Apoquel 3.6mg Film-coated Tablet for Dogs

The tablets can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs.
4.2 Indications for use, specifying the target species
Treatment of pruritus associated with allergic dermatitis in dogs.
Treatment of clinical manifestations of atopic dermatitis in dogs.
4.3 Contraindications
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.

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4.4 Special warnings for each target species
None.
4.5 Special precautions for use
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
4.6 "Adverse reactions"), periodic monitoring with complete blood counts and serum
biochemistry is recommended when dogs are on long-term treatment.
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.
iii) Other precautions
Not applicable.

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4.6 Adverse reactions (frequency and seriousness)
Dogs:
Very common
(>1 animal / 10 animals treated):
pyoderma, skin lump, papillomaCommon
(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 4.5
"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 the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
4.7 Use during pregnancy, lactation or lay
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.
4.8 Interaction with other medicinal products and other forms of interaction
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

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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.
4.9 Amount(s) to be administered and administration route
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.
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.
Bodyweight
(kg) of dog
Strength and number of tablets to be administered:Apoquel 3.6 mg
tablets
Apoquel 5.4 mg
tablets
Apoquel 16 mg
tablets
3.0–4.4½4.5–5.9½