Hemopure® (South Africa)
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Hemopure® [hemoglobin glutamer-250 (bovine)], manufactured by HbO2 Therapeutics LLC, is a hemoglobin-based oxygen carrier (HBOC) ready for immediate infusion that transports and delivers oxygen from the plasma and expands the circulating volume. Hemopure is supplied in 250-ml units as a sterile solution of approximately 32.5 g total purified, glutaraldehyde-polymerized, bovine hemoglobin (Hb) in an iso-oncotic balanced modified Ringer’s lactate solution at a pH of 7.6 to 7.9. It is stored at room temperature (2 to 30oC) for up to three years.
Hemopure can be administered immediately and is compatible with all blood types; blood-type testing and cross-matching is unnecessary. It does not require warming or reconstitution prior to administration and can be administered through a standard intravenous line. Upon administration, it immediately transports oxygen to tissues served by blood flow and, because of the relatively small molecular diameter, has the potential of transporting oxygen through constricted or partially blocked blood vessels via the movement of plasma through tissues in which red blood cell (RBC) flow is restricted. Hemopure has an oxygen dissociation curve that is right-shifted with a P50 of 40 mmHg, compared to 27 mmHg for corpuscular hemoglobin.
Hemopure is manufactured from a plentiful and well-controlled source material, bovine hemoglobin. Only cattle from the United States are utilized as donors, and an extensive herd-management program ensures that only certified disease-free animals less than 30 months of age are used to provide the hemoglobin. The extraction and purification process used in production has been validated for the removal of potential contaminants including plasma proteins, red blood cell stroma, endotoxin, bacteria, viruses and the agents that are thought to cause transmissible spongiform encephalopathies such as bovine spongiform encephalopathy (BSE) and variant Creutzfeld-Jakob disease (vCJD). This process produces a sterile, pyrogen-free balanced salt solution containing glutaraldehyde cross-linked bovine hemoglobin polymers, which range in size from 130 to 500 kDa and have an average molecular weight of 250 kDa.
In contrast to human hemoglobin whose oxygen affinity relies on adequate levels of 2,3-bisphosphoglycerate, the affinity of bovine hemoglobin for oxygen is regulated by the concentration of chloride ions in the plasma. It has a dose-dependent intravascular half-life of 19 to 24 hours.
Hemopure and RBCs containing the same concentration of hemoglobin, have the same oxygen carrying capacity (1.39 mL O2/g Hb). A unit of packed red blood cells (pRBC) typically has a higher hemoglobin concentration (26-32 g/dl) than does Hemopure (13.1 g/dl) and, therefore, has a higher oxygen carrying capacity (= higher efficacy) than does Hemopure.
For this reason, and because units of pRBC (250-300 mL) and Hemopure (250 mL) may have different volumes, Hemopure should not be considered a unit-for-unit alternative to pRBC. Rather, the clinical need for oxygen carrying capacity and the total circulating hemoglobin concentration (RBC Hb + plasma Hb) should guide determination of Hemopure dose. Achieving a particular target total Hb concentration will require a larger number of Hemopure units than pRBC units.
Numerous in vivo and in vitro pharmacology and toxicology studies have been performed on Hemopure over a period of more than 15 years. These studies have defined the pharmacological and toxicological properties of Hemopure in a variety of animal models ranging from ischemia, hemorrhagic shock, and cardiac arrest and include the appropriate complement of toxicology studies.
Hemopure has been administered to more than 800 human subjects in 22 completed clinical trials, including red blood cell-controlled trials in elective surgical patients where the product was administered at doses up to 300 g (10 units). Hemopure eliminated or reduced the requirement for allogeneic blood transfusions. Results from two red blood cell-controlled trials in general and orthopedic surgery have been published and are listed in the literature.
Risk of exposure to any infection with Hemopure is effectively nil and certainly many orders of magnitude less than the potential infective risk of receiving several units of human blood. Risk of Transmissible Spongiform Encephalopathy (TSE) transmission, mad cows disease, has been independently evaluated and judged safe by the European Directorate for Quality Medicines (EDQM), and they have issued a Certificate of Suitability for Hemopure. Potential microbial contamination is monitored by bioburden and endotoxin testing performed throughout the processing of the drug substance. The extensive filtration, chemical purification and polymerization process used to manufacture Hemopure removes and inactivates possible bacterial and viral contaminants. This has been demonstrated by viral clearance studies which have been carried out during the various production phases of Hemopure. Both RNA and DNA viruses, as well as enveloped and non-enveloped viruses have been shown to be cleared by the proprietary production process.
A herd management program ensures that the source material, bovine whole blood, is collected from animals that meet strict safety requirements. Suppliers maintain adequate records to document sourcing (USA and Canada only), age (less than 30 months), appropriate feed, health and vaccination programs, and animals must pass USDA inspection for use as beef for human consumption. OPK Biotech maintains separate facilities for the collection of its source material and a process designed to assure efficient, clean collection of a pharmaceutical raw material.
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