Apoquel Tablets for Dogs

Veterinarian Prescription (Rx) Required 

Description

Apoquel Tablets by Zoetis are a prescription medication containing oclacitinib for the control of pruritus associated with allergic dermatitis and the control of atopic dermatitis in dogs at least 12 months of age.

Oclacitinib is a Janus Kinase (JAK) inhibitor that targets signaling pathways involved in allergic itch and inflammation. This targeted mechanism provides an oral option for managing acute and chronic allergic skin conditions under the direction of a veterinarian.

Apoquel Tablets may be administered with or without food. The standard labeled regimen begins with twice-daily administration for up to 14 days, followed by once-daily maintenance therapy.

Uses & Benefits

• Controls pruritus associated with allergic dermatitis
• Controls atopic dermatitis
• Helps relieve allergic itching
• Helps control inflammation associated with allergic skin disease
• Targets specific pathways involved in itch and inflammation
• FDA-approved for dogs at least 12 months of age
• Oral tablet formulation
• May be given with or without food
• Suitable for veterinarian-directed maintenance therapy
• Prescription medication specifically formulated for dogs

How It Works

Apoquel contains oclacitinib maleate, a synthetic Janus Kinase (JAK) inhibitor.

Oclacitinib inhibits the function of several cytokines involved in allergic reactions, inflammation, and pruritus that depend on JAK enzyme activity. By modulating these signaling pathways, Apoquel helps control the itching and inflammation associated with allergic and atopic dermatitis.

Indications

For use in dogs at least 12 months of age for:

• Pruritus associated with allergic dermatitis / Atopic dermatitis

Apoquel is for oral use in dogs only and requires a prescription from a licensed veterinarian.

Ingredients

Active Ingredients:

• Oclacitinib, provided as oclacitinib maleate

Inactive Ingredients:

• Refer to manufacturer label for complete inactive ingredient information.

The current FDA/DailyMed prescribing information does not provide a complete inactive ingredient list for Apoquel Tablets.

Directions

Administer Apoquel orally exactly as prescribed by your veterinarian.

Apoquel may be given with or without food.

Follow your veterinarian's instructions regarding the duration of treatment and continued maintenance therapy.

Weight / Dosage

The recommended dose is 0.18–0.27 mg oclacitinib per lb (0.4–0.6 mg/kg) of body weight, administered orally:

• Twice daily for up to 14 days
• Once daily thereafter for maintenance therapy

Administer exactly as prescribed by your veterinarian. Follow all dosing and administration instructions provided on the prescription label and by your veterinarian. Do not adjust the dose, frequency, route, or duration of administration unless directed by your veterinarian.

Cautions

• For oral use in dogs only.
• Federal law restricts this drug to use by or on the order of a licensed veterinarian.
• Do not use in dogs less than 12 months of age.
• Apoquel is not for use in dogs with serious infections.
• Apoquel modulates the immune system and may increase susceptibility to infection, including demodicosis.
• Apoquel may exacerbate neoplastic conditions.
• New neoplastic conditions, both benign and malignant, have been observed in dogs treated with Apoquel.
• Consider the risks and benefits before initiating treatment in dogs with a history of recurrent serious infections, recurrent demodicosis, or neoplasia.
• Keep out of reach of children.

Possible Side Effects

Adverse reactions reported during clinical studies include:

• Diarrhea / Vomiting / Decreased appetite or anorexia / Lethargy / New cutaneous or subcutaneous lumps

Apoquel modulates the immune system and may increase susceptibility to infections and neoplastic conditions. Changes in certain laboratory values have also been observed during treatment.

Contact your veterinarian if your dog develops persistent vomiting or diarrhea, significant appetite changes, unusual lumps, signs of infection, skin changes, significant lethargy, or another concerning reaction.

Precautions

• Use only under the direction of a licensed veterinarian
• Not for use in dogs less than 12 months of age
• Not for use in dogs with serious infections
• Monitor dogs for the development of infections during treatment
• Monitor for the development of neoplasia
• Consider periodic complete blood counts and serum biochemistry monitoring during long-term therapy
• Consider the risks and benefits before use in dogs with recurrent serious infections, recurrent demodicosis, or neoplasia
• Safe use has not been evaluated in breeding, pregnant, or lactating dogs
• Tell your veterinarian about all medications and supplements your dog receives

Storage

Store at controlled room temperature according to the current manufacturer label. Keep medication in its original container and protect it from inappropriate temperature and moisture conditions. Keep out of reach of children and animals.

Disposal

Dispose of unused or expired medication according to your veterinarian's, pharmacist's, or local medication disposal recommendations. Keep discarded medication where children and animals cannot access it.