Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia

Description

i. Initial Dose

For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient’s circulatory volume is properly controlled and will not impose an inappropriate risk.

ii. Subsequent Doses

The need for additional dose administration should be assessed after each infusion as clinically indicated.

Dosing will be stopped if any one of the following occurs:

* resolution of critical ischemia
* death
* recovery of native Hemoglobin levels to > 6 g/dL,
* evidence of reticulocytosis