APOQUEL TABLET (CHEWABLE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OCLACITINIB (OCLACITINIB MALEATE)

Available from:

ZOETIS CANADA INC

Dosage:

5.4MG

Pharmaceutical form:

TABLET (CHEWABLE)

Composition:

OCLACITINIB (OCLACITINIB MALEATE) 5.4MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic group:

DOGS

Product summary:

Active ingredient group (AIG) number: 0155910002

Authorization status:

APPROVED

Authorization date:

2022-09-14

Patient Information leaflet

APOQUEL chewable tablets
Draft Product Labels
Zoetis version August 8, 2022
EXTENDED LABEL - 3.6 MG, 5.4 MG AND 16 MG TABLETS - 100 COUNT BOTTLES
3.6 MG STRENGTH
APOQUEL chewable tablets
Draft Product Labels
Zoetis version August 8, 2022
5.4 MG STRENGTH
APOQUEL chewable tablets
Draft Product Labels
Zoetis version August 8, 2022
16 MG STRENGTH
APOQUEL chewable tablets
Draft Product Labels
Zoetis version August 8, 2022
PACKAGE INSERT (part of the extended label and applicable to all
strengths)
DIN XXXXXXXX
DIN XXXXXXXX
DIN XXXXXXXX
oclacitinib chewable tablets
VETERINARY USE ONLY
JANUS KINASE INHIBITOR FOR DOGS
DESCRIPTION: The active ingredient in
APOQUEL
TM
chewable tablets is oclacitinib (as
oclacitinib maleate), a synthetic Janus Kinase inhibitor. The chemical
name of oclacitinib is N-
methyl[trans-4-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)
cyclohexyl]methanesulfonamide
(2Z)-2-butenedioate.
The chemical structure of oclacitinib maleate is:
INDICATIONS: For the control of pruritus associated with allergic
dermatitis and for the control of
atopic dermatitis in dogs at least 12 months of age.
DOSAGE AND ADMINISTRATION: The dose of APOQUEL chewable tablets is 0.4
mg/kg 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. APOQUEL chewable
tablets are palatable and
readily consumed by the majority of dogs (see EFFICACY). APOQUEL
chewable tablets may
be administered by hand, in a bowl, with or without food.
DOSING CHART
DOG BODY WEIGHT
(KG)
3.6 MG CHEWABLE
TABLETS
5.4 MG CHEWABLE
TABLETS
16 MG CHEWABLE
TABLETS
3 – 4.4
0.5
4.5 – 5.9
0.5
6 – 8.9
1
9 – 13.4
1
13.5 – 19.9
0.5
APOQUEL chewable tablets
Draft Product Labels
Zoetis version August 8, 2022
20 – 26.9
2
27 – 39.9
1
40 – 54.9
1.5
55 – 80
2
CONTRAINDICATIONS:
APOQUEL chewable tablets should not be given to dogs with known or
suspected allergy or
intolerance to oclacitinib maleate or any other components of this
product.
APOQUEL chewable tablets are