[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f3gu2sfdan8sgl":5},{"data":4},[],{"data":6,"error":10},{"id":7,"documentId":8,"slug":9,"name":9,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":27,"available_strengths":39,"label_statements":44,"drug_classes":64,"specialties":70,"medical_conditions":71,"animal_species":77},1867,"zn4ozmqt343xgw12ho76tr84","ilunocitinib",null,[],[13,19,23],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"EMA centrally authorised medicines","EMA reuse with attribution","https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Freport\u002Fmedicines-output-medicines-report_en.xlsx","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients",{"source":24,"licence":25,"source_url":26,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",[28,34],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":10,"source_label":33},13794,"Administer orally 0.27 to 0.36 mg ilunocitinib\u002Flb (0.6 to 0.8 mg ilunocitinib\u002Fkg) body weight, once daily, with or without food.","Dogs","Oral","Zenrelia™",{"id":35,"dose_text":36,"species":10,"administration_route":37,"limitation":10,"source_label":38},13795,"The dose of Zenrelia (ilunocitinib tablets) is 0.27 to 0.36 mg ilunocitinib\u002Flb (0.6 to 0.8 mg ilunocitinib\u002Fkg) body weight, administered orally, once daily, with or without food.\nDosing Chart\nWeight Range\n(in lb)\nWeight Range\n(in kg)\nNumber of Tablets to be Administered\n4.8 mg tablets\n6.4 mg tablets\n8.5 mg tablets\n15 mg tablets\n6.6 – 8.8\n3.0 - 4.0\n0.5\n8.9 – 11.8\n4.1 – 5.3\n0.5\n11.9 – 14.3\n5.4 – 6.5\n0.5\n14.4 – 17.7\n6.6 – 8.0\n1\n17.8 – 23.6\n8.1 – 10.6\n1\n23.7 – 31.1\n10.7 – 14.1\n1\n31.2 – 35.4\n14.2 – 16.0\n1.5\n35.5 – 43.1\n16.1 – 19.5\n1.5\n43.2 – 55.0\n19.6 – 24.9\n1\n55.1 – 62.5\n25.0 – 28.3\n2\n62.6 – 83.3\n28.4 – 37.4\n1.5\n83.4 – 110.0\n37.5 – 49.9\n2\n110.1 – 137.5\n50.0 – 62.4\n2.5\n137.6 – 166.0\n62.5 – 74.9\n3\n≥ 166.1\n≥ 75\nAdminister the appropriate combination\nof tablet strengths","ORAL","FDA application 141-585",[40],{"id":41,"strength_text":42,"dosage_form":43,"proprietary_name":33,"species":31,"source_label":33},11985,"4.8, 6.4, 8.5, or 15 mg of ilunocitinib per tablet","Tablet",[45,49,52,56,60],{"id":46,"kind":47,"statement":48,"species":31,"limitation":10,"source_label":33},20265,"indication","For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.",{"id":50,"kind":47,"statement":51,"species":10,"limitation":10,"source_label":38},20266,"Zenrelia is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.",{"id":53,"kind":54,"statement":55,"species":10,"limitation":10,"source_label":38},20267,"warning","User Safety Warnings\nNot for use in humans. Keep this drug out of the reach of children. Wash hands immediately after handling tablets. In case of accidental ingestion, seek medical attention immediately.\nAnimal Safety Warnings\nDue to the risk of infections, dogs should be up to date on vaccinations prior to starting Zenrelia (see\nTarget Animal Safety\n).\nDue to the risk of an inadequate immune response to vaccines, do not administer vaccines to a dog receiving Zenrelia. Discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and withhold Zenrelia for at least 28 days after vaccination (see\nTarget Animal Safety\n).\nDogs should be monitored for the development of infections because Zenrelia may increase susceptibility to infections, including adenoviral hepatitis and pancreatitis, demodicosis, interdigital furunculosis, coccidiosis, and pneumonia, and exacerbation of subclinical or uncomplicated infections (see Target Animal Safety and Adverse Reactions).\nZenrelia is not for use in dogs with serious infections.\nZenrelia may cause a progressive or persistently decreased hematocrit, hemoglobin, and\u002For red blood cell count without a corresponding increase in absolute reticulocyte count (see\nTarget Animal Safety\n).\nNew neoplastic conditions (benign and malignant) were observed in dogs treated with Zenrelia during clinical studies (see\nAdverse Reactions\n).\nConsider the risks and benefits of treatment prior to initiating Zenrelia in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasia (see\nAdverse Reactions\nand\nTarget Animal Safety\n).\nZenrelia modulates the immune system.\nZenrelia is not for use in dogs less than 12 months of age (see\nTarget Animal Safety\n).\nKeep Zenrelia in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":57,"kind":58,"statement":59,"species":10,"limitation":10,"source_label":38},20268,"adverse_reaction","Control of Atopic Dermatitis\nIn a masked field study assessing effectiveness and safety of Zenrelia for the control of atopic dermatitis in dogs, 181 Zenrelia-treated dogs and 87 placebo-treated dogs diagnosed with atopic dermatitis were evaluated for safety up to 112 days. By Day 112, 66.7% of placebo-treated dogs and 22.1% of Zenrelia-treated dogs exited the study. Adverse reactions seen during the field study are summarized in Table 1 below.\nTable 1. Adverse Reactions through Day 112\nN = number of dogs\nAdverse Reaction\nZenrelia N = 181\nNumber of Dogs (%)\nPlacebo N = 87\nNumber of Dogs (%)\nVomiting or nausea\n40 (22.1 %)\n14 (16.1 %)\nDiarrhea\n36 (19.9 %)\n9 (10.3 %)\nLethargy\n22 (12.2 %)\n9 (10.3 %)\nOtitis externa\n19 (10.5 %)\n20 (23.0 %)\nAnorexia\n17 (9.4 %)\n7 (8.0 %)\nDermal growth (e.g., cyst, papilloma)\n16 (8.8 %)\n4 (4.6 %)\nEpiphora or ocular discharge\n14 (7.7 %)\n1 (1.1 %)\nCoughing or wheezing,\nincluding respiratory infections\n12 (6.6 %)\n2 (2.3 %)\nBacterial skin infection\n10 (5.5 %)\n9 (10.3 %)\nElevated liver enzyme(s)\n10 (5.5 %)\n2 (2.3 %)\nUrinary tract infection\n10 (5.5 %)\n2 (2.3 %)\nUpset stomach,\nincluding flatulence and abdominal pain\n10 (5.5 %)\n0\nLeukopenia\n9 (4.9 %)\n1 (1.1 %)\nSneezing\n8 (4.4 %)\n1 (1.1 %)\nLipoma\n7 (3.9 %)\n1 (1.1 %)\nWeight gain\n7 (3.9 %)\n0\nIncreased water intake\n4 (2.2 %)\n2 (2.3 %)\nGingivitis (occurrence or worsening)\n4 (2.2 %)\n0\nBlood in stool\n4 (2.2 %)\n0\nElevated total bilirubin\n4 (2.2 %)\n0\nElevated triglyceride\n4 (2.2 %)\n0\nHistiocytoma\n3 (1.7 %)\n0\nIncreased appetite\n3 (1.7 %)\n0\nFungal skin infection\n3 (1.7 %)\n2 (2.3 %)\nWeight loss\n2 (1.1 %)\n1 (1.1 %)\nMetastatic neoplasia (i.e., hemangiosarcoma)\n1 (0.6 %)\n0\nSystemic fungal infection\n1 (0.6 %)\n0\nMast cell tumor\n1 (0.6 %)\n0\nAbnormal hematology results likely related to Zenrelia treatment included thrombocytopenia, leukopenia, neutropenia, lymphopenia, eosinopenia, monocytopenia, and decreased red blood cell count.\nAbnormal serum chemistry results likely related to Zenrelia treatment included increased hepatobiliary parameters (alanine transaminase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, and total bilirubin), increased blood urea nitrogen (concurrently with an increase in creatinine for one dog), hypertriglyceridemia, hypercholesterolemia, hypoalbuminemia (without a concurrent hyperglobulinemia), and hypoglobulinemia (with or without a decrease in total protein).\nTwelve Zenrelia-treated dogs withdrew from the study early due to an adverse reaction, nine of which were considered likely related to Zenrelia treatment. These reactions included repeated episodes of vomiting, leukopenia, neutropenia, worsening of pre-existing lymphocytosis, enlargement of a non-resolving histiocytoma, eyelid mass with bacterial blepharitis, otitis interna with vestibular disease, urinary tract infection, and upper respiratory infection. Five placebo dogs withdrew from the study early due to an adverse reaction (i.e., lethargy, worsening of pre-existing lymphocytosis, occurrence of nystagmus, skin infection, and teat infection).\nOne Zenrelia-treated dog was diagnosed with splenic and liver masses on Day 112. Histopathologic diagnosis after euthanasia one month later confirmed metastatic splenic and hepatic hemangiosarcoma. Another Zenrelia-treated dog experienced traumatic tendonitis and a puncture wound four days prior to study completion, which progressed to a serious infection. The owner elected amputation after study completion. A third Zenrelia-treated dog experienced a moderate neutropenia on Day 28 associated with a pre-existing subclinical urinary tract infection (UTI) that had progressed into a clinical UTI. The neutrophil count normalized seven days later while still receiving Zenrelia, prior to exiting the study to receive antibiotics.\nControl of Pruritus Associated with Allergic Dermatitis\nIn a masked field study assessing effectiveness and safety of Zenrelia for the control of pruritus associated with allergic dermatitis in dogs, 206 Zenrelia-treated dogs and 100 placebo-treated dogs diagnosed with allergic dermatitis were evaluated for safety up to 112 days. By Day 112, 84% of placebo-treated dogs and 49.5% of Zenrelia-treated dogs exited the study. Adverse reactions seen during the field study are summarized in Table 2 below.\nTable 2. Adverse Reactions through Day 112\nN = number of dogs\nAdverse Reaction\nZenrelia N = 206\nNumber of Dogs (%)\nPlacebo N = 100\nNumber of Dogs (%)\nVomiting or nausea\n32 (15.5%)\n11 (11.0 %)\nDiarrhea\n26 (12.2 %)\n5 (5.0 %)\nLethargy\n25 (12.1 %)\n7 (7.0 %)\nUrinary tract infection\n13 (6.3 %)\n2 (2.0 %)\nAnorexia\n10 (4.9 %)\n3 (3.0 %)\nCoughing, wheezing, or difficulty breathing\n9 (4.4 %)\n0\nElevated liver enzyme(s)\n8 (3.9 %)\n0\nOtitis externa\n8 (3.9 %)\n5 (5.0 %)\nIncreased water intake\n7 (3.4 %)\n2 (2.0 %)\nUpset stomach, including flatulence,\nretching, and abdominal pain\n5 (2.4 %)\n4 (4.0 %)\nOcular discharge\n5 (2.4 %)\n1 (1.0 %)\nElevated triglyceride\n5 (2.4 %)\n0\nDermal or subcutaneous growth\n(e.g., cyst, nodule)\n3 (1.5 %)\n2 (2.0 %)\nSneezing\n3 (1.5 %)\n0\nBlood in stool\n3 (1.5 %)\n0\nIncreased urination\n3 (1.5 %)\n0\nBacterial skin infection\n2 (1.0 %)\n4 (4.0 %)\nWeight gain\n2 (1.0 %)\n0\nNeurological disorder (e.g., tremors, ataxia)\n2 (1.0 %)\n0\nIncreased appetite\n1 (0.5 %)\n0\nFungal skin infection\n1 (0.5 %)\n0\nFever\n1 (0.5 %)\n0\nHematuria (without urinary tract infection)\n1 (0.5 %)\n0\nAbnormal hematology results likely related to Zenrelia treatment included thrombocytosis, leukopenia, neutropenia, eosinopenia, and monocytopenia.\nAbnormal serum chemistry results likely related to Zenrelia treatment included increased hepatobiliary parameters (alanine transaminase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, and total bilirubin), increased blood urea nitrogen, increased creatinine, hypertriglyceridemia, hypercholesterolemia, hypoproteinemia, and hypoglobulinemia (with or without a decrease in total protein).\nSeven Zenrelia-treated dogs withdrew from the study early due to an adverse reaction, four of which were considered likely related to Zenrelia treatment. These reactions included vomiting, lethargy, soft stool, neutropenia, increased liver enzymes, fever, abdominal discomfort, coughing, and wheezing. Four placebo treated dogs also withdrew from the study early due to an adverse reaction (i.e., splenic hemangiosarcoma, restlessness, abdominal pain, lethargy, and vomiting).",{"id":61,"kind":62,"statement":63,"species":10,"limitation":10,"source_label":38},20269,"mechanism_of_action","Mechanism of Action\nIlunocitinib is a non-selective JAK inhibitor which inhibits the function of a variety of pruritogenic, pro-inflammatory and allergy related cytokines that are dependent upon JAK enzymes. Ilunocitinib has a high potency for JAK1, JAK2, and tyrosine kinase 2 (TYK2) inhibition. Ilunocitinib is not a corticosteroid or an antihistamine.\nPharmacokinetics\nIlunocitinib is rapidly and well absorbed and excreted via the biliary\u002Ffecal route after oral administration in dogs. Following a single oral or intravenous administration of ilunocitinib at 0.8 mg\u002Fkg, the oral bioavailability based on area under the curve from the time of dosing to the last quantifiable plasma concentration (AUClast) was 80% in the fed state and 60% in the fasted state. The systemic clearance following intravenous administration was 399 mL\u002Fhour(h)\u002Fkg with a terminal half-life of 3.6 h. The volume of distribution was 1390 mL\u002Fkg (n=8). The maximum plasma concentration (Cmax) and AUClast were 120% and 45% higher, respectively, in the fed state as compared to the fasted state (n=16).\nIn a laboratory margin of safety study, healthy adult dogs (see\nTarget Animal Safety\n) received daily oral administration of Zenrelia at 0.8 mg\u002Fkg, 1.6 mg\u002Fkg, 2.4 mg\u002Fkg, or 4.0 mg\u002Fkg for 182 consecutive days. Dogs were dosed in the fed state, the prandial state of maximum bioavailability. At 0.8 mg\u002Fkg, the ilunocitinib mean (coefficient of variation %) Cmax was 310 ng\u002FmL (20.6%) with a median time to Cmax of 2 h (range 1 – 2 h), and the AUClast and half-life were 1360 h*ng\u002FmL (25.1%) and 3.3 h (11.9%), respectively. Minimal accumulation was observed between Days 1 and 182 with geometric mean accumulation ratios for Cmax and AUClast between 1.1 and 1.6. After the first dose, Cmax increased in a linear but less than proportional manner where a 5-fold increase in dose resulted in a 3.4-fold (90% confidence limit: 2.9 – 4.0) increase in Cmax. There was a non-linear relationship between dose and AUClast where a 5-fold increase in dose resulted in a 4.2-fold (90% confidence limit: 3.4 – 5.1) increase in AUClast. Pharmacokinetic parameters are presented as geometric means.",[65],{"id":66,"documentId":67,"slug":68,"name":69},968,"kuytl7ouqgwa3kt55y2t1kwc","agents-for-dermatitis-excluding-corticosteroids","Agents for dermatitis, excluding corticosteroids",[],[72],{"id":73,"documentId":74,"slug":75,"title":76},116,"gx0rf6pbk00x5p9rlai2h5p7","atopic-dermatitis","Atopic dermatitis",[]]