New Indication for Neupogen
March 30, 2015 - Amgen has announced that Neupogen® (filgrastim) received approval from the U.S. Food and Drug Administration (FDA) and it is not indicated for treating children and adults who have Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS). H-ARS is acute radiation injury, radiation sickness or radiation poisoning which follows high exposure to radiation and may occur in a short period of time. Radiation damages bone marrow and reduces the production of new blood cells and can cause Neutropenia. Neutropenia is when there are a very low number of neutrophils, white blood cells that form a major part of the immune system, which causes individuals to be more prone to infections and less able to fight bacteria, fungi and other infective agents.
Neupogen, one of several drugs that have been used off-label to treat radiation exposures, is the first drug to receive FDA approval gaining the indication to treat H-ARS. Initially, Neupogen was approved almost 25 years ago to reduce infections for cancer patients who need chemotherapy drugs that damage bone marrow. During it’s time on the market, Neupogen has expanded indications for patients with other types of neutropenia and for bone marrow transplant patients. Neupogen dosing is based on body weight. For H-ARS 10mcg/kg is given subcutaneously once a day beginning as soon after exposure as possible and continuing until neutrophil counts increase into normal ranges.
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