Palladia: Product Information

PALLADIA- toceranib phosphate tablet
Zoetis Inc.

Antineoplastic For oral use in dogs only

Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

PALLADIA, a multi-kinase inhibitor targeting several receptor tyrosine kinases (RTK), is the phosphate salt of toceranib. The empirical formula is C22 H25 FN4 O2 H3 O4 P 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

Chemical Structure
(click image for full-size original)

Indications

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.

Dosage and Administration

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.

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