NutreStore

Table 3 provides the number of subjects by system-organ class experiencing at least one adverse event during the 4- week treatment period of the SBS study. To be listed in Table 3, an adverse event must have occurred in more than 10% of subjects in any treatment group.

Table 3 : Controlled Trial Adverse Events—Initial 4 Week Treatment Period

Table 4 summarizes the number of subjects by systemorgan class who experienced an adverse event during weeks 5 to 18 of the randomized, controlled SBS study. To be listed in Table 4, an adverse event must have occurred in more than 10% of subjects in any treatment group.

Table 4: Controlled Trial Adverse Events - Weeks 5 to 18

The safety profile in patients receiving oral glutamine with growth hormone was similar to the safety profile in patients receiving growth hormone without glutamine. During the initial 4 week treatment period, 100% of patients receiving growth hormone with and without glutamine reported at least one adverse event (AE), whereas 89% of patients receiving growth hormone placebo with glutamine reported at least one AE. During weeks 5 to 18, 81% of patients receiving growth hormone with glutamine, 80% of patients receiving growth hormone without glutamine and 78% of patients receiving growth hormone placebo with glutamine experienced at least one AE. There were no deaths in this study.

Glutamine is an amino acid that affects the processes of growth and function of cells in the stomach and intestines.

Glutamine is a medical food product that is used to supplement dietary sources of glutamine. This medicine is used to treat a glutamine deficiency, or a loss of glutamine caused by injury or illness.

Glutamine is also used in combination with human growth hormone to treat short bowel syndrome.

Glutamine may also be used for purposes not listed in this medication guide.

To make sure glutamine is safe for you, tell your doctor if you have:

• liver disease; or

• kidney disease.

FDA pregnancy category C. It is not known whether glutamine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether glutamine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

An overdose of glutamine is not expected to produce life-threatening symptoms.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;

• hearing problems; or

• signs of infection such as fever, chills, sore throat, flu symptoms, mouth sores, unusual weakness.

Common side effects may include:

• nausea, vomiting, stomach pain, gas;

• swelling in your hands or feet;

• muscle or joint pain, back pain;

• headache, dizziness, tired feeling;

• mild skin rash or itching; or

• dry mouth, runny nose, increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use NutreStore as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Follow how to use as you have been told by the doctor or read the package insert.
• Mix with water as told before you take NutreStore. Do not swallow the dry powder.
• Take with meals or snacks.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Feeling of needing to have a bowel movement often.
• Rectal irritation.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.

Increased Serum Ammonia and Glutamate

Glutamine is metabolized to glutamate and ammonia, which may increase in patients with hepatic dysfunction. Therefore, routine monitoring of renal and hepatic function is recommended in patients receiving intravenous parenteral nutrition (IPN) and Nutrestore, particularly in those with renal or hepatic impairment.

Nutrestore is supplied in preprinted paper-foil-plastic laminate packets containing 5 g of L-glutamine powder and is supplied as follows:

• Carton of 84 packets (NDC 42457-001-84)

Store at 25°C (77°F) with excursions allowed to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]

Applies to glutamine: compounding powder, oral capsule, oral powder for reconstitution, oral tablet

Cardiovascular

Cardiovascular side effects have included chest pain (19%) and vascular disorder (11%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (13% to 31%), vomiting (11% to 19%), abdominal pain (11% to 25%), tenesmus (6% to 33%), flatulence (22% to 25%), hemorrhoids (6% to 11%), dry mouth (6% to 11%), pancreatitis (6% to 11%), constipation (11%), aggravated Crohn's disease (11%), gastric ulcer (11%), and gastrointestinal fistula (11%).[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain (6% to 11%), arthralgia (31% to 44%), and myalgia (11% to 13%).[Ref]

Respiratory

Respiratory side effects have included rhinitis (7% to 19%), laryngitis (11%), and pharyngitis (11%).[Ref]

Psychiatric

Psychiatric side effects have included depression (11% to 22%).[Ref]

Other

Other side effects have included peripheral edema (11% to 81%), facial edema (44% to 50%), generalized edema (13%), enlarged abdomen (11%), pain (6% to 19%), vascular disorder (11%), female breast pain (6% to 11%), vaginal fungal infection (11%), increased sweating (13%) and ear or hearing symptoms (13%).[Ref]

Immunologic

Immunologic side effects have included fever (6% to 22%), chills (11%), malaise (13%), flu-like disorder (6% to 11%), viral or bacterial infection (6% to 19%), sepsis (6% to 20%), and moniliasis (13%).[Ref]

Metabolic

Metabolic side effects have included dehydration (11% to 19%), and thirst (11%).[Ref]

Dermatologic

Dermatologic side effects have included rash (7% to 11%) and skin and appendage disorders (11% to 13%).[Ref]

Local

Local side effects have included injection site pain and/or injection site reaction (11% to 31%).[Ref]

Nervous system

Central nervous system side effects have included dizziness (6% to 13%), hypoesthesia (6% to 11%), insomnia (11%) and headache (6% to 11%).[Ref]

Genitourinary

Genitourinary side effects have included pyelonephritis (11%) and renal calculus (11%).[Ref]

Hepatic

Hepatic side effects have included abnormal hepatic function (11%).[Ref]

Some side effects of NutreStore may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.