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.
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.
ENDARI is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years of age 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 hands or feet, back pain, and chest pain.
Side effects that lead to a stop in treatment during the clinical study were, one 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 with sickle cell disease younger than 5 years old.
Talk to your doctor to determine if prescription ENDARI is right for you. You may report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088. You can also call Emmaus Medical, Inc. at 1-855-725-0900.
For more information, please read the full Prescribing Information, including Instructions for Use, for ENDARI.