The chemical composition of APOQUEL is N-methyl[trans-4-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino) cyclohexyl]methanesulfonamide (2Z)-2-butenedioate.Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.APOQUEL is not for use in dogs less than 12 months of age (see APOQUEL is not for use in dogs with serious infections.APOQUEL may increase susceptibility to infection, including demodicosis, and exacerbate neoplastic conditions (see This product is not for human use. During the 30-day study, there were no fatalities and no adverse reactions requiring hospital care. 0000022856 00000 n During the study, dogs could not be treated with other drugs that could affect the assessment of effectiveness, such as corticosteroids, anti-histamines, or cyclosporine. h�T�=AQ ���=\���.�f���?�@u6��`�e�����̢ܟpY���Re�gy�y{�����OPc`^d�~���I�sř�c�8bM65f����s�'I�K�� C��J�vG��+e��&�DVb��2�Q%um�rx`��{⮘ʗ�� z��B�?/�/G�ϐf�` ��%� 0000161048 00000 n 0000085654 00000 n Each tablet is scored and marked with AQ and either an S, M, or L that correspond to the different tablet strengths on both sides.Copyright © 2020 Animalytix LLC. 0000023343 00000 n However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.We comply with the HONcode standard for trustworthy health information - 0000012517 00000 n
For dogs that continued APOQUEL treatment beyond one week, the Veterinarian-assessed dermatitis scores continued to improve through study end at Day 30.Oclacitinib maleate was administered to healthy, one-year-old Beagle dogs twice daily for 6 weeks, followed by once daily for 20 weeks, at 0.6 mg/kg (1X maximum exposure dose, 8 dogs), 1.8 mg/kg (3X, 8 dogs), and 3.0 mg/kg (5X, 8 dogs) oclacitinib for 26 weeks. 0 0000161011 00000 n In case of accidental ingestion, seek medical attention immediately.APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches.The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. 0000090498 00000 n Every effort has been made to ensure the accuracy of the Apoquel information published above. Keep this and all drugs out of reach of children. APOQUEL may be administered with or without food.
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Eight dogs received placebo (empty gelatin capsule) at the same dosage schedule. One oclacitinib maleate-treated dog (26-weeks-old) was euthanized on Day 74 after physical examination revealed the dog to be febrile, lethargic, with pale mucous membranes and frank blood in stool. 0000135743 00000 n 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 APOQUEL administration, respectively. Necropsy revealed pneumonia of short duration and evidence of chronic lymphadenitis of mesenteric lymph nodes. 0000086270 00000 n 0000001685 00000 n Additional clinical observations were primarily related to the interdigital furunculosis and included dermatitis (local alopecia, erythema, abrasions, scabbing/crusts, and edema of feet) and lymphadenopathy of peripheral nodes. Inhibition of canine cytochrome P450 enzymes by oclacitinib is minimal; the inhibitory concentrations (ICMean (95% CL) total body oclacitinib clearance from plasma was low - 316 (237, 396) mL/h/kg body weight (5.3 mL/min/kg body weight). The study enrolled 436 client-owned dogs with a history of allergic dermatitis attributed to one or more of the following conditions: atopic dermatitis, flea allergy, food allergy, contact allergy, and other/unspecified allergic dermatitis. Dogs on APOQUEL 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. Following IV and PO administration, the terminal tA double-masked, 112-day, controlled study was conducted at 18 U.S. veterinary hospitals. 59 0 obj <>stream Save up to 30% on all Apoquel, product line, shop with confidence and get the highest quality Apoquel, and pet supplies delivered to your doorsteps … 0000136017 00000 n
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xref 0000089074 00000 n 0000164061 00000 n 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 APOQUEL administration, and one dog that developed generalized demodicosis after 28 days of APOQUEL administration. 0000161647 00000 n
By Day 30, 86% (127/147) of the placebo group dogs and 15% (23/152) of the APOQUEL group dogs withdrew from the masked study because of worsening clinical signs, and had the option to enroll in an unmasked study and receive APOQUEL.
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