Frequently Asked Questions
ENDARI is a prescription medication that is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older. Acute complications include episodes of painful crises.
ENDARI is prescribed to reduce the acute complications of sickle cell disease in patients 5 years of age and older. ENDARI has been shown to reduce hospitalizations due to pain crises in patients. It has also been shown to increase the time between pain crises.
ENDARI may cause some side effects. The most common side effects are the following:
- Pain in stomach area
- Pain in hands or feet
- Back pain
- Chest pain
Side effects that led to stopping treatment during the clinical trial were one case of each:
- Overactive spleen (an organ that helps filter blood)
- Pain in stomach area
- Burning sensation
- Hot flash
These are not all the possible side effects of ENDARI. 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-1088 or www.fda.gov/medwatch.
Yes. Each dose of ENDARI should be mixed with 8 ounces of a cold or room temperature beverage, like water, milk or apple juice. Patients can also mix ENDARI with 4 to 6 ounces of food like yogurt or applesauce. Patients should take their full dose of ENDARI immediately after mixing it. ENDARI can be taken even if it does not fully dissolve.
In the clinical study, 63.4% of enrolled patients had been stable on hydroxyurea for at least three months before the clinical trial began and continued using hydroxyurea throughout the clinical trial. Talk to your doctor if you are on hydroxyurea before taking ENDARI.
During the clinical trials, patients received blood transfusions. Talk to your doctor if you are receiving blood transfusions and are considering ENDARI.
There is no available information on ENDARI use in pregnant women. During the clinical trials, women who became pregnant were taken off the study. Talk to your doctor if you are pregnant or thinking about becoming pregnant.
There is no available information on ENDARI use in human milk, the effect on breast feeding, or the effect on production of milk. Talk to your doctor if you are breastfeeding.
ENDARI is available through specialty pharmacies. Ask your doctor about the specialty pharmacies in your area.
No. ENDARI is pharmaceutical grade L-glutamine and not a dietary or nutritional supplement. You can only get ENDARI at a specialty pharmacy with a prescription.
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.