glutamine

Glutamine is the most abundant amino acid in the body and is prescribed as nutritional support in the treatment of sickle cell disease and short bowel syndrome. Glutamine produced by the body is usually adequate during normal conditions, but the body may require additional amounts to cope with stress caused by illnesses. Glutamine is an oral powder taken as supplemental glutamine to meet the body’s requirements in certain conditions.

Glutamine is essential for many cellular functions including synthesis of protein and glutathione (natural antioxidant), energy production and immune function. Glutamine increases antioxidant synthesis, reducing oxidative stress in sickle cell disease. Oxidative stress is caused by free radicals (reactive oxygen species), which are unstable molecules that result from cellular metabolic processes. Excessive free radicals can damage cells, and sickle-shaped red blood cells are more susceptible to oxidative damage than normal red cells.

Glutamine plays a role in gastrointestinal cell growth, function and regeneration, and may help improve bowel health when administered in combination with recombinant human growth hormone for short bowel syndrome. Short bowel syndrome is a condition caused by shortening of the small intestines due to surgical removal, or congenital condition which results in nutrient malabsorption because of inadequate bowel length.

The Endari brand of glutamine is approved by the FDA for use as a nutritional supplement in patients with sickle cell disease, who are 5 years old and older. NutreStore brand of glutamine is approved for use in adults with short bowel syndrome, in combination with recombinant human growth hormone and specialized oral diet.

Glutamine is metabolized in the body into glutamate and ammonia. Ammonia levels may rise in patients with impaired liver function. Kidney and liver function should be monitored in patients who are receiving intravenous parenteral nutrition along with glutamine (NutreStore), especially those with liver or kidney function impairment.

Common side effects of glutamine (Endari) include:

• Constipation
• Nausea
• Abdominal pain
• Headache
• Cough
• Pain in extremities
• Chest pain
• Back pain

Common side effects of glutamine(NutreStore) in combination with recombinant human growth hormone include:

• Gas (flatulence)
• Abdominal pain
• Nausea
• Vomiting
• Frequent urge to pass stools without being able to (tenesmus)
• Hemorrhoids
• Dry mouth
• Constipation
• Pancreas inflammation (pancreatitis)
• Aggravation of Crohn’s disease
• Gastric ulcer
• Gastrointestinal fistula
• Enlarged abdomen
• Swelling of extremities (peripheral edema)
• Facial edema
• Generalized edema
• Back pain
• Chest pain
• Generalized pain
• Fever 
• Flu-like disorder
• Fatigue
• Feeling unwell (malaise)
• Rigors
• Allergic reaction
• Joint pain (arthralgia)
• Muscle pain (myalgia)
• Injection site reaction
• Injection site pain
• Infection
• Bacterial infection
• Viral infection
• Candida yeast infection (moniliasis)
• Sepsis
• Rash
• Itching (pruritus)
• Increased sweating
• Nail disorder
• Headache
• Dizziness
• Reduced skin sensation (hypoesthesia)
• Thirst
• Dehydration
• Nasal inflammation (rhinitis)
• Voice box inflammation (laryngitis)
• Throat inflammation (pharyngitis)
• Kidney inflammation (pyelonephritis)
• Kidney stone (renal calculus)
• Depression
• Insomnia
• Breast pain in women
• Vaginal fungal infection
• Ear or hearing symptoms
• Abnormal liver function
• Vascular disorder

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Powder for oral administration

• 5 g/packet (as L-glutamine)

Adult and Pediatric:

Sickle Cell Disease

• Endari: Indicated to reduce acute complications of sickle cell disease in adults and children aged 5 years or above
• Children below 5 years: Safety and efficacy not established

Adults and children 5 years or above

• Weight below 30 kg (below 66 lb): 5 g orally twice daily
• Weight 30-65 kg (66-143 lb): 10 g orally twice daily
• Weight 65 kg or more (143 lb or more): 15 g orally twice daily
• Also see Administration regarding mixing oral powder with beverage or food

Short Bowel Syndrome

• NutreStore: Safety and efficacy not established in pediatric patients
• NutreStore: Indicated for short bowel syndrome in adult patients receiving specialized nutritional support when used in conjunction with recombinant human growth hormone
• 30 g/day orally in divided doses (i.e., 5 g taken 6 times each day) for up to 16 weeks
• Also see Administration regarding mixing oral powder with water

Administration

Endari

• Mix immediately before ingestion with 8 oz of cold or room temperature beverage (e.g., water, milk, apple juice) or 4-6 oz of soft food (e.g., 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-hour intervals while awake
• If transiently intolerant to oral intake, a dose may be delayed for up to 2 hours

Overdose

Glutamine overdose may intensify its side effects. Overdose may be treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• No formal drug interactions study has been done with glutamine.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• No animal reproductive studies have been conducted on glutamine use during pregnancy and no data are available on glutamine use in pregnant women to inform a drug-associated risk for major birth defects or adverse maternal or fetal outcomes.
• There is no information on the presence of glutamine breastmilk, or its effects on milk production or on the breastfed infant. Decision to breastfeed should be based on the mother’s clinical need for the drug, the developmental and health benefits of breastfeeding, and potential risks to the breastfed infant from exposure to glutamine or because of the mother’s underlying condition.

• Take glutamine exactly as instructed.
• Store glutamine safely out of reach of children.
• In case of overdose, seek medical help or contact Poison Control.