Apoquel Tablets for Dogs

Apoquel Tablets control itching (pruritus) associated with allergic dermatitis and control atopic dermatitis in dogs at least 12 months of age. Apoquel has been prescribed for over 14 million dogs⁶ and is #1 in pet owner and vet satisfaction for oral medications for allergic itch in dogs*.^7,8 It goes right to the source to help stop itching and relieve associated inflammation in affected canines providing relief in as little as 4 hours.⁵ Apoquel is given twice daily for up to 14 days, and then given once daily for maintenance therapy. You can use for both short-term or long-term therapy in your dog and discontinue use without tapering. Since Apoquel is neither a steroid nor an antihistamine, your dog will avoid many of the unpleasant side effects that are often associated with these medications. In a 5-year safety review, the most common individual side effects reported with Apoquel were vomiting, diarrhea, lethargy, anorexia, and bloodwork changes.⁹ The most common reported side-effects occurred at a rate of less than one dog reacting out of 10,000 dogs treated.¹⁰ Apoquel Chewable (oclacitinib chewable tablet) is now available and is another easy-to-administer option if your dog is difficult to pill. Both Apoquel Tablet and Apoquel Chewable are available by prescription only. Talk to your veterinarian about which is best for your dog.

Do not use Apoquel in dogs less than 12 months of age or those with serious infections. Apoquel may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. Apoquel has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel has been used safely with many common medications including parasiticides, antibiotics and vaccines. See full Prescribing Information at ApoquelPI.com.

*Vets, n=250, Pet Owners, n=491

1. Data on file, PetTrak Total Unique Patient Count, December 2022, Zoetis Inc. (TI-09437)

2. Data on file: Study Report A161C-US-21-C02, Zoetis Inc., 2022 (TI-09898)

3. Cosgrove SB, Cleaver DM, King VL, et al. Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life. Vet Dermatol. 2015;26(3):171-179, e35. doi:10.1111/vde.12194 (AR-01949)

4. Data on file: Study Report A461N-US-21-B66, Zoetis Inc. 2022

5. FOI Apoquel Chewable FOI Summary: 2023/06/09 Original NADA 141-555 (v2.0).

6. Gonzales AJ, Bowman JW, Fici GJ, et al. Oclacitinib (APOQUEL)is a novel Janus kinase inhibitor with activity against cytokines involved in allergy. J Vet Pharmacol Therapy. 2014;37(4)317-24. doi:10.1111/jvp.12101 (AR-00542)

7. Data on file, Apoquel Cytopoint Vet Tracker Wave 11 (December 20 2018) (TI-04447)

8. Data on file, APOQUEL/CYTOPOINT Pet Owner Tracker Wave 11, 2022, Zoetis Inc. (TI- 08418)

9. Data on file. A Five-Year Post-Approval Safety Review for Apoquel® in the US (May 2013 to August 2018), Zoetis Inc (TI-04506)

10. Volume 6C Summary of the Product Characteristics: SPC European Commission, Brussels. 1 Vol. 6C. July 10, 2006, 1-11. (AR-08728)

Dogs (12 months of age and older)

Oclacitinib maleate

Janus Kinase (JAK) inhibitor, Immunomodulator

This product is an unflavored coated tablet formulation. For the flavored chewable tablet formulation, please see Apoquel Chewable for Dogs.

Apoquel tablets are scored and are available in four strengths, containing 3.6 mg, 5.4 mg, or 16 mg of oclacitinib per tablet. Please ensure the selected product and quantity are appropriate for your pet, as recommended by your veterinarian.

For current availability, please refer to the product selection above.

Apoquel should be administered as directed by your veterinarian. Wash your hands immediately after handling tablets. Please consult your veterinarian before making any changes or discontinuing the prescribed dosing schedule.

If a dose is missed: Administer it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not give more medication than prescribed or two doses at once. If you have questions about your pet’s prescribed dosing schedule (e.g., timing, interval), please contact your veterinarian.

Give Apoquel to your dog as directed by your veterinarian. Apoquel is given twice daily for up to 14 days of therapy and once daily thereafter for maintenance. Apoquel may be given orally with or without food.

Store in a cool, dry place at a controlled room temperature between 68° to 77°F, with excursions between 59° to 104°F. Keep this and all other medications in a secure location out of the reach of children and animals. Any remaining half-tablets should be stored in the original package and used for the next dose.

Exposure to extreme temperatures, light, or moisture can affect the integrity and effectiveness of medications. Always store this medication properly (e.g., away from the bathroom, kitchen sink, or other damp places).

Apoquel is generally well tolerated. The most common side effects reported for this medication are vomiting, diarrhea, decreased appetite, and lethargy. These effects usually diminish over time.

Other reported side effects include (but may not be limited to) elevated liver enzymes, dermatitis, seizures, and increased thirst.

Contact your veterinarian immediately if you notice signs of an infection (e.g., increased itching, bleeding or oozing skin sores, painful urination, etc.), any new and abnormal skin changes/growths, or enlargement of existing skin masses.

The information provided above may not encompass all possible side effects. Please notify your veterinarian if your pet experiences any side effects, including those listed above, or if you notice anything unusual.

For oral use in dogs only.

This product is not for human use. Keep this and all drugs in a secure location out of reach of children and animals to prevent accidental ingestion or overdose. 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 may increase your pet’s susceptibility to infection, including demodicosis, and exacerbation of neoplastic conditions.

Do NOT administer this medication to breeding, pregnant, or lactating animals.

Do not administer this medication to animals with a known or suspected allergy/hypersensitivity to it or any of its ingredients. Allergic reactions to medications may occur. Please inform Vetsource and your veterinarian if your pet has any known sensitivities or allergies, especially to medications and supplements.

If your pet displays symptoms of an allergic reaction, discontinue therapy and call your veterinarian immediately or seek emergency veterinary attention. Symptoms may include (but are not limited to): swollen lips, tongue, face, or airways; difficulty breathing; agitation; profuse salivation; and widespread hives or itching.

The use of Apoquel has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. However, Apoquel and Apoquel Chewable have been used safely with many common medications, including parasiticides, antibiotics, and vaccines.

The following drugs* may have potential interactions with this medication: corticosteroids (e.g., dexamethasone, prednisone), cyclosporine, methotrexate, and mycophenolate.

*NOTE: This may not be a comprehensive list. As with all medications, please consult your veterinarian if you have any questions or concerns prior to use. Contact your veterinarian if your pet experiences any unusual reactions when multiple medications and/or supplements are given together.

Please ensure your veterinarian is aware of all medications, supplements, and over-the-counter (OTC) products that your pet is currently using. Your veterinarian may prescribe multiple medications, even if a potential drug interaction may occur. In these instances, your veterinarian may adjust the dosages or monitor your pet more closely.

If you are concerned that your pet has experienced an adverse reaction to this medication, please contact Zoetis at 1-888-963-8471 or Vetsource Pet Owner Care at 877-738-4443.

If you have any reason to suspect accidental consumption or overdose, call your doctor/veterinarian or the appropriate poison control resource immediately.

The national toll-free Poison Help line, 1-800-222-1222, will connect you to your local poison center in case of emergency. This service is available nationwide and in most U.S. territories.

The ASPCA Animal Poison Control Center is available 24 hours a day, 365 days a year at 888-426-4435.

Pet Poison Helpline also provides a 24/7 animal poison control service at 855-764-7661.

All content, including the images and product description above, is intended for general informational purposes only and should not be considered a substitute for professional veterinary consultation, diagnosis, or treatment.

For additional information about this product and how it fits into your pet's individual treatment plan, please consult your veterinarian.