Toceranib

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

Contraindications

Do not use in dogs used for breeding, or for pregnant or lactating bitches (see Clinical Pharmacology ).

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.

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. Human Warnings NOT FOR USE IN HUMANS. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Children should not come in contact with PALLADIA. Keep children away from feces, urine, or vomit of treated dogs. To avoid exposure to drug, wash hands with soap and water after administering PALLADIA and wear protective gloves to prevent direct contact with feces, urine, vomit, and broken or moistened PALLADIA tablets. Place all waste materials in a plastic bag and seal before general disposal. If eyes are accidentally exposed to the drug, rinse eyes with water immediately. In case of accidental ingestion by a person, seek medical advice immediately, show the package insert or label to the physician. Gastrointestinal discomfort such as vomiting or diarrhea may occur if this drug is accidentally ingested. Pregnant women, women who may become pregnant, or nursing mothers should pay special attention to these handling precautions. (See handling instructions above.) PALLADIA, like other drugs in its class, prevents the formation of new blood vessels in tumors. In a similar manner, PALLADIA may affect blood vessel formation in the developing fetus and may harm an unborn baby (cause birth defects). For pregnant women, accidental ingestion of PALLADIA may have adverse effects on pregnancy.

Description

PALLADIA, a multi-kinase inhibitor targeting several receptor tyrosine kinases (RTK), is the phosphate salt of toceranib. The empirical formula is C 22 H 25 FN 4 O 2 H 3 O 4 P and the molecular weight is 494.46. The chemical name is (Z)-5-[(5-Fluoro-2-oxo-1,2-dihydro-3 H -indol-3-ylidene)methyl]-2,4-dimethyl- N -(2-pyrrolidin-1-ylethyl)-1 H -pyrrole-3-carboxamide phosphate. Toceranib phosphate is a small molecule with an indolinone chemical structure. The chemical structure of toceranib phosphate is Chemical Structure

Information for Owners

Always provide Client Information Sheet with prescription and review with owners. Owners should be advised on possible adverse reactions and when to stop drug and call the veterinarian. Owners should be advised of the handling instructions.

Storage

Store at controlled room temperature 20° to 25° C (68° to 77° F).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming toceranib as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.