Posted from: Friday, July 06, 2018 - 04:18 PM - Present

Leukine Receives New Indication

June 6, 2018 – The U.S. FDA has approved a new indication for Leukine® (sargramostim), manufactured by Partner Therapeutics. The drug is now indicated to treat adult and pediatric patients who have had acute exposure to myelosuppressive doses of radiation, known as Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS).

Leukine is the first drug approved to treat H-ARS that has demonstrated an improvement in survival when initiated 48 hours following radiation exposure. It works by aiding the recovery of red blood cells following the destruction of stem cells in the bone marrow that contribute to the proper function of the body’s immune system. Individuals affected by H-ARS are at increased risk of infection, bleeding, and death due to the loss of these stem cells.

In animal studies, Leukine improved survival by 85% compared to placebo in populations exposed to radiation levels sufficient to cause up to 60% fatalities. It has also been shown to improve recovery of white blood cells in patients who have undergone autologous or allogeneic bone marrow transplantation. In addition, these patients experienced improved survival rates and a reduced incidence of severe or life-threatening infections.

The FDA first approved Leukine in 1991, and the drug holds numerous hematologic indications in oncology. Recommended dosing is based on weight and age.

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 Sunday, November 18, 2018 - 10:17 AM.