Target species
Cats
Indications for use
Immunotherapy to be used in addition to surgery and radiotherapy in cats with fibrosarcoma (2-5 cm diameter) without metastasis or lymph node involvement in order to reduce the risk of relapse and to increase the time to relapse (local recurrence or metastasis). This was demonstrated in a field trial over a period of 2 years.
Contra-indications
None.
Special warnings for each target species
Use of the recommended mode of administration in 5 injection points is important for achieving efficacy of the product; injection in 1 point may lead to reduced efficacy. Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to the treatment course described.
Efficacy has not been tested in cats with metastasis or lymph node involvement.
As safety and efficacy of repetition of the treatment to treat fibrosarcoma recurrence have not been investigated, repetition of the treatment should be considered by the veterinarian taking into account the benefit-risk balance.
Efficacy of the treatment has not been investigated beyond 2 years following treatment.
Special precautions for use
Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily. Moreover feline IL-2 has been shown to have very low biological activity on human leukocytes compared to human IL-2. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Transient apathy and hyperthermia (above 39.5 °C) may occur. A moderate local reaction may occur (pain on palpation, swelling, scratching) that usually disappears spontaneously within 1 week at most.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation.
Interactions
No information is available on the safety and efficacy of this product when used with any other product. A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Subcutaneous use.
After reconstitution of the lyophilisate with the solvent, shake gently and administer five injections (each approximately 0.2 ml) around the tumour excision site: one injection at each corner and one injection at the centre of a 5 cm x 5 cm square centred on the middle of the surgical scar.
Treatment course: 4 administrations at 1 week intervals (day 0, day 7, day 14, day 21) followed by 2 administrations at 2 week intervals (day 35, day 49).
Start the treatment course the day before radiation therapy, preferably within one month after surgical excision.
Overdose
After the administration of an overdose (10 doses), transient moderate to marked hyperthermia, as well as local reactions (swelling, erythema or slight pain, and in some cases, heat at the injection site) may occur.