Brief Summary of Prescribing Information For oral use in dogs only Caution: Federal (USA) 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 (oclacitinib maleate) tablets 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. APOQUEL may be administered with or without food.
Dosing Chart Weight Range Weight Range
(in lb)
Low 6.6
10.0 15.0 20.0 30.0 45.0 60.0 90.0
130.0 Warnings:
APOQUEL is not for use in dogs less than 12 months of age (see Animal Safety). APOQUEL is not for use in dogs with serious infections. APOQUEL may increase susceptibility to infection,
neoplastic conditions (see Adverse Reactions and Animal Safety).
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:
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. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.
Adverse Reactions: 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 APOQUEL 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% APOQUEL, 3.4% placebo), vomiting (3.9% APOQUEL, 4.1% placebo), anorexia (2.6% APOQUEL, 0% placebo), new cutaneous or subcutaneous lump (2.6% APOQUEL, 2.7% placebo), and lethargy (2.0% APOQUEL, 1.4% placebo). In most cases, diarrhea, vomiting, anorexia, and lethargy spontaneously resolved with continued dosing. 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. Mean lymphocyte counts were transiently increased at Day 14 in the APOQUEL group.
Dogs that withdrew from the masked field study could enter an unmasked study where all dogs received APOQUEL. Between the masked and unmasked study, 283 dogs received at least one dose of APOQUEL. 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 se- vere secondary pyoderma after 19 days of APOQUEL administration, and one dog that developed generalized demodicosis after 28 days of APOQUEL administration. Two other dogs on APOQUEL 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 APOQUEL administration, and one dog that developed a Grade III mast cell tumor after 60 days of APOQUEL 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 APOQUEL were hospitalized for diagnosis and treatment of pneumonia (one dog), transient bloody vomiting and stool (one dog), and cystitis with urolithiasis (one dog).
including demodicosis, and exacerbate
High 9.9
14.9 19.9 29.9 44.9 59.9 89.9
129.9 175.9
Low 3.0
4.5 6.0 9.0
13.5 20.0 27.0 40.0 55.0
(in Kg)
High 4.4
5.9 8.9
13.4 19.9 26.9 39.9 54.9 80.0
Number of Tablets to be Administered
3.6 mg 5.4 mg 16 mg Tablets Tablets
0.5 -
1 - - - - - -
Tablets -
0.5 -
1 -
2 - - -
- - - -
0.5 -
1
1.5 2
In the 283 dogs that received APOQUEL, the following additional clinical signs were reported after beginning APOQUEL (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 APOQUEL 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% APOQUEL, 0.9% placebo), vomiting (2.3% APOQUEL, 1.8% placebo), lethargy (1.8% APOQUEL, 1.4% placebo), anorexia (1.4% APOQUEL, 0% placebo), and polydipsia (1.4% APOQUEL, 0% placebo). In most of these cases, signs spontaneously resolved with continued dosing. Five APOQUEL 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 APOQUEL 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 APOQUEL group increased at Day 7, but returned to pretreatment levels by study end without a break in APOQUEL administration. Serum cholesterol increased in 25% of APOQUEL group dogs, but mean cholesterol remained within the reference range.
Continuation Field Study
After completing APOQUEL field studies, 239 dogs enrolled in an unmasked (no placebo control), continuation therapy study receiving APOQUEL 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 APOQUEL administration. One dog developed dermal pigmented viral plaques following 266 days of APOQUEL administration. One dog developed a moderately severe bronchopneumonia after 272 days of APOQUEL administration; this infection resolved with antimicrobial treatment and temporary discontinuation of APOQUEL. One dog was euthanized after developing abdominal ascites and pleural effusion of unknown etiology after 450 days of APOQUEL 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 APOQUEL administration, respectively. Two dogs each developed a Grade II mast cell tumor after 52 and 91 days of APOQUEL administration, respectively. One dog developed low grade B-cell lymphoma after 392 days of APOQUEL administration. Two dogs each developed an apocrine gland adenocarcinoma (one dermal, one anal sac) after approximately 210 and 320 days of APOQUEL administration, respectively. One dog developed a low grade oral spindle cell sarcoma after 320 days of APOQUEL administration.
To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, 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
http://www.fda.gov/AnimalVeterinary/SafetyHealth.
Storage Conditions: APOQUEL 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 tablets contain 3.6 mg, 5.4 mg, or 16 mg of oclacitinib as oclacitinib maleate per tablet. Each strength tablets are packaged in 20 and 100 count bottles. 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.
NADA #141-345, Approved by FDA Made in Italy
Distributed by: Zoetis Inc.
Kalamazoo, MI 49007 February 2013
428007800A&P
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