Target species
Dogs.
Indications for use
For the treatment of pruritus associated with allergic dermatitis in dogs.
For the treatment of the clinical manifestations associated with atopic dermatitis in dogs, including pruritus.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Safety of this veterinary medicinal product has not been investigated in dogs younger than 6 months of age or weighing less than 3 kg1. Use of the veterinary medicinal product in younger animals or animals with a lower bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Complicating factors such as bacterial, fungal or parasitic infections (e.g., fleas, Demodex mites), in addition to any underlying causes of allergic and atopic dermatitis (e.g., flea allergy, contact allergy, food allergy) should be investigated and treated.
Use of the veterinary medicinal product has not been evaluated in combination with systemic immunosuppressive agents such as glucocorticoids, cyclosporine or other immunosuppressive agents. Furthermore, the safety of the veterinary medicinal product has not been investigated in dogs with evidence of immunosuppression (for example, uncontrolled primary hypothyroidism, rickettsial disease) or dogs with evidence of progressive malignant neoplasia. Use in such cases should be based on a benefit-risk assessment by the responsible veterinarian.
1 only applies to SPC of the lowest 4.8 mg strength.
Operator warnings
Wash hands thoroughly with soap and water immediately after use of the veterinary medicinal product.
Adverse Reactions
Dogs:
Common (1 to 10 animals / 100 animals treated): | Emesis, diarrhoea Lethargy, anorexia |
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 or lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs.
Pregnancy and lactation:
The use of the veterinary medicinal product during pregnancy and lactation is not recommended. Laboratory studies in rats and rabbits have shown effects on prenatal development inherent to the class of JAK inhibitors.
Fertility:
The use of the veterinary medicinal product is not recommended in breeding animals.
Laboratory studies in male rats showed an effect on sperm counts and sperm motility.
Interactions
No drug interactions were observed in field studies where the veterinary medicinal product was administered concomitantly with other veterinary medicinal products such as antimicrobials (including topical preparations), ecto- and endoparasiticides (isoxazolines, milbemycins, avermectins, pyrethrins and pyrethroids), nutritional supplements, topical skin and ear cleansers that did not contain glucocorticoids, and medicated shampoos.
The user is also referred to ‘Special precautions for safe use in the target species’ section for additional guidance.
In a controlled laboratory study, a similar serological response to vaccination with modified live canine adenovirus type-2 (CAV), canine distemper virus (CDV), canine parvovirus (CPV) and inactivated rabies virus (RV) was observed when 6-month-old vaccine naïve puppies were administered the veterinary medicinal product at 3.6 mg/kg atinvicitinib (3 times the maximum labelled dose) once daily for 84 days, compared to dogs receiving the vaccines alone. The veterinary medicinal product was well-tolerated with no adverse clinical effects related to treatment when used concomitantly with vaccination.
Amounts to be administered and administration route
Oral use.
The veterinary medicinal product should be administered once daily at the recommended dose of 0.8 to 1.2 mg atinvicitinib/kg bodyweight at or around the time of feeding, in accordance with the following dosing table. Doses in the table, achieved within each weight band, correspond to the recommended dose of atinvicitinib in milligrams per kilogram bodyweight:
The tablets are breakable along the score line.
Dogs outside the listed weight bands, for example dogs above 79 kg bodyweight, can be dosed with a combination of full and/or half tablets of the appropriate tablet strengths to achieve a target dose of 0.8 to 1.2 mg atinvicitinib/kg bodyweight (see section Special precautions for use). However, the available tablet strengths do not allow for accurate dosing of dogs weighing less than 2 kg bodyweight.
The intensity and duration of pruritus associated with allergic dermatitis and the clinical manifestations of atopic dermatitis are variable. The need for long-term treatment of dogs receiving the veterinary medicinal product should be based on an individual benefit-risk assessment.
Overdose
For atinvicitinib, a high selectivity of JAK1 was shown, reducing the potential for adverse effects mediated via the inhibition of other JAK family enzymes.
The veterinary medicinal product was well tolerated when administered orally to healthy 6-month-old puppies treated with overdoses of up to 5 times the maximum recommended dose once daily over a period of 6 months. However, the administration of significant overdoses of the veterinary medicinal product may lead to a higher susceptibility to infection; for example, the development of bacterial, fungal and/or parasitic skin disease in treated dogs. In case of adverse clinical effects following an overdose, the dog should be treated symptomatically.
Withdrawal periods
Not applicable.