Product Description

Zenrelia Tablets are indicated for the management of allergic and atopic skin disease in dogs. Ilunocitinib targets the JAK signalling pathway involved in the release of pruritogenic cytokines, providing anti-itch and anti-inflammatory activity. When treating pruritus associated with allergic dermatitis, underlying causes should be investigated and treated alongside therapy. Zenrelia is an unflavoured tablet, making it suitable for dogs with food hypersensitivity.

For Dogs:

Treatment of pruritus associated with allergic dermatitis

Treatment of the clinical manifestations of atopic dermatitis

Which Animals Can Use Zenrelia Tablets?

Zenrelia Tablets are licensed for use in dogs only. They must not be used in dogs with evidence of immune suppression or progressive malignant neoplasia, or in cases of hypersensitivity to ilunocitinib or any of the excipients. Use in dogs younger than 12 months of age is not recommended. The product is not licensed for use in cats or any other species. Always use only under the direction of your vet.

Available Strengths & Sizes

Please order the specific strength and pack size as directed on your veterinary prescription. The 4.8 mg tablet is indicated for dogs weighing 3–8 kg.

Not all pack sizes may be marketed. Tablets can be divided into two equal halves along the score-line. Any remaining half tablet must be stored in the blister and discarded if not used within 20 days.

Directions for Use

Zenrelia 4.8 mg Tablets are a prescription medication and must be used exactly as directed by your veterinary surgeon. The tablets are administered orally once daily; dosage depends on the dog's bodyweight, which must be determined as accurately as possible before commencing treatment. Tablets may be given with or without food; however, it is recommended to administer consistently in relation to feeding, as bioavailability is higher when given with food. The requirement for long-term therapy should be based on an individual benefit-risk assessment. For long-term treatment, the dog should be re-weighed regularly so that the dose can be adjusted if bodyweight changes significantly.

Contraindications

Source: SPC Section 3.3

Do not use in dogs with evidence of immune suppression

Do not use in dogs with evidence of progressive malignant neoplasia

Do not use in cases of hypersensitivity to the active substance (ilunocitinib) or to any of the excipients

Storage & Handling

No special storage conditions are required. Any remaining half tablet must be stored in the blister and discarded if not used within 20 days. Keep out of the sight and reach of children and animals at all times. No withdrawal period applies as this product is for use in companion animals only.

Important Warnings

Source: SPC Section 3.5

Minimum age: Use in dogs younger than 12 months of age is not recommended; if use cannot be avoided, a veterinary benefit-risk assessment is required

Immunosuppression and infection risk: Ilunocitinib modulates the immune system and may increase susceptibility to opportunistic infections and exacerbate neoplastic conditions; dogs receiving this product should be monitored for the development of infections and neoplasia throughout treatment

Haematological monitoring: The product may cause a decrease in leukocyte counts (monocyte, eosinophil, and neutrophil) and a reduction in red cell mass parameters (red blood cell count, haemoglobin, and haematocrit) when initiating treatment; these changes typically remain within the laboratory reference range, stabilise within the first month, and are not usually clinically relevant; however, periodic monitoring of complete blood counts and serum biochemistry is recommended during long-term treatment

Anaemia: Use in dogs with anaemia has not been evaluated; use only according to a benefit-risk assessment by the responsible veterinary surgeon

Hepatic and renal disease: Use of this product has not been evaluated in dogs with hepatic or renal disease; use in these animals should be according to a benefit-risk assessment by the responsible veterinary surgeon

Underlying causes of pruritus: When treating pruritus associated with allergic dermatitis, investigate and treat underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity); also investigate and treat complicating factors such as bacterial, fungal, or parasitic infections and infestations (e.g. fleas, mange)

Vaccination: The effect of administering vaccines concomitantly with ilunocitinib has been evaluated only in laboratory settings; the decision on whether to administer vaccines concomitantly with Zenrelia should be made according to a benefit-risk assessment by the responsible veterinary surgeon

Pregnancy and lactation: The safety of this product has not been established during pregnancy, lactation, or in breeding dogs; laboratory studies in rats have shown evidence of foetotoxic effects; use is not recommended during pregnancy, lactation, or in dogs intended for breeding

Drug interactions — immunosuppressive agents: Concurrent administration with other drugs with potential immunosuppressive effects (e.g. systemic glucocorticoids, ciclosporin A) must only be undertaken based on a benefit-risk assessment by the responsible veterinary surgeon

Drug interactions — P-glycoprotein substrates: Ilunocitinib is a substrate for the P-glycoprotein transporter; co-treatment with other drugs that are P-glycoprotein substrates, inhibitors, or inducers could give rise to pharmacokinetic drug interactions; the potential clinical consequences have not been investigated

Drug interactions — gastric pH modifiers: Use of gastric pH modifying products (e.g. antacids, proton pump inhibitors) may affect the oral bioavailability of ilunocitinib; such products should be used with caution

Long-term bodyweight monitoring: Dogs on long-term treatment should be re-weighed regularly so that dosing can be adjusted in the event of a significant change in bodyweight

Human safety — Accidental ingestion: Accidental ingestion of this product may cause gastro-intestinal effects; in case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician

Wash hands thoroughly after administration

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 52127/5060