Apoquel (oclacitinib) 16 mg, 30 Tablets

Active Ingredient:

Oclacitinib

View Apoquel Drug Facts Sheet.

• The dose of APOQUEL tablets is 0.18 to 0.27 mg/lb (0.4 to 0.6 mg/kg)
• APOQUEL should be given twice daily (BID) for up to 14 days of therapy and once daily (SID) thereafter for maintenance
• APOQUEL may be given with or without food
• APOQUEL may be discontinued without tapering

Quick Tips

• Should be administered twice daily during the therapeutic period and once daily for maintenance period
• May be used with other common therapies including NSAIDs, antibiotics, vaccines, and allergen immunotherapy
• More information on dosing should be available in the prescription information.
• Administer doses orally twice daily for up to 14 days, then reduced by half for maintenance
• May be administered with or without food
• Tablets of Apoquel can be administered when split to allow for partial doses

Safety:

The safety profile of APOQUEL is supported by pharmacovigilance data over 5 years

The overall adverse reactions incidence rate during a 5-year review is rare (more than 1 but less than 10 animals reacting per 10,000 treatments administered)

• The incidence rate of the most commonly reported individual adverse reactions (in decreasing order: vomiting, diarrhea, lethargy, anorexia and bloodwork changes) associated with the use of APOQUEL was very rare (less than 1 dog out of 10,000 treated)
• Results are consistent with pre-approval pivotal safety and efficacy studies. APOQUEL is performing as expected under field conditions

Safe to use in dogs 12 months of age and older

Side effects were similar to placebo over short term

• Most common side effects in a short-term clinical trial included vomiting and diarrhea and were self-limiting

Can be used long term for maintenance therapy

Can be used concomitantly with many medications, including NSAIDs, anti-infectives, parasiticides, antifungals and allergen-specific immunotherapy

• The use of APOQUEL has not been evaluated in combination with other systemic immuno suppressants, such as corticosteroids and cyclosporine

Not for use in dogs with serious infections or for use in breeding, pregnant or lactating dogs

Rare is defined as more than 1 but less than 10 animals reacting per 10,000 treatments administered; very rare is defined as less than 1 animal reacting per 10,000 treatments administered. Reported incidence rate (calculated) is an estimated rate. Includes all ARs regardless of whether the product was administered per label directions, concomitantly or if a potential causal relationship existed.

See signs of allergic itch? See your veterinarian

All dogs scratch, lick, and chew - but if it's becoming more frequent and excessive, it may mean something more.

Common signs

• Frequent scratching, licking, biting, or chewing
• Excessive rolling, rubbing, or scooting
• Recurrent ear problems (such as head shaking, ear discharge/odor, or scratching at ears)
• Hair loss, body odor, or skin changes (such as rash, redness, greasy skin, or scabs)

Common causes

• Flea allergy
• Food allergy
• Environmental indoor and outdoor allergens (such as pollen, dust mites, and mold)
• Contact allergy (such as carpet cleaners, shampoos, plants, and insecticidal products)

Caution:

Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.

Warnings:

APOQUEL is not for use in dogs less than 12 months of age (see Animal Safety).

APOQUEL is not for use in dogs with serious infections.

APOQUEL may increase susceptibility to infection, including demodicosis, and exacerbate neoplastic conditions (see Adverse Reactions and Animal Safety).

Human Warnings:

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.

Precautions:

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.

Storage:

APOQUEL should be stored at controlled room temperature between 20° to 25°C (68° to 77°F) with excursions between 15° to 40°C (59° to 104°F)