Atopica for Cats

Warnings

ATOPICA for Cats is a systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia. One of 205 field study cats died of the effusive form of feline infectious peritonitis. (See Adverse Reactions) Persistent, progressive weight loss that resulted in hepatic lipidosis occurred in 2 of 205 cats on treatment with ATOPICA for Cats in field studies. Monitoring of body weight is recommended.

Precautions

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. Cats should be tested and found to be negative for FeLV and FIV infections before treatment.

As with any immunosuppressive regimen, exacerbation of sub-clinical neoplastic and infectious conditions may occur. ATOPICA for Cats is not for use with other immunosuppressive agents.

Cats that are seronegative for Toxoplasma gondii may be at risk of developing clinical toxoplasmosis if they become infected while under treatment, which can be fatal. In a controlled laboratory study, cats seronegative for T. gondii were administered cyclosporine and subsequently infected with T. gondii, resulting in increased susceptibility to infection and subsequent expression of toxoplasmosis.

Cyclosporine did not increase T. gondii oocyst shedding (see Animal Safety). Potential exposure of seronegative cats to T. gondii should be avoided (e.g. keep indoors, avoid raw meat or scavenging).

In cases of clinical toxoplasmosis or other serious systemic illness, stop treatment with cyclosporine and initiate appropriate therapy.

ATOPICA for Cats may cause elevated levels of serum glucose, creatinine, and urea nitrogen. ATOPICA for Cats should be used with caution in cases with diabetes mellitus or renal insufficiency.

ATOPICA for Cats should be used with caution with drugs that affect the P-450 enzyme system. Simultaneous administration of ATOPICA for Cats 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

Food and Drug Interactions

Human Warnings

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

Possible Side Effects

The clinical safety of ATOPICA for Cats was assessed in a masked, controlled 6-week field study followed by a 12-week open-labeled dose-tapering field study. In these two field studies, 205 cats received treatment with ATOPICA for Cats for up to 126 days. Two cats died or were euthanized within two weeks following study exit. One cat was diagnosed with the effusive form of feline infectious peritonitis and died following normal study exit, and one cat with pre-existing anemia that worsened during the study was diagnosed with aplastic anemia and euthanized because of a poor prognosis for recovery.

Fourteen of the 205 cats (6.8%) were withdrawn from the studies due to the occurrence of an adverse reaction. Adverse reactions in these 14 cats included weight loss, anorexia, vomiting, diarrhea, hypersalivation, lethargy, hepatic lipidosis and jaundice, upper respiratory signs, ocular discharge, cough, toxoplasmosis, lymphopenia, anemia, bacterial dermatitis, seizure, ataxia, and small cell gastrointestinal lymphoma. The most commonly reported adverse reaction was vomiting. In most cases, vomiting spontaneously resolved with continued dosing. Adverse reactions occurred most often with daily dosing compared to other dosing regimes.

Contact your veterinarian if you believe your pet is experiencing side effects.

Product Administration

Oral

Product Form

Ingredients

cyclosporine

Storage

ATOPICA for Cats should only be dispensed in the original container and stored at controlled room temperature between 59 and 77°F (15-25°C). Once opened, use contents within two months for the 5 mL container and 11 weeks for the 17 mL container.

Manufacturer

Elanco

Prescribing Info/Brochures

• https://www.elancolabels.com/us/atopica-for-cats