Endari

How ENDARI Works

How does ENDARI work?

Oxidative stress is caused by an imbalance in cells between reactive oxygen and the cell’s ability to detoxify reactive oxygen. Oxidative stress phenomena are involved in the pathophysiology of sickle cell disease. Sickle red blood cells are more susceptible to oxidative damage than normal red blood cells, which may contribute to the chronic hemolysis and vaso-occlusive events associated with sickle cell disease.

How ENDARI Works

The mechanism of action of the amino acid L-glutamine in treating sickle cell disease is not fully understood. It is believed that ENDARI helps to restore the ratio of NADH/NAD(total) in the red blood cells. NADH is a natural antioxidant in the cell and is involved in regulating and preventing oxidative damage in red blood cells. In individuals with sickle cell disease, the ratio of NAD+ and NADH may be altered when compared to healthy individuals. ENDARI improves and restores the ratio of NADH to NADtotal, which may help sickle red blood cells tolerate increased oxidative stress.

INDICATION

ENDARI [L-glutamine oral powder] is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older.

IMPORTANT SAFETY INFORMATION

The most common side effects in clinical studies were constipation, nausea, headache, pain in the stomach area, cough, pain in the hands or feet, back pain, and chest pain.

Side effects that led to a stop in treatment during the clinical studies were 1 case each of overactive spleen (an organ that helps filter your blood), pain in the stomach area, indigestion, burning sensation and hot flash.

It is not known whether ENDARI is safe and effective in children younger than 5 years old with sickle cell disease.

Please see full Prescribing Information.

You are encouraged to report all possible negative side effects of ENDARI to Emmaus Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1080 or www.fda.gov/medwatch.