Drug guide
Oclacitinib for Dogs: Dosage, Contraindications & Safety
Oclacitinib is an immunosuppressant used in dogs.[5] In dogs, oclacitinib has been shown to be effective in the treatment of nonspecific allergic dermatitis and atopic dermatitis.[8] The dose of APOQUEL 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.[5] In dogs, inhibition of canine cytochrome P450 enzymes by oclacitinib is minimal, and the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low.[4]
Overview
Oclacitinib is an immunosuppressant used in dogs.[5]
- Use in dogs: Oclacitinib has been shown to be effective in the treatment of nonspecific allergic dermatitis and atopic dermatitis in dogs.[8]
- Route: APOQUEL tablets, film-coated tablets, and chewable tablets are for oral use.[2][3][4][5]
Dosage by species
The reported dog dose is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) orally twice daily for up to 14 days, then once daily for maintenance therapy.[5]
| Species | Dose | Route | Frequency / duration | Product / notes |
|---|---|---|---|---|
| Dogs | 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight | Oral | twice daily for up to 14 days, and then once daily for maintenance therapy | APOQUEL tablets.[5] |
| Dogs | 0.4 mg/kg to 0.6 mg oclacitinib/kg body weight | orally | twice daily for up to 14 days, and then administered once daily for maintenance therapy | APOQUEL chewable tablets; may be administered by hand, in a bowl, with or without food.[4] |
Indications
In dogs, oclacitinib has been shown to be effective in the treatment of nonspecific allergic dermatitis and atopic dermatitis.[8]
- Allergic dermatitis: Oclacitinib has been shown to be effective in nonspecific allergic dermatitis in dogs.[8]
- Atopic dermatitis: Oclacitinib has been shown to be effective in atopic dermatitis in dogs.[8]
Contraindications & warnings
A vaccination study in puppies found reduced serological responses to some vaccines during oclacitinib treatment.[2][3]
- Vaccination response: In 16 week old vaccine naive puppies, an adequate immune response (serology) to canine distemper virus and canine parvovirus vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.[2][3]
- Reduced serology: In the same puppies, the findings indicated a reduction in serological response to vaccination with canine parainfluenza and inactivated rabies vaccine in puppies being treated with oclacitinib compared to untreated controls.[2][3]
- Clinical relevance: The clinical relevance of these observed vaccination effects for animals vaccinated while being administered oclacitinib in accordance with the recommended dosing regimen is unclear.[2][3]
Drug interactions
The reported risk of metabolic drug-drug interactions from oclacitinib inhibition is very low in dogs.[4]
- Cytochrome P450: In dogs, inhibition of canine cytochrome P450 enzymes by oclacitinib is minimal; the inhibitory concentrations (IC50s) are 50-fold greater than the observed Cmax values at the use dose.[4]
- Interaction risk: In dogs, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low.[4]
Adverse effects
Field-study withdrawals included dermatitis flare, severe secondary pyoderma, generalized demodicosis, and malignant neoplasia cases.[1][4]
- Dermatitis flare / pyoderma: In 283 dogs that received at least one dose of oclacitinib, one dog was withdrawn from study because of an intense flare-up of dermatitis and severe secondary pyoderma after 19 days of oclacitinib administration.[1][4]
- Demodicosis: In the same population, one dog was withdrawn from study because generalized demodicosis developed after 28 days of oclacitinib administration.[1][4]
- Neoplasia cases: In the same population, two other dogs on oclacitinib 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 administration and one dog that developed a Grade III mast cell tumor after 60 days of oclacitinib administration.[1][4]
- Short-term study: In a 30-day study, there were no fatalities and no adverse reactions requiring hospital care.[5]
- Course of signs: In most of these study cases, signs spontaneously resolved with continued dosing.[5]
Overdose & toxicity
A 26-week safety study in healthy Beagle dogs described dose-related and microscopic changes at 1X, 3X, and 5X maximum exposure doses.[1][4]
- Exposure studied: In healthy, one-year-old Beagle dogs, oclacitinib was administered twice daily for 6 weeks, followed by once daily for 20 weeks, at 0.6 mg/kg (1X maximum exposure dose), 1.8 mg/kg (3X, 8 dogs), and 3.0 mg/kg (5X, 8 dogs) for 26 weeks.[1][4]
- Clinical findings: Clinical observations considered likely to be related to oclacitinib included papillomas and a dose-dependent increase in the number and frequency of interdigital furunculosis (cysts) on one or more feet during the study.[1][4]
- Additional observations: 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.[1][4]
- Microscopic findings: Microscopic findings considered to be oclacitinib-related included decreased cellularity (lymphoid) in Gut-Associated Lymphoid Tissue (GALT), spleen, thymus, cervical and mesenteric lymph node, and decreased cellularity of sternal and femoral bone marrow.[1][4]
- Other pathology: Lymphoid hyperplasia and chronic active inflammation were seen in lymph nodes draining feet affected with interdigital furunculosis, and five oclacitinib-treated dogs had microscopic evidence of mild interstitial pneumonia.[1][4]
Clinical notes
Oclacitinib is metabolized mainly by metabolism, with minor renal and biliary elimination in dogs.[1][4]
- Metabolism: Oclacitinib is metabolized in the dog to multiple metabolites, and one major oxidative metabolite was identified in plasma and urine.[1][4]
- Clearance route: In dogs, the major clearance route is metabolism, with minor contributions from renal and biliary elimination.[1][4]
- Plasma clearance: Mean (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).[1]
- Half-life: Following IV and PO administration, the terminal t1/2 appeared similar with mean values of 3.5 (2.2, 4.7) and 4.1 (3.1, 5.2) hours, respectively.[1]
- Tablet strengths: APOQUEL tablets contain 3.6 mg, 5.4 mg, or 16 mg of oclacitinib as oclacitinib maleate per tablet, and 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.[5]
- Chewable administration: APOQUEL chewable tablets are palatable and readily consumed by the majority of dogs, and they may be administered by hand, in a bowl, with or without food.[4]
- Onset note: Because oclacitinib is quick-acting, most dogs respond within 24 hours, and peak plasma concentrations are reached within one hour.[9]
Frequently asked questions
What is the oral dose of oclacitinib in dogs?
The dose of APOQUEL 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.[5] The dose of APOQUEL chewable tablets is 0.4 mg/kg 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.[4]
How quickly does oclacitinib work in dogs?
Can Apoquel chewable tablets be given with food?
APOQUEL chewable tablets may be administered by hand, in a bowl, with or without food.[4]
Does oclacitinib affect vaccine responses in puppies?
In 16 week old vaccine naive puppies, an adequate immune response (serology) to canine distemper virus and canine parvovirus vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days.[2][3] In the same study, the findings indicated a reduction in serological response to vaccination with canine parainfluenza and inactivated rabies vaccine in puppies being treated with oclacitinib compared to untreated controls, and the clinical relevance was unclear.[2][3]
What drug interaction risk is reported for oclacitinib in dogs?
What adverse events caused dogs to be withdrawn from oclacitinib studies?
Among 283 dogs that received at least one dose of oclacitinib, one dog was withdrawn because of an intense flare-up of dermatitis and severe secondary pyoderma after 19 days, and one dog was withdrawn because generalized demodicosis developed after 28 days.[1][4] Two other dogs on oclacitinib were withdrawn due to suspected or confirmed malignant neoplasia and subsequently euthanized, including one dog with signs associated with a heart base mass after 21 days and one dog with a Grade III mast cell tumor after 60 days of oclacitinib administration.[1][4]
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References
- Apoquel for Dogs
Passage read from this source
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 severe 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…
Oclacitinib is metabolized in the dog to multiple metabolites and one major oxidative metabolite was identified in plasma and urine. Overall the major clearance route is metabolism with minor contributions from renal and biliary elimination. Inhibition of canine cytochrome P450 enzymes by oclacitinib is minimal; the inhibitory concentrations (IC50s) are 50 fold greater than the observed Cmax values at the use dose. Mean (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). Following IV and PO administration, the terminal t1/2 appeared similar with mean values of 3.5 (2.2, 4.7) and 4.1 (3.1, 5.2) hours, respectively.
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. Eight dogs received placebo (empty gelatin capsule) at the same dosage schedule. Clinical observations that were considered likely to be related to oclacitinib maleate included papillomas and a dose-dependent increase in the number and frequency of interdigital furunculosis (cysts) on one or more feet during the study. 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. Microscopic…
- Clinical particulars - Apoquel chewable tablets for dogs (NI)
Passage read from this source
The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naive puppies has been studied. An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days. However, the findings of this study indicated a reduction in serological response to vaccination with CPI and RV in puppies being treated with oclacitinib compared to untreated controls. The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear. Administration routes and dosage For…
- Clinical particulars - Apoquel film-coated tablets for dogs ...
Passage read from this source
The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naive puppies has been studied. An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days. However, the findings of this study indicated a reduction in serological response to vaccination with CPI and RV in puppies being treated with oclacitinib compared to untreated controls. The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear. Amount(s) to be administered and…
- Apoquel 16 mg chewable tablets for Dogs (Canada)
Passage read from this source
The dose of APOQUEL chewable tablets is 0.4 mg/kg 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 chewable tablets are palatable and readily consumed by the majority of dogs (see EFFICACY). APOQUEL chewable tablets may be administered by hand, in a bowl, with or without food. Dosing Chart | | | | | | --- | --- | --- | --- | | Dog body weight (kg) | 3.6 mg chewable tablets | 5.4 mg chewable tablets | 16 mg chewable tablets | | 3 - 4.4 | 0.5 | | | | 4.5 - 5.9 | | 0.5 | | | 6 -…
Dogs that withdrew from the masked field study could enter an unmasked study where all dogs received oclacitinib. Between the masked and unmasked study, 283 dogs received at least one dose of oclacitinib. 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 administration, and one dog that developed generalized demodicosis after 28 days of oclacitinib administration. Two other dogs on oclacitinib 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 administration, and one…
Oclacitinib is metabolized in the dog to multiple metabolites. One major oxidative metabolite was identified in plasma and urine. Overall, the major clearance route is metabolism, with minor contributions from renal and biliary elimination. Inhibition of canine cytochrome P450 enzymes by oclacitinib is minimal; the inhibitory concentrations (IC50s) are 50-fold greater than the observed Cmax values at the use dose. Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low. Efficacy:
Oclacitinib 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) for 26 weeks. Eight dogs received placebo (empty gelatin capsule) at the same dosage schedule. Clinical observations that were considered likely to be related to oclacitinib-included papillomas and a dose-dependent increase in the number and frequency of interdigital furunculosis (cysts) on one or more feet during the study. 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. Microscopic findings considered to be…
- FREEDOM OF INFORMATION SUMMARY
Passage read from this source
Freedom of Information Summary NADA 141-345 Page 3 of 28 I. GENERAL INFORMATION A. File Number NADA 141-345 B. Sponsor Zoetis Inc. 333 Portage St. Kalamazoo, MI 49007 Drug Labeler Code: 054771 C. Proprietary Name APOQUEL D. Established Name Oclacitinib tablet E. Pharmacological Category Immunosuppressant F. Dosage Form Tablet G. Amount of Active Ingredient 3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet H. How Supplied APOQUEL tablets contain 3.6 mg, 5.4 mg, or 16 mg of oclacitinib as oclacitinib maleate per tab let. 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…
(4) Adverse Reactions: All 436 (216 oclacitinib maleate and 220 placebo) of the enrolled dogs received at least one dose of study drug, and were evaluated for safety. During the 30-day study, there were no fatalities and no adverse reactions requiring hospital care. Because the majority of dogs in the placebo group withdrew after the 8 -day Study Phase, the incidence of adverse reactions is provided for the Study Phase. See Table 8, below. In most of these cases, signs spontaneously resolved with continued dosing.
Investigator-Assessed RTT 6.4 b (n = 139) 1.0 (n = 132) Owner-Assessed RTT 6.8 b (n = 139) 0.7 (n = 131) a The group means are estimated least squares mean RTT VAS scores. b Significant difference between the oclacitinib maleate and placebo groups at p
Freedom of Information Summary NADA 141-345 Page 23 of 28 III. TARGET ANIMAL SAFETY A. Margin of Safety Title: Margin of Safety Study of PF-03394197 Administered for 26 Weeks to Adult Dogs. Study number 1462N-60-10-A29 (Study A29) 1. Type of Study: Laboratory s tudy 2. Study Dates: September 16, 2010 to April 8, 2011 3. Investigator and Location: Phyllis B. Malpas, DVM, PhD, DABT Kalamazoo, MI 4. Study Design: a. Purpose of Study: To evaluate the margin of safety of oclacitinib maleate administered orally in dogs at 1, 3, and 5 times maximum exposure dose of 0.6 mg/kg oclacitinib twice daily (BID) for 6 weeks, then once daily (SID) for 20 weeks. b. Study Animals: Sixteen male and sixteen female…
- summary of product characteristics
Passage read from this source
The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
- Revised: April 2024 AN: 02337/2023 Page 1 of 7
Passage read from this source
The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
- Oclacitinib - Clinician's Brief
Passage read from this source
Oclacitinib has been shown to be effective in the treatment of nonspecific allergic dermatitis and atopic dermatitis in dogs (Figures 1 and 2). 8,9 The recommended dose is 0.4-0.6 mg/kg PO twice daily, administered for the first 2 weeks, followed by PO 0.4-0.6 mg/kg once daily as a maintenance dose. 7,9 Long-term twice-daily administration is ...
- Apoquel Q&A: Will oclacitinib revolutionize the ... - dvm360
Passage read from this source
How is Apoquel dosed? The labeled dose of Apoquel is 0.4 to 0.6 mg/kg twice a day for up to 14 days and then once a day. Because it is quick-acting, most dogs respond within 24 hours. It is rapidly absorbed, reaching peak plasma concentrations within one hour.
- Oclacitinib Maleate (Apoquel) - Veterinary Partner - VIN
Passage read from this source
Oclacitinib maleate is used twice daily for two weeks and then dropped to a maintenance dose of once daily. It generally reduces itching very quickly — within 24 hours — and is felt to be as effective as corticosteroids, such as prednisolone.
For veterinary professionals. Information supports — never replaces — clinical judgement; always check the current product label and local regulations.