Oclacitinib

Oclacitinib
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Edzel Lorraine Co, DMD, MD[2]

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Overview

Oclacitinib is an immunomodulator that is FDA approved for the treatment of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Oclacitinib FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Oclacitinib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Oclacitinib Contraindications in the drug label.

Warnings

There is limited information regarding Oclacitinib Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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.

Postmarketing Experience

The following adverse events are based on postapproval 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 papilomas and histiocytomas), lymphoma and other cancers have been reported. Death (including euthanasia) has been reported.

Drug Interactions

There is limited information regarding Oclacitinib Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Oclacitinib in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oclacitinib in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Oclacitinib during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Oclacitinib in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Oclacitinib in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Oclacitinib in geriatric settings.

Gender

There is no FDA guidance on the use of Oclacitinib with respect to specific gender populations.

Race

There is no FDA guidance on the use of Oclacitinib with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Oclacitinib in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Oclacitinib in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Oclacitinib in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Oclacitinib in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Oclacitinib Administration in the drug label.

Monitoring

There is limited information regarding Oclacitinib Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Oclacitinib and IV administrations.

Overdosage

There is limited information regarding Oclacitinib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Oclacitinib Mechanism of Action in the drug label.

Structure

Oclacitinib inhibits the function of a variety of pruritogenic cytokines and proinflammatory cytokines, as well as cytokines involved in allergy that are dependent on JAK1 or JAK3 enzyme activity. It has little effect on cytokines involved in hematopoiesis that are dependent on JAK2. Oclacitinib is not a corticosteroid or an antihistamine.

Pharmacodynamics

There is limited information regarding Oclacitinib Pharmacodynamics in the drug label.

Pharmacokinetics

In dogs, oclacitinib maleate is rapidly and well absorbed following oral administration, with mean time to peak plasma concentrations (T ) of less than 1 hour. Following oral administration of 0.4-0.6 mg oclacitinib/kg to 24 dogs, the mean (90% confidence limits [CL]) maximum concentration (C ) was 324 (281, 372) ng/mL and the mean area under the plasma concentration-time curve from 0 and extrapolated to infinity (AUC ) was 1890 (1690, 2110) ng∙hr/mL. The prandial state of dogs does not significantly affect the rate or extent of absorption. The absolute bioavailability of oclacitinib maleate was 89%. Oclacitinib has low protein binding with 66.3-69.7% bound in fortified canine plasma at nominal concentrations ranging from 10-1000 ng/mL. The apparent mean (95% CL) volume of distribution at steady-state was 942 (870, 1014) mL/kg body weight. Oclacitinib is metabolized in the dog to multiple metabolites and one major oxidative metabolite was identified in plasma and urine. Overall the major clearance route is metabolism with minor contributions from renal and biliary elimination. Inhibition of canine cytochrome P450 enzymes by oclacitinib is minimal; the inhibitory concentrations (IC ) are 50 fold greater than the observed C values at the use dose. Mean (95% CL) total body oclacitinib clearance from plasma was low – 316 (237, 396) mL/h/kg body weight (5.3 mL/min/kg body weight). Following IV and PO administration, the terminal t appeared similar with mean values of 3.5 (2.2, 4.7) and 4.1 (3.1, 5.2) hours, respectively.

Nonclinical Toxicology

There is limited information regarding Oclacitinib Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Oclacitinib Clinical Studies in the drug label.

How Supplied

APOQUEL tablets contain 3.6 mg, 5.4 mg, or 16 mg of oclacitinib as oclacitinib maleate per tablet. Each strength tablets are packaged in 100 and 250 count bottles. Each tablet is scored and marked with AQ and either an S, M, or L that correspond to the different tablet strengths on both sides.

Storage

APOQUEL 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).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Oclacitinib Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Oclacitinib interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Oclacitinib Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Oclacitinib Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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