Tanovea-CA1: Product Information (Page 2 of 5)

WARNINGS:

USER SAFETY WARNINGS:

NOT FOR USE IN HUMANS. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Do not store near food or with medications intended for use in humans. Do not eat, drink, or smoke while handling the product.

CHILDREN SHOULD NOT COME INTO CONTACT WITH TANOVEA. Children should not come into contact with feces, urine, vomit, and saliva of treated dogs for 5 days after each treatment.

Drug Handling and Administration

Pregnant women, women who may become pregnant, and nursing women should not handle, prepare, or administer TANOVEA. Rabacfosadine is cytotoxic and may cause birth defects and affect female and male fertility.

Use standard measures for the safe handling of all chemotherapeutic drugs. Refer to Occupational Safety and Health Administration (OSHA) for appropriate guidelines, recommendations, and regulations for handling antineoplastic agents.

Do not come into direct contact with TANOVEA. Wear chemotherapy-resistant gloves, goggles, and protective clothing when handling or administering TANOVEA. After removing and disposal of gloves, wash hands immediately and thoroughly with soap and water.

Accidental Exposure to TANOVEA

In the case of accidental self-injection:

  • Remove glove.
  • Let the wound bleed a few drops of blood.
  • Rinse the wound thoroughly with tap water.
  • Seek medical advice immediately and show the package insert, label, or client information sheet to the physician.

In case of accidental skin contact:

  • Wash the affected area immediately and thoroughly with soap and water.

In the case of accidental eye exposure:

  • Remove contact lenses.
  • Rinse the eyes with large amounts of tap water (use eyewash station if present) for 10 minutes while holding back the eyelid.
  • Seek medical advice immediately and show the package insert, label, or client information sheet to the physician.

In the case of accidental ingestion:

  • Seek medical advice immediately and show the package insert, label, or client information sheet to the physician.

Handling of Excreta and Soiled Items

Do not come into direct contact with the treated dog’s feces, urine, vomit, and saliva for 5 days after each treatment with TANOVEA.

When cleaning up feces, urine, vomit, and saliva, wear disposable chemotherapy-resistant gloves to collect the contaminated substances with disposable absorptive material (such as paper towels) and place them into a plastic bag. Carefully remove the gloves and place them in the bag, and tie or fasten it securely before general disposal. Wash hands immediately and thoroughly with soap and water afterwards.

Do not wash any items soiled with feces, urine, vomit, and saliva from the dog for 5 days after each treatment with other laundry.

Wear disposable chemotherapy-resistant gloves when handling the dog’s toys, food bowl, and water bowl. Wash food and water bowls separately from other items for 5 days after each treatment.

Accidental Exposure to Excreta

In the case of direct skin contact with feces, urine, vomit, and saliva of dogs for 5 days after each treatment:

  • Wash the affected skin immediately and thoroughly with soap and water.

ANIMAL SAFETY WARNINGS:

TANOVEA is associated with life-threatening or fatal pulmonary fibrosis. The pulmonary fibrosis may be an idiosyncratic toxicity. Monitoring for signs of pulmonary dysfunction is recommended (see ADVERSE REACTIONS).

PRECAUTIONS:

TANOVEA is associated with dermatopathies (e.g., otitis, alopecia, dermatitis, erythema, pruritus, hyperpigmentation, skin ulcerations, and bacterial skin infections) which can worsen with subsequent treatment (see ADVERSE REACTIONS). Careful monitoring for changes in the skin and ears is recommended. Dose reductions and/or dose delays should be considered to mitigate dermatologic adverse reactions.

TANOVEA can cause neutropenia with a nadir around seven days post-treatment. Dogs should be frequently monitored for evidence of neutropenia during treatment with TANOVEA (see ADVERSE REACTIONS and TARGET ANIMAL SAFETY).

Extravasation of TANOVEA may cause pain and/or tissue injury. If extravasation is suspected, discontinue infusion immediately. Monitor the site for evidence of injury; consider local and systemic treatment measures as needed.

The safety and effectiveness of TANOVEA has not been evaluated in conjunction with other chemotherapeutic agents or other modalities for the treatment of lymphoma.

The effect of concomitant medications on the metabolism of TANOVEA has not been evaluated.

ADVERSE REACTIONS:

A randomized, placebo-controlled, masked, multicenter clinical field study evaluated the effectiveness and safety of TANOVEA for the treatment of lymphoma. One-hundred and twenty dogs received TANOVEA at a dose of 1 mg/kg, administered as a 30-minute intravenous infusion once every three weeks for one to five doses. Thirty-eight dogs received a placebo (saline) infusion.

The Veterinary Cooperative Oncology Group — common terminology criteria for adverse events (VCOG-CTCAE)1 definitions were used to grade the adverse reactions observed: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death or euthanasia). Most adverse reactions were Grade 1 or 2. The adverse reactions observed in the study and number of dogs experiencing each adverse reaction is summarized in Table 2 below.

The most common adverse reactions included diarrhea, decreased appetite, vomiting, lethargy, weight loss, and neutropenia. Though diarrhea, decreased appetite, vomiting, lethargy, and weight loss were observed in both groups, the incidence was higher in the TANOVEA group and there were more Grade 2 and 3 adverse reactions compared to the Placebo group.

Table 2. Adverse Reactions Reported During the Field Study

a Most neutropenias were Grade 1 or 2. However, eight instances of Grade 3 and three instances of Grade 4 neutropenia were reported. Neutropenia was reported seven days after treatment and returned to the normal range in all but two instances by the next cycle.

b Represents combined terms of Otitis Externa and Otitis Not Otherwise Specified (NOS)

c Pulmonary disorders included pulmonary fibrosis or possible pulmonary fibrosis (five dogs), pulmonary interstitial pattern (three dogs), pneumonia (three dogs), alveolar pattern on radiographs (two dogs), pneumomediastinum (one dog), pneumonitis (one dog), pulmonary infiltrates on radiographs (one dog). Some dogs were reported with more than one abnormality.

d Masses included skin and subcutaneous masses

e Glucosuria ranges from 1+ to 4+. In one dog, a 1+ ketonuria was reported at the same time as a 4+ glucosuria.

f Digestive tract disorders NOS included regurgitation (three dogs) and abnormal stool color (three dogs).


TANOVEA (n=120) Placebo (n=38)
n % n %
Diarrhea 105 87.5 19 50
Decreased appetite 82 68.3 15 39.5
Emesis 82 68.3 9 23.7
Lethargy 76 63.3 24 63.2
Weight loss 58 48.3 4 10.5
Neutropeniaa 55 45.8 0
Polydipsia 40 33.3 6 15.8
Anorexia 34 28.3 7 18.4
Otitisb 31 25.8 0
Alopecia 30 25 2 5.3
Adipsia 29 24.2 5 13.2
Polyuria 29 24.2 2 5.3
Dermatitis 25 20.8 0
Increased appetite 24 20 6 15.8
Hypoalbuminemia 24 20 5 13.2
Anemia 20 16.7 3 7.9
Hematochezia 20 16.7 0
Dehydration 17 14.2 1 2.6
Nausea 15 12.5 2 5.3
Erythema 15 12.5 1 2.6
Pruritus 15 12.5 1 2.6
Hyperpigmentation 14 11.7 0
Leukopenia 14 11.7 0
Monocytosis 13 10.8 3 7.9
Elevated alanine aminotransferase (ALT) 13 10.8 2 5.3
Proteinuria 13 10.8 2 5.3
Pulmonary disorderc 13 10.8 0
Elevated creatine-kinase (CK) 12 10 1 2.6
Oliguria 12 10 1 2.6
Urinary tract infection 12 10 1 2.6
Cough 11 9.2 3 7.9
Increased blood urea nitrogen (BUN) or creatinine 11 9.2 2 5.3
Elevated aspartate aminotransferase (AST) 11 9.2 0
Neutrophilia 10 8.3 3 7.9
Hematuria 10 8.3 1 2.6
Massd 10 8.3 0
Hyperthermia 9 7.5 4 10.5
Thrombocytopenia 9 7.5 3 7.9
Elevated symmetrical dimethylarginine (SDMA) 9 7.5 2 5.3
Hypocalcemia 9 7.5 2 5.3
Glucosuriae 9 7.5 0
Skin ulceration 9 7.5 0
Tachypnea 8 6.7 5 13.2
Dyspnea 7 5.8 5 13.2
Elevated total bilirubin 7 5.8 1 2.6
Hypokalemia 7 5.8 1 2.6
Bacterial skin infection 7 5.8 0
Desquamation 7 5.8 0
Leukocytosis 6 5 5 13.2
Pinnal irritation 6 5 1 2.6
Digestive tract disorders NOSf 6 5 0
Hypoproteinemia 6 5 0

The type and frequency of reported adverse reactions did not vary greatly by cycle of TANOVEA treatment. A single cycle was the day of treatment and the 20 days after treatment (total of 21 days). However, during Cycles 1 and 2 (after the first or second dose), the majority of adverse reactions were primarily related to gastrointestinal and constitutional signs (i.e. lethargy, weight loss), while dermatopathies began to occur more frequently in Cycles 3 through 5 (after the third through fifth dose).

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