Oclacitinib

The text below is quoted verbatim from approved veterinary drug labels published by the US FDA (Animal Drugs @ FDA) and DailyMed.

Indications (2)

Dogs (1)
  • Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

    APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

    apoquel®

Species not stated (1)
  • Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

    apoquel

Warnings (3)

Species not stated (3)
  • APOQUEL CHEWABLE is not for use in dogs less than 12 months of age (see Animal Safety). APOQUEL CHEWABLE modulates the immune system. APOQUEL CHEWABLE is not for use in dogs with serious infections. APOQUEL CHEWABLE may increase susceptibility to infection, including demodicosis, and exacerbation of neoplastic conditions (see Precautions, Adverse Reactions, Post-Approval Experience and Animal Safety). New neoplastic conditions (benign and malignant) were observed in dogs treated with oclacitinib film-coated tablets (FCT) during clinical studies and have been reported in the post-approval period (see Adverse Reactions and Post-Approval Experience). Consider the risks and benefits of treatment prior to initiating APOQUEL CHEWABLE in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasia (see Adverse Reactions, Post-Approval Experience, and Animal Safety). Keep APOQUEL CHEWABLE in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

    apoquel chewable

  • APOQUEL is not for use in dogs less than 12 months of age (see Animal Safety). APOQUEL modulates the immune system. APOQUEL is not for use in dogs with serious infections. APOQUEL may increase susceptibility to infection, including demodicosis, and exacerbation of neoplastic conditions (see Precautions, Adverse Reactions, Post-Approval Experience and Animal Safety). New neoplastic conditions (benign and malignant) were observed in dogs treated with APOQUEL during clinical studies and have been reported in the post-approval period (see Adverse Reactions and Post-Approval Experience). Consider the risks and benefits of treatment prior to initiating APOQUEL in dogs with a history of recurrent serious infections or recurrent demodicosis or neoplasia (see Adverse Reactions, Post-Approval Experience, and Animal Safety). Keep APOQUEL in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

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  • This product is not for human use. Keep this and all drugs out of reach of children. For use in dogs only. Wash hands immediately after handling the tablets. In case of accidental eye contact, flush immediately with water or saline for at least 15 minutes and then seek medical attention. In case of accidental ingestion, seek medical attention immediately.

    apoquel

Adverse reactions (1)

Species not stated (1)
  • The safety of APOQUEL CHEWABLE was established by pharmacokinetic data comparing oclacitinib film-coated tablets to APOQUEL CHEWABLE (see Clinical Pharmacology).

    apoquel chewable

Dosage (3)

Dogs (2)
  • The dose is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy.

    Oral

    apoquel® chewable

  • Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.

    Oral

    APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches. The use of APOQUEL has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving APOQUEL should be monitored for the development of infections, including demodicosis, and neoplasia.

    apoquel®

Species not stated (1)
  • The dose of APOQUEL (oclacitinib maleate) tablets is 0.18 to 0.27 mg oclacitinib/lb (0.4 to 0.6 mg oclacitinib/kg) body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy. APOQUEL may be administered with or without food. Dosing Chart Weight Range (in lb) Weight Range (in Kg) Number of Tablets to be Administered Low High Low High 3.6 mg Tablets 5.4 mg Tablets 16 mg Tablets 6.6 9.9 3.0 4.4 0.5 - - 10.0 14.9 4.5 5.9 - 0.5 - 15.0 19.9 6.0 8.9 1 - - 20.0 29.9 9.0 13.4 - 1 - 30.0 44.9 13.5 19.9 - - 0.5 45.0 59.9 20.0 26.9 - 2 - 60.0 89.9 27.0 39.9 - - 1 90.0 129.9 40.0 54.9 - - 1.5 130.0 175.9 55.0 80.0 - - 2

    ORAL

    apoquel

Available strengths (2)

ProductDosage formAvailable strengths
apoquel®Tablet3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet
apoquel® chewableChewable Tablets3.6, 5.4, or 16 mg of oclacitinib as oclacitinib maleate per tablet