole), may lead to increased plasma levels of cyclosporine.

Treatment with Atopica for Cats may result in decreased immune response to vaccination. Naïve cats may not develop protective titers during treatment.

The following drugs* may have potential interactions with this medication: ACE inhibitors (e.g., benazepril), azole antifungals (e.g., ketoconazole), corticosteroids (e.g., dexamethasone, prednisolone), digoxin, JAK inhibitors (e.g., oclacitinib), loop diuretics (e.g., furosemide), methotrexate, mycophenolate, NSAIDs, phenobarbital, sirolimus, spironolactone, sulfa antibiotics, telmisartan (Semintra), and warfarin.

*NOTE: This is not a comprehensive list of all possible interactions. As with all medications, please consult your veterinarian if you have any questions or concerns prior to use. Contact your veterinarian if your pet experiences any unusual reactions when multiple medications and/or supplements are given together.

Please ensure your veterinarian is aware of all medications, supplements, and over-the-counter (OTC) products that your pet is currently using. Your veterinarian may prescribe multiple medications, even if a potential drug interaction may occur. In these instances, your veterinarian may adjust the dosages or monitor your pet more closely.

If you are concerned that your pet has experienced an adverse reaction to this medication, please contact Elanco at 1-888-545-5973 or Vetsource Pet Owner Care at 877-738-4443.

If you have any reason to suspect accidental consumption or overdose, call your doctor/veterinarian or the appropriate poison control resource immediately.

The national toll-free Poison Help line, 1-800-222-1222, will connect you to your local poison center in case of emergency. This service is available nationwide and in most U.S. territories.

The ASPCA Animal Poison Control Center is available 24 hours a day, 365 days a year at 888-426-4435.

Pet Poison Helpline also provides a 24/7 animal poison control service at 855-764-7661.

All content, including the images and product description above, is intended for general informational purposes only and should not be considered a substitute for professional veterinary consultation, diagnosis, or treatment.

For additional information about this product and how it fits into your pet's individual treatment plan, please consult your veterinarian.