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|Drug Name and Strength||Oclacitinib maleate 3.6mg|
|Indication||Treatment of pruritus associated with allergic dermatitis in dogs, and of clinical manifestations of atopic dermatitis in dogs.|
|Contraindications||Do not use in animals with known hypersensitivity to oclacitinib, or 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.|
|Actions||Oclacitinib is not a corticosteroid or an antihistamine. Oclacitinib inhibits the function of a variety of pruritogenic cytokines and proinflammatory cytokines, as well as cytokines involved in allergy that are dependent on JAK1 or JAK3 enzyme activity, but it has little effect on cytokines involved in haematopoiesis that are dependent on JAK2.Pharmacokinetics Oclacitinib maleate is rapidly and well absorbed after oral administration, with least squares mean time to peak plasma concentrations (tmax) of less than 1 hour. The absolute bioavailability of oclacitinib maleate is 89%. The prandial state of dogs does not significantly affect the rate or extent of absorption. Oclacitinib is metabolised in the dog to multiple metabolites, and one major oxidative metabolite was identified in plasma and urine. Overall, the major clearance route is metabolism, with minor contributions from renal and biliary elimination. Inhibition of canine cytochrome P450s by Apoquel is minimal, with IC50s 50-fold greater than the observed mean Cmax (333 nanogram/mL or 0.997 microM) after 0.6 mg/kg oral administration in the target animal safety study. Therefore, the risk of metabolic drug–drug interactions due to oclacitinib inhibition is very low. No accumulation was observed in the blood of dogs treated for 6 months. No drug interactions were observed in field studies in which oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and anti-inflammatories.|
|Precautions||Apoquel (oclacitinib) modulates the immune system and may increase the susceptibility to infection and the development of papillomas, and may exacerbate neoplastic conditions, including subclinical neoplastic conditions. Dogs receiving Apoquel should therefore be monitored for the development of infections and neoplasia. The safety of the drug has not been studied in breeding male dogs, nor in pregnant or lactating female dogs. In the absence of such studies, it is not recommended to use the drug in pregnant or lactating bitches or in dogs intended for breeding. Apoquel is not for use in dogs less than 12 months of age or less than 3 kg bodyweight. The use of Apoquel has not been evaluated in combination with glucocorticoids, cyclosporin or other systemic immunosuppressive agents.Will irritate the eyes. Avoid contact with eyes. Wash hands after use. Accidental ingestion of oclacitinib can be harmful for children. To avoid accidental ingestion, administer the tablet to the dog immediately after removal from the package. Keep out of reach and sight of children.|
|Dosage and Administration||Dose. 0.4 to 0.6 mg/kg bodyweight, administered twice daily for up to 14 days, then administered once daily for maintenance therapy. Tablets are breakable. Tablets can be administered with or without food. Dogs should be carefully observed after administration to ensure that each tablet is swallowed.|
|Storage||Store below 25°C (air conditioning). In-use shelf life. Half tablets should be stored in the provided bottle with cap sealed. Use half tablets within 14 days.|
|MSDS (external link)||Apoquel MSDS|
|Label (external link)||Apoquel Label|
|Manufacturer||Zoetis Australia Pty Ltd|