Palladia 10 mg Film-Coated Tablets for Dogs

For any mast cell tumour treatable by surgery, surgery should be the first choice of
treatment.

Special precautions for use in animals
Dogs should be carefully monitored. Dose reductions and/or dose interruptions may
be needed to manage adverse events. Treatment should be reviewed weekly for the
first six weeks and every six weeks thereafter or at intervals deemed appropriate by
the veterinarian. Evaluations should include assessment of clinical signs reported by
the pet owner.
To appropriately use the dose adjustment table it is advised that a complete blood
cell count, serum chemistry panel and urinalysis be conducted prior to initiation of
treatment and approximately one month after treatment is initiated; thereafter at
approximately six week intervals or as determined by the veterinarian. Periodic
monitoring of laboratory variables should be completed in the context of the clinical
signs and condition of the animal and results of laboratory variables at prior visits.
The safety of Palladia was evaluated in mast cell tumour-bearing dogs with the
following:
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Palladia can cause vascular dysfunction which can lead to oedema and
thromboembolism, including pulmonary thromboembolism. Discontinue treatment
until clinical signs and clinical pathology have normalised. Before performing
surgery, discontinue treatment for at least 3 days in order to assure vasculature
homeostasis.
If systemic mastocytosis is present, standard pre-emptive care (e.g., H-1 and H-2
blockers) should be implemented prior to initiation of Palladia to avoid or minimize
clinically significant mast cell degranulation and subsequent potentially severe
systemic side effects.
Palladia has been associated with diarrhoea or gastrointestinal bleeding which may
be severe and requires prompt treatment. Dose interruptions and dose reductions
may be needed depending upon the severity of clinical signs.
In rare cases, serious and sometimes fatal gastrointestinal complications including
gastrointestinal perforation occurred in dogs treated with Palladia (See section 4.6).

Revised: April 2025
AN: 04193/2024
If gastrointestinal ulceration is suspected, whether or not due to Palladia or to mast
cell tumour degranulation, stop the administration of Palladia and treat appropriately.
Toceranib is metabolised in the liver and in the absence of any studies on the effects
of renal or hepatic impairment, should be used with caution in dogs suffering from
hepatic disease.
Treatment should be permanently discontinued if severe adverse events recur or
persist despite appropriate supportive care and dose reduction as described in the
following table.
Dose Adjustment Based on Clinical Signs / PathologyClinical signs / pathologyDose Adjustment*Anorexia<50% food intake ≥2Discontinue treatment and institute dietary
modification ± supportive care until food intake
improves, then decrease dose by 0.5 mg/kg
Diarrhoea<4 watery stools/day for < 2
days or soft stools
Maintain dose level and institute supportive care>4 watery stools/day or
days
Discontinue treatment until formed stools and
institute supportive care, then decrease dose by
0.5 mg/kg
Gastrointestinal Bleeding Fresh blood in stool or black
tarry stool for >2 days or frank
haemorrhage or blood clots in
stool
Discontinue treatment and institute supportive
care until resolution of all clinical signs of blood in
stool, then decrease dose by 0.5 mg/kg
Hypoalbuminemia (albumin)Albumin <1.5 g/dlDiscontinue treatment until >1.5 g/dl and clinical
signs normal, then decrease dose by 0.5 mg/kg
Neutropenia (neutrophil count)>1000/µlMaintain dose level≤1000/µl
or infection
Discontinue treatment until >1000/µl and clinical
signs normal, then decrease dose by 0.5 mg/kg
Anaemia (hematocrit)>26%Maintain dose level≤26%Discontinue treatment until >26%, then decrease
dose by 0.5 mg/kg
Hepatic Toxicity (ALT, AST)>1X – 3X upper normal limitMaintain dose level; discontinue hepatotoxic
drugs, if used
>3X upper normal limitDiscontinue treatment until ≤3X upper normal
limit, discontinue hepatotoxic drugs, if used, then
decrease dose by 0.5 mg/kg

Revised: April 2025
AN: 04193/2024
Renal Toxicity (creatinine)<1.25 X upper normal limitMaintain dose level≥1.25 X upper normal limitDiscontinue treatment until <1.25 X upper normal
limit, then decrease dose by 0.5 mg/kg
Concurrent anaemia, azotemia, hypoalbuminemia and hyperphosphatemiaDiscontinue treatment for 1 to 2 weeks until values have improved and albumin
>2.5 g/dl, then decrease dose by 0.5 mg/kg.
*A 0.5 mg/kg dose decrease is a decrease from 3.25 mg/kg to 2.75 mg/kg or from
2.75 mg/kg to 2.25 mg/kg. The dose should not be <2.2 mg/kg.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Palladia may impair male and female fertility and embryo/foetal development. Avoid
skin contact with the tablets, faeces, urine, and vomit of treated dogs. The tablets
must be administered as a whole and should not be broken or ground. If a broken
tablet is rejected by the dog after chewing, it should be disposed of. Wash hands
thoroughly with soap and water following handling of the product, and disposing of
vomit, urine, or faeces of treated dogs.
Pregnant women should not routinely administer Palladia, should avoid contact with
faeces, urine and vomit from treated dogs and broken or moistened Palladia tablets.
Ingestion of Palladia may be harmful for children. Children must not come into
contact with the product. Keep children away from faeces, urine or vomit of treated
dogs.
Gastrointestinal discomfort such as vomiting or diarrhoea may occur if this drug is
accidentally ingested. In the case of accidental ingestion, seek medical advice
immediately and show Package Leaflet or label to the physician.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.

Revised: April 2025
AN: 04193/2024