Animal Health Solutions

FCT administration, and one dog that developed generalized demodicosis after 28 days of oclacitinib FCT administration. Two other dogs on oclacitinib FCT were withdrawn from study due to suspected or confirmed malignant neoplasia and subsequently euthanized, including one dog that developed signs associated with a heart base mass after 21 days of oclacitinib FCT administration, and one dog that developed a Grade III mast cell tumor after 60 days of oclacitinib FCT administration. One of the 147 dogs in the placebo group developed a Grade I mast cell tumor and was withdrawn from the masked study. Additional dogs receiving oclacitinib FCT were hospitalized for diagnosis and treatment of pneumonia (one dog), transient bloody vomiting and stool (one dog), and cystitis with urolithiasis (one dog). In the 283 dogs that received oclacitinib FCT, the following additional clinical signs were reported after beginning oclacitinib FCT (percentage of dogs with at least one report of the clinical sign as a non-pre-existing finding): pyoderma (12.0%), non-specified dermal lumps (12.0%), otitis (9.9%), vomiting (9.2%), diarrhea (6.0%), histiocytoma (3.9%), cystitis (3.5%), anorexia (3.2%), lethargy (2.8%), yeast skin infections (2.5%), pododermatitis (2.5%), lipoma (2.1%), polydipsia (1.4%), lymphadenopathy (1.1%), nausea (1.1%), increased appetite (1.1%), aggression (1.1%), and weight loss (0.7). Control of Pruritus Associated with Allergic Dermatitis In a masked field study to assess the effectiveness and safety of oclacitinib for the control of pruritus associated with allergic dermatitis in dogs, 216 dogs treated with oclacitinib FCT and 220 dogs treated with placebo (vehicle control) were evaluated for safety. During the 30-day study, there were no fatalities and no adverse reactions requiring hospital care. Adverse reactions reported (and percent of dogs affected) during Days 0-7 included diarrhea (2.3% oclacitinib FCT, 0.9% placebo), vomiting (2.3% oclacitinib FCT, 1.8% placebo), lethargy (1.8% oclacitinib FCT, 1.4% placebo), anorexia (1.4% oclacitinib FCT, 0% placebo), and polydipsia (1.4% oclacitinib FCT, 0% placebo). In most of these cases, signs spontaneously resolved with continued dosing. Five oclacitinib FCT group dogs were withdrawn from study because of: darkening areas of skin and fur (1 dog); diarrhea (1 dog); fever, lethargy and cystitis (1 dog); an inflamed footpad and vomiting (1 dog); and diarrhea, vomiting, and lethargy (1 dog). Dogs in the oclacitinib FCT group had a slight decrease in mean white blood cell counts (neutrophil, eosinophil, and monocyte counts) that remained within the normal reference range. Mean lymphocyte count for dogs in the oclacitinib FCT group increased at Day 7, but returned to pretreatment levels by study end without a break in oclacitinib FCT administration. Serum cholesterol increased in 25% of oclacitinib FCT group dogs, but mean cholesterol remained within the reference range. Continuation Field Study After completing oclacitinib FCT field studies, 239 dogs enrolled in an unmasked (no placebo control), continuation therapy study receiving oclacitinib FCT for an unrestricted period of time. Mean time on this study was 372 days (range 1 to 610 days). Of these 239 dogs, one dog developed demodicosis following 273 days of oclacitinib FCT administration. One dog developed dermal pigmented viral plaques following 266 days of oclacitinib FCT administration. One dog developed a moderately severe bronchopneumonia after 272 days of oclacitinib FCT administration; this infection resolved with antimicrobial treatment and temporary discontinuation of oclacitinib FCT. One dog was euthanized after developing abdominal ascites and pleural effusion of unknown etiology after 450 days of oclacitinib FCT administration. Six dogs were euthanized because of suspected malignant neoplasms: including thoracic metastatic, abdominal metastatic, splenic, frontal sinus, and intracranial neoplasms, and transitional cell carcinoma after 17, 120, 175, 49, 141, and 286 days of oclacitinib FCT administration, respectively. Two dogs each developed a Grade II mast cell tumor after 52 and 91 days of oclacitinib FCT administration, respectively. One dog developed low grade B-cell lymphoma after 392 days of oclacitinib FCT administration. Two dogs each developed an apocrine gland adenocarcinoma (one dermal, one anal sac) after approximately 210 and 320 days of oclacitinib FCT administration, respectively. One dog developed a low grade oral spindle cell sarcoma after 320 days of oclacitinib FCT administration. Post-Approval Experience (2020): The following adverse events are based on post-approval adverse drug experience reporting for oclacitinib FCT. Not all adverse events 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 these data. The following adverse events reported in dogs are listed in decreasing order of reporting frequency. Vomiting, lethargy, anorexia, diarrhea, elevated liver enzymes, dermatitis (i.e. crusts, pododermatitis, pyoderma), seizures, polydipsia, and demodicosis. Benign, malignant, and unclassified neoplasms, dermal masses (including papillomas and histiocytomas), lymphoma and other cancers have been reported. Death (including euthanasia) has been reported. Contact Information: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae. Storage Conditions: APOQUEL CHEWABLE should be stored at controlled room temperature between 20° to 25°C (68° to 77°F) with excursions between 15° to 40°C (59° to 104°F). How Supplied: APOQUEL CHEWABLE tablets contain 3.6 mg, 5.4 mg, or 16 mg of oclacitinib as oclacitinib maleate per tablet. Each strength chewable tablets are packaged in 100 and 250 count bottles. Each chewable tablet is pentagon shaped, scored on both sides and have a dose descriptor (S S, M M or L L) debossed on one face across the score line. The S (small), M (medium) and L (large) markings correspond to the tablet strengths of 3.6 mg, 5.4 mg and 16 mg respectively. Approved by FDA under NADA # 141-555 Distributed by: Zoetis Inc. Kalamazoo, MI 49007 April 2023 40034485A&P Brief Summary of full Prescribing Information Immunomodulator For oral use in dogs only Caution: Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Indications: Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Dosage and Administration: The dose of APOQUEL CHEWABLE (oclacitinib chewable tablet) is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy. Dosing Chart Weight Range (in lb) Weight Range (in Kg) Number of Tablets to be Administered Low High Low High 3.6 mg Tablets 5.4 mg Tablets 16 mg Tablets 6.6 9.9 3.0 4.4 0.5 - - 10.0 14.9 4.5 5.9 - 0.5 - 15.0 19.9 6.0 8.9 1 - - 20.0 29.9 9.0 13.4 - 1 - 30.0 44.9 13.5 19.9 - - 0.5 45.0 59.9 20.0 26.9 - 2 - 60.0 89.9 27.0 39.9 - - 1 90.0 129.9 40.0 54.9 - - 1.5 130.0 175.9 55.0 80.0 - - 2 Warnings: APOQUEL CHEWABLE is not for use in dogs less than 12 months of age (see Animal Safety). APOQUEL CHEWABLE modulates the immune system. APOQUEL CHEWABLE is not for use in dogs with serious infections. APOQUEL CHEWABLE may increase susceptibility to infection, including demodicosis, and exacerbation of neoplastic conditions (see Precautions, Adverse Reactions, Post-Approval Experience and Animal Safety). New neoplastic conditions (benign and malignant) were observed in dogs treated with oclacitinib film-coated tablets (FCT) during clinical studies and have been reported in the post-approval period (see Adverse Reactions and Post-Approval Experience). Consider the risks and benefits of treatment prior to initiating APOQUEL CHEWABLE in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasia (see Adverse Reactions, Post-Approval Experience, and Animal Safety). Keep APOQUEL CHEWABLE in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. Human Warnings: This product is not for human use. Keep this and all drugs out of reach of children. For use in dogs only. Wash hands immediately after handling the tablets. In case of accidental eye contact, flush immediately with water or saline for at least 15 minutes and then seek medical attention. In case of accidental ingestion, seek medical attention immediately. Precautions: Dogs receiving APOQUEL CHEWABLE should be monitored for the development of infections, including demodicosis, and neoplasia. The use of APOQUEL CHEWABLE has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. APOQUEL CHEWABLE is not for use in breeding dogs, or pregnant or lactating bitches. Adverse Reactions: The safety of APOQUEL CHEWABLE was established by pharmacokinetic data comparing oclacitinib film-coated tablets to APOQUEL CHEWABLE (see Clinical Pharmacology). Control of Atopic Dermatitis In a masked field study to assess the effectiveness and safety of oclacitinib for the control of atopic dermatitis in dogs, 152 dogs treated with oclacitinib FCT and 147 dogs treated with placebo (vehicle control) were evaluated for safety. The majority of dogs in the placebo group withdrew from the 112-day study by Day 16. Adverse reactions reported (and percent of dogs affected) during Days 0-16 included diarrhea (4.6% oclacitinib FCT, 3.4% placebo), vomiting (3.9% oclacitinib FCT, 4.1% placebo), anorexia (2.6% oclacitinib FCT, 0% placebo), new cutaneous or subcutaneous lump (2.6% oclacitinib FCT, 2.7% placebo), and lethargy (2.0% oclacitinib FCT, 1.4% placebo). In most cases, diarrhea, vomiting, anorexia, and lethargy spontaneously resolved with continued dosing. Dogs on oclacitinib FCT had decreased leukocytes (neutrophil, eosinophil, and monocyte counts) and serum globulin, and increased cholesterol and lipase compared to the placebo group but group means remained within the normal range. Mean lymphocyte counts were transiently increased at Day 14 in the oclacitinib FCT group. Dogs that withdrew from the masked field study could enter an unmasked study where all dogs received oclacitinib FCT. Between the masked and unmasked study, 283 dogs received at least one dose of oclacitinib FCT. Of these 283 dogs, two dogs were withdrawn from study due to suspected treatment-related adverse reactions: one dog that had an intense flare-up of dermatitis and severe secondary pyoderma after 19 days of oclacitinib

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