Palladia
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Questions & Answers
Side Effects & Adverse Reactions
PALLADIA may cause vascular dysfunction which can lead to edema and thromboembolism, including pulmonary thromboembolism. Discontinue drug until clinical signs and clinical pathology have normalized. To assure vasculature homeostasis, wait at least 3 days after stopping drug before performing surgery (see Adverse Reactions).
Serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred rarely in dogs treated with PALLADIA (see Adverse Reactions). If gastrointestinal ulceration is suspected, stop drug administration and treat appropriately.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PALLADIA tablets are indicated for the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
History
There is currently no drug history available for this drug.
Other Information
PALLADIA, a multi-kinase inhibitor targeting several receptor tyrosine kinases (RTK), is the phosphate salt of toceranib. The empirical formula is C22H25FN4O2H3O4P and the molecular weight is 494.46. The chemical name is (Z)-5-[(5-Fluoro-2-oxo-1,2-dihydro-3H -indol-3-ylidene)methyl]-2,4-dimethyl-N-(2-pyrrolidin-1-ylethyl)-1H-pyrrole-3-carboxamide phosphate. Toceranib phosphate is a small molecule with an indolinone chemical structure.
The chemical structure of toceranib phosphate is
Sources
Palladia Manufacturers
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Pharmacia And Upjohn Company
![Palladia (Toceranib Phosphate) Tablet [Pharmacia And Upjohn Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Palladia | Pharmacia And Upjohn Company
Always provide Client Information Sheet with prescription. Administer an initial dosage of 3.25 mg/kg (1.48 mg/lb) body weight, orally every other day (see Table 1). Dose reductions of 0.5 mg/kg (to a minimum dose of 2.2 mg/kg (1.0 mg/lb) every other day) and dose interruptions (cessation of PALLADIA for up to two weeks) may be utilized, if needed, to manage adverse reactions (see Table 2 as well as Warnings and Precautions). Adjust dose based on approximately weekly veterinary assessments for the first 6 weeks and approximately every 6 weeks, thereafter. PALLADIA may be administered with or without food. Do not split tablets.
Table 1. 3.25 mg/kg Dose Chart Dog Body Weight Number of Tablets Pounds Kilograms Dose 10 mg 15 mg 50 mg 11.0 – 11.8 5.0 - 5.3 15 mg 1 11.9 – 15.2 5.4 - 6.9 20 mg 2 15.3 – 18.5 7.0 - 8.4 25 mg 1 1 18.6 – 22.0 8.5 - 10.0 30 mg 2 22.1 – 25.4 10.1 - 11.5 35 mg 2 1 25.5 – 28.7 11.6 - 13.0 40 mg 1 2 28.8 – 32.2 13.1 - 14.6 45 mg 3 32.3 – 35.5 14.7 - 16.1 50 mg 1 35.6 – 38.8 16.2 - 17.6 55 mg 1 3 38.9 – 42.3 17.7 - 19.2 60 mg 1 1 42.4 – 45.6 19.3 - 20.7 65 mg 1 1 45.7 – 50.7 20.8 - 23.0 70 mg 2 1 50.8 – 59.3 23.1 - 26.9 80 mg 2 1 59.4 – 65.9 27.0 - 29.9 95 mg 3 1 66.0 – 71.2 30.0 - 32.3 100 mg 2 71.3 – 76.3 32.4 - 34.6 110 mg 1 2 76.4 – 79.6 34.7 - 36.1 115 mg 1 2 79.7 – 84.7 36.2 - 38.4 120 mg 2 2 84.8 – 94.8 38.5 - 43.0 130 mg 2 2 94.9 – 105.0 43.1 - 47.6 150 mg 3 105.1 – 110.0 47.7 - 49.9 160 mg 1 3 110.1 – 113.5 50.0 - 51.5 165 mg 1 3 113.6 – 118.6 51.6 - 53.8 170 mg 2 3 118.7 – 128.8 53.9 - 58.4 180 mg 2 3 128.9 – 138.9 58.5 - 63.0 200 mg 4 139.0 – 144.0 63.1 - 65.3 210 mg 1 4 144.1 – 157.6 65.4 - 71.5 215 mg 1 4 157.7 – 173.1 71.6 - 78.5 250 mg 5 173.2 – 177.9 78.6 - 80.7 260 mg 1 5 178.0 – 191.6 80.8 - 86.9 265 mg 1 5 191.7 – 220.5 87.0 - 100.0 300 mg 6 Table 2. Dose Modification Based on Toxicity Observed Toxicity Dose Adjustment Neutropenia >1000/µL Maintain dose level ≤1000/µL or neutropenic fever or infection Stop drug until >1000/µL and clinical signs normal; then decrease dose by 0.5 mg/kg Renal Toxicities (Creatinine) <2.0 mg/dL Maintain dose level ≥2.0 mg/dL Stop drug until <2.0 mg/dL then decrease dose by 0.5 mg/kg Albumin <1.5 g/dL Stop drug until >2.5 g/dL then decrease dose by 0.5 mg/kg Hematocrit <26% Stop drug until >30% then decrease dose by 0.5 mg/kg Diarrhea <4 watery stools/day for less than 2 days Maintain dose level and institute supportive care ≥4 watery stools/day or ≥ 2 days Stop drug until formed stools and institute supportive care. When dosing is resumed, decrease dose by 0.5 mg/kg GI Bleeding Fresh blood in stool or black tarry stool for > 2 days or frank hemorrhage or blood clots in stool. Stop drug and institute supportive care until resolution of all clinical signs of blood in stool, then decrease dose by 0.5 mg/kg. -
Zoetis Inc.
Palladia | Zoetis Inc.
Always provide Client Information Sheet with prescription. Administer an initial dosage of 3.25 mg/kg (1.48 mg/lb) body weight, orally every other day (see Table 1). Dose reductions of 0.5 mg/kg (to a minimum dose of 2.2 mg/kg (1.0 mg/lb) every other day) and dose interruptions (cessation of PALLADIA for up to two weeks) may be utilized, if needed, to manage adverse reactions (see Table 2 as well as Warnings and Precautions). Adjust dose based on approximately weekly veterinary assessments for the first 6 weeks and approximately every 6 weeks, thereafter. PALLADIA may be administered with or without food. Do not split tablets.
Table 1. 3.25 mg/kg Dose Chart Dog Body Weight Number of Tablets Pounds Kilograms Dose 10 mg 15 mg 50 mg 11.0 – 11.8 5.0 - 5.3 15 mg 1 11.9 – 15.2 5.4 - 6.9 20 mg 2 15.3 – 18.5 7.0 - 8.4 25 mg 1 1 18.6 – 22.0 8.5 - 10.0 30 mg 2 22.1 – 25.4 10.1 - 11.5 35 mg 2 1 25.5 – 28.7 11.6 - 13.0 40 mg 1 2 28.8 – 32.2 13.1 - 14.6 45 mg 3 32.3 – 35.5 14.7 - 16.1 50 mg 1 35.6 – 38.8 16.2 - 17.6 55 mg 1 3 38.9 – 42.3 17.7 - 19.2 60 mg 1 1 42.4 – 45.6 19.3 - 20.7 65 mg 1 1 45.7 – 50.7 20.8 - 23.0 70 mg 2 1 50.8 – 59.3 23.1 - 26.9 80 mg 2 1 59.4 – 65.9 27.0 - 29.9 95 mg 3 1 66.0 – 71.2 30.0 - 32.3 100 mg 2 71.3 – 76.3 32.4 - 34.6 110 mg 1 2 76.4 – 79.6 34.7 - 36.1 115 mg 1 2 79.7 – 84.7 36.2 - 38.4 120 mg 2 2 84.8 – 94.8 38.5 - 43.0 130 mg 2 2 94.9 – 105.0 43.1 - 47.6 150 mg 3 105.1 – 110.0 47.7 - 49.9 160 mg 1 3 110.1 – 113.5 50.0 - 51.5 165 mg 1 3 113.6 – 118.6 51.6 - 53.8 170 mg 2 3 118.7 – 128.8 53.9 - 58.4 180 mg 2 3 128.9 – 138.9 58.5 - 63.0 200 mg 4 139.0 – 144.0 63.1 - 65.3 210 mg 1 4 144.1 – 157.6 65.4 - 71.5 215 mg 1 4 157.7 – 173.1 71.6 - 78.5 250 mg 5 173.2 – 177.9 78.6 - 80.7 260 mg 1 5 178.0 – 191.6 80.8 - 86.9 265 mg 1 5 191.7 – 220.5 87.0 - 100.0 300 mg 6 Table 2. Dose Modification Based on Toxicity Observed Toxicity Dose Adjustment Neutropenia >1000/µL Maintain dose level ≤1000/µL or neutropenic fever or infection Stop drug until >1000/µL and clinical signs normal; then decrease dose by 0.5 mg/kg Renal Toxicities (Creatinine) <2.0 mg/dL Maintain dose level ≥2.0 mg/dL Stop drug until <2.0 mg/dL then decrease dose by 0.5 mg/kg Albumin <1.5 g/dL Stop drug until >2.5 g/dL then decrease dose by 0.5 mg/kg Hematocrit <26% Stop drug until >30% then decrease dose by 0.5 mg/kg Diarrhea <4 watery stools/day for less than 2 days Maintain dose level and institute supportive care ≥4 watery stools/day or ≥ 2 days Stop drug until formed stools and institute supportive care. When dosing is resumed, decrease dose by 0.5 mg/kg GI Bleeding Fresh blood in stool or black tarry stool for > 2 days or frank hemorrhage or blood clots in stool. Stop drug and institute supportive care until resolution of all clinical signs of blood in stool, then decrease dose by 0.5 mg/kg.
![Palladia (Toceranib Phosphate) Tablet [Zoetis Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ae09ae83-0812-4ddc-92e3-730f7a1ae449&name=palladia-02.jpg)
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