Each 1 ml dose contains: 10, 20, 30 or 40 mg Lokivetmab.

Lokivetmab is a caninised monoclonal antibody expressed through recombinant techniques in Chinese hamster ovary (CHO) cells.

Solution for injection.

Clear to opalescent solution without any visible particles.

Treatment of pruritus associated with allergic dermatitis in dogs.

Treatment of clinical manifestations of atopic dermatitis in dogs.

Subcutaneous use. Avoid excessive shaking or foaming of the solution. Administer the entire contents (1 ml) of the vial.

Dose according to the dosing chart below. For dogs above 40 kg, the contents of more than one vial are required to administer in a single dose. In those cases, withdraw the appropriate content from each required vial into the same syringe. To allow for mixing of the solution, gently invert the syringe three or four times before administering.

The recommended minimum dose is 1 mg/kg bodyweight, once a month. The need for repeat or longer-term treatment in dogs with allergic dermatitis should be based on the needs of the individual patient including an assessment by the responsible veterinarian of the ability to avoid/eliminate the allergenic stimulus. Dose according to the dosing chart below:

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 3 kg bodyweight.

Lokivetmab may induce transient or persistent anti-drug antibodies. The induction of such antibodies is uncommon and may have no effect (transient anti-drug antibodies) or may result in a noticeable decrease in efficacy (persistent anti-drug antibodies) in animals that responded to treatment previously.

Avoidance or elimination of the allergen is an important consideration in the successful treatment of allergic dermatitis. When treating pruritus associated with allergic dermatitis with lokivetmab, investigate and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity); this product is not intended to be used as a long-term maintenance therapy if the offending allergen(s) can be successfully avoided or eliminated. 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).

It is recommended to monitor dogs for bacterial infections associated with atopic dermatitis, especially during the first weeks of treatment.

If no or limited response is observed within one month after initial dosing, an improvement in response may be observed after administration of a second dose one month later. However, if the animal does not show a better response after the second dose, the veterinary surgeon should consider alternative treatments.

Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.

Accidental self-injection may result in an immune response to lokivetmab. It is not expected for this to cause any adverse effects, however, repeated self-administration may increase the risk of hypersensitivity reactions.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.

Do not use in breeding animals

No drug interactions were observed in field studies where lokivetmab was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials, anti-inflammatories and vaccines.

If a vaccine(s) is to be administered at the same time as treatment with lokivetmab, the vaccine(s) should be administered at a different site to that of lokivetmab.

Do not mix with any other veterinary medicinal product.

Dogs:

Rare (1 to 10 animals / 10,000 animals treated):	Hypersensitivity reaction1 (anaphylaxis, facial oedema, urticaria) Vomiting2, diarrhoea2 Neurological signs (ataxia, convulsion, seizure)
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Injection site pain, injection site swelling Clinical signs of immune mediated diseases (e.g. immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia)

1 In case of such reactions, appropriate treatment should be administered immediately.

2 May occur in connection with hypersensitivity reactions. Treatment should be administered as needed.

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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.

Store in a refrigerator (2 °C - 8 °C).

Do not freeze.

Store in the original package. Protect from light.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: use immediately

Keep out of the sight and reach of children.

For animal treatment only.

Single dose clear glass Type I vials with chlorobutyl rubber stopper.

Pack sizes:

CYTOPOINT 10, 20, 30 and 40 mg solution for injection for dogs:

Cardboard box with 1 vial of 1 ml, 2 vials of 1 ml or 6 vials of 1 ml

Not all pack sizes may be marketed.

Not applicable.

Lokivetmab is a caninised monoclonal antibody (mAb) specifically targeting canine interleukin-31. The blocking of IL-31 by lokivetmab prevents IL-31 from binding to its co-receptor and thereby inhibits IL-31 mediated cell signalling, providing relief from atopic dermatitis-related pruritus and anti-inflammatory activity.

In a laboratory model study lokivetmab demonstrated an onset of efficacy for pruritus by the first time point at 8 hours post administration.

In field studies up to 9 months, treatment of dogs with atopic dermatitis was demonstrated to have a favourable effect on the reduction of pruritus and on the reduction of disease severity as evaluated by Canine Atopic Dermatitis Extent and Severity Index (CADESI) 03 scores. A small number of dogs showed a low, or an absence of, clinical response to lokivetmab. This is likely due to the highly targeted mechanism of action of lokivetmab in the context of a complex disease and heterogeneous pathogenesis.

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

UK(GB): Vm 42058/5017-5020

UK(NI): EU/2/17/205/001-012