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Oxyglobin Solution Questions & Answers for Veterinary Professionals

• Dosage and administration:

• What is the dosage?
  
• How long does Oxyglobin last? How long does it stay in the body?
  
• How do I administer Oxyglobin?
  
• Can I infuse Oxyglobin with saline?
  
• What gauge needle should be used to administer Oxyglobin?
  
• Can Oxyglobin be administered repeatedly?
  
• Can Oxyglobin be administered using an infusion pump?
  

• Packaging and storage:

• How is Oxyglobin packaged?
  
• Why is the bag covered with a foil overwrap?
  
• How should Oxyglobin be stored?
  
• What is the shelf life of Oxyglobin?
  
• Can I store unused Oxyglobin and reuse it later?
  
• Can Oxyglobin be used after its expiration date?
  

• Clinical:

• Can Oxyglobin be used in cats?
  
• Does Oxyglobin work in hemolytic anemia?
  
• What are the most common side effects associated with Oxyglobin?
  
• Are there any immunologic implications of administration of foreign hemoglobin?
  
• When should Oxyglobin be used?
  
• Can Oxyglobin be used with other blood products?
  
• How does Oxyglobin affect serum chemistry results?
  

• Features:

• Does Oxyglobin have to be typed or crossmatched?
  
• Does Oxyglobin have to be reconstituted or filtered?
  
• Does Oxyglobin have to be warmed prior to administration?
  

• Mechanism of action:

• How does Oxyglobin carry oxygen?
  
• How is Oxyglobin cleared from the body?
  
• Is Oxyglobin a colloid?
  
• How does Oxyglobin work?
  

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Dosage and administration:

What is the dosage?

10 - 30 ml/kg intra-venously administered.

Clinicians should consider four separate criteria when determining the dosage to administer to a canine patient.

1) Degree of anemia:  As a general rule, a patient with a lower packed cell volume (PCV) (i.e.,12%) requires more oxygen carrying support than a patient with a higher PCV (i.e., 27%).

2) Clinical status of the patient:  A patient with a rapid onset anemia is likely to exhibit moderate to severe clinical signs of anemia while a patient with a chronic anemia may only exhibit mild clinical signs. The former will require more oxygen carrying support than the latter.

3) Desired duration of effect:   Oxyglobin's duration of effect is dose dependent. The more that is administered, the longer the clinical effects. At a dosage of 10 ml/kg, the expected duration of effect is 11 - 23 hours while at 30 ml/kg the expected duration of effect is 74 - 82 hours.

  (See How long does Oxyglobin last?)

4) Blood volume status of the patient:   A patient that is normovolemic or hypervolemic (e.g., a dog with chronic anemia) is more prone to volume overload from the colloidal effects of Oxyglobin. Thus, the maximum dosage of Oxyglobin should be used cautiously in these patients.

The rate of administration should be chosen carefully. A slower rate (e.g. ≤ 4 ml/kg/hr) should be chosen if the animal is hypervolemic.

How long does Oxyglobin last? How long does it stay in the body?

Oxyglobin increases systemic oxygen content and improves the clinical signs of anemia. The plasma half-life of Oxyglobin is dose dependent. See Table A.

Table A: Pharmacokinetic parameters at multiple dose levels after a single infusion of Oxyglobin® Solution

Dose (mL/kg)	Immediate post infusion concentration (g/dL)	Duration (hours): Oxyglobin® levels over 1 g/dL	Terminal half-Life* (hours)	Cleared from plasma (days)***
10	1.5 - 2.0	11 - 23	18 - 26	4 - 5
15	2.0 - 2.5	23 - 39	19 - 30	4 - 6
21	3.4 - 4.3	66 - 70	25 - 34	5 - 7
30	3.6 - 4.8	74 - 82	22 - 43**	5 - 9**

* range based on mean ± SD
**range based on estimated mean value with bounds of a 95% prediction interval
***range based on 5 terminal half-lives

How do I administer Oxyglobin?

Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter through a central or peripheral vein at a maximum rate of 10 mL/kg/hr. Choice of the rate of administration should be based on the status of the blood volume of the dog i.e., slower if an expanded blood volume is present and faster if hypovolemia is present.

Oxyglobin can be administered using any intravenous infusion pump including a roller pump. However, a pump is not necessary for the administration of Oxyglobin.

Subcutaneous or intraperitoneal administration of Oxyglobin is not recommended.

Can I infuse Oxyglobin with saline?

Oxyglobin should not be mixed with other solutions. Oxyglobin may be administered sequentially with other fluids via the same catheter and vein. Although there are no known contraindications to administering Oxyglobin with other fluids, caution should be used because of the potential for volume overload. The rate of administration should not exceed 10 mL/kg/hr and the animal should be monitored for signs of circulatory overload, especially when administered in conjunction with other colloidal solutions.

What gauge needle should be used to administer Oxyglobin?

Oxyglobin can be administered through any size needle via a standard infusion set.

Can Oxyglobin be administered repeatedly?

Oxyglobin is labeled for a single administration. A peer reviewed article in which 9 infusions were given over one year has been published.

Hamilton RG, Kelly N, Gawryl MS, Rentko VT. Absence of Immunopathology Associated with Repeated IV Administration of Bovine Hb-Based Oxygen Carrier in Dogs. Transfusion 2001;(41):219-225.

Can Oxyglobin be administered using an infusion pump?

Yes. Oxyglobin is compatible with any intravenous administration pump.

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Packaging and storage:

How is Oxyglobin packaged?

Oxyglobin is packaged in a 125 mL single dose infusion bag and a 60 mL single dose infusion bag.

• Two 125 mL bags in a shipping box
• Two 60 mL bags in a shipping box

Why is the bag covered with a foil overwrap?

The foil overwrap serves as an oxygen barrier, protecting the hemoglobin from oxidation to methemoglobin, the inactive form of hemoglobin.

How should Oxyglobin be stored?

Oxyglobin can be stored at room temperature or refrigerated (2°-30°C). Recommended storage is at room temperature to avoid accidental freezing. Because of denaturation of protein on thawing, Oxyglobin should not be frozen. Oxyglobin must be stored in its sealed foil overwrap to avoid exposure to oxygen.

What is the shelf life of Oxyglobin?

Oxyglobin remains stable at room temperature or refrigerated for 3 years from the date of manufacture. The expiration date is printed on the bag. Oxyglobin must remain in its sealed foil overwrap during storage to avoid exposure to oxygen.

Can I store unused Oxyglobin and reuse it later?

No. Once the overwrap is removed, Oxyglobin should be used within 24 hours. Oxyglobin is packaged sterile. Once opened, there is risk for bacterial contamination, and over time, the hemoglobin oxidizes to methemoglobin. Replacement inside the foil overwap does not prevent this oxidation.

Can Oxyglobin be used after its expiration date?

No. Oxyglobin can be used until the last day of the month and year which is embossed on the bag and overwrap.

The foil overwrap protects the bag containing Oxyglobin from exposure to oxygen which can oxidize the hemoglobin to methemoglobin. Methemoglobin does not carry oxygen.

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Clinical:

Can Oxyglobin be used in cats?

Oxyglobin is FDA-approved to treat anemia in dogs only. Safety or efficacy studies in cats have not been completed. The only safety information available regarding the use of Oxyglobin in cats appears in two retrospective studies:

1. Gibson,GR, Callan MB, et al. Use of Hemoglobin-Based Oxygen-Carrying Solution in Cats: 72 Cases (1998 - 2000). J Vet Med Assoc. 2002; 221(1):96 -102.
2. Weingart C, Kohn B. Use of Oxyglobin® in cats: 46 cases (2002-2006). J Vet Int Med. 2007;21(3):623-624.

Does Oxyglobin work in hemolytic anemia?

Oxyglobin delivers oxygen and treats anemia regardless of the cause. It may be useful in treating hemolytic anemia because Oxyglobin has no cellular antigens which are the target of hemolytic anemia.

References:

Grundy SA, Barton C. Influence of drug treatment on survival of dogs with immune-mediated hemolytic anemia: 88 cases (1989-1999) JAVMA 2001;218(4):543-546.

Birkenbeur A, Ford RB. Immune-mediated hemolytic anemia. Compendium's Standards of Care 1999;1(1):1-12.

Day TK, MacIntire DK, Murtaugh RJ, Mathews KA. Differing opinions on treatment of immune mediated hemolytic anemia. JAVMA 2001;218(9):1414-1415.

Weinkle TK, Center SA, Randolph JF, Warner K, Barr SC. Evaluation of prognostic factors, survival rates, and treatment protocols for immune-mediated hemolytic anemia in dogs: 151 cases (1993-2002). JAVMA 2005;226(11):1869-1880.

What are the most common side effects associated with Oxyglobin?

The most common side effects of Oxyglobin are discoloration of the skin, mucous membranes and urine. The use of Oxyglobin is contraindicated in dogs with impaired cardiac function or other conditions that predispose to circulatory overload. Patients should be monitored for signs of circulatory overload such as coughing, dyspnea, pulmonary edema and pleural effusion. The safety and efficacy of repeat administration have not been determined. Other adverse reactions such as vomiting and melena have occurred. See package insert for a complete listing of side effects.

Are there any immunologic implications of administration of foreign hemoglobin?

Administration of any foreign protein has the potential to cause immunologic reactions; however, no anaphylactic reactions have been reported with the administration of Oxyglobin.

IgG antibodies are formed following the repeated administration of Oxyglobin but no immunopathology has been noted.

Hamilton RG, Kelly N, Gawryl MS, Rentko VT. Absence of Immunopathology Associated with Repeated IV Administration of Bovine Hb-Based Oxygen Carrier in Dogs. Transfusion 2001;(41):219-225.

When should Oxyglobin be used?

Oxyglobin is effective for the treatment of anemia caused by blood loss, hemolysis, and ineffective erythropoiesis. As a result, Oxyglobin can be used in all causes of canine anemia. Oxyglobin is most used as an oxygen bridge in regenerative anemia in which a dog's hematopoietic system is functioning normally. Oxyglobin has been used successfully to treat anemia due to the following conditions:

• Immune Mediated Hemolytic Anemia
• Intra-operative hemorrhage
• Post-operative blood loss
• GI parasites
• Trauma
• Rat poisoning
• Babesiosis
• GI ulcers
• Splenectomy
• Hit by car
• Zinc toxicosis
• Bite wounds
• Ectoparasites
• Fracture repair
• Peri-operative oxygen carrying support

Can Oxyglobin be used with other blood products?

Oxyglobin is compatible with the use of all blood products, either before or after a transfusion. Since both blood and Oxyglobin are colloids, clinicians should carefully monitor for signs of circulatory overexpansion.

How does Oxyglobin affect serum chemistry results?

Because of the presence of Oxyglobin, the plasma/serum from a dog which received Oxyglobin will appear red. The presence of Oxyglobin in serum may result in artifactual increases or decreases in the results of some serum chemistry tests, depending on the type of analyzer and reagents used.

The red plasma/serum is due to the presence of Oxyglobin and should not be confused with hemolysis of the red blood cells. (Note: Hemolysis cannot be detected in the presence of Oxyglobin). Interferences may occur as long as hemoglobin is present in the plasma. Table B shows valid analytes by instrumention.

Contact Technical Services 1-888-400-0030 for additional information.

Additional laboratory interference information is available at www.HBOClab.com

View the full prescribing information.

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Features:

Does Oxyglobin have to be typed or crossmatched?

No, there is no need for typing or crossmatching. Oxyglobin consists of ultrapurified hemoglobin that contains no other red blood cell components, such as cell membranes.

Does Oxyglobin have to be reconstituted or filtered?

Oxyglobin does not have to be filtered or reconstituted. Oxyglobin comes in a 125 mL or 60 mL ready to use infusion bag.

Does Oxyglobin have to be warmed prior to administration?

If desired, Oxyglobin may be warmed up to 37°C using a warm water bath prior to administration. Do not warm in a microwave oven.

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Mechanism of action:

How does Oxyglobin carry oxygen?

Oxyglobin consists of ultrapurified, chemically crosslinked hemoglobin that works like hemoglobin in red blood cells to pick up and deliver oxygen to the tissues. However, unlike hemoglobin in red blood cells, Oxyglobin increases systemic oxygen content by carrying oxygen in the plasma. It also enhances the offloading of oxygen from existing red blood cells.

How is Oxyglobin cleared from the body?

Like hemoglobin in red blood cells, Oxyglobin is metabolized and eliminated by the reticuloendothelial system. Small amounts of unstabilized hemoglobin (<5%) may be filtered through the kidneys, resulting in transient discoloration (red) of the urine following the infusion. A laboratory study showed that at a dose of 30 mL/kg the duration of urine discoloration lasted for up to 4 hours in normal dogs. (Note: The duration of urine discoloration may vary with the clinical condition of the dog.) The transient discoloration of the urine is expected and it should not be interpreted as being due to intravascular hemolysis. Filtration has no effect on renal function.

Is Oxyglobin a colloid?

Yes. Oxyglobin is a colloid and will expand the circulatory volume. It has an average molecular weight of 200 kD. Its colloidal properties are similar to hetastarch.

How does Oxyglobin work?

Oxyglobin is chemically modified hemoglobin of bovine origin. The hemoglobin is crosslinked into larger molecules. Oxyglobin is stored in the bag in a deoxygenated state. The hemoglobin becomes oxygenated as it passes through the lungs. Oxyglobin off-loads oxygen to tissue and carries CO₂ similar to hemoglobin in red blood cells. Because it is carried in the plasma component of blood,  Oxyglobin increases plasma and total hemoglobin concentrations and thus increases systemic oxygen content.

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