APOQUEL 3,6 MG 20 CHEWABLE TABLETS FOR DOGS

APOQUEL CHEWABLE TABLETS FOR DOGS

Qualitative and quantitative composition

Active substance:

Apoquel 3,6 mg chewable tablets for dogs

Each chewable tablet contains 3,6 mg oclacitinib (as oclacitinib maleate).

Apoquel 5,4 mg chewable tablets for dogs

Each chewable tablet contains 5,4 mg oclacitinib (as oclacitinib maleate).

Apoquel 16 mg chewable tablets for dogs

Each chewable tablet contains 16 mg oclacitinib (as oclacitinib maleate).

Pharmaceutical form

Chewable pills.

Light to dark brown, speckled and scored pentagonal tablets on both sides. The tablets are marked with the corresponding strength (“SS” for 3,6 mg, “MM” for 5,4 mg and “LL” for 16 mg). The tablets can be divided into two equal parts.

target species

Dogs.

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.

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 weighing less than 3 kg.

Do not use in dogs with evidence of immunosuppression, such as hyperadrenocorticism, or with obvious progressive malignancy as the active substance has not been evaluated in these cases.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals:

Oclacitinib modulates the immune system and may increase susceptibility to infections and exacerbate neoplastic conditions. Therefore, dogs treated with Apoquel tablets should be monitored for the development of infections and neoplasia.

When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying cause (eg, flea allergy dermatitis, contact dermatitis, food hypersensitivity). In addition, 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 (eg fleas and scabies).

Due to its potential effect on certain clinicopathological parameters (see section 4.6), periodic monitoring with complete blood counts and serum biochemistry is recommended in long-term treatment.

The tablets are flavored. To avoid accidental ingestion, store tablets in a safe place out of the reach of animals.

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

Wash hands after administration.

In case of accidental ingestion, consult a doctor immediately and show him the package leaflet or the label.

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

Adverse reactions (frequency and seriousness)

Common adverse reactions seen up to day 16 in field trials.

After day 16, the following adverse reactions have been observed:

– pyoderma and non-specific skin lumps very frequently;

– otitis, vomiting, diarrhea, histiocytoma, cystitis, skin yeast infections, pododermatitis, lipoma, polydipsia, lymphadenopathy, nausea, increased appetite and frequently aggressiveness.

Treatment-related clinicopathological changes 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 white blood cell count observed in oclacitinib-treated dogs was not progressive, affecting all white cell cell types (neutrophil, eosinophil, and monocyte counts) with the exception of lymphocyte counts. None of these clinicopathological changes was clinically significant.

Papilloma development was observed in a number of dogs in a laboratory study.

Anemia and lymphoma have been reported very rarely in spontaneous reports.

Regarding susceptibility to infections and neoplastic processes, see section 4.5.

Use during pregnancy, lactation or lay

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

Dosage and route of administration

Orally.

Dose and treatment schedule:

The recommended starting dose is 0,4 to 0,6 mg oclacitinib/kg body weight, administered orally, twice daily for 14 days.

As maintenance therapy, the same dose (0,4 to 0,6 mg oclacitinib/kg body weight) should be administered once daily only. Long-term maintenance therapy should be based on an individual benefit-risk assessment.

Apoquel tablets are chewable, palatable and easily consumed by most dogs.

These tablets can be administered with or without food.

The following dosage table shows the number of tablets needed. The tablets are divisible at the splitting score.

Dog weight (kg):

3.0-4.4: ½ tab apoquel 3.6mg

4.5-5.9: ½ tab apoquel 5.4 mg

6.0-8.9: 1 tab apoquel 3.6mg

9.0-13.4: 1 tab apoquel 5.4 mg

13.5-19.9: ½ tab apoquel 16mg

20.0-26.9: 2 tab apoquel 5.4mg

27.0-39.9: 1 tab apoquel 16mg

40.0-54.9: 1 ½ tab apoquel 16mg

55.0-80.0: 2 tab apoquel 16mg

Timeouts

Not applicable.

Period of validity

Shelf-life of the veterinary medicinal product packaged for sale in blister packs: 2 years.

Special storage precautions

Store in the original container in order to protect from moisture.

The remaining parts of the tablet should be stored in the blister and supplied at the next administration.

APOQUEL