Palladia 15mg Tablets for Dogs

DESCRIPTION: 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.

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.

CAUTION: Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of reach of children.

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.

Contraindications:Do not use in dogs used for breeding, or for pregnant or lactating bitches

WARNINGS: : 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. 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.

Precautions:

: Temporarily discontinue the use of PALLADIA if anemia, azotemia, hypoalbuminemia, and hyperphosphatemia occur simultaneously. Resume treatment at a dose reduction of 0.5 mg/kg after 1 to 2 weeks when values have improved and albumin is >2.5 g/dL. Temporary treatment interruptions may be needed if any one of these occurs alone: hematocrit <26%, creatinine ≥2.0 mg/dL or albumin <1.5 g/dL. Then resume treatment at a dose reduction of 0.5 mg/kg once the hematocrit is >30%, the creatinine is <2.0 mg/dL, and the albumin is >2.5 g/dL. Temporarily discontinue the use of PALLADIA if neutrophil count is ≤1000/µL. Resume treatment after 1 to 2 weeks at a dose reduction of 0.5 mg/kg, when neutrophil count has returned to >1000/µL. Further dose reductions may be needed if severe neutropenia reoccurs. The presence of systemic mast cell tumor prior to treatment may predispose a dog to clinically significant mast cell degranulation with possible severe systemic adverse reactions when treated with PALLADIA. Attempts should be made to rule out systemic mastocytosis prior to initiation of treatment with PALLADIA. PALLADIA has been associated with severe diarrhea or GI bleeding that requires prompt treatment. Dose interruptions and dose reductions may be needed depending upon the severity of clinical signs. (See Table 2 in Dosage and Administration.) Use non-steroidal anti-inflammatory drugs with caution in conjunction with PALLADIA due to an increased risk of gastrointestinal ulceration or perforation. PALLADIA is metabolized in the liver. Co-administration of PALLADIA with strong inhibitors of the CYP3A4 family may increase PALLADIA concentrations. The effect of concomitant medications that may inhibit the metabolism of PALLADIA has not been evaluated. Drug compatibility should be monitored in patients requiring concomitant medications. The safe use of PALLADIA has not been evaluated in dogs less than 24 months of age or weighing less than 5 kg.