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Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Drug information

Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Drug information
(For additional information see "Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Patient drug information" and see "Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Endari
Pharmacologic Category
  • Amino Acid;
  • Gastrointestinal Agent, Miscellaneous
Dosing: Adult
Oral mucositis prevention, in patients with head and neck cancer receiving chemoradiotherapy

Oral mucositis prevention, in patients with head and neck cancer receiving chemoradiotherapy (off-label use): Oral: 10 g 3 times daily throughout chemoradiotherapy (Tsujimoto 2015) or 10 to 30 g/day during chemoradiotherapy (MASCC/ISOO [Elad 2020]).

Sickle cell disease

Sickle cell disease : Endari: Note: Only the Endari brand/formulation is approved for sickle cell disease (SCD); avoid the use of other glutamine formulations for SCD (Quinn 2018).

Prevention of vaso-occlusive pain in patients with frequent episodes (≥2 in the prior year), either as an adjunct to hydroxyurea or as an alternative in patients unable to tolerate hydroxyurea (Niihara 2018):

<30 kg: Oral: 5 g (1 packet) twice daily (total dose 10 g/day).

30 to 65 kg: Oral: 10 g (2 packets) twice daily (total dose 20 g/day).

>65 kg: Oral: 15 g (3 packets) twice daily (total dose 30 g/day).

Supplement

Supplement (nutritional):

Note: Several products are available and specific dosing may not be represented here; refer to manufacturer labeling for product-specific dosing.

GlutImmune, GlutaMent, GlutaSolve, Glutapak-10, Sympt-X: Oral: Average dose: 10 g 3 times per day; dosing range: 5 to 30 g/day.

Glutamine (capsules, tablets): Oral: 500 mg daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Pediatric

(For additional information see "Glutamine (including L-glutamine [pharmaceutical grade] and supplements): Pediatric drug information")

Note: Dose is presented as grams of l-glutamine.

Sickle cell disease

Sickle cell disease: Note: Only the Endari brand/formulation is approved for sickle cell disease (SCD); avoid the use of other glutamine formulations for SCD (Quinn 2018).

Children ≥5 years and Adolescents: Endari: Oral Powder:

<30 kg: Oral: 5 g (1 packet) twice daily; total daily dose: 10 g/day.

30 to 65 kg: Oral: 10 g (2 packets) twice daily; total daily dose: 20 g/day.

>65 kg: Oral: 15 g (3 packets) twice daily; total daily dose: 30 g/day.

Supplement

Supplement (nutritional):

Sympt-X: Children and Adolescents: Oral: 0.25 to 0.5 g/kg/day given in 3 divided doses; usual adult dose: 10 g/dose.

Glutasolve: Children >3 years and Adolescents: Oral: 15 g (1 packet)/dose; frequency determined based on patient's clinical status, indication, and nutritional assessment.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Nutritional supplements/medical foods are contraindicated in renal impairment.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Nutritional supplements/medical foods are contraindicated in liver impairment.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 500 mg

Packet, Oral:

Endari: 5 g (1 ea, 60 ea)

Tablet, Oral:

Generic: 500 mg

Generic Equivalent Available: US

May be product dependent

Dosage Forms Considerations

Sympt-X is available in US in 300 g jars, 500 g jars and packets (10 g L-glutamine + 5 g maltodextrin)

Administration: Adult

Oral:

Endari: Mix each dose with 240 mL cold or room temperature beverage (eg, water, milk, apple juice) or with 120 to 180 mL of food (eg, applesauce or yogurt). Complete dissolution is not required prior to administration. Prepare immediately prior to administration.

GlutaMent: Do not mix with hot beverages as this may reduce potency; mix 1 packet with 120 to 180 mL of water, juice or other liquid. May also add to applesauce, pudding, or yogurt. For mucositis, mix each 10 g packet with 120 mL water; administer using a swish-and-swallow technique. If administering via feeding tube, mix 1 packet with 30 mL water; mix well and administer slowly via syringe; flush with 15 to 30 mL water before and after administration. Do not mix directly with enteral formula.

Glutapak-10: Prior to use, mix with 60 to 120 mL liquid or semisolid food. If administering via feeding tube, mix each 10 g packet with 60 to 120 mL water, and flush feeding tube before and after administration. Do not mix directly with enteral formula. Use immediately after preparation.

GlutaSolve: Mix each 22.5 g packet (containing l-glutamine 15 g) with 120 mL water. May also be mixed in hot or cold beverages, applesauce, pudding, or yogurt. If administering via feeding tube, mix with 60 to 120 mL warm water for 20 seconds. Flush tube with 15 to 30 mL water before and after administration. Use immediately after preparation. Do not mix directly with enteral formula.

GlutImmune: Mix with food or hot or cold beverages.

Sympt-X: Mix dose (10 g) with 180 to 240 mL water, juice, or another beverage; may also be mixed with semi-solid foods such as yogurt or smoothie. Use immediately after preparation. May administer via feeding tube.

Administration: Pediatric

Oral:

Endari: Children ≥5 years and Adolescents: Mix each dose with 240 mL cold or room temperature beverage (eg, water, milk, apple juice) or with 4 to 6 ounces of semi-solid food (eg, applesauce, yogurt); do not use hot beverage or food. Complete dissolution is not required prior to administration. Prepare immediately prior to administration; do not save for later use.

Glutasolve: Children >3 years and Adolescents: Mix each 22.5 g packet (containing l-glutamine 15 g) with 120 mL hot or cold beverage. May also be mixed in applesauce, pudding, or yogurt. Stir well and use immediately.

Feeding tube administration: Mix with 60 to 120 mL warm water; do not mix directly with enteral formula. Flush tube with 15 to 30 mL water before and after administration. Use immediately after preparation.

Sympt-X: Children and Adolescents: Mix dose with 180 to 240 mL water, juice, or another beverage (<40°C [104°F]); may not completely dissolve; may also be mixed with semi-solid foods such as yogurt or smoothie. Use immediately after preparation. May administer via feeding tube.

Use: Labeled Indications

Sickle cell disease (Endari only): To reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older.

In the clinical trial, Endari was used for the prevention of vaso-occlusive pain in patients with frequent episodes (≥2 in the prior year), either as an adjunct to hydroxyurea or as an alternative in patients unable to tolerate hydroxyurea (Niihara 2018).

Supplement (nutritional): Medical food used to promote GI tract healing and nutritional supplementation with GI disorders, HIV/AIDS, cancer, and other critical illnesses.

Note: A medical food is formulated to be administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs (eg, requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).

Use: Off-Label: Adult

Oral mucositis prevention, in patients with head and neck cancer receiving chemoradiation

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Chest pain (12%)

Central nervous system: Headache (18%)

Gastrointestinal: Flatulence (22%), constipation (21%), nausea (19%), abdominal pain (17%)

Neuromuscular & skeletal: Limb pain (13%), back pain (12%)

Respiratory: Cough (16%)

Frequency not defined:

Cardiovascular: Peripheral edema, vascular disease

Central nervous system: Chills, depression, hypoesthesia, insomnia, pain

Dermatologic: Nail disease, pruritus, skin rash

Endocrine & metabolic: Dehydration, increased thirst

Gastrointestinal: Abdominal distention, Crohn disease, gastric ulcer, gastrointestinal fistula, hemorrhoids, pancreatitis, tenesmus, vomiting, xerostomia

Genitourinary: Fungal vaginosis, mastalgia

Hepatic: Hepatic insufficiency

Hypersensitivity: Hypersensitivity reaction

Infection: Bacterial infection, infection, viral infection

Local: Injection site reaction

Neuromuscular & skeletal: Myalgia

Respiratory: Flu-like symptoms, laryngitis, pharyngitis, rhinitis

Renal: Nephrolithiasis, pyelonephritis

Miscellaneous: Fever

Contraindications

Endari: There are no contraindications listed in the manufacturer's labeling.

OTC labeling: Renal or liver impairment; Reye syndrome; shock; multi-organ failure

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Lactulose: Glutamine may diminish the therapeutic effect of Lactulose. Specifically, glutamine may diminish the ammonia-lowering effects of lactulose. Risk C: Monitor therapy

Pregnancy Considerations

Endogenous glutamine can be detected in cord blood and concentrations are decreased in low birth-weight infants (Ivorra 2012).

Breastfeeding Considerations

Endogenous glutamine is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Renal function, hepatic function

Mechanism of Action

Glutamine is considered a "conditionally essential" amino acid during metabolic stress and injury. Glutamine is a precursor for nicotinamide adenine dinucleotide (NAD). In sickle cell disease, NAD and its reduced form, NADH, have a role in regulating and preventing red blood cell oxidative damage; in sickle red blood cells, the ratio of NADH to total NAD is lower, which results in a decreased NAD redox potential (Niihara 1998). Glutamine may improve NAD redox potential in sickle red blood cells through increased availability of reduced glutathione.

Pharmacokinetics

Distribution: Adults (healthy): IV: Vd: ~200 mL/kg

Metabolism: Hepatic metabolism to glutamate and ammonia

Half-life elimination: Adults (healthy): IV: ~1 hour

Time to peak, serum: Adults (healthy): ~30 minutes

Pricing: US

Capsules (Glutamine Oral)

500 mg (per each): $0.09

Pack (Endari Oral)

5 g (per each): $24.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Adamin-G (CZ);
  • An Kai Shu (CN);
  • Convales (IN);
  • Diamin (BR);
  • Glutamin (AR);
  • Glutapak-10 (MX);
  • Glutapure (EC);
  • Glutaven (IT);
  • Glutrop (ID);
  • Pure Warrior Powered By Swisse (AU);
  • Shi Lin (CN);
  • Xin Kun Chang (CN);
  • Xin Mai Lin (CN)


For country code abbreviations (show table)
  1. Elad S, Cheng KKF, Lalla RV, et al; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020;126(19):4423-4431. doi:10.1002/cncr.33100 [PubMed 32786044]
  2. Endari (glutamine) [prescribing information]. Torrance, CA: Emmaus Medical, Inc; October 2020.
  3. GlutaMent (glutamine) [prescribing information]. Lancaster, PA: Medtrition, Inc; received June 2021.
  4. Glutamine capsules [prescribing information]. Fayetteville, AR: BioTech Pharmacal; received August 2015.
  5. Glutapak-10 (glutamine) [prescribing information]. Miami, FL: Victus; received January 2016.
  6. Glutasolve (glutamine) [prescribing information]. Florham Park, NJ: Nestle Health Science; received May 2019.
  7. GlutImmune (glutamine) [prescribing information]. San Diego, CA: Wellwisdom, LLC; received November 2015.
  8. Institute of Medicine (IOM). Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Washington, DC: National Academies Press; 2005.
  9. Ivorra C, García-Vicent C, Chaves FJ, Monleón D, Morales JM, Lurbe E. Metabolomic profiling in blood from umbilical cords of low birth weight newborns. J Transl Med. 2012;10:142. doi: 10.1186/1479-5876-10-142. [PubMed 22776444]
  10. L-Glutamine tablets [prescribing information]. Long Island City, NY: Freeda Vitamins; received August 2015.
  11. Martindale RG, McClave SA, Vanek VW, et al, “Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.),” JPEN J Parenter Enteral Nutr, 2007, 33(3):277-316. [PubMed 19398613]
  12. Niihara Y, Miller ST, Kanter J, et al; Investigators of the Phase 3 Trial of l-Glutamine in Sickle Cell Disease. A phase 3 trial of l-glutamine in sickle cell disease. N Engl J Med. 2018;379(3):226-235. doi: 10.1056/NEJMoa1715971. [PubMed 30021096]
  13. Niihara Y, Zerez CR, Akiyama DS, et al. Oral l-glutamine therapy for sickle cell anemia: subjective clinical improvement and favorable change in red cell NAD redox potential. Am J Hematol. 1998;58(2):117-121. [PubMed 9625578]
  14. Quinn CT. l-glutamine for sickle cell anemia: more questions than answers. Blood. 2018;132(7):689-693. doi: 10.1182/blood-2018-03-834440. [PubMed 29895661]
  15. Sympt-X (glutamine) [prescribing information]. Richardson, Texas; TSPC America, Inc: September 2012.
  16. Tsujimoto T, Yamamoto Y, Wasa M, et al. L-glutamine decreases the severity of mucositis induced by chemoradiotherapy in patients with locally advanced head and neck cancer: a double-blind, randomized, placebo-controlled trial. Oncol Rep. 2015;33(1):33-39. doi:10.3892/or.2014.3564 [PubMed 25351453]
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