Atopica For Cats: Product Information

ATOPICA FOR CATS- cyclosporine solution
Elanco US Inc.

Caution:

Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

ATOPICA for Cats (cyclosporine oral solution) USP MODIFIED is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in ATOPICA for Cats, is a cyclic polypeptide, immune modulating agent consisting of 11 amino acids. It is produced as a metabolite by the fungal species Beauveria nivea.

Chemically, cyclosporine A is designated Cyclo[[(E)(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methylL-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-ananyl-Nmethyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl].

The structural formula is:

Structural Formula
Structural Formula

Indication:

ATOPICA for Cats 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 (1.4 kg) in body weight.

Dosage and Administration:

Always provide the Instructions for Assembling the Dispensing System and Preparing a Dose of ATOPICA for Cats and the Information for Cat Owners with prescription.

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)

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. Naïve cats may not develop protective titers during treatment (see Animal Safety).

Adverse Reactions:

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.

Adverse reactions reported with greater than 2% frequency in the two field studies.

*Cats may have experienced more than one type or occurrence of a reaction during the studies.

Adverse Reaction* Number (Percent) of Cases n = 205
Vomiting/Retching/Regurgitation 72 (35.1%)
Weight Loss 42 (20.5%)
Diarrhea 31 (15.1%)
Anorexia/Decreased Appetite 29 (14.1%)
Lethargy/Malaise 28 (13.6%)
Hypersalivation 23 (11.2%)
Behavioral Disorder
(hiding, hyperactivity, aggression)
18 (8.8%)
Ocular Discharge/Epiphora/Conjunctivitis 14 (6.8%)
Sneezing/Rhinitis 11 (5.4%)
Gingivitis/Gingival Hyperplasia 9 (4.4%)
Polydipsia 6 (2.9%)

The following adverse reactions were reported in less than or equal to 2% of cats treated with ATOPICA for Cats in the two field studies: bacterial dermatitis, hepatic lipidosis and jaundice, gastrointestinal small cell lymphoma, constipation, cough, toxoplasmosis, muscle wasting, muscle tremors, ataxia, convulsion, polyuria, urinary tract infection, inappropriate urination or defection, seborrhea, worsening otitis externa, papilloma, leukotrichia (whitening of hair) and excessive hair growth, anemia, lymphopenia, worsening monocytosis, worsening neutrophilia, hyperglobulinemia, increased serum creatinine and urea nitrogen, and increased alanine aminotransferase.

To report adverse effects, access medical information, or obtain additional product information call 1-888-545-5973. Alternatively, suspected adverse drug reactions may be reported to FDA at 1-800-FDA-VETS or http://www.fda.gov/reportanimalae

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