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

TARGET ANIMAL SAFETY:

The margin of safety and toxicity of rabacfosadine (not commercial formulation) was evaluated in three laboratory safety studies and one laboratory cardiovascular study. For each laboratory safety study, there were six male and six female, seven to eight month old Beagle dogs per treatment group. Three dogs/sex/group were necropsied following the last dose and three dogs/sex/group were necropsied following a 21-day recovery period. The VCOG-CTCAE1 definitions were used to grade the adverse reactions observed.

In the first study, a single dose of rabacfosadine was administered by a 30-minute intravenous infusion at doses of 0 (5% dextrose for injection), 0.25, 0.82, 2.5, and 8.2 mg/kg. Doses up to 2.5 mg/kg were tolerated. There were no adverse signs in the dogs administered 0.25 mg/kg. One dog administered 0.82 mg/kg vomited once. Dogs administered 2.5 mg/kg had abnormal feces (black, green, liquid, red, soft, mucoid) beginning on Day 4 and resolving by Day 10, and vomiting. There was a dose dependent weight loss and decreased food consumption in dogs administered ≥0.82 mg/kg. In all groups, including control, there were dermatologic changes (fur loss, thin fur, dry skin, red skin, skin lesions, scabs); there appeared to be a higher incidence in the dogs administered 2.5 mg/kg. Hematological changes included dose dependent leukopenia and Grade 1 to 4 neutropenia in dogs administered ≥0.82 mg/kg, with the nadir occurring between Days 6 and 9 and recovery occurring by Day 12. The 8.2 mg/kg dose was not tolerated. Dogs administered 8.2 mg/kg had clinical signs of abnormal feces, dehydration, vomiting, salivation, fever, tremors, decreased activity, and weakness resulting in a moribund state, and were either preterminally found dead or euthanized by Day 7. On necropsy at Day 3, pathology changes included dose-dependent effects on the gastrointestinal tract, lymphoid tissue, bone marrow, prostate, adrenal cortex, and kidneys (see below for more details). Following a 21-day recovery period, the majority of the changes in the intestines and lymphoid tissues reversed. Dose-dependent effects on the kidney were still observed.

In the second study, rabacfosadine was administered by a 30-minute intravenous infusion at doses of 0 (5% dextrose for injection), 0.082, 0.25, and 0.82 mg/kg once daily for 5 consecutive days and was tolerated at all dose levels. Dogs administered 0.82 mg/kg/day had suspected dehydration, vomiting, abnormal feces (soft, liquid, green, red), anorexia/hyporexia, decreased activity, and fever. Dogs with suspected dehydration received Lactated Ringers Solution subcutaneously. Treatment-related body weight loss and decreased food consumption were observed in dogs administered ≥0.25 mg/kg/day. In all groups, including control, there were dermatologic changes (fur loss, thin fur, dry skin, red skin, skin lesions, and scabs); there appeared to be a higher incidence in the groups administered drug.

Hematological changes included dose dependent leukopenia in all treated groups and dose dependent Grade 1 to 4 neutropenia in dogs administered ≥0.25 mg/kg/day with nadirs occurring between Days 6 and 9 with recovery by Day 12. On necropsy at Day 6, pathology changes included dose-dependent effects on the gastrointestinal tract, lymphoid tissue, bone marrow, and male reproductive system (see below for more details). Following a 21-day recovery period, dose-dependent changes were present in the gastrointestinal tract, salivary gland, kidney, and testes in all treated dogs, in the pancreas and thymus in dogs administered ≥0.25 mg/kg/ day, and in the bone marrow in dogs administered 0.82 mg/kg/day.

In the third study, rabacfosadine was administered by a 30-minute intravenous infusion at doses of 0 (5% dextrose for injection), 0.25, 0.50, and 1.0 mg/kg once every 7 days for 3 doses was tolerated at all dose levels. Treatment-related body weight loss and decreased food consumption were observed in dogs administered 1.0 mg/kg. In all groups, including control, there were dermatologic changes (fur loss, thin fur, dry skin, red skin, skin lesions, scabs); there appeared to be a higher incidence in the groups administered drug. Hematological changes included Grade 1 neutropenia predominantly in dogs administered 1.0 mg/kg. On necropsy on Day 16, pathology changes included dose-dependent effects on the gastrointestinal tract and lymphoid tissue, and non-dose dependent effects on the salivary gland, male reproductive tract, and kidney (see below for more details). These changes had only partial reversibility after a 21-day recovery period.

The pathology changes observed in the three studies included, in the gastrointestinal tract, necrosis of the stomach and combinations of mucosal hemorrhage, dilatation of mucosal glands/crypts, necrosis of crypt epithelial cells, atrophy of the mucosa/villi, edema, and inflammation of the intestinal wall. In the lymphoid tissue, observations included atrophy and necrosis of the thymus, spleen, lymph nodes, and gut associated lymphoid tissue (GALT). In the bone marrow, observations included hematopoietic hypocellularity. In the mandibular salivary gland, observations included glandular cell necrosis, atrophy, and inflammation. In the male reproductive tract, observations included small testes and epididymides, degeneration/atrophy of the seminiferous epithelium, and necrosis of the prostate. In the kidneys, observations included renal tubular vacuolation, dilatation, basophilia, degeneration, necrosis, and fibrosis. Tubular regeneration was observed following the recovery period. In the adrenal gland, observations included increased mitotic figures/necrosis in the adrenal cortex and adrenal fibrosis. In the pancreas, observations included acinar cell necrosis.

In the cardiovascular study, four telemeterized male, seven to eight month old Beagle dogs were administered 0 (5% dextrose for injection), 0.25, and 2.5 mg/kg rabacfosadine intravenously in an escalating dose regimen with a washout between doses. Dogs were monitored for 24 hours following dosing. There were no treatment-related effects on arterial blood pressure (mean, systolic, diastolic), heart rate, or electrocardiographic parameters.

STORAGE CONDITIONS:

Unopened vials: Store the vials refrigerated at 2 °C to 8 °C (36 °F to 46 °F). Retain in the original package to protect from light.

After reconstitution: Store at 20 °C to 25 °C (68 °F to 77 °F). TANOVEA should be diluted for infusion within 4 hours of reconstitution. The infusion solution should be used within 24 hours of being added to the infusion bag or syringe and within 4 hours of attachment to an intravenous administration set. Protection from light is not needed.

Disposal: Dispose of any unused product or waste materials in accordance with proper procedures for cytotoxic drugs.

HOW SUPPLIED:

TANOVEA is supplied in a 3 mL amber Type I glass vial with rubber stopper, aluminum over-seal, and plastic flip-off cap, packaged in a carton. Each vial contains 16.4 mg of rabacfosadine, as succinate salt.

Pack size: 4 vials and 10 vials

REFERENCES:

  1. Veterinary Cooperative Oncology Group. Veterinary cooperative oncology group — common terminology criteria for adverse events (VCOG-CTCAE) following chemotherapy or biological antineoplastic therapy in dogs and cats v1.1. Veterinary and Comparative Oncology 2016;14(4):417-446.
  2. Vail DM, et al. Response evaluation criteria for peripheral nodal lymphoma in dogs (v1.0)–a veterinary cooperative oncology group (VCOG) consensus document. Veterinary and Comparative Oncology 2009;8(1):28-37.

Manufactured for:

VetDC, Inc.

Fort Collins, CO 80524

Product of USA TP1.04 Aug 2021

Principal Display Panel — 16.4 mg 10 Vials Carton Label

TANOVEA ®

(rabacfosadine for injection)

Antineoplastic

For intravenous use in dogs

Elanco

16.4 mg rabacfosadine per vial

10 single-use vials

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

INDICATION: For the treatment of lymphoma in dogs

Net contents: 10 single-use vials

Approved by FDA under NADA # 141-545

Principal Display Panel -- 16.4 mg 10 Vials Carton Label
(click image for full-size original)

Principal Display Panel — 16.4 mg 4 Vials Carton Label

TANOVEA ®

(rabacfosadine for injection]

Antineoplastic

For intravenous use in dogs

Elanco

16.4 mg rabacfosadine per vial

4 single-use vials

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

INDICATION: For the treatment of lymphoma in dogs

Net contents: 4 single-use vials

Approved by FDA under NADA # 141-545

Principal Display Panel -- 16.4 mg 4 Vials Carton Label
(click image for full-size original)
TANOVEA-CA1
rabacfosadine succinate injection, powder, for solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0077
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABACFOSADINE SUCCINATE (RABACFOSADINE) RABACFOSADINE SUCCINATE 16.4 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0077-3 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (58198-0077-1)
1 NDC:58198-0077-1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS This package is contained within the CARTON (58198-0077-3)
2 NDC:58198-0077-2 4 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (58198-0077-1)
2 NDC:58198-0077-1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS This package is contained within the CARTON (58198-0077-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141545 07/15/2021
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Eurofins CDMO Alphora Inc 243895310 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Piramal Pharma Solutions Inc. 794520721 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Sentry BioPharma Services 362182060 PACK, LABEL

Revised: 11/2021 Elanco US Inc.

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