Dogs.

Treatment of pruritus associated with allergic dermatitis in dogs.

Treatment of clinical manifestations of atopic dermatitis in dogs.

Do not use in cases of hypersensitivity to the active substance or to any of the

excipients.

Do not use in dogs less than 12 months of age or less than 3 kg bodyweight.

Do not use in dogs with evidence of immune suppression, such as hyperadrenocorticism, or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases.

None.

i) Special precautions for use in animals

Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions. Dogs receiving the veterinary medicinal product should therefore be monitored for the development of infections and neoplasia.

When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity). Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).

Given the potential for effects on certain clinicopathological parameters (see section “Adverse reactions”), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.

The tablets are flavoured. In order to avoid accidental ingestion, store tablets in a safe place out of reach of animals.

ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after administration.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Ingestion of this product may be harmful to children. To avoid accidental ingestion, administer the tablet(s) to the dog immediately after removal from the blister packaging.

iii) Other precautions

Not applicable.

Dogs:

Very common (>1 animal / 10 animals treated):	pyoderma, skin lump, papilloma
Common (1 to 10 animals / 100 animals treated):	lethargy, lipoma, polydipsia, increased appetite nausea, vomiting, diarrhoea, anorexia histiocytoma, fungal skin infection, pododermatitis otitis lymphadenopathy cystitis aggression
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	anaemia, lymphoma, convulsion

Treatment-related clinical pathology changes were restricted to an increase in mean serum cholesterol and a decrease in mean leukocyte count, however, all mean values remained within the laboratory reference range. The decrease in mean leukocyte count observed in oclacitinib-treated dogs was not progressive, and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts) except lymphocyte counts. Neither of these clinical pathology changes appeared clinically significant.

Regarding susceptibility to infection and neoplastic conditions, see section “Special precautions for use”.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding.

No drug interactions were observed in field studies where oclacitinib was

administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and anti-inflammatories.

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.

For oral use.

The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.

For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day. The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment.

Apoquel tablets are chewable, palatable and readily consumed by the majority of dogs.

These tablets can be administered with or without food.

The dosing table below shows the number of tablets required. The tablets are breakable along the score line.

Oclacitinib tablets were administered to healthy, one year old Beagle dogs twice daily for 6 weeks, followed by once per day for 20 weeks, at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw for a total of 26 weeks.

Clinical observations that were considered likely to be related to oclacitinib treatment included: alopecia (local), papilloma, dermatitis, erythema, abrasions and scabbing/crusts, interdigital “cysts”, and oedema of the feet.

Dermatitis lesions were mostly secondary to the development of interdigital furunculosis on one or more feet during the study, with the number and frequency of observations increasing with increasing dose. Lymphadenopathy of peripheral nodes was noted in all groups, increasing in frequency with increasing dose, and was frequently associated with interdigital furunculosis.

Papilloma was considered treatment related, but not dose related.

There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.

Not applicable.