Apoquel® (oclacitinib tablet) Safety

The safety profile of Apoquel is supported by pharmacovigilance data over 5 years

adverse-effects adverse-effects adverse-effects

Adverse reactions during the 5-year review were rare1*†

More than 1 but less than 10 dogs had an adverse reaction per 10,000 dogs treated1,2

*In decreasing order: vomiting, diarrhea, lethargy, anorexia and blood-work changes.

less-than-dog less-than-dog less-than-dog

Less than 1 dog out of 10,000 treated experienced a reaction1*†

Results are consistent with preapproval pivotal safety and efficacy studies. Apoquel is performing as expected under field conditions1

Rare is defined as more than 1 but less than 10 dogs reacting per 10,000 dogs treated; very rare is defined as less than 1 dog reacting per 10,000 dogs treated. Reported incidence rate (calculated) is an estimated rate. Includes all adverse reactions regardless of whether the product was administered per label directions, concomitantly or if a potential causal relationship existed.2

Safe to use in dogs 12 months of age and older

Short-term side effects in a clinical trial

Most common side effects in a short-term clinical trial included vomiting and diarrhea3

Can be used long term for maintenance therapy

Not for use in dogs with serious infections or for use in breeding, pregnant or lactating dogs

Can be used concomitantly with many medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), anti-infectives, parasiticides, antifungals and allergen-specific immunotherapy4

The use of Apoquel has not been evaluated in combination with other systemic immunosuppressants, such as corticosteroids and cyclosporines

Study Results

Adverse events from 2 studies: vs placebo and prednisolone in dogs with allergic dermatitis

Apoquel vs placebo3

Clinical Sign
Number (%) of Dogs Placebo Group, n=220
Number (%) of Dogs Apoquel Group, n=216
DAYS 0-7
DAYS 0-7
Diarrhea
2 (0.9)
5 (2.3)
Vomiting
4 (1.8)
5 (2.3)
Lethargy
3 (1.4)
4 (1.8)
Anorexia
0 (0)
3 (1.4)
Polydipsia
0 (0)
3 (1.4)

Apoquel vs prednisolone5(cyclosporine capsule, USP)

Clinical Sign
Number (%) of Dogs Prednisolone Group, n=62
Number (%) of Dogs Apoquel Group, n=61
DAYS 0-28
DAYS 0-28
Elevated liver enzymes
8 (16)
2 (4.3)
Pyoderma (including folliculitis)
6 (9.7)
6 (9.8)
Dermatitis
3 (4.8)
2 (3.3)
Dermatomycosis
0 (0)
2 (3.3)
Otitis externa
1 (1.6)
2 (3.3)
Haematuria
0 (0)
2 (3.3)
Emesis
2 (3.2)
2 (3.3)
Lameness
0 (0)
2 (3.3)
Diarrhea
2 (3.2)
1 (1.6)
Lethargy
3 (4.8)
1 (1.6)
Pinnal irritation
2 (3.2)
0 (0.0)

Adverse events from 2 studies: vs placebo and ATOPICA® (cyclosporine capsules, USP) in dogs with atopic dermatitis

Apoquel vs placebo6

Clinical Sign
Number (%) of Dogs Placebo Group, n=147
Number (%) of Dogs Apoquel Group, n=152
DAYS 0-16
DAYS 0-16
Diarrhea
5 (3.4)
7 (4.6)
Vomiting
6 (4.1)
6 (3.9)
Anorexia
0 (0)
4 (2.6)
New dermal,epidermal or subcutaneous mass
4 (2.7)
4 (2.6)
Lethargy
2 (1.4)
3 (2)

Apoquel vs ATOPICA® (cyclosporine capsules, USP)7

Clinical Sign
Number (%) of Dogs ATOPICA Group, n=112
Number (%) of Dogs Apoquel Group, n=114
DAYS 0-84
DAYS 0-84
Vomiting
49 (43.8)
16 (14)
Pyoderma
14 (12.5)
13 (11.4)
Dermatitis
6 (5.4)
1 (0.9)
Unspecified skin lump
6 (5.4)
8 (7)
Lethargy
6 (5.4)
7 (6.1)
Diarrhea
18 (16.1)
3 (2.6)
Hepatopathy(elevated liver enzymes)
9 (8)
3 (2.6)

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References: 1. Data on file, A Five-Year Post-Approval Safety Review for Apoquel® in the US (May 2013 to August 2018), Zoetis Inc. 2. Volume 6C Summary of the Product Characteristics: SPC European Commission, Brussels. 1 Vol. 6C. July 10, 2006, 1-11. 3. Cosgrove SB, Wren JA, Cleaver DM, et al. Efficacy and safety of oclacitinib for the control of pruritus and associated skin lesions in dogs with canine allergic dermatitis. Vet Dermatol. 2013;24(5):479-e114. doi:10.1111/vde.12047. 4. Cosgrove SB, Cleaver DM, King VL, et al. Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life. Vet Dermatol. 2015;26(3):171-e35. doi:10.1111/vde.12194. 5. Gadeyne C, Little P, King VL, et al. Efficacy of oclacitinib (Apoquel®) compared with prednisolone for the control of pruritus and clinical signs associated with allergic dermatitis in client-owned dogs in Australia. Vet Dermatol. 2014;25(6):512-e86. doi:10.1111/vde.12166. 6. Cosgrove SB, Wren JA, Cleaver DM, et al. A blinded, randomized, placebo-controlled trial of the efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis.Vet Dermatol. 2013;24(6):587-e142. doi:10.1111/vde.12088. 7. Little PR, King VL, Davis KR, et al. A blinded, randomized clinical trial comparing the efficacy and safety of oclacitinib and ciclosporin for the control of atopic dermatitis in client-owned dogs. Vet Dermatol. 2015;26(1):23-e8. doi:10.1111/vde.12186. 

Apoquel Indications

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Apoquel Important Safety Information

Do not use Apoquel in dogs less than 12 months of age or those with serious infections. Apoquel may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. Apoquel has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel has been used safely with many common medications including parasiticides, antibiotics and vaccines.

For more information, please see the full Prescribing Information.

Apoquel Indications

Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

Apoquel Important Safety Information

Do not use Apoquel in dogs less than 12 months of age or those with serious infections. Apoquel may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. Apoquel has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel has been used safely with many common medications including parasiticides, antibiotics and vaccines.

For more information, please see the full Prescribing Information.