The initial dose of ATOPICA for Cats is 3.2 mg/lb/day (7 mg/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 desired 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. To dose the cat, the syringe should be filled to the nearest 1 lb corresponding to the cat's body weight (round down if 0.1 to 0.4 lb, round up if 0.5 to 0.9 lb). Each pound graduation on the syringe delivers a volume of 0.032 mL providing 3.2 mg/lb. Do not rinse or clean the oral dosing syringe between uses. (See Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA for Cats)

Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA for Cats

Assembling the Dispensing System
The dispensing system consists of 4 parts:

1. A bottle containing the medicine, with rubber stopper and a screw cap to close the bottle after use.

2. A plastic adapter with dip tube that you will push into the neck of the bottle. The adapter must always remain in the bottle after first use.

3. An oral dosing syringe that fits into the top of the plastic adapter to withdraw the prescribed dose of medicine from the bottle.

4. A plastic vial containing the plastic adapter and oral dosing syringe. Save the plastic vial to store the oral dosing syringe between each use.

Fitting the Plastic Adapter into the New Bottle of Medicine

- Remove and save the screw cap.

- Remove and dispose of the rubber stopper.

- Hold the open bottle upright on a table and push the plastic adapter firmly into the neck of the bottle as far as you can, then close the bottle with the screw cap.

- To provide a child-resistant closure, push down on the child-resistant screw cap as you turn it.

Note: To prepare a dose, carefully follow the instructions for Preparing a Dose of Medicine.

Preparing a Dose of Medicine

1. Push and turn the child-resistant screw cap to open the bottle. Note: Always close the bottle with the child-resistant screw cap after use.

2. Check that the plunger of the oral dosing syringe is pushed all the way down.

3. Keep the bottle upright and insert the oral dosing syringe firmly into the plastic adapter.

4. Slowly pull the plunger up so that the oral dosing syringe fills with the medicine.

5. Expel any large bubbles by pushing and pulling the plunger a few times. The presence of a few tiny bubbles is not important for dosing accuracy.

6. Withdraw the dose of medicine prescribed by your veterinarian. The scale on the oral dosing syringe corresponds to the cat's body weight.

Note: If the prescribed dose is more than the maximum volume marked on the oral dosing syringe, you will need to reload the syringe to withdraw the full dose.

7. Remove the oral dosing syringe by gently twisting it out of the plastic adapter.

You can now place the oral dosing syringe over a small amount of food or introduce the syringe in the mouth of your cat and push the medicine out of the syringe. See Information for Cat Owners for complete administration instructions.

Do not rinse or clean the oral dosing syringe between uses. Store the oral dosing syringe in the plastic tube between each use.

ATOPICA for Cats should be stored in the original container at 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.

Close the bottle with the child-resistant screw cap after use.

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.

Contraindications:

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.

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. (See Adverse Reactions)

Human Warnings:

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.

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. Na?ve cats may not develop protective titers during treatment (see Animal Safety).

Adverse Reactions:

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.

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.