Tanovea-CA1: Product Information

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

(rabacfosadine for injection)

16.4 mg rabacfosadine per vial

Antineoplastic

For intravenous use in dogs only

Approved by FDA under NADA # 141-545

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed.

DESCRIPTION:

TANOVEA (rabacfosadine for injection) is an acyclic nucleotide phosphonate. The molecular weight of rabacfosadine is 526.5 g/mole. The empirical formula is C21 H35 N8 O6 P. The structural formula is:

Structural Formula

TANOVEA 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 mg of rabacfosadine, present as the succinate salt, along with 20 mg of mannitol and 1.6 mg of citrate as excipients.

INDICATION:

TANOVEA is indicated for the treatment of lymphoma in dogs.

DOSAGE AND ADMINISTRATION:

Always provide the Client Information Sheet to the dog owner with each dose administration.

Administer TANOVEA 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 is supplied as a sterile lyophilized powder for reconstitution before use. After reconstitution with 2 mL of 0.9% Sodium Chloride Injection, USP, the reconstituted solution contains 8.2 mg/mL of rabacfosadine.

Reconstitution and administration of TANOVEA

Wear chemotherapy-resistant gloves, goggles, and protective clothing in the preparation and administration of TANOVEA. Use aseptic technique in the preparation and administration of TANOVEA.

Reconstitution instructions

  1. Obtain the desired number of vials from the refrigerator.
  2. Add 2 mL of 0.9% Sodium Chloride Injection, USP to the single-use vial.
  3. Gently invert the vial several times until the drug has completely dissolved and the solution is particle free.
  4. 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 should be diluted for infusion within 4 hours of reconstitution.
  2. Add the calculated volume of reconstituted TANOVEA (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/kg.
  3. The volume of reconstituted TANOVEA 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 as a 30-minute intravenous infusion.
Table 1. Example doses and volumes at 1 mg/kg.

a TANOVEA can be administered to dogs less than 5 kg and greater than 40 kg. Always calculate the dose based on the exact weight of the dog.

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)
5a 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
40a 88 40 4.9 75.1 80 2.7

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

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 may cause birth defects and affect female and male fertility. TANOVEA has not been evaluated in pregnant, lactating, or breeding dogs.

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