Hemoglobin Glutamer-200 (bovine): what the FDA reviewed for dog products
2 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Hemoglobin Glutamer-200 (bovine), as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Oxyglobin® (NADA/ANADA 141-067)
Oxyglobin® NADA 141-067, Supplemental approval, January 11, 2000; sponsor OPK Biotech, LLC; species: Dogs; foi_id 603; FDA PDF
Indication
Treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin concentration) and improving clinical signs of anemia regardless of cause (hemolysis, blood loss, ineffective erythropoiesis).
Dose regimen
10-30 mL/kg body weight, Intravenous infusion, One-time dose, Rate up to 10 mL/kg/hr; supplement changes the fixed 30 mL/kg dose to a flexible 10-30 mL/kg range; duration of action increases with dose
The recom mended dosage of Oxyglobin is a one-time dose of 10-30 mL/kg of body weight administered intravenously at a rate of up to 10 mL/kg/hr.
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| half-life | 17-25 hours (7 mL/kg); 18-26 hours (10 mL/kg); 19-30 hours (15 mL/kg) | Terminal half-life of plasma hemoglobin; single IV infusion in acutely isovolemically hemodiluted Beagles (18 dogs, 3 groups of 6); range based on mean ± SD | Dose mL/kg Duration (hours)*: oxyglobin levels over 1 g/dL Terminal half-life (hours)* 7 4 - 9 17-25 10 11 - 23 18-26 15 23 - 39 19-30 *range based on mean ±SD |
| other | Duration of plasma hemoglobin over 1 g/dL: 4 - 9 h (7 mL/kg), 11 - 23 h (10 mL/kg), 23 - 39 h (15 mL/kg) | Same PK study (Study 2022-97), noncompartmental analysis; columns are dose, duration over 1 g/dL, terminal half-life | Dose mL/kg Duration (hours)*: oxyglobin levels over 1 g/dL Terminal half-life (hours)* 7 4 - 9 17-25 10 11 - 23 18-26 15 23 - 39 19-30 *range based on mean ±SD |
| other | 10 mL/kg provides 1 g/dL plasma hemoglobin for 11 to 23 hours | Conclusion of PK study; basis for the 10 mL/kg lower dose | In this study, an Oxyglobin (hemoglobin based oxygen carrier) dose of 10 mL/kg provides a 1 g/dL plasma hemoglobin level for 11 to 23 hours. |
Effectiveness
Laboratory tissue oxygenation study in a canine acute normovolemic hemodilution model comparing stored red cells, fresh blood and polymerized bovine hemoglobin (HBOC-201), plus the pharmacokinetics study above; supports 10 mL/kg as the lower end of the dose range; n = 24 Foxhounds (3 groups of 8); primary endpoint: Skeletal muscle tissue oxygen tension immediately after dosing; result: Baseline tissue oxygenation restored by a plasma hemoglobin augmentation of as little as 0.7 g/dL with HBOC-201
2) Test Animals: 24 Foxhounds divided into 3 groups of 8 dogs each.
Extraction notes: Supplemental approval changing the dose from fixed 30 mL/kg to 10-30 mL/kg; safety relies on the original 1998 approval (no new safety data). The summary has no Species/Class field; 'Dogs' is taken from the indication. The tissue oxygenation study used HBOC-201 (a related formulation) rather than Oxyglobin (HBOC-301). PK table quoted as a flattened block; result of tissue study: 'In the dogs receiving HBOC-201, the mean baseline tissue oxygenation was restored by a hemoglobin augmentation of 0.7g/dL.'
Oxyglobin® NADA 141-067, Original approval, January 12, 1998; sponsor OPK Biotech, LLC; species: Dogs; foi_id 3700; FDA PDF
Indication
Treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin) and improving clinical signs of anemia for at least 24 hours, regardless of cause.
Dose regimen
30 mL/kg body weight, Intravenous at a rate of up to 10 mL/kg/hr, One-time dose, Field trial infused at 15 ± 5 mL/kg/hr; rate subsequently reduced to 10 mL/kg/hr to prevent volume overload
The recommended dosage of Oxyglobin® is a one-time d ose of 30 mL/kg of body weight.
Target-animal safety
dose multiples 1X (30 mL/kg), 2X (60 mL/kg), 3X (90 mL/kg); duration Two infusions (Days 1 and 4) at 10 mL/kg/hr after acute normovolemic hemodilution; necropsy Day 6 or Day 32; animals 40.
b) Test Animals: 40 healthy Beagle dogs approximately 6 months old. Eight dogs (4M, 4F) were randomly assigned to each of 5 test groups.
| Finding | Quote |
|---|---|
| Yellow-orange discoloration of skin/mucous membranes/sclera, discolored feces and urine, decreased appetite, vomiting, diarrhea at the recommended dose | Clinical signs: yellow-orange discoloration of skin, ear canals, pinnae, mucous membranes (gums), and sclera, red-dark-green discoloration of feces |
| Dose-dependent transient AST/ALT increases (up to 25-fold AST, 11-fold ALT at higher doses) without hepatic lesions | In the higher dose groups, up to 25-fold increase in AST and up to 11-fold increase in ALT were observed after one dose. |
| Arteriolitis, slight glomerulonephropathy and reversible renal tubular necrosis considered pathologic effects | The arteriolitis, slight glomerulonephropathy, and reversible tubular necrosis seen microscopically are pathologic effects of Oxyglobin®. |
| Anti-bovine hemoglobin IgG antibodies in 11/12 treated dogs | Low levels of canine immunoglobulin-G class antibodies to bovine hemoglobin (anti-BvHb) were produced in 11/12 Oxyglobin® treated dogs (4 in the 1x dose, 4 in the 2x dose, 3 in the 3x dose). |
| Repeat administration not evaluated for safety or efficacy | However, no data were collected to evaluate the safety or efficacy of repeat administration of Oxyglobin® in dogs. |
Effectiveness
Multi-center, randomized, untreated (negative) controlled clinical field trial in anemic client-owned dogs (6 university sites); sequential double-triangular design stopped at 64 dogs; single 30 mL/kg IV dose; n = 64 (30 Oxyglobin, 34 untreated control); primary endpoint: Treatment success = no need for additional oxygen-carrying support for 24 hours; also change in plasma hemoglobin, Physical Condition Scale score and time to failure; result: Success 20/21 (95%) vs 9/28 (32%) in the efficacy population and 22/30 (73%) vs 10/34 (29%) intent-to-treat (Fisher's exact p<=0.001); plasma hemoglobin increased 2.79 g/dL at 24 h; longer time to failure than controls (p<0.001)
64 client-owned dogs of various sexes, weights, and breeds. 30 dogs were randomized to the Oxyglobin® treatment group and 34 dogs were randomized to the untreated control group (22 of these control dogs later received Oxyglobin® due to need for additional oxygen carrying support).
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Discoloration of mucous membranes (yellow, red, purple, brown) | 69% | Discoloration Mucous Membranes° 69 47 | |
| Vomiting | 35% | Gastrointestinal Vomiting 35 72 | |
| Increased central venous pressure (measured in 17 dogs only) | 33% | Increased CVP† 33 47 | |
| Ventricular arrhythmia (AV block, tachycardia, VPCs) | 15% | Ventricular Arrhythmia‡ 15 78 | |
| Death/Euthanasia | 15% | Death/Euthanasia 15 63 | |
| Pulmonary edema | 12% | Pulmonary Edema 12 67 |
Extraction notes: Original approval. No Species/Class field in General Information; 'Dogs' from indication. Adverse reaction table covers Oxyglobin-treated dogs only (n=52, including control dogs later treated); first number in each quoted row is % of treated dogs with the reaction, second number is % of those reactions occurring in dogs with hemolytic anemia (no untreated-control column). Dose selection from a GLP dose-titration study (15, 30, 45 mL/kg) in hemodiluted splenectomized Beagles; 30 mL/kg was the lowest dose significantly increasing arterial oxygen content at 60 min and 24 h. Margin-of-safety study used a hemodilution model with human serum albumin/saline protein control and an untreated negative control.
Reproduce: foi_structured_search(query="Hemoglobin Glutamer-200 (bovine)") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).