glutamine (Rx)

Brand and Other Names:Endari, NutreStore
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for oral administration

  • 5g/packet (as L-glutamine)
more...

Sickle Cell Disease

Endari: Indicated to reduce acute complications of sickle cell disease

<30 kg (<66 lb): 5 g PO BID

30-65 kg (66-143 lb): 10 g PO BID

≥65 kg (≥143 lb): 15 g PO BID

Also see Administration regarding mixing oral powder with beverage or food

Short Bowel Syndrome

NutreStore: Indicated for short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with recombinant human growth hormone

30 g/day PO in divided doses (ie, 5 g taken 6 times each day) for up to 16 weeks

Also see Administration regarding mixing oral powder with water

Dosage Forms & Strengths

powder for oral administration

  • 5g/packet (as L-glutamine)
more...

Sickle Cell Disease

Endari: Indicated to reduce acute complications of sickle cell disease in adults and children aged ≥5 yr

<5 years: Safety and efficacy not established

≥5 years

  • <30 kg (<66 lb): 5 g PO BID
  • 30-65 kg (66-143 lb): 10 g PO BID
  • ≥65 kg (≥143 lb): 15 g PO BID
  • Also see Administration regarding mixing oral powder with beverage or food

Short Bowel Syndrome

NutreStore: Safety and efficacy not established

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Adverse Effects

>10%

Endari

  • Constipation (21%)
  • Nausea (19%)
  • Headache (18%)
  • Abdominal pain (17%)
  • Cough (16%)
  • Pain in extremity (13%)
  • Back pain (12%)
  • Chest pain (12%)

NutreStore

  • Adverse effects listed below are those reported that exceed growth hormone without glutamine supplementation
  • Peripheral edema (81%)
  • Nausea (31%)
  • Tenesmus (19%)
  • Rhinitis (19%)
  • Dizziness (13%)
  • Rash (13%)
  • Ear or hearing symptoms (13%)

1-10%

NutreStore

  • Pruritus (6%)
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Warnings

Contraindications

None

Cautions

Metabolized to glutamate and ammonia; levels of these metabolites may increase with hepatic impairment

Monitor renal and hepatic function

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Pregnancy & Lactation

Pregnancy

No available data regarding use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

more...
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Pharmacology

Mechanism of Action

Sickle cell disease

  • 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 RBCs are more susceptible to oxidative damage than normal RBCs, which may contribute to the chronic hemolysis and vaso-occlusive events associated with SCD
  • 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

Short bowel syndrome

  • L-glutamine has important functions in regulation of gastrointestinal cell growth, function, and regeneration
  • When glutamine was administered in combination with growth hormone to rats, villous height, bowel growth, plasma insulin-like growth factor I, and body weight were significantly higher than in rats treated with either glutamine or rhGH alone

Absorption

Peak plasma time: 30 min

Peak plasma concentration: 150 mcg/mL

Distribution

Vd: ~200 mL/kg

Metabolism

Glutamine participates in various metabolic activities, including the formation of glutamate, and synthesis of proteins, nucleotides, and amino sugars

Elimination

Half-life: ~1 hr

Metabolism is the major route of elimination for glutamine

Although glutamine is eliminated by glomerular filtration, it is almost completely reabsorbed by the renal tubules

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Administration

Oral Administration

Endari

  • Mix immediately before ingestion with 8 oz of cold or room temperature beverage (eg, water, milk, apple juice) or 4-6 oz of soft food (eg, applesauce, yogurt)
  • Complete dissolution is not required prior to administration

NutreStore

  • Dissolve each 5 g packet in 8 oz water prior to drinking; volume of water may be varied according to the patient’s preference
  • Take with meals or snacks at 2-3 hr intervals while awake
  • If transiently intolerant to oral intake, a dose may be delayed for up to 2 hr

Storage

Store at 20-25°C (68-77°F) away from direct sunlight

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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