Palladia
Active substance
ATC code
Species
Dogs.
Indications
Treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours in dogs.
Dose to be administered and administration route
Oral use.
Tablets can be administered with or without food.
The initial recommended dose is 3.25 mg/kg bodyweight, administered every second day (see Dosing table for details).
The dose given should be based on veterinary assessments conducted weekly for the first six weeks and, thereafter, every six weeks. Duration of treatment depends on the response to treatment. Treatment should continue in the case of stable disease, or partial or complete response, provided that the product is sufficiently well tolerated. In case of tumour progression, treatment is unlikely to be successful and should be reviewed.
DOSING TABLE: PALLADIA TABLETS AT 3.25 MG/KG BODYWEIGHT
|
Dog Bodyweight (kg) |
Number of Tablets |
||||
|
10 mg (blue) |
15 mg (orange) |
50 mg (red) |
|||
|
5.0* – 5.3 |
1 |
||||
|
5.4 – 6.9 |
2 |
||||
|
7.0 – 8.4 |
1 |
plus |
1 |
||
|
8.5 – 10.0 |
2 |
||||
|
10.1 – 11.5 |
2 |
plus |
1 |
||
|
11.6 – 13.0 |
1 |
plus |
2 |
||
|
13.1 – 14.6 |
3 |
||||
|
14.7 – 16.1 |
1 |
||||
|
16.2 – 17.6 |
1 |
plus |
3 |
||
|
17.7 – 19.2 |
1 |
plus |
1 |
||
|
19.3 – 20.7 |
1 |
plus |
1 |
||
|
20.8 – 23.0 |
2 |
plus |
1 |
||
|
23.1 – 26.9 |
2 |
plus |
1 |
||
|
27.0 – 29.9 |
3 |
plus |
1 |
||
|
30.0 – 32.3 |
2 |
||||
|
32.4 – 34.6 |
1 |
plus |
2 |
||
|
34.7 – 36.1 |
1 |
plus |
2 |
||
|
36.2 – 38.4 |
2 |
plus |
2 |
||
|
38.5 – 43.0 |
2 |
plus |
2 |
||
|
43.1 – 47.6 |
3 |
||||
|
47.7 – 49.9 |
1 |
plus |
3 |
||
|
50.0 – 51.5 |
1 |
plus |
3 |
||
|
51.6 – 53.8 |
2 |
plus |
3 |
||
|
53.9 – 58.4 |
2 |
plus |
3 |
||
|
58.5 – 63.0* |
4 |
||||
* The number of tablets required for dogs below 5.0 kg or above 63 kg bodyweight, should be calculated based on the 3.25 mg/kg dosage regime.
Dose adjustment/reduction:
To manage adverse reactions, the dose may be reduced to 2.75 mg/kg bodyweight or further to 2.25 mg/kg bodyweight administered every second day or treatment can be discontinued for up to two weeks (see Dose Adjustment table in section 4.5).
Adverse reactions
Dogs:
Very common (>1 animal / 10 animals treated): | Mild to moderate: Diarrhoea, vomiting, blood in faeces, haemorrhagic diarrhoea, digestive tract haemorrhage Anorexia, dehydration, lethargy, weight loss Lameness, musculoskeletal disorder Dermatitis, pruritus Decreased haematocrit, hypoalbuminaemia, elevated alanine aminotransferase (ALT), neutropenia, thrombocytopaenia |
Common (1 to 10 animals / 100 animals treated): | Mild to moderate: Localised pain, general pain, polydipsia, pyrexia Depigmentation of the nasal plane, hair coat discolouration, alopecia Nausea, flatulence Tachypnoea Urinary tract infection Elevated total bilirubin, elevated creatinine Severe: Anorexia, dehydration, pyrexia, weight loss, septicaemia, lethargy Diarrhoea, vomiting, blood in faeces, haemorrhagic diarrhoea, digestive tract haemorrhage, duodenal ulcer, nausea Skin necrosis Decreased haematocrit, elevated alanine aminotransferase (ALT) |
Uncommon (1 to 10 animals / 1,000 animals treated): | Severe: Lameness, musculoskeletal disorder Circulatory shock |
Results from the clinical field study involving 151 treated and placebo-treated dogs showed that the clinical signs of the disease (mast cell tumour) and treatment related adverse reactions are very similar in nature.
• There were two deaths that were possibly treatment related. In one dog, pathology findings revealed vascular thrombosis with disseminated intravascular coagulopathy (DIC) and pancreatitis. The other dog died following gastric perforation.
• There were two further deaths; however, relation to treatment could not be established.
• Two dogs developed epistaxis that was not associated with thrombocytopenia. Another dog developed epistaxis with concurrent disseminated intravascular coagulopathy.
• Three dogs had seizure-like activity; however, relation to treatment could not be established.
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 the package leaflet for respective contact details.
