Apoquel (oclacitinib) Tablets, 5.4 mg

Apoquel is an oral tablet that works differently than other allergy medications. It is also available in a chewable tablet. It goes straight to the source to help relieve itch and inflammation at its core-addressing the underlying cause of irritation and soothing allergic reactions. It starts to relieve those unpleasant symptoms within 4 hours, and effectively controls itching within 24. Apoquel is ideal for both short or long-term treatment and can help to offer relief without many of the side effects associated with steroids.

Indications

Apoquel is indicated for the relief of itching and inflammation caused by allergic skin disease (atopy, atopic dermatitis) in dogs 12 months of age or older.

Prescription items are NON-RETURNABLE and NON-REFUNDABLE.

Please note product may arrive in a Hardy Paw Pharmacy vial, manufacturer packaging is shown for reference.

Dosage and Administration:

The dose of APOQUEL CHEWABLE (oclacitinib chewable tablet) 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.

Warnings:

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.

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.

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.

Keep APOQUEL CHEWABLE in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

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:

Dogs receiving APOQUEL CHEWABLE should be monitored for the development of infections, including demodicosis, and neoplasia.

The use of APOQUEL CHEWABLE has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents.

APOQUEL CHEWABLE is not for use in breeding dogs, or pregnant or lactating bitches.

Possible Side Effects

The most common side effects were vomiting and diarrhea and similar to those seen with placebo (sugar pills). These side effects occurred in only a small percentage of dogs treated with Apoquel and typically stopped on their own.

Drug & Food Interactions

Apoquel has not been tested in dogs receiving medications commonly used to treat skin conditions such as glucocorticoids, cyclosporines, and other systemic immunosuppressive agents.

Storage Conditions:

APOQUEL CHEWABLE 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)

FAQ

What is it for?

Apoquel is the first, and still the only, Janus kinase (JAK) inhibitor approved for use in dogs (for the control of pruritus associated with allergic dermatitis and the control of atopic dermatitis).

How effective is it?

Apoquel is the #1 prescribed oral medicine for allergic itch1 and is effective for

• Flea allergy
• Food allergy
• Contact allergy
• Atopic dermatitis

What is the most important thing I should know about Apoquel Chewable?

Apoquel Chewable is used to relieve itching and inflammation caused by a variety of diagnoses, including allergic dermatitis and atopic dermatitis.

What should I discuss with my veterinarian before giving Apoquel Chewable to my pet?

Tell your veterinarian if your pet has ever had an allergic reaction to the medication.

What are the potential side effects of Apoquel Chewable?

Apoquel Chewable may increase susceptibility to infection, including demodicosis. It may also exacerbate neoplastic conditions. Adverse reactions reported in a masked field study included diarrhea, vomiting, anorexia, new cutaneous or subcutaneous lumps, and lethargy. In most cases, diarrhea, vomiting, anorexia, and lethargy spontaneously resolved with continued dosing.

What happens if I miss giving a dose of Apoquel Chewable?

Give the missed dose with food as soon as you remember and resume a regular dosing schedule.

What happens if I overdose my pet on Apoquel Chewable?

Contact your veterinarian immediately.

What should I avoid while giving Apoquel Chewable to my pet?

Apoquel Chewable should not be given to dogs younger than 12 months or those with serious infections. Apoquel Chewable is not for use in breeding dogs, or pregnant or lactating bitches. The use of Apoquel Chewable has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. Dogs receiving Apoquel Chewable should be monitored for the development of infections, including demodicosis and neoplasia.

What other drugs will affect Apoquel Chewable?

Talk to your veterinarian before giving any prescription or over the counter medications.