
Profile
General Information
Endari (L-glutamine oral powder) reduces oxidant damage to red blood cells by improving the redox potential of nicotinamide adenine dinucleotide (NAD), a coenzyme that has been identified as the primary regulator of oxidation.
Endari is specifically indicated to reduce the severe complications of sickle cell disease (SCD) in adult and pediatric patients age 5 and older.
Endari is supplied as a powder to be reconstituted to a liquid for oral administration. Administer Endari orally, twice per day at the dose based on body weight according to the following table.
Weight in kilograms | Weight in pounds | Per dose in grams | Per day in grams | Packets per dose | Packets per day |
less than 30 | less than 66 | 5 | 10 | 1 | 2 |
30 to 65 | 66 to 143 | 10 | 20 | 2 | 4 |
greater than 65 | greater than 143 | 15 | 30 | 3 | 6 |
Mechanism of Action
Endari (L-glutamine oral powder) reduces oxidant damage to red blood cells by improving the redox potential of nicotinamide adenine dinucleotide (NAD), a coenzyme that has been identified as the primary regulator of oxidation.
Side Effects
Adverse effects associated with the use of Endari may include, but are not limited to, the following:
- constipation
- nausea
- headache
- abdominal pain
- cough
- pain in extremity
- back pain
- chest pain (non-cardiac)
Clinical Trial Results
The FDA approval of Endari was supported by efficacy data from a 48-week randomized, double-blind, placebo-controlled, multicenter Phase IIIclinical trial evaluating the effects of Endari, prescription grade L-glutamine, as compared to placebo on 230 adults and children with SCD. The results demonstrated that Endari reduced the frequency of sickle cell crises by 25% and hospitalizations by 33%. Additional findings showed a decrease in cumulative hospital days by 41% and lower incidence of ACS by more than 60%.
Approval Date: 2017-07-01
Company Name: Emmaus Life Sciences