pharmacopeia
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/api/v1/drug/glutamine

Mechanism of action

Sourced from openFDA

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.

Indications

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

Contraindications

Sourced from openFDA
  • None None ( 4 )contraindicated

Dosage & administration

Sourced from openFDA

5 grams to 15 grams orally, twice daily based on body weight. ( 2 ) Each dose of Endari should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 oz. to 6 oz. of food before ingestion. ( 2 ) 2.1 Dosage Administer Endari orally, twice per day at the dose based on body weight according to Table 1. Table 1. Recommended Dosing 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 2.2 Preparation of Product Mix Endari immediately before ingestion with 8 oz. (240 mL) of cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. to 6 oz. of food such as applesauce or yogurt. Complete dissolution is not required prior to administration.

Adverse reactions

Sourced from openFDA

Most common adverse reactions (incidence > 10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Emmaus Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Endari in 187 patients, including 136 exposed for 6 months and 109 exposed for ≥1 year. Endari was studied in 2 placebo-controlled clinical trials (a phase 3 study, n=230 and a phase 2 study, n=70). In these trials, patients with sickle cell anemia or sickle β 0 -thalassemia were randomized to receive Endari (n=187) or placebo (n=111) orally twice daily for 48 weeks followed by 3 weeks of tapering. Both studies included pediatric and adult patients (5-58 years of age) and 54% were female. The majority of patients were black (97.3%), had a diagnosis of sickle cell anemia (89.9%) and were receiving hydroxyurea at baseline (63.4%). Treatment discontinuation due to adverse reactions was reported in 2.7% (n=5) of patients receiving Endari. These adverse reactions included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are no available data on Endari use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with Endari. 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 U.S. 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. 8.2 Lactation Risk Summary There are no data on the presence of Endari 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 Endari and any potential adverse effects on the breastfed child from Endari or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of Endari have been established in pediatric patients 5 years and older. Use of Endari is supported by evidence from 2 placebo-controlled studies in adult and pediatric patients with sickle cell disease.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of L-glutamine has been studied in healthy subjects and a variety of disease states. Relevant results from published literature are summarized below.

Overdosage

Sourced from openFDA

Single oral doses of L-glutamine at about 20 g/kg to 22 g/kg, 8 g/kg to 11 g/kg, and 19 g/kg were lethal in mice, rats, and rabbits, respectively. Supportive measures should be undertaken in the event of overdose of Endari.

Approval history

Sourced from openFDA
  • Jul 7, 2017NDANDA208587Emmaus Medcl
  • Jul 8, 2024ANDAANDA215647Novitium Pharma
  • May 14, 2026ANDAANDA219750Stira

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
5,186 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Sickle Cell Anaemia With Crisis1,64332%
  2. 2Product Dose Omission Issue67713%
  3. 3Pain3236.2%
  4. 4Nausea3045.9%
  5. 5Product Dose Omission2805.4%
  6. 6Headache2605.0%
  7. 7Diarrhoea2424.7%
  8. 8Fatigue2023.9%
  9. 9Hospitalisation1933.7%
  10. 10Abdominal Pain Upper1853.6%
  11. 11Constipation1753.4%
  12. 12Pain In Extremity1553.0%
  13. 13Arthralgia1502.9%
  14. 14Drug Ineffective1452.8%
  15. 15Drug Dose Omission1442.8%

Literature

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Recent PubMed references pinned to Glutamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 294 ClinicalTrials.gov registrations naming Glutamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Glutamine work?
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.
What is Glutamine used for?
According to FDA labeling, Glutamine carries indications including: Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ENDARI 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Glutamine?
Glutamine is classified as Amino acids and derivatives, Amino Acid, Biological Macromolecular Activity, Metabolic Activity Alteration.
What are the brand names for Glutamine?
Glutamine is marketed under brand names including Endari.
What are the contraindications for Glutamine?
Glutamine labeling lists contraindications including: None None ( 4 ). Always consult the full prescribing information and a clinician.
Note. Data for glutamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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