Description

Zenrelia Tablets

Ilunocitinib tablets for Dogs | Immunomodulator

A Janus kinase (JAK) inhibitor for the control of pruritus associated with allergic dermatitis and atopic dermatitis in dogs.

Manufactured/Marketed by:

Elanco US Inc., Indianapolis, Indiana, USA.

Country of Origin:

USA (manufacturer information in the supplied leaflet).

Dosage form: Oral tablets (scored).

Presentation:

4.8 mg, 6.4 mg, 8.5 mg and 15 mg tablets. Available in 10- and 30-count blister packages and 90-count bottles.

Ingredients & Composition:

Ilunocitinib (active ingredient). The supplied leaflet identifies four tablet strengths: 4.8 mg, 6.4 mg, 8.5 mg and 15 mg.

Description / Action

Zenrelia Tablets contain ilunocitinib that is a synthetic Janus kinase (JAK) inhibitor belonging to the pyrimidine class of JAK inhibitors. Ilunocitinib is a non-selective JAK inhibitor with high potency for JAK1, JAK2 and tyrosine kinase 2 (TYK2) inhibition.

It inhibits the function of various pruritogenic, pro-inflammatory and allergy-related cytokines dependent on JAK enzymes. It is neither a corticosteroid nor an antihistamine.

Class:

Immunomodulator; Janus kinase (JAK) inhibitor.

Indication / Uses

Control of pruritus associated with allergic dermatitis in dogs.

Control of atopic dermatitis in dogs at least 12 months of age.

Dosage and administration

Dose: 0.27–0.36 mg ilunocitinib/lb (0.6–0.8 mg/kg) body weight, administered orally once daily, with or without food.

Zenrelia Dosing Chart

Administration: Tablets are scored and can be divided to provide the prescribed dose. Use the manufacturer’s weight-based dosing chart and appropriate tablet strengths.

Overdoses / Side effects / Contraindications / Warnings

Side effects

Adverse reactions reported in clinical studies include:

• • Vomiting or nausea, diarrhea and lethargy.
  • Anorexia, increased appetite, weight gain and weight loss.
  • Otitis externa, bacterial and fungal skin infections, interdigital cysts and dermal growths.
  • Coughing, wheezing and respiratory infections.
  • Urinary tract infections and elevated liver enzymes.
  • Hematological changes, including leukopenia, neutropenia and decreased red blood cell parameters.

New benign and malignant neoplastic conditions were observed during clinical studies.

Contraindications and warnings

• • Not for use in dogs less than 12 months of age.
  • Not for use in dogs with serious infections.
  • Dogs should be monitored for infections due to increased susceptibility associated with immunomodulation.
  • Consider risks and benefits before initiating treatment in dogs with recurrent serious infections, recurrent demodicosis or neoplasia.
  • May cause progressive or persistently decreased hematocrit, hemoglobin and/or red blood cell count without a corresponding increase in absolute reticulocyte count.
  • Dogs should be up to date on vaccinations before starting treatment.

Vaccine warning: Dogs receiving Zenrelia are at risk of an inadequate immune response to vaccines. Discontinue Zenrelia for at least 28 days to 3 months before vaccination and withhold it for at least 28 days after vaccination. The longer pre-vaccination interval is supported by the vaccine-response findings described in the label.

Overdose: The supplied US label describes adverse findings in dose-escalation and margin-of-safety studies, including interdigital furunculosis, hematological changes and serious infections at higher exposures. It does not provide a specific clinical overdose-treatment protocol.

Pharmaceutical precautions / Instructions

Keep out of reach of children and animals.

Wash hands immediately after handling tablets.

In case of accidental human ingestion, seek medical attention immediately.

Store securely to prevent accidental ingestion or overdose by dogs, cats or other animals.

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

Monitor for infections and relevant hematological abnormalities during treatment.

Safety: Age / Pregnancy / Withdrawal

Age: Not for use in dogs under 12 months of age.

Pregnancy and lactation: Safe use has not been evaluated in breeding, pregnant or lactating dogs.

Vaccination: Discontinue for at least 28 days to 3 months before vaccination and withhold for at least 28 days after vaccination, as directed by the prescribing veterinarian.

Withdrawal period: Not applicable as a food-producing animal withdrawal period in the supplied label, which is for dogs only.

Pharmaceutical precautions / Storage

Storage conditions: Store at room temperature between 15–25°C (59–77°F). Excursions permitted between 5–40°C (41–104°F).

Packaging: Scored tablets in four strengths: 4.8 mg, 6.4 mg, 8.5 mg and 15 mg. Available in 10- and 30-count blister packages and 90-count bottles.

Substitute

These are alternative treatments for allergic or atopic dermatitis, not direct dose-for-dose substitutes.

1. 1. Apoquel (oclacitinib) — Another JAK inhibitor used for control of pruritus associated with allergic dermatitis and atopic dermatitis in dogs. It has its own dosing, contraindications and safety precautions.
   2. Cytopoint (lokivetmab) — A monoclonal antibody targeting canine interleukin-31, used for control of pruritus associated with atopic dermatitis. It is a different therapeutic class.