Apoquel (FOR ANIMALS) 16 mg, 100 tablets

White to off-white, oblong, film-coated tablets with a breakline and the letters “AQ” and “S” (for 100 mg tablets), “AQ” and “M” (for 150 mg tablets) and “AQ” and “L” (for 450 mg tablets) on both sides.

Tablets can be divided into equal halves when used.

0.5 g of tablets contain the active ingredient (mg):

• oclacitinib (as oclacitinib maleate) – 18.0.

Excipients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate.

The tablet shell contains: lactose monohydrate, hydroxypropyl methylcellulose (E464), titanium dioxide (E1 71), macrogol 400 (E1521).

APOKVEL® tablets for dogs are available in three dosages:

• tablet weighing 100 mg (contains oclacitinib (as oclacitinib maleate) – 3.6 mg);
• tablet weighing 150 mg (contains oclacitinib (as oclacitinib maleate) – 5.4 mg);
• tablet weighing 450 mg (contains oclacitinib (as oclacitinib maleate) – 16 mg).

ATS vet classification code QD11AN90 – anti-dermatitis drugs, except corticosteroids.

Oclacitinib is a Janus kinase inhibitor (JAK – involved in intracellular signal transduction from cytokine receptors). It inhibits the function of various cytokines that depend on the activity of the Janus kinase enzymes JAK1 or JAK3. The target cytokines for oclacitinib are pro-inflammatory cytokines and those that play a role in allergic reactions or pruritus. However, oclacitinib may also affect other cytokines (for example, those involved in host defense or hematopoiesis) with the potential for undesirable effects.

After oral administration to dogs, oclacitinib maleate is rapidly and well absorbed, reaching peak plasma concentrations in less than an hour. The absolute bioavailability of oclacitinib maleate is 89%. Food intake does not affect the rate and extent of absorption of oclacitinib. It is excreted unchanged, mainly in the urine, with a half-life of 3 to 4 hours.

No accumulation of the drug was observed in dogs treated with oclacitinib for 6 months.

Treatment of dogs suffering from allergic dermatitis (itch control), as well as with clinical manifestations of atopic dermatitis.

Oral at an initial dose of 0.4-0.6 mg oclacitinib per 1 kg of animal body weight twice daily for 14 days. For maintenance therapy at the same dose (0.4-0.6 mg oclacitinib per 1 kg of animal body weight) the drug is given once daily. The need for long-term maintenance therapy should be based on an individual benefit-risk assessment.

The drug is administered with or without food. The tablets are brittle along the dividing groove in the middle of the tablet.

Do not use in case of hypersensitivity to the active substance or any of the excipients. Do not use in dogs under 12 months of age or weighing less than 3 kg. Do not use in dogs with signs of immunosuppression, such as hyperadrenocorticism, or with signs of progressive malignant neoplasia, as the effect of the active substance has not been studied in such cases.

Side effects and complications with short-term use of Apoquel may include depression, gastrointestinal dysfunction, and cystitis; in animals receiving Apoquel for more than 16 days, approximately 1% of cases may experience increased appetite and aggression, skin and subcutaneous neoplasms, skin infections caused by yeast fungi, enlarged lymph nodes, exacerbation of demodicosis, and cancer.

In case of an overdose of the drug, the following symptoms may be observed in the animal: depression, vomiting, diarrhea, local alopecia, thickening of the skin fold, the formation of scabs and crusts, interdigital cysts, swelling of the limbs. There are no specific antidotes, the animal is treated symptomatically.

No pharmacological interactions were found when Apoquel was used together with antimicrobial, anti-inflammatory and antiparasitic drugs.

Apoquel is not intended for use in productive animals.

White plastic bottles with child-resistant caps containing 20, 50 or 100 tablets for each dosage form.

Dry, dark place inaccessible to children at a temperature of 15 ° C to 25 ° C. Shelf life – 3 years.

Any unused half tablet should be immediately placed back in the bottle and used within 3 days.