Apoquel , for atopic dermatitis in dogs, 20 tablets

Description:
Product for the treatment of pruritus associated with allergic dermatitis in dogs. Product used in the treatment of clinical manifestations of atopic dermatitis in dogs.

Ingredients:
Oclacitinib 16 mg
Excipients: Microcrystalline cellulose, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate, Lactose monohydrate, Hypromellose (E464), Titanium dioxide (E171), Macrogol 400 (E1521).

Key benefits:
Oclacitinib is a Janus kinase (JAK) inhibitor. Oclacitinib can inhibit the function of various cytokines dependent on the activity of the JAK enzyme. For oclacitinib, the target cytokines are those that have a pro-inflammatory role or are involved in the allergic/pruritogenic response.

Intended for:
Dogs.

Method of administration:
Oral administration.

Presentation form:
Box of 20 tablets.

Possible adverse effects:

After day 16, the following adverse reactions were observed:
– pyoderma and non-specific dermal nodules, very commonly observed;
– otitis, vomiting, diarrhoea, histiocytoma, cystitis, fungal skin infections, pododermatitis, lipoma, polydipsia, lymphadenopathy, nausea, increased appetite and aggression, were commonly observed.
Treatment-related changes in clinical pathology were limited 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 dogs treated with oclacitinib was not progressive and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts), except for lymphocytes.
None of these changes in clinical pathology were considered clinically significant.
Papilloma development has been observed in a number of dogs in a laboratory study.
Anaemia and lymphoma have been reported very rarely in spontaneous reports.
If you notice any serious reactions or other unusual features, please inform your veterinarian.

Precautions:
Oclacitinib modulates the immune system and may increase susceptibility to infections 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 allergy dermatitis, contact dermatitis, food hypersensitivity).
It is also recommended that in case of allergic dermatitis or atopic dermatitis, investigate and treat complicating factors such as bacterial, fungal or parasitic infections/infestations (e.g. fleas or mange).
Considering the potential for effects on certain clinicopathological parameters, periodic monitoring of complete blood count and serum biochemistry is recommended when dogs are on long-term treatment.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding males, therefore use is not recommended during pregnancy, lactation or in dogs intended for breeding.

Storage:
Store in a dry place away from moisture and direct sunlight, at temperatures up to 25°C.

In case of overdose:
Oclacitinib tablets were administered to healthy 1-year-old Beagle dogs twice daily for 6 weeks, followed by once daily administration for 20 weeks at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw. for a total period of 26 weeks.
Clinical observations considered most likely to be associated with oclacitinib treatment included: alopecia (local), papillomas, dermatitis, erythema, abrasions and crusts/scabs, interdigital “cysts” and foot edema.
Dermatitis lesions were secondary to the development of interdigital furunculosis in one or more limbs during the study, with the number and frequency of observations increasing with increasing dose.
Peripheral lymphadenopathy was observed in all groups, increasing in frequency with increasing dose, and was frequently associated with interdigital furunculosis.
Papillomas were considered to be treatment-related but not dose-related.
There is no specific antidote and in cases with signs of overdose, the dog should be treated symptomatically.
In case of overdose, please contact your veterinarian immediately.