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 dogs with evidence of progressive malignant neoplasia.
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:
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.
Adverse events
Dogs:
| |
Common (1 to 10 animals / 100 animals treated): | Emesis, Diarrhoea |
Undetermined frequency | Pododermatitis, Papilloma |
| |
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. However, laboratory studies in rats have shown evidence of foetotoxic effects. Therefore, its use is not recommended during pregnancy, lactation or in dogs intended for breeding.
Interaction with other medicinal products and other forms of interaction
Based on adverse event reporting, no known drug interactions were observed under field conditions following concomitant administration of ilunocitinib with other veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials, vaccines or non-steroidal anti-inflammatories.
However, during these clinical trials no specific investigation of the potential for drug interactions was conducted in animals receiving ilunocitinib with another veterinary medicinal product concomitantly.
Concurrent administration with other drugs with potential immunosuppressive effects (e.g. systemic glucocorticoids, cyclosporin A) must only be based on a benefit:risk assessment by the responsible veterinary surgeon.
The effect of ilunocitinib administration concomitantly with vaccines has only been evaluated in the laboratory using vaccines authorised in the USA. A similar serological response to vaccination was seen in Beagle dogs administered the vaccine concomitantly with ilunocitinib at 1x the recommended treatment dose (0.6-0.8 mg/kg bodyweight) compared to dogs administered the vaccine alone. The clinical relevance of these findings (correlate of protection) has not been established and infection challenge studies have not been conducted. The decision on whether to administer vaccines concomitantly with the veterinary medicinal product should be made according to a benefit:risk assessment by the responsible veterinary surgeon.
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 of such interactions have not been investigated.
The use of gastric pH modifiers may affect the oral bioavailability of ilunocitinib. Therefore, such products should be used with caution.
Administration routes and dosage
For oral use.
The recommended dose is 0.6 to 0.8 mg ilunocitinib/kg bodyweight, administered once daily. Bodyweight must be determined as accurately as possible prior to commencing treatment.
The requirement for long-term therapy should be based on an individual benefit-risk assessment.
The tablets can be administered with or without food. However, it is recommended that the veterinary medicinal product is administered in a consistent manner in relation to feeding since its bioavailability is increased by administering the product with food.
The dosing table below shows the number of tablets required. The tablets are breakable along the score-line allowing them to be divided into equal halves, if required.
| | | | |
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)
A target species tolerance study was conducted in which ilunocitinib tablets (final marketed formulation) were administered orally to healthy 11-12 month old Beagle dogs once daily for 6 months at 0.8 mg/kg bw, 1.6 mg/kg bw, 2.4 mg/kg bw and 4.0 mg/kg bw (1, 2, 3 and 5x the recommended treatment dose, respectively). Prior to this, a similar target species tolerance pilot study was carried out with a near-final ilunocitinib tablet formulation. Clinical signs recorded in one or both of these studies that were likely to be related to ilunocitinib treatment included: generalised demodicosis, gum infections, interdigital cysts with or without discharge, papillomas, swollen feet (attributed to interstitial oedema), scabs on the paws and paw thickening and/or discolouration.
A mild-moderate reduction in red blood cell mass (mean haematocrit, haemoglobin and red blood cell count) was recorded in animals administered 2x to 5x the recommended treatment dose of ilunocitinib, with these parameters sometimes falling below the lower limit of the laboratory reference range. This was of no apparent clinical relevance in any of the treated animals.
In a separate study, seven of eight 10-month old vaccine-naïve Beagle dogs administered the veterinary medicinal product at 3x the recommended treatment dose (2.4 mg/kg/day) for up to 88 days developed clinical signs of coccidiosis (haemorrhagic diarrhoea, vomiting, weight loss and pale mucous membranes) due to Isospora canis infection, compared to 0/8 dogs administered placebo tablets. The origin of the parasite was unclear. Two of these eight dogs subsequently developed progressive severe clinical signs (haematemesis, lethargy, dehydration and depression) which were unresponsive to anticoccidial treatment and supportive therapy, necessitating early removal from the study and euthanasia.
In these two dogs, clinical presentation and progression and post-mortem findings were consistent with environmentally-acquired canine adenovirus-1 (CAV-1) infection which was potentially exacerbated by the immunosuppressive effects of ilunocitinib. Four of eight dogs in the ilunocitinib group developed thickening and crusting of the ear margins of unidentified aetiology compared to 0/8 dogs in the placebo group.
There is no specific antidote and in case of signs of overdose in dogs, the veterinary medicinal product should be withdrawn, and the signs 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.