Do not use in cats with a history of malignant disorders or suspected malignancy.
Do not use in cats infected with feline leukemia virus FeLV or feline immunodeficiency virus FIV.
Do not use in cats with a hypersensitivity to cyclosporine.
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.
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.
Not for human use. Keep this and all drugs out of reach of children. For use only in cats.
Special precautions to be taken when administering ATOPICA for Cats:
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.
Keep out of reach of children!
Always close the bottle with the child-resistant screw cap after use. To provide a child-resistant closure, push down on the child-resistant screw cap as you turn it.
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.
Information for Cat Owners:
Owners should be advised to discontinue ATOPICA for Cats and contact their veterinarian in case of signs of serious illness and/or persistent, progressive weight loss. Owners should be informed of the risks of increased susceptibility to infection and the development of neoplasia, and they should be provided advice on how to avoid exposure of their cat to Toxoplasma gondii infection.