Cyclosporine

Indications

MODULIS ® for Dogs is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight.

Dosage and Administration

Always provide the Instructions for Assembling the Dispensing System and Preparing a Dose of MODULIS ® for Dogs and the Information for Dog Owners with prescription. The initial dose of MODULIS ® for Dogs is 5 mg/kg/day as a single daily dose for 30 days. Following this initial daily treatment period, the dose of MODULIS ® for Dogs may be tapered by decreasing the frequency of dosing to every other day or twice weekly, until a minimum frequency is reached which will maintain the desired therapeutic effect. MODULIS ® for Dogs should be given at least one hour before or two hours after a meal. 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 oral dosing syringes to accompany MODULIS ® for Dogs: - For dogs 4 lbs to 40 lbs, use the 1 mL syringe: The 1 mL syringe is graduated in 1 pound (lb) increments. To dose the dog, the syringe should be filled to the nearest 1 lb graduation corresponding to the dog's body weight in lbs (round down to the nearest whole lb if 0.1 to 0.4 lb, or round up to the nearest whole lb if 0.5 to 0.9 lb). Each 1-lb graduation on the 1 mL syringe delivers a volume of 0.023 mL, providing 2.3 mg/lb (5 mg/kg) dose. - For dogs 41 lbs to 125 lbs, use the 3 mL syringe: The 3 mL syringe is graduated in 5 pound (lb) increments. To dose the dog, the syringe should be filled to the nearest 5 lb graduation corresponding to the dog's body weight in lbs (round down to the nearest whole lb if 0.1 to 0.4 lb, or round up to the nearest whole lb if 0.5 to 0.9 lb). Each 5-lb graduation on the 3 mL syringe delivers a volume of 0.115 mL, providing 2.3 mg/lb (5 mg/kg) dose. Do not rinse or clean the oral dosing syringe between uses. Note: Always close the bottle with the child-resistant screw cap after each use. The 1 mL syringe is graduated in 1 lb increments corresponding to 0.023 mL/lb. This syringe is for dosing dogs 4 to 40 lb. The 1 mL syringe will be included with the 4.7, 15, and 30 mL bottles. The 3 mL syringe is graduated in 5 lb increments corresponding to 0.115 mL/5 lb. This syringe is for dosing dogs 41 to 125 lb. The 3 mL syringe will be included with the 30 and 50 mL bottles. (See Instructions for Assembling the Dispensing System and Preparing a Dose of MODULIS ® for Dogs )

Contraindications

MODULIS ® for Dogs is contraindicated for use in dogs with a history of neoplasia. Do not use in dogs with a hypersensitivity to cyclosporine.

Warnings

MODULIS ® for Dogs (cyclosporine oral solution) is a systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia. Human Warnings: Not for human use. Keep this and all drugs out of reach of children. For use only in dogs. Wear gloves during administration. Special precautions to be taken when administering MODULIS ® for Dogs: Do not eat, drink, smoke, or use smokeless tobacco while handling MODULIS ® for Dogs. 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 MODULIS ® for Dogs.

Precautions

The safety and effectiveness of cyclosporine has not been established in dogs less than 6 months of age or less than 4 lbs body weight. MODULIS ® for Dogs is not for use in breeding dogs, pregnant or lactating bitches. As with any immunomodulation regimen, exacerbation of sub-clinical neoplastic and infectious conditions may occur. Gastrointestinal problems and gingival hyperplasia may occur at the initial recommended dose. (See

Adverse Reactions

A total of 265 dogs were included in the field study safety analysis. One hundred and eleven (111) dogs were treated with placebo for the first 30 days. For the remainder of the study, all dogs received cyclosporine capsules. Fourteen dogs withdrew from the study due to adverse reactions. Four dogs withdrew from the study after vomiting. One dog each withdrew from the study after diarrhea; vomiting, diarrhea and pruritus; vomiting, depression and lethargy; lethargy, anorexia and hepatitis; gingival hyperplasia, lethargy, polyuria/polydipsia and soft stool; seizure; sebaceous cyst; pruritus; erythema; or otitis externa. Vomiting and diarrhea were the most common adverse reactions occurring during the study. In most cases, signs spontaneously resolved with continued dosing. In other cases, temporary dose modifications (brief interruption in dosing, divided dosing, or administration with a small amount of food) were employed to resolve signs. Persistent otitis externa, urinary tract infections, anorexia, gingival hyperplasia, lymphadenopathy and lethargy were the next most frequent adverse events observed. Gingival hyperplasia regressed with dose tapering. Owners of four dogs reported seizures while dogs were receiving cyclosporine. In one dog, seizures were the result of a brain tumor diagnosed one month into the study. Another dog experienced seizures before and after the study. Otitis externa, allergic otitis, or pinna erythema, with or without exudates, commonly accompanies atopy. Many dogs entered the study with otitis externa, which did not resolve without otic treatment. New cases of otitis externa, allergic otitis, or pinna erythema developed while dogs were receiving cyclosporine. However, the incidence rate was lower with cyclosporine compared to placebo. A change in the dose frequency was not necessary when new cases occurred. Number of Dogs Displaying Each Clinical Observation in the Field Study Clinical Sign % out of 265 Vomiting 30.9% Diarrhea 20.0% Persistent Otitis Externa 6.8% Urinary Tract Infection 3.8% Anorexia 3.0% Lethargy 2.3% Gingival Hyperplasia 2.3% Lymphadenopathy 2.3% The following clinical signs were reported in less than 2% of dogs treated with cyclosporine in the field study: constipation, flatulence, Clostridial organisms in the feces, nausea, regurgitation, polyuria/polydipsia, strong urine odor, proteinuria, pruritus, erythema/flushed appearance, pyoderma, sebaceous adenitis, crusty dermatitis, excessive shedding, coarse coat, alopecia, papillomas, histiocytoma, granulomatous mass or lesion, cutaneous cyst, epulis, benign epithelial tumor, multiple hemangioma, raised nodule on pinna, seizure, shaking/trembling, hind limb twitch, panting, depression, irritability, hyperactivity, quieter, increased light sensitivity, reluctance to go outside, weight loss, hepatitis. The following clinical signs were observed in 1.5-4.5% of dogs while receiving the placebo: vomiting, diarrhea and urinary tract infection. The following clinical signs were observed in less than 1% of dogs receiving the placebo: anorexia, otitis externa, cutaneous cysts, corneal opacity, lymphadenopathy, erythema/flushed appearance. Clinical Pathology Changes: During the study, some dogs experienced changes in clinical chemistry parameters while receiving cyclosporine, as described in the following table: Clinical Chemistry % Affected (out of 265) Elevated Creatinine 7.8% Hyperglobulinemia 6.4% Hyperphosphatemia 5.3% Hyperproteinemia 3.4% Hypercholesterolemia 2.6% Hypoalbuminemia 2.3% Hypocalcemia 2.3% Elevated BUN 2.3% In addition, the following changes in clinical chemistry parameters were noted in less than 2% of dogs: hypernatremia; hyperkalemia, elevated ALT, elevated ALP, hypercalcemia and hyperchloremia. These clinical pathology changes were generally not associated with clinical signs. Post-approval Experience: (Rev 2014) The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are grouped by body system and are presented in decreasing order of reporting frequency. Gastrointestinal: Emesis, diarrhea, gingival hyperplasia, hemorrhagic diarrhea, abdominal pain, hematemesis, digestive tract hemorrhage, hypersalivation, retching, flatulence, tenesmus, intestinal stasis, digestive tract hypermotility, melena, pancreatitis, involuntary defecation General: Lethargy, anorexia, weight loss, polydipsia, hyperthermia, pale mucous membrane, general pain, collapse, dehydration, edema Dermatologic: Pruritus, dermatitis and eczema, alopecia, erythema, papilloma, bacterial skin infection, skin lesion, skin and/or appendage neoplasm, pigmentation disorder, hair change, hyperkeratosis, histiocytoma, fungal skin infection, dermal cyst(s), desquamation Behavioral: Hyperactivity, behavioral changes, anxiety, vocalization, aggression, inappropriate urination, disorientation Neurologic: Muscle tremor, convulsion, ataxia, paresis Respiratory: Tachypnea, dyspnea, cough Urologic: Polyuria, urine abnormalities (hematuria, urinary tract infection, proteinuria, glucosuria, decreased urine concentration) urinary incontinence, cystitis, renal failure, renal insufficiency Immune: Urticaria, anaphylaxis, allergic edema Blood and lymphatic: Lymphadenopathy, anemia, hypoalbuminemia, leukopenia Hepatic: Elevated Liver Enzymes, hepatopathy, hepatomegaly, hepatitis Musculoskeletal: Lameness, limb weakness, myositis Ear and labyrinth: Otitis externa Cardio-vascular: Tachycardia Endocrine: Diabetes mellitus, hyperglycemia In some cases, death/euthanasia has been reported as an outcome of the adverse events listed above. Neoplasms have been reported in dogs taking cyclosporine, including reports of lymphoma/lymphosarcoma and mast cell tumor. It is unknown if these were preexisting or developed de novo while on cyclosporine. Diabetes mellitus has been reported; West Highland White Terriers are the most frequently reported breed. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data sheet, contact Ceva Animal Health, LLC at 1-800-999-0297 or ceva.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Description

MODULIS ® for Dogs (cyclosporine oral solution) USP MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in MODULIS ® for Dogs, 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-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl -L-alanyl-D-ananyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]. The structural formula is: Chemical Structure

Information for Owners

MODULIS ® for Dogs is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs. (1.8 kg) body weight. Dogs with atopic dermatitis scratch, lick and chew their skin which can cause red, raised crusty bumps, open sores and/or hair loss. Atopic dermatitis is a common skin disease in dogs and is caused by allergens such as house dust mites or pollens which stimulate an exaggerated immune response. The disease is chronic, recurrent, and requires lifelong management. This summary contains important information about MODULIS ® for Dogs. You should read this information before starting your dog on MODULIS ® for Dogs. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about MODULIS ® for Dogs. What is MODULIS ® for Dogs? MODULIS ® for Dogs is an oral solution of cyclosporine that lowers the immune response. MODULIS ® for Dogs selectively acts on the immune cells involved in the allergic reaction. MODULIS ® for Dogs reduces the inflammation and itching associated with atopic dermatitis. What kind of results can I expect when my dog takes MODULIS ® for Dogs for the control of atopic dermatitis? MODULIS ® for Dogs should be given daily until improvement is seen. This will generally be the case within 30 days. You should contact your veterinarian if you are not satisfied with your dog's response. Once the signs of atopic dermatitis are satisfactorily controlled, your veterinarian may reduce the frequency of administration of the product. Dose adjustment should only be carried out in consultation with your veterinarian. Your veterinarian will perform a clinical assessment at regular intervals and adjust the frequency of administration up or down according to the clinical response obtained. What dogs should not take MODULIS ® for Dogs? Your dog should not be given MODULIS ® for Dogs if s/he: Has a history of cancer or may possibly have cancer Has a history of seizures, diabetes mellitus, and infections Is hypersensitive to cyclosporine What to discuss with your veterinarian before giving MODULIS ® for Dogs to your dog. Tell your veterinarian about: Any digestive upset (vomiting or diarrhea) your dog has had Any history of lack of appetite and/or weight loss your dog has had Any serious disease or health conditions your dog has had Any allergies that your dog has now or has had All medications that you are giving your dog or plan to give your dog, including those you can get without prescription (over the counter) and any dietary supplements If you plan to breed your dog, or if your dog is pregnant or nursing Talk to your veterinarian about: What tests might be done before MODULIS ® for Dogs is prescribed The potential side effects your dog may experience while taking MODULIS ® for Dogs How often your dog may need to be examined by your veterinarian The risks and benefits of using MODULIS ® for Dogs What are the possible side effects that may occur in my dog during therapy with MODULIS ® for Dogs? MODULIS ® for Dogs, like all other drugs, may cause some side effects in individual dogs. These are normally mild, but serious side effects have been reported in dogs taking MODULIS ® for Dogs. Serious side effects can, in rare situations, result in death. It is important to stop the medication and contact your veterinarian immediately if you think your dog may have a medical problem or side effect while on MODULIS ® for Dogs. To report adverse effects, access medical information, or obtain additional product information call 1-800-999-0297. In clinical studies, the most commonly reported side effect for cyclosporine was vomiting and diarrhea. In most cases, the vomiting and diarrhea stopped with continued use or dose modification. Persistent otitis externa, urinary tract infection, anorexia, lethargy, gingival hyperplasia, and lymphadenopathy were the next most frequent side effects observed. Persistent, progressive weight loss may be associated with more serious side effects. You should monitor your dog's appetite and body weight. If you think that your dog is losing weight, you should contact your veterinarian. MODULIS ® for Dogs may increase susceptibility to infection and to the development of tumors. MODULIS ® for Dogs should only be given to dogs. People should not take MODULIS ® for Dogs. Keep MODULIS ® for Dogs and all medication out of reach of children. Call your physician immediately if you accidentally swallow MODULIS ® for Dogs. How to give MODULIS ® for Dogs to your dog. MODULIS ® for Dogs should be given according to your veterinarian's instructions. Your veterinarian will tell you what amount of MODULIS ® for Dogs is right for your dog. MODULIS ® for Dogs should be given at least one hour before or two hours after a meal. Do not change the way you give MODULIS ® for Dogs to your dog without first speaking with your veterinarian. 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. Do not rinse or clean the oral dosing syringe between uses. Advice on Correct Administration. See Instructions for Assembling the Dispensing System and Preparing a Dose of MODULIS ® for Dogs . If your veterinarian has already assembled the dispensing system, skip the instructions for assembling the dispensing system and follow the instructions for preparing a dose of medicine. How to Store MODULIS ® for Dogs. MODULIS ® for Dogs should be stored and dispensed in the original container at temperatures between 59 and 77°F (15-25°C). MODULIS ® for Dogs does not require refrigeration. Once opened, use contents within 9 weeks for the 4.7 mL container and 16 weeks for the 15, 30, and 50 mL containers. Special precautions to be taken when administering MODULIS ® for Dogs: Do not eat, drink, smoke, or use smokeless tobacco while handling MODULIS ® for Dogs. Wear gloves during administration. Wash hands after administration. In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician. People with known hypersensitivity to cyclosporine should avoid contact with MODULIS ® for Dogs. Can MODULIS ® for Dogs be given with other medications? MODULIS ® for Dogs should not be given with other drugs that may lower the immune response. Cyclosporine has been safely used in conjunction with other common medications. However, interactions with certain medications are possible. Therefore, always tell your veterinarian about all medications that you have given your dog in the past and all medications that you are planning to give with MODULIS ® for Dogs. What can I do in case my dog gets more than the prescribed amount of MODULIS ® for Dogs? Contact your veterinarian immediately if your dog gets more than the prescribed amount of MODULIS ® for Dogs. What else should I know about MODULIS ® for Dogs? If your dog becomes seriously ill, consult your veterinarian who will recommend the appropriate treatment. This sheet provides a summary of information about MODULIS ® for Dogs. If you have any questions or concerns about MODULIS ® for Dogs or atopic dermatitis in dogs, talk to your veterinarian. As with all prescribed medications, MODULIS ® for Dogs should only be given to the dog for which it was prescribed. It should be given to your dog only for the condition for which it was prescribed, at the prescribed dose, and as directed by your veterinarian. Image Image Image PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton Modulis ® for Dogs (cyclosporine oral solution) USP MODIFIED 100 mg/mL

Storage

MODULIS ® for Dogs should only be dispensed in the original container and stored at controlled room temperature between 59 and 77°F (15-25°C). Modulis ® for Dogs does not require refrigeration. Once opened, use contents within 9 weeks for the 4.7 mL container and 16 weeks for the 15, 30, and 50 mL containers.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Modulis ® for Cats (cydosporine oral solution) USP Modified, Ceva Sante Animale. Set id 42cc1948-dec5-4e3d-bf62-37bdf9186eb8.
• Atopica™ for Cats (cyclosporine oral solution) USP MODIFIED 100 mg/mL, Elanco US Inc.. Set id 47f70173-a1d9-4156-9a7f-0f296e5dd64b.
• CYCLAVANCE® (cyclosporine oral solution) USP MODIFIED, Virbac AH Inc. Set id 8f80a779-0914-4fc5-8768-4393af34353a.
• Atopica™, Elanco US Inc.. Set id 99642708-0a9f-4ff0-bc08-f2b18691927e.
• Sporimune™ (cyclosporine capsules) USP MODIFIED, Dechra Veterinary Products LLC. Set id d6be661d-58e3-4a9b-afb3-3819ba7544e9.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming cyclosporine as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.