Elanco Ilunocitinib 15 mg Film-coated Tablets for Dogs

None.

Special precautions for safe use in the target species:
Use of this veterinary medicinal product in dogs younger than 12 months of age is not
recommended and should be based on a benefit-risk assessment by the responsible
veterinary surgeon.
When dogs are to be administered long-term treatment, it is recommended that they
are re-weighed on a regular basis so that the dose can be adjusted accordingly in the
case of a significant change in bodyweight.
Use of the veterinary medicinal product has not been evaluated in dogs with hepatic
or renal disease. Use of the product in these sub-populations should be according to
a benefit:risk assessment by the responsible veterinary surgeon.
Ilunocitinib modulates the immune system and may increase susceptibility to
opportunistic infection and exacerbate neoplastic conditions. Dogs receiving the
veterinary medicinal product should therefore be monitored for the development of
infections and neoplasia.
The veterinary medicinal product may cause a decrease in leukocyte (monocyte,
eosinophil and neutrophil) counts 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 of treatment and do not appear to be clinically relevant. However, periodic
monitoring of complete blood counts and serum biochemistry is recommended when
dogs are on long-term treatment.
Use of the product in dogs with anaemia has not been evaluated and should be
according to a benefit:risk assessment by the responsible veterinary surgeon.
When treating pruritus associated with allergic dermatitis with ilunocitinib, investigate
and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food
hypersensitivity). Furthermore, in cases of allergic dermatitis and atopic dermatitis, it
is recommended to investigate and treat complicating factors, such as bacterial, fungal
or parasitic infections/infestations (e.g. flea and mange).
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Accidental ingestion of the product may cause gastro-intestinal effects.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Wash hands after administration.
Special precautions for the protection of the environment:
Not applicable.