Target species
Dogs
Indications for use for each target species
Treatment of pruritus associated with allergic dermatitis in dogs.
Treatment of clinical manifestations of atopic dermatitis in dogs.
Contraindications
Do not use in dogs with evidence of immune suppression.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Safety of this veterinary medicinal product has not been investigated in dogs younger than 12 months of age or weighing less than 3 kg. Therefore, its use in such cases should be based on a benefit-risk assessment by the responsible veterinarian.
Ilunocitinib modulates the immune system and may increase susceptibility to opportunistic infection. Dogs receiving the veterinary medicinal product should be monitored for the development of infections and neoplasia.
Do not use in dogs with evidence of malignant neoplasia, demodicosis or immune suppression such as hyperadrenocorticism, as the active substance has not been evaluated in these cases.
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:
Wash hands after administration.
Accidental ingestion may be harmful.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Keep tablets and unused half tablets in the original packaging until next administration, in order to prevent children from getting direct access to the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
| |
Common (1 to 10 animals / 100 animals treated): | Emesis, Diarrhoea, Lethargy |
Uncommon (1 to 10 animals / 1 000 animals treated): | Papilloma, Interdigital Cyst |
| |
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy, lactation, or in breeding dogs.
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
Laboratory studies in rats have shown evidence of teratogenic, and foetotoxic effects.
Fertility:
The use is not recommended in breeding animals.
Interaction with other medicinal products and other forms of interaction
No drug interactions were observed in field studies where ilunocitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials, vaccines and non-steroidal anti-inflammatory drugs.
The effect of ilunocitinib administration on vaccination with canine parvovirus (CPV), canine distemper virus (CDV), canine adenovirus-2 (CAV-2), canine parainfluenza (CPiV) and inactivated rabies vaccine (RV), has been studied in 10-month-old vaccine naïve dogs, receiving 2.4 mg/kg (3X the maximum recommended label dose) for 89 days. Based on assessment of serological antibody titres, an adequate immune response to canine core Modified Live Vaccines (CAV-2, CDV and CPV) was observed following primary vaccination on Day 28. Response to primary CPiV (non-core vaccine) vaccination in treated animals was 4 of 6 above threshold vs 6 of 8 controls above threshold following primary vaccination. A delayed or reduced response to RV was observed. The clinical relevance of these observed effects in animals vaccinated while being administered ilunocitinib in accordance with the recommended dosing regimen is unclear. The effect of ilunocitinib on response to booster vaccinations has been studied in 10-month-old previously vaccinated dogs receiving 1X or 3X the recommended label dose (0.6 -0.8 or 1.8 -2.4 mg/kg, respectively) for 56 days and showed no difference in booster vaccination response between control and 1X or 3X ilunocitinib treated groups.
Administration routes and dosage
Oral use.
The recommended dose is 0.6 to 0.8 mg ilunocitinib/kg bodyweight, administered once daily.
The requirement for long-term therapy should be based on an individual benefit-risk assessment by the responsible veterinarian.
The tablets can be administered with or without food.
The dosing table below shows the number of tablets required. The tablets are breakable along the score-line.
| | | | |
Body weight (kg) of dog | Strength and number of tablets to be administered: |
4.8 mg tablets | 6.4 mg tablets | 8.5 mg tablets | 15 mg tablets |
3.0 - 4.0 | 0.5 | | | |
4.1 - 5.3 | | 0.5 | | |
5.4 - 6.5 | | | 0.5 | |
6.6 - 8.0 | 1 | | | |
8.1 - 10.6 | | 1 | | |
10.7 - 14.1 | | | 1 | |
14.2 - 16.0 | | 1.5 | | |
16.1 - 19.5 | | | 1.5 | |
19.6 - 24.9 | | | | 1 |
25.0 - 28.3 | | | 2 | |
28.4 - 37.4 | | | | 1.5 |
37.5 - 49.9 | | | | 2 |
50.0 - 62.4 | | | | 2.5 |
62.5 - 74.9 | | | | 3 |
≥ 75 | Administer the appropriate combination of tablet strengths |
| | | | |
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Ilunocitinib tablets were administered orally to healthy 11-12 month old Beagle dogs once daily for 6 months at 0.8 mg/kg body weight (bw), 1.6 mg/kg bw, 2.4 mg/kg bw and 4.0 mg/kg bw. Clinical signs that were likely to be related to ilunocitinib treatment included: interdigital cysts, with or without discharge, swollen and/or scabs on the paws and paw thickening and/or discoloration. More commonly in males, a mild reduction in red blood cell mass was noted in some animals at 3X dose after 8 weeks of use. This reduction was self-limiting, with gradual recovery to pre-treatment measurements.
There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.