A Generic Oral Cyclosporine Product Has Been Approved by the FDA for Cats with Allergic Dermatitis.

01Jul '23

A Generic Oral Cyclosporine Product Has Been Approved by the FDA for Cats with Allergic Dermatitis.

BY: SAMANTHA BARTLETT, DVM

In March of this year, the U.S. Food and Drug Administration approved the first generic oral cyclosporine solution for cats. The product, Modulis, is indicated for control of itching, dermatitis, overgrooming and plaques associated with feline allergy. Cyclosporine is immunosuppressive and focuses on cell-mediated immune response. It primarily acts by suppressing T-cell activation, but also has some inhibitory effect on cytokine production and release. 

Cyclosporine is contraindicated in cats that have neoplasia or a past history of neoplasia and in cats that are FELV or FIV positive. It should be used cautiously in cats with diabetes mellitus or renal insufficiency. Cats should be tested for FELV and FIV and toxoplasmosis before starting treatment with cyclosporine. Additionally a baseline CBC and blood chemistry along with urinalysis should be performed. Rechecks of CBC, chemistry and urinalysis are recommended every 3-6 months. 

Extra-label indications for oral cyclosporine include chronic stomatitis, pemphigus erythematous and foliaceus, and inflammatory bowel disease. 

Modulis is the same concentration and dosing as Atopica for Cats, the only approved name brand product. Atopica for cats was approved in 2011. Modulis is available in 4.7, 15 and 30mL bottles. Cats must be at least 6 months old and weight 3 or more pounds to use Modulis. The product is available by prescription only. 

Cyclosporine is classified as hazardous and personal protective equipment is recommended by the National Institute for Occupational Safety. Safety considerations for pet owners handling Modulis include avoiding ingestion of the product and washing hands immediately after administration. Some people have hypersensitivity to cyclosporine and should avoid contact with Modulis. 

References: 

FDA approves first generic cyclosporine oral solution for cats for treatment of allergic dermatitis. News release. FDA. March 29, 2023. Accessed June 23, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-cyclosporine-oral-solution-cats-treatment-allergic-dermatitis?utm_medium=email&utm_source=govdelivery

Plumb DC. Cyclosporine. Plumb’s Veterinary Drugs. https://app.plumbs.com/drug-monograph/b2qDVutWDRPROD. Updated March 2022. Accessed June 23, 2023.

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