Apoquel
Authorised
This medicine is authorised for use in the European Union
oclacitinib maleate
MedicineVeterinaryAuthorised
Overview
Apoquel is a veterinary medicine used to treat pruritus (itching) associated with allergic dermatitis (inflammation of the skin) as well as atopic dermatitis in dogs. It contains the active substance oclacitinib.
Apoquel can only be obtained with a prescription; it is available as film-coated tablets and chewable tablets in different strengths to cover a range of dog weights. Treatment should be started at a dose of 0.4 – 0.6 mg per kilogram bodyweight twice a day for up to two weeks. Treatment may then be continued at the same dose given once a day.
For more information about using Apoquel, see the package leaflet or contact your veterinarian or pharmacist.
The active substance in Apoquel, oclacitinib, is an immunomodulator (a medicine that changes the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the processes of inflammation and itchiness including those involved in allergic dermatitis and atopic dermatitis in dogs. By blocking the enzymes, Apoquel reduces the inflammation and itchiness associated with the disease.
In a study involving 220 dogs and comparing the effects of Apoquel film-coated tablets against pruritus associated with allergic dermatitis with prednisolone, both medicines were shown to be effective, with a successful response seen in 68% of dogs treated with Apoquel, and 76% of those treated with prednisolone. In another study performed in 436 dogs, the effects of Apoquel film-coated tablets against pruritus associated with allergic dermatitis were compared with placebo (dummy treatment). When compared with placebo, the success rate was 67% for Apoquel film-coated tablets-treated dogs and 29% for placebo-treated dogs. The measure of effectiveness in the studies was based on the assessment by the dog owner of the severity of the pruritus and improvements in the dog’s behaviour using a standard scale.
The effect of Apoquel film-coated tablets against atopic dermatitis when compared to placebo was investigated in two studies involving 220 and 299 dogs, respectively. Studies in atopic dermatitis also used assessment of skin lesions on a score known as the canine atopic dermatitis extent and severity index (CADESI). The treatment success rate for Apoquel film-coated tablets-treated dogs in the first study was 66% compared with 4% in placebo-treated dogs using pruritus assessment; the results for CADESI scores were 49% and 4%, respectively. The success rates in the second study were similar.
The company also provided the results of studies showing that Apoquel chewable tablets are "bioequivalent" to the film-coated tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
The most common side effects with Apoquel (which may affect up to 1 in 10 animals) were diarrhoea, vomiting, loss of appetite and nodules on or under the skin.
For the full list of side effects and restrictions of Apoquel, see the package leaflet.
Safety information has been included in the summary of product characteristics and the package leaflet for Apoquel, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
The European Medicines Agency decided that Apoquel's benefits are greater than its risks and it can be authorised for use in the EU.
Apoquel received a marketing authorisation valid throughout the EU on 12 September 2013.
Product information
Latest procedure affecting product information: X/0019
13/12/2021
Product details
- Name of medicine
- Apoquel
- Active substance
- oclacitinib maleate
- International non-proprietary name (INN) or common name
- oclacitinib maleate
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QD11AH90
Pharmacotherapeutic group
Agents for dermatitis, excluding corticosteroidsTherapeutic indication
- Treatment of pruritus associated with allergic dermatitis in dogs.
- Treatment of clinical manifestations of atopic dermatitis in dogs.
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