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INDICATION

ENDARI is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.

IMPORTANT SAFETY INFORMATION

The most common adverse reactions (incidence > 10%) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain.

Adverse reactions leading to treatment discontinuation included 1 case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.

The safety and efficacy of ENDARI in pediatric patients with sickle cell disease younger than 5 years of age has not been established.

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.