Important Information for Veterinarians About TANOVEA-CA1

Designed to target and kill lymphoma cells 1, 2

  • Accumulates primarily in lymphoid cells
  • Inhibits the proliferation of lymphocytes and lymphoma cell lines by inhibiting DNA synthesis

Easy to administer

  • One dose every three weeks
  • Only five doses for full treatment
  • Simple, 30-minute intravenous infusion of 1 mg/kg
  • Stepwise dose reductions or dose delays can help manage adverse reactions

Reasonable expectation of efficacy 3

  • 77% overall response rate in clinical studies in 22 dogs receiving TANOVEA-CA1 once every three weeks
  • 134 day overall median progression-free survival time in responding dogs
  • Can be used in dogs with naive and relapsed/refractory lymphoma

Generally well-tolerated in clinical studies 3

  • The majority of adverse reactions were Veterinary Cooperative Oncology Group (VCOG)4 grade 1 or 2
  • Common adverse reactions included neutropenia, diarrhea, anorexia, weight loss, lethargy, and skin problems
  • Less frequent, but more severe adverse reactions have occurred – see prescribing information for further details
  • Most adverse reactions resolved spontaneously, with supportive treatment, dose modifications, or dose delays

TANOVEA-CA1 was found to inhibit lymphoma cell proliferation in vivo.

Uptake of the 18F-fluorothymidine tracer via positron emission tomography/computed tomography (PET/CT) following TANOVEA-CA1 treatment.5, 6

Figure 1 - Dog Lymphoma x-ray beforeFigure A depicts the tracer present in lymph nodes, bone marrow, bladder, kidneys and spleen of a dog with lymphoma prior to treatment.

Figure B - Dog lymphoma afterFigure B shows the same dog nine weeks following TANOVEA-CA1 treatment, with markedly reduced tracer uptake in the lymph nodes, which correlated with a complete response in this dog.


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TANOVEA-CA1 mechanism of action

 

Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-475.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal Law to use this product other than as directed in the labeling.

 

Important Safety Information: TANOVEA®-CA1 (rabacfosadine for injection) is not for use in humans and should be kept out of the reach of children. Wear chemotherapy-resistant gloves to prevent contact with feces, urine, vomit, and saliva of treated dogs for five days following treatment. 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. Serious and sometimes fatal respiratory complications, including pulmonary fibrosis have occurred in dogs treated with TANOVEA®-CA1. Do not use in dogs with pulmonary fibrosis, a history of chronic pulmonary disease that could lead to fibrosis, or in breeds with a predisposition to this condition such as West Highland White Terriers. Use with caution in other terrier breeds. Do not use in dogs that are pregnant, lactating, or intended for breeding. Most common adverse reactions included diarrhea, neutropenia, hyporexia, weight loss, and lethargy. Please see the package insert for full prescribing information.

Guidance for TANOVEA-CA1 Extravasation Events:

TANOVEA-CA1 (rabacfosadine for injection) is a cytotoxic anticancer agent and should be administered under the supervision of a veterinarian experienced in the use of cancer chemotherapeutic agents. Standard measures for the safe handling and administration of a cytotoxic agent should be employed, and full PPE in accordance with USP-800 and/or OSHA requirements is recommended.

There have been no studies of the vesicant properties of TANOVEA-CA1. However, based on limited extravasation reports from clinics, it appears that it has mild to moderate vesicant properties. The effects are roughly similar to those seen with the vinca alkaloids (e.g. vincristine), not the severe, potentially limb-threatening effects that may be seen with extravasation of agents like doxorubicin or actinomycin D. Less than half of reported extravasation cases developed clinical signs, and these all resolved in 2 to 4 weeks.

Because TANOVEA-CA1 may cause pain and tissue damage, avoid extravasation injuries. If signs of extravasation occur, the following has been recommended:

  • Stop the infusion immediately.
  • If possible, withdraw 3 to 5 mL of blood through the catheter to remove some of the drug.
  • Try to aspirate additional material from any swelling through separate percutaneous sticks with a 25-gauge needle.
  • Remove the infusion catheter and delineate the infiltrated area on the patient’s skin with a felt tip marker.
  • Consider intermittent cold packing for 48-72 hours.
  • Avoid pressure or friction; do not rub the area.
  • Observe for signs of increased erythema, pain, or skin necrosis.
  • Ensure that no medication is given distally to the extravasation site.
  • After 48 hours, encourage the patient to use the extremity normally to promote full range of motion.
  • Avoid self-trauma through the use of an Elizabethan collar.
  • Provide supportive care as necessary.
  • In the event of tissue necrosis, desquamation, or ulceration, clinician preference for management of wound therapy should be employed. Anecdotally, some clinicians have reported successful resolution of these events by employing a variety of therapies including non-irritating wound cleansers, steroids, topical agents, bandaging, pain management, and/or systemic antibiotics when appropriate.
  • Because there have been only a few extravasation incidents reported and the reported information has been extremely limited (see below for a summary of the reported events), there is no information available about the effect or the advisability of employing agents such as DMSO or hyaluronidase to mitigate the effects of TANOVEA-CA1 extravasation.

Please report any possible extravasation event to VetDC, Inc. at 1-844-342-8129 for additional guidance.

REFERENCES 1. Reiser H, Wang J, Chong L, et al. GS-9219—A novel acyclic nucleotide analogue with potent antineoplastic activity in dogs with spontaneous non-Hodgkin’s lymphoma. Clin Cancer Res 2008;14:2824–2832. 2. Kramata P, Downey KM, Paborsky LR. Incorportation and excision of 9-(2-phosphonylmethoxyethyl)guanine (PMEG) by DNA polymerase delta and epsilon in vitro. J Biol Chem 1998;273:21966–21971. 3. TANOVEA-CA1 [package insert]. VetDC Inc., Dec 2016. Data on file, VetDC Inc., Fort Collins, CO. 4. Veterinary Cooperative Oncology Group – common terminology criteria for adverse events (VCOG-CTCAE) following chemotherapy or biologic antineoplastic therapy in dogs and cats v1.1. Vet Comp Oncol. 20 Jul 2011, DOI: 10.1111/j.1476-5829.2011.00283.x. 5. Lawrence J, Vanderhoek M, Barbee D, et al. Use of 3’-deoxy-3’-[18F]fluorothymidine PET/CT for evaluating response to cytotoxic chemotherapy in dogs with non-Hodgkin’s lymphoma. Vet Radiol Ultrasound 2009;50:660–668. 6. Vail DM, Thamm DH, Reiser H, Ray AS, Wolfgang GHI, Watkins WJ, Babusis D, Henne IN, Hawkins MJ, Kurzman ID, Jeraj R, Vanderhoek M, Plaza S. Assessment of GS-9219 in a pet dog model of non-Hodgkin’s lymphoma. Clin Cancer Res 2009 May 15;15(10):3503-10.