TANOVEA-CA1: Product Information

TANOVEA-CA1- rabacfosadine succinate injection, powder, for solution
VetDC, Inc.

Dosage and Administration

Always provide the Client Information Sheet to the dog owner with each dose administration.
Administer TANOVEA-CA1 at 1 mg/kg body weight as a 30-minute intravenous infusion, once every three weeks, for up to five doses.
Stepwise dose reductions to 0.8 mg/kg and 0.66 mg/kg or dose delays may be used to manage adverse reactions.
TANOVEA-CA1 is supplied as a sterile lyophilized powder for reconstitution before use. After reconstitution with 2 mL 0.9% Sodium Chloride Injection, USP, the reconstituted solution contains 8.2 mg/mL of rabacfosadine.
Reconstitution and administration of TANOVEA-CA1
Wear chemotherapy resistant gloves, goggles, and protective clothing in the preparation and administration of TANOVEA-CA1. Use aseptic technique in the preparation and administration of TANOVEA-CA1.
Reconstitution instructions
• Obtain the desired number of vials from the refrigerator.
• Add 2 mL of 0.9% Sodium Chloride Injection, USP to the single-use vial.
• Gently invert the vial several times until the drug has completely dissolved and the solution is particle free.
• The solution should be clear without visible particulates. If particulates are observed, the solution should be discarded.
Dilution for infusion and administration instructions
1. TANOVEA-CA1 should be diluted for infusion within 4 hours of reconstitution.
2. Add the calculated volume of reconstituted TANOVEA-CA1 (8.2 mg/mL) to 0.9% Sodium Chloride Injection, USP in a polyvinyl chloride (PVC) infusion bag or polypropylene infusion syringe to yield a total infusion volume of 2 mL per kg body weight.
3. The volume to add should be calculated based on the exact weight of the dog. (See Table 1. for example doses and administration volumes).
4. The infusion solution should be used within 24 hours of being added to the infusion bag or syringe and within 4 hours of being added to an intravenous transfer set. Protection from light is not needed.
5. Administer TANOVEA-CA1 as a 30-minute intravenous infusion.

Table 1. Example doses and volumes.
The dose to be administered should be calculated based on the exact weight of the dog. The table shows example doses and administration volumes at 1 mg/kg over 30 minutes.

Dog weight (kg)
Dog weight (lb)
Dose (mg) Volume of reconstituted TANOVEA™
solution (mL)
Volume 0.9% NaCl (mL) Total infusion volume (mL)
Rate of infusion (mL/minute)
5 11 5 0.6 9.4 10 0.3
10 22 10 1.2 18.8 20 0.7
15 33 15 1.8 28.2 30 1.0
20 44 20 2.4 37.6 40 1.3
25 55 25 3.0 47.0 50 1.7
30 66 30 3.7 56.3 60 2.0
35 77 35 4.3 65.7 70 2.3
40 88 40 4.9 75.1 80 2.7

Compatibility of administration sets containing ethyl vinyl acetate (EVA) has not been evaluated.

Description

Rabacfosadine is an acyclic nucleotide phosphonate. The molecular weight of rabacfosadine is 526.5 g/mole. The empirical formula is C21H35N8O6P.

The structural formula is:
TANOVEA-CA1 is supplied as a sterile, white to off-white lyophilized powder in the form of a cake contained in a 3 mL amber glass vial. Each single-use vial contains
16.4 g of rabacfosadine, present as the succinate salt, along with 20 mg of mannitol and 1.6 mg of citrate as excipients.

Indications

TANOVEA-CA1 is indicated for the treatment of lymphoma in dogs.

Contraindications

Do not use in dogs with pulmonary fibrosis or a history of chronic pulmonary disease that could lead to fibrosis, such as chronic bronchitis (see WARNINGS). Do not use in West Highland White Terriers due to a genetic predisposition for development of pulmonary fibrosis. Use with caution in other terrier breeds due to potential genetic predisposition for development of pulmonary fibrosis.

Do not use in dogs that are pregnant, lactating, or intended for breeding. Rabacfosadine is cytotoxic and can cause birth defects and affect female and male fertility. TANOVEA-CA1 has not been evaluated in pregnant, lactating, or breeding dogs.

Warnings

Rabacfosadine was associated with life-threatening or fatal pulmonary fibrosis in the field studies. The pulmonary fibrosis may be an idiosyncratic toxicity. Monitoring for signs of pulmonary dysfunction and/or radiographic changes consistent with pulmonary fibrosis is recommended (see ADVERSE REACTIONS).

Human Warnings

NOT FOR USE IN HUMANS. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Wear chemotherapy resistant gloves to prevent contact with feces, urine, vomit, and saliva of treated dogs for 5 days following treatment. Place all waste materials in a plastic bag and seal before general disposal. Rabacfosadine is cytotoxic and can cause birth defects and affect female and male fertility. Pregnant and breast feeding women should not prepare or administer the product.
Special instructions for preparing and administering the product:
TANOVEA-CA1 should be administered under the supervision of a veterinarian experienced in the use of cancer chemotherapeutic agents.
Use standard measures for the safe handling of cytotoxic drugs
• Wear chemotherapy resistant gloves, goggles, and protective clothing
• Do not eat, drink, or smoke while handling the product
• Do not store food in or near the preparation area
Accidental skin contact
• In case of accidental contact with the skin, wash the affected area immediately and thoroughly with soap and water
Accidental eye exposure
• Remove contact lenses
• Rinse the eyes with large amounts of tap water (use eyewash station if present) for at least 10 minutes while holding back the eyelid
• Seek medical advice immediately and show the package insert or label to the physician
Accidental self-injection
• Remove glove
• Let the wound bleed a few drops of blood
• Rinse the wound thoroughly with plenty of tap water
• Seek medical advice immediately and show the package insert or label to the physician

Precautions

The safety and effectiveness of TANOVEA-CA1 has not been evaluated in conjunction with other chemotherapeutic agents or other treatment modalities.
The effect of concomitant medications on the metabolism of TANOVEA-CA1 has not been evaluated.

Adverse reactions

In two multi-institutional field studies, 22 dogs with untreated, relapsed, or refractory lymphoma received single-agent rabacfosadine (not commercial formulation) as an intravenous infusion at doses of 0.66 to 1.2 mg/kg administered once every three weeks for one to six doses.
All dogs experienced at least one adverse reaction, however not all adverse reactions were seen in each dog. Adverse reactions associated with rabacfosadine treatment when administered once every three weeks include:
General: lethargy, dehydration, fever
Gastrointestinal: anorexia/hyporexia, vomiting, diarrhea
Renal: increased creatinine, increased blood urea nitrogen, proteinuria, pyuria, bacteruria
Hepatic: elevated liver enzymes, elevated bilirubin
Cardiorespiratory: pulmonary fibrosis, aspiration pneumonia, tachypnea, dyspnea, tachycardia
Metabolic: weight loss
Hematologic: neutropenia, thrombocytopenia, anemia, hypertriglyceridemia, hypoproteinemia, hypoglobulinemia, hypoalbuminemia, increased creatine kinase, hypokalemia, hypophosphatemia
Ocular: injected sclera
Dermatologic: otitis externa, alopecia, dermatitis, pyoderma, ulcerations, excoriations
Most adverse reactions were Veterinary Cooperative Oncology Group (VCOG)1 Grade 1-2. Grade 3 reactions included anorexia/hyporexia, weight loss, vomiting, diarrhea, otitis externa, dehydration, aspiration pneumonia, neutropenia, thrombocytopenia, anemia, bilirubinemia, and hypertriglyceridemia. Grade 4 reactions included tachypnea and neutropenia. Grade 5 reactions included dyspnea (secondary to pulmonary fibrosis). With the exception of pulmonary fibrosis, adverse reactions resolved either spontaneously, with supportive treatment,
dose modifications, or dose delays.
Additional adverse reactions seen in dogs administered rabacfosadine at more frequent dosing schedules include:
• Dermatopathy including pruritic and erythemic lesions on the dorsum, and exudation, crusting, erythema, and necrosis with epidermal sloughing on the ears, face, ventral neck, and/or forelimbs.
• Glucosuria
• Type II pneumocyte hyperplasia (based on necropsy)
To report suspected adverse events, for technical assistance, or to obtain a copy of the Safety Data Sheet, contact VetDC, Inc at 1-877-468-3832.
For additional information about adverse drug experience reporting for animal drugs, contact FDA by telephone at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Informatio for Dog Owners

Always provide the Client Information Sheet and review it with the dog owner or person responsible for care of the dog. Advise dog owners about possible adverse reactions, when to contact a veterinarian, and how to clean up any saliva, urine, or feces from dogs treated with TANOVEA-CA1. The Client Information Sheet also contains warnings for humans and what to do in case of accidental human exposure to TANOVEA-CA1.

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