Generic Name: L-Glutamine
Class: Other Miscellaneous Therapeutic Agents
Chemical Name: (2S)-2,5-diamino-5-oxopentanoic acid
Molecular Formula: C5H10N2O3
CAS Number: 184161-19-1
L-Glutamine is an amino acid.1
Uses for Endari
L-Glutamine has the following uses:
L-Glutamine is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.1
Endari Dosage and Administration
L-Glutamine is available in the following dosage form(s) and strength(s):
Oral powder: 5 grams of L-glutamine powder per paper-foil-plastic laminate packet.1
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
5 grams to 15 grams orally, twice daily based on body weight.1
Each dose of L-glutamine should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 oz. to 6 oz. of food before ingestion.1
Cautions for Endari
There are no available data on L-glutamine use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with L-glutamine.1
Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.1
There are no data on the presence of L-glutamine in human milk, the effect on the breastfed infant or the effect on milk production. The developmental and health benefits from breastfeeding should be considered along with the mother's clinical need for L-glutamine and any potential adverse effects on the breastfed child from L-glutamine or from the underlying maternal condition.1
The safety and effectiveness of L-glutamine have been established in pediatric patients 5 years and older. Use of L-glutamine is supported by evidence from 2 placebo-controlled studies in adult and pediatric patients with sickle cell disease. The clinical studies enrolled 110 pediatric patients in the following age groups: 46 children (5 years up to less than 12 years) and 64 adolescents (12 years to less than 17 years).1
The safety and effectiveness of L-glutamine in pediatric patients with sickle cell disease younger than 5 years old has not been established.1
Clinical studies of L-glutamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.1
Common Adverse Effects
Most common adverse reactions (incidence >10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain.1
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Please see product labeling for drug interaction information.
Mechanism Of Action
The mechanism of action of the amino acid L-glutamine in treating sickle cell disease (SCD) is not fully understood. Oxidative stress phenomena are involved in the pathophysiology of SCD. Sickle red blood cells (RBCs) are more susceptible to oxidative damage than normal RBCs, which may contribute to the chronic hemolysis and vaso-occlusive events associated with SCD. The pyridine nucleotides, NAD+ and its reduced form NADH, play roles in regulating and preventing oxidative damage in RBCs. L-Glutamine may improve the NAD redox potential in sickle RBCs through increasing the availability of reduced glutathione.1
Advice to Patients
Dosage and Administration
Advise patient to take a missed dose as soon as they remember. Patient should not double the dose that they take.1
Instruct patient to mix each dose in 8 oz. (240 mL) of cold or room temperature beverage or 4 to 6 oz. of food. 1
Advise patient that complete dissolution is not required prior to administration.1
AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Powder, For Solution
Emmaus Medical Inc.
AHFS Drug Information. © Copyright 2017, Selected Revisions July 31, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
1. Emmaus Medical, Inc.. Endari (L-glutamine) oral powder prescribing information. 2017 Jul.
More about Endari (glutamine)
- Side Effects
- During Pregnancy
- Dosage Information
- Support Group
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- Drug class: nutraceutical products
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