Regulatory product record
ATOPICA
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- ATOPICA
- DIN
- 02282054
- DPD drug code
- 76770
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- CAPSULE
- Ingredients
- CYCLOSPORINE (25 MG)
- Species (DPD record)
- DOGS
- Company
- ELANCO CANADA LIMITED (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 76770
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications3
Atopic dermatitis (well-established, similar efficacy to prednisolone), perianal fistulas, IMHA (refractory), IBD
DogOn-label (ON_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Atopic dermatitis (well-established, similar efficacy to prednisolone), perianal fistulas, IMHA (refractory), IBD — Authorized (Atopica, atopic dermatitis)
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Allergic dermatitis (Atopica for cats), eosinophilic granuloma complex, IBD, feline asthma, stomatitis
CatOn-label (ON_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Allergic dermatitis (Atopica for cats), eosinophilic granuloma complex, IBD, feline asthma, stomatitis — Authorized (Atopica, feline allergic dermatitis)
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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.
CatOn-label (ON_LABEL)United States1 source record · View provenance
- Cat · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens5
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects206
Vomiting, anorexia, diarrhea — Most common, especially early in therapy
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Gingival hyperplasia, hypertrichosis, papillomatosis — With chronic use
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Reactivation of latent viral infection (esp. FHV-1) — Documented
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Nephro/hepatotoxicity — Only at very high blood levels (>3000 ng/mL)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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. 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. Contact Information: http://www.fda.gov/reportanimalae To report suspected adverse drug events or for technical assistance, contact Elanco US Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or *Cats may have experienced more than one type or occurrence of a reaction during the studies. Adverse Reaction* Number (Percent)of Casesn = 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%)
CatOn-label (ON_LABEL)United States1 source record · View provenance
- Cat · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Vomiting4,514 reports
- Diarrhoea2,556 reports
- Depression1,288 reports
- Anorexia1,211 reports
- Pruritus1,120 reports
- Emesis875 reports
- Other abnormal test result NOS717 reports
- Lethargy (see also Central nervous system depression in 'Neurological')712 reports
- Elevated serum alkaline phosphatase (SAP)691 reports
- INEFFECTIVE, ATOPY CONTROL604 reports
- Elevated alanine aminotransferase (ALT)585 reports
- Gingival hyperplasia564 reports
Cat
- Vomiting656 reports
- Weight loss390 reports
- Lack of efficacy - NOS324 reports
- Diarrhoea301 reports
- Hypersalivation295 reports
- Anorexia257 reports
- Lethargy (see also Central nervous system depression in 'Neurological')226 reports
- Other abnormal test result NOS218 reports
- Emesis201 reports
- Behavioural disorder NOS169 reports
- Drooling152 reports
- Death by euthanasia133 reports
Monitoring1
Trough blood levels (if titrating for refractory disease, not required for routine atopic dermatitis dosing); CBC/chemistry with long-term immunosuppressive use; FeLV/FIV status in cats before starting
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications2
Hypersensitivity; history of malignant neoplasia (dog label); do not use in FeLV/FIV-positive cats
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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.
CatOn-label (ON_LABEL)United States1 source record · View provenance
- Cat · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions7
Hepatic/renal disease; check FeLV/FIV status before starting in cats; naive (seronegative) cats at ↑ risk of clinical toxoplasmosis if exposed while on the drug
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Sandimmune and Atopica/Neoral are NOT bioequivalent — dosing tables differ; never assume interchangeability between formulations.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Vomiting is common when starting therapy — a gradual dose-escalation protocol with early metoclopramide can improve tolerance.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Response for atopic dermatitis may take 2–4 weeks — bridge with other antipruritics (steroids, oclacitinib) during the induction period.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Ketoconazole co-administration is a well-established, deliberate cost-reduction strategy — but requires blood-level monitoring awareness.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions5
Azole antifungals (ketoconazole, itraconazole, fluconazole) — ↑ cyclosporine levels — deliberately used to reduce cyclosporine dose/cost
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Macrolides, cimetidine, metoclopramide, grapefruit juice — ↑ cyclosporine levels
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Rifampin, phenobarbital, phenytoin, griseofulvin — ↓ cyclosporine levels
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
NSAIDs, aminoglycosides, other nephrotoxic drugs — Additive nephrotoxicity risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Live vaccines — Reduced efficacy — avoid
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics5
Bioavailability — 20–45% (dog, variable); food reduces by ~15–22%
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — 5–12h (dog, Plumb's); 8–9h avg (dog)/8–10h avg (cat), Papich
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Extensive hepatic CYP450
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Biliary — <1% unchanged in urine
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cyclosporine is an immunosuppressive agent that has been shown to work via suppression of T-helper and T-suppressor cells and inhibition of interleukin-2. It does not depress hematopoesis or the function of phagocytic cells. ATOPICA for Cats is not a corticosteroid or antihistamine. Following an intravenous dose of 2 mg/kg in a 24-hour fasted state, clearance of cyclosporine A in cats was 0.199 L/kg x h and half life was ~24 hours. After oral administration, the terminal elimination half life has been estimated to be as short as 6.8 to longer than 40 hours in some normal healthy cats. The bioavailability of ATOPICA for Cats is highly variable both within and between cats. A pharmacokinetic study showed no consistent difference in the mean extent of drug absorption when administered orally to fed or fasted cats or mixed in with food. Blood levels of cyclosporine in field studies were highly variable, even among cats with similar clinical response, suggesting no generalizable correlations can be made between cats with regard to blood cyclosporine levels and clinical response (effectiveness and safety). Nevertheless, individual differences in the relationship between drug exposure and clinical response may exist. Therefore, to minimize individual fluctuations in drug absorption, ATOPICA for Cats should be administered on a consistent schedule with regard to meals and time of day.
CatOn-label (ON_LABEL)United States1 source record · View provenance
- Cat · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Fetotoxic/embryotoxic in lab animals at 2–5x normal doses — avoid in pregnancy. Human FDA category C. Distributed into milk — not recommended while nursing.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 329–332 (systemic cyclosporine monograph; topical ophthalmic form is separate, p. 1211); Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 193–196 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references19
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Comparative effects of topical Maresin-1 and cyclosporine A in a capsaicin-induced rat model of neurotrophic keratopathy.
Study summary not available in the imported record. Open the original citation to review the study.
- LPS‑induced impairment of neuroregeneration is alleviated by fluoxetine in Dugesia japonica.
Study summary not available in the imported record. Open the original citation to review the study.
- Cyclosporine as a Novel Therapeutic Option for Eosinophilic Cystitis in a Paraplegic Dog.
Study summary not available in the imported record. Open the original citation to review the study.
- Medical management of multifocal immune-mediated punctate keratitis in 3 dogs: A case series.
Study summary not available in the imported record. Open the original citation to review the study.
- Comparative evaluation of cyclosporine A and thymoquinone treatments in a benzalkonium chloride-induced experimental dry eye model.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.