Zoetis Apoquel Manual

Zoetis Ikke kategoriseret Apoquel

Læs nedenfor 📖 manual på dansk for Zoetis Apoquel (2 sider) i kategorien Ikke kategoriseret. Denne guide var nyttig for 6 personer og blev bedømt med 4.5 stjerner i gennemsnit af 2 brugere

Download PDF
Side 1/2
Immunomodulator
For oral use in dogs only
Caution: Federal (USA) Law restricts this drug to use by or on the order of a licensed
veterinarian.
Description: APOQUEL (oclacitinib maleate) is a synthetic Janus Kinase (JAK) inhibitor. The
chemical composition of APOQUEL 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: Control of pruritus associated with allergic dermatitis and control of atopic
dermatitis in dogs at least 12 months of age.
Dosage and Administration: The dose of APOQUEL (oclacitinib maleate) tablets 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. APOQUEL
may be administered with or without food.
Dosing Chart
Weight Range
(in lb)
Weight Range
(in Kg)
Number of Tablets to be
Administered
Low High Low High 3.6 mg
Tablets
5.4 mg
Tablets
16 mg
Tablets
6.6 9.9 3.0 4.4 - - 0.5
10.0 14.9 4.5 5.9 - - 0.5
15.0 19.9 6.0 8.9 - -1
20.0 29.9 9.0 13.4 - -1
30.0 44.9 13.5 19.9 - - 0.5
45.0 59.9 20.0 26.9 - -2
60.0 89.9 27.0 39.9 - - 1
90.0 129.9 40.0 54.9 - - 1.5
130.0 175.9 55.0 80.0 - - 2
Warnings:
APOQUEL is not for use in dogs less than 12 months of age (see ).Animal Safety
APOQUEL modulates the immune system.
APOQUEL is not for use in dogs with serious infections.
APOQUEL may increase susceptibility to infection, including demodicosis, and exacerbation of
neoplastic conditions (see Precautions, Adverse Reactions, Post-Approval Experience and
Animal Safety).
New neoplastic conditions (benign and malignant) were observed in dogs treated with
APOQUEL during clinical studies and have been reported in the post-approval period
(see ).Adverse Reactions and Post-Approval Experience
Consider the risks and benefits of treatment prior to initiating APOQUEL in dogs with a history
of recurrent serious infections or recurrent demodicosis or neoplasia (see Adverse Reactions,
Post-Approval Experience Animal Safety, and ).
Keep APOQUEL 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 should be monitored for the development of infections, including
demodicosis, and neoplasia.
The use of APOQUEL has not been evaluated in combination with glucocorticoids,
cyclosporine, or other systemic immunosuppressive agents.
APOQUEL is not for use in breeding dogs, or pregnant or lactating bitches.
Adverse Reactions:
Control of Atopic Dermatitis
In a masked field study to assess the effectiveness and safety of oclacitinib for the control
of atopic dermatitis in dogs, 152 dogs treated with APOQUEL and 147 dogs treated with
placebo (vehicle control) were evaluated for safety. The majority of dogs in the placebo group
withdrew from the 112-day study by Day 16. Adverse reactions reported (and percent of
dogs affected) during Days 0-16 included diarrhea (4.6% APOQUEL, 3.4% placebo), vomiting
(3.9% APOQUEL, 4.1% placebo), anorexia (2.6% APOQUEL, 0% placebo), new cutaneous or
subcutaneous lump (2.6% APOQUEL, 2.7% placebo), and lethargy (2.0% APOQUEL, 1.4%
placebo). In most cases, diarrhea, vomiting, anorexia, and lethargy spontaneously resolved
with continued dosing. Dogs on APOQUEL had decreased leukocytes (neutrophil, eosinophil,
and monocyte counts) and serum globulin, and increased cholesterol and lipase compared
to the placebo group but group means remained within the normal range. Mean lymphocyte
counts were transiently increased at Day 14 in the APOQUEL group.
Dogs that withdrew from the masked field study could enter an unmasked study where all
dogs received APOQUEL. Between the masked and unmasked study, 283 dogs received at
least one dose of APOQUEL. Of these 283 dogs, two dogs were withdrawn from study due
to suspected treatment-related adverse reactions: one dog that had an intense flare-up of
dermatitis and severe secondary pyoderma after 19 days of APOQUEL administration, and one
dog that developed generalized demodicosis after 28 days of APOQUEL administration. Two
other dogs on APOQUEL were withdrawn from study due to suspected or confirmed malignant
neoplasia and subsequently euthanized, including one dog that developed signs associated
with a heart base mass after 21 days of APOQUEL administration, and one dog that developed
a Grade III mast cell tumor after 60 days of APOQUEL administration.
One of the 147 dogs in the placebo group developed a Grade I mast cell tumor and was
withdrawn from the masked study. Additional dogs receiving APOQUEL were hospitalized
for diagnosis and treatment of pneumonia (one dog), transient bloody vomiting and stool
(one dog), and cystitis with urolithiasis (one dog).
In the 283 dogs that received APOQUEL, the following additional clinical signs were reported
after beginning APOQUEL (percentage of dogs with at least one report of the clinical sign as
a non-pre-existing finding): pyoderma (12.0%), non-specified dermal lumps (12.0%), otitis
(9.9%), vomiting (9.2%), diarrhea (6.0%), histiocytoma (3.9%), cystitis (3.5%), anorexia (3.2%),
lethargy (2.8%), yeast skin infections (2.5%), pododermatitis (2.5%), lipoma (2.1%), polydipsia
(1.4%), lymphadenopathy (1.1%), nausea (1.1%), increased appetite (1.1%), aggression
(1.1%), and weight loss (0.7).
Control of Pruritus Associated with Allergic Dermatitis
In a masked field study to assess the effectiveness and safety of oclacitinib for the control of
pruritus associated with allergic dermatitis in dogs, 216 dogs treated with APOQUEL and
220 dogs treated with placebo (vehicle control) were evaluated for safety. During the 30-day
study, there were no fatalities and no adverse reactions requiring hospital care. Adverse
reactions reported (and percent of dogs affected) during Days 0-7 included diarrhea
(2.3% APOQUEL, 0.9% placebo), vomiting (2.3% APOQUEL, 1.8% placebo), lethargy
(1.8% APOQUEL, 1.4% placebo), anorexia (1.4% APOQUEL, 0% placebo), and polydipsia
(1.4% APOQUEL, 0% placebo). In most of these cases, signs spontaneously resolved with
continued dosing. Five APOQUEL group dogs were withdrawn from study because of:
darkening areas of skin and fur (1 dog); diarrhea (1 dog); fever, lethargy and cystitis (1 dog);
an inflamed footpad and vomiting (1 dog); and diarrhea, vomiting, and lethargy (1 dog). Dogs
in the APOQUEL group had a slight decrease in mean white blood cell counts (neutrophil,
eosinophil, and monocyte counts) that remained within the normal reference range. Mean
lymphocyte count for dogs in the APOQUEL group increased at Day 7, but returned to
pretreatment levels by study end without a break in APOQUEL administration. Serum
cholesterol increased in 25% of APOQUEL group dogs, but mean cholesterol remained
within the reference range.
Continuation Field Study
After completing APOQUEL field studies, 239 dogs enrolled in an unmasked (no placebo
control), continuation therapy study receiving APOQUEL for an unrestricted period of time.
Mean time on this study was 372 days (range 1 to 610 days). Of these 239 dogs, one
dog developed demodicosis following 273 days of APOQUEL administration. One dog
developed dermal pigmented viral plaques following 266 days of APOQUEL administration.
One dog developed a moderately severe bronchopneumonia after 272 days of APOQUEL
administration; this infection resolved with antimicrobial treatment and temporary
discontinuation of APOQUEL. One dog was euthanized after developing abdominal ascites
and pleural effusion of unknown etiology after 450 days of APOQUEL administration. Six dogs
were euthanized because of suspected malignant neoplasms: including thoracic metastatic,
abdominal metastatic, splenic, frontal sinus, and intracranial neoplasms, and transitional cell
carcinoma after 17, 120, 175, 49, 141, and 286 days of APOQUEL administration, respectively.
Two dogs each developed a Grade II mast cell tumor after 52 and 91 days of APOQUEL
administration, respectively. One dog developed low grade B-cell lymphoma after 392 days
of APOQUEL administration. Two dogs each developed an apocrine gland adenocarcinoma
(one dermal, one anal sac) after approximately 210 and 320 days of APOQUEL administration,
respectively. One dog developed a low grade oral spindle cell sarcoma after 320 days of
APOQUEL administration.
Post-Approval Experience (2020):
The following adverse events are based on post-approval adverse drug experience reporting
for APOQUEL. Not all adverse events are reported to FDA/CVM. It is not always possible to
reliably estimate the adverse event frequency or establish a causal relationship to product
exposure using these data.
The following adverse events reported in dogs are listed in decreasing order of reporting
frequency.
Vomiting, lethargy, anorexia, diarrhea, elevated liver enzymes, dermatitis (i.e. crusts,
pododermatitis, pyoderma), seizures, polydipsia, and demodicosis.
Benign, malignant, and unclassified neoplasms, dermal masses (including papillomas and
histiocytomas), lymphoma and other cancers have been reported.
Death (including euthanasia) has been reported.
Contact Information:
To report suspected adverse events, for technical assistance or to obtain a copy of the
Safety Data Sheet, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.
For additional information about adverse drug experience reporting for animal drugs, contact
FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

Produkt Specifikationer

Mærke: Zoetis
Kategori: Ikke kategoriseret
Model: Apoquel

Har du brug for hjælp?

Hvis du har brug for hjælp til Zoetis Apoquel stil et spørgsmål nedenfor, og andre brugere vil svare dig


Ikke kategoriseret Zoetis Manualer

Zoetis

Zoetis Rimadyl Manual

20 August 2024
Zoetis

Zoetis Cazitel Manual

16 August 2024
Zoetis

Zoetis Cerenia Manual

16 August 2024
Zoetis

Zoetis Apoquel Manual

15 August 2024

Ikke kategoriseret Manualer

Nyeste Ikke kategoriseret Manualer

Elektron

Elektron Overbridge Manual

26 November 2024
Elektron

Elektron Sidstation Manual

26 November 2024
SKROSS

SKROSS World Adapter Pro+ Manual

26 November 2024
SKROSS

SKROSS PRO – World & USB Manual

26 November 2024
SoundTube

SoundTube IPD-RS82-EZ Manual

26 November 2024
Kramer

Kramer 4x1VB Manual

26 November 2024
Kramer

Kramer RC-63A Manual

26 November 2024
SoundTube

SoundTube IPD-HP82-EZ Manual

26 November 2024
Kramer

Kramer RK-KVM-1U-PP3 Manual

26 November 2024
Gioteck

Gioteck VX-2 (PS3) Manual

26 November 2024