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.
The safety of Apoquel 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.
Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions. Dogs receiving Apoquel tablets 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 below), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
(>1 animal / 10 animals treated):
pyoderma, skin lump, papilloma
(1 to 10 animals / 100 animals treated):
lethargy, lipoma, polydipsia, increased appetite
nausea, vomiting, diarrhoea, anorexia
histiocytoma, fungal skin infection, pododermatitis
(<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.
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.
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 naïve 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 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.
Oclacitinib tablets were 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 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 increased with increasing dose. Lymphadenopathy of peripheral nodes was noted in all groups, increasing in frequency with increased 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.
Wash hands after administration.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the doctor.