Posted from: Wednesday, May 16, 2018 - 04:10 PM - Present

Leukine Receives New Indication

March 29, 2018 – The U.S. FDA has approved a new indication for Leukine® (sargramostim), manufactured by Sanofi, to increase survival of adult and pediatric patients who have had acute exposure to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS), such as may occur during a radiation emergency.

Myelosupression interferes with the body’s ability to produce blood cells, and can occur when radiation damages bone marrow. In severe cases, the condition can be fatal. Symptoms and severity can be affected by which types of blood cells the body’s bone marrow is no longer able to produce.

A recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF), Leukine helps the body increase the production and function of white blood cells. When administered within 48 hours of radiation exposure, Leukine can increase chances of survival in cases of total body irradiation expected to be fatal to 50% of patients under conditions of minimal supportive care.

Originally approved in 1991, Leukine is also indicated for use following chemotherapy or bone marrow transplant. It is the third drug to be approved by the FDA as a medical countermeasure for ARS. The other two are Amgen’s Neulasta® (pegfilgrastim) and Neupogen® (filgrastim).

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Thursday, September 19, 2019 - 05:01 PM.