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NutreStore

Last reviewed on RxList: 5/4/2016
NutreStore Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/4/2016

NutreStore (L-glutamine powder for oral solution) is indicated for the treatment of Short Bowel Syndrome (SBS) in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication. Common side effects of NutreStore include:

The recommended dosage of NutreStore is 30 g daily in divided doses (5 g taken 6 times each day orally) for up to 16 weeks. Each dose of NutreStore (5g) should be reconstituted in 8-oz (250-mL) of water prior to consumption. NutreStore may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, NutreStore should be taken only if prescribed. It is unknown if it would affect a fetus. It is unknown if NutreStore passes into breast milk. Consult your doctor before breastfeeding.

Our NutreStore (L-glutamine powder for oral solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

NutreStore Professional Information

SIDE EFFECTS

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

Adverse Experiences Group A rhGH+SOD1
N=16 n(%)
Group B rhGH+SODfGLN]1
N=16 n (%)
Group C SOD [GLN]1
N=9 n(%)
Total Number of Subjects with At Least One AE 16 (100) 16 (100) 8 (89)
Body as a Whole: General Disorders 15 (94) 15 (94) 4 (44)
Edema, Peripheral 11(69) 13(81) 1 (11)
Edema, Facial 8 (50) 7(44) 0 (0)
Pain 3 (19) 1(6) 1 (11)
Chest Pain 3 (19) 0 (0) 0 (0)
Fever 0 (0) 1(6) 2 (22)
Back Pain 1 (6) 0 (0) 1 (11)
Flu-like Disorder 0 (0) 1 (6) 1 (11)
Malaise 2 (13) 0 (0) 0 (0)
Edema, Generalized 2 (13) 0 (0) 0 (0)
Abdomen, Enlarged 0 (0) 0 (0) 1 (11)
Allergic Reaction 0 (0) 0 (0) 1 (11)
Rigors (Chills) 0 (0) 0 (0) 1 (11)
Gastrointestinal System Disorders 12 (75) 12 (75) 6 (67)
Flatulence 4 (25) 4 (25) 2 (22)
Abdominal Pain 4 (25) 2 (13) 1 (11)
Nausea 2 (13) 5 (31) 0 (0)
Tenesmus 1 (6) 3 (19) 3 (33)
Vomiting 3 (19) 3 (19) 1 (11)
Hemorrhoids 1 (6) 0 (0) 1 (11)
Mouth Dry 1 (6) 0 (0) 1 (11)
Musculoskeletal System Disorders 7 (44) 7 (44) 1 (11)
Arthralgia 7 (44) 5 (31) 0 (0)
Myalgia 2 (13) 0 (0) 1 (11)
Resistance Mechanism Disorders 6 (38) 3 (19) 4 (44)
Infection 0 (0) 1 (6) 3 (33)
Infection Bacterial 3 (19) 0 (0) 1 (11)
Infection Viral 1 (6) 2 (13) 0 (0)
Moniliasis 2 (13) 0 (0) 0 (0)
Application Site Disorders 5 (31) 4 (25) 1 (11)
Injection Site Reaction 3 (19) 4 (25) 1 (11)
Injection Site Pain 5 (31) 0 (0) 0 (0)
Central and Peripheral Nervous System Disorders 4 (25) 4 (25) 2 (22)
Dizziness 1 (6) 2 (13) 0 (0)
Headache 1 (6) 1 (6) 1 (11)
Hypoesthesia 1 (6) 1 (6) 1 (11)
Skin and Appendages Disorders 4 (25) 4 (25) 2 (22)
Rash 1 (6) 2 (13) 0 (0)
Pruritis 0 (0) 1 (6) 1 (11)
Sweating Increased 2 (13) 0 (0) 0 (0)
Nail Disorder 0 (0) 0 (0) 1 (11)
Respiratory System Disorders 1 (6) 5 (31) 1 (11)
Rhinitis 0 (0) 3 (19) 1 (11)
Metabolic and Nutritional Disorders 3 (19) 1 (6) 1 (11)
Dehydration 3 (19) 0 (0) 1 (11)
Thirst 0 (0) 0 (0) 1 (11)
Urinary System Disorders 2 (13) 1 (6) 1 (11)
Pyelonephritis 0 (0) 0 (0) 1 (11)
Psychiatric Disorders 1 (6) 0 (0) 2 (22)
Depression 0 (0) 0 (0) 2 (22)
Reproductive Disorders, Female 2 (13) 0 (0) 1 (11)
Breast Pain, Female 1 (6) 0 (0) 1 (11)
Hearing and Vestibular Disorders 0 (0) 2 (13) 0 (0)
Ear or Hearing Symptoms 0 (0) 2 (13) 0 (0)
1SOD[GLN] = Specialized Oral Diet supplemented with Glutamine; rhGH+SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine
Group A: rh-GH + SOD for 4 weeks followed by SOD for 12 weeks.
Group B: rh-GH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.
Group C: rh-GH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks

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

Adverse Experiences Group ArhGH+SOD1
N=15 n (%)
Group BrhGH+SOD [GLN]1
N=16 n (%)
Group CSOD[GLN]1
N=9 n (%)
Total Number of subjects with At Least One AE 12 (80) 13 (81) 7 (78)
Gastrointestinal System Disorders 7 (47) 7 (44) 3 (33)
Nausea 3 (20) 0 (0) 2 (22)
Vomiting 2 (13) 3 (19) 0 (0)
Abdominal Pain 3 (20) 1 (6) 0 (0)
Tenesmus 0 (0) 3 (19) 1 (11)
Pancreatitis 0 (0) 1 (6) 1 (11)
Constipation 0 (0) 0 (0) 1 (11)
Crohn's Disease Aggravated 0 (0) 0 (0) 1 (11)
Gastric Ulcer 0 (0) 0 (0) 1 (11)
Gastrointestinal Fistual 0 (0) 0 (0) 1 (11)
Resistance Mechanism Disorders 6 (40) 5 (31) 5 (56)
Infection Bacterial 0 (0) 2 (13) 3 (33)
Infection Viral 3 (20) 1 (6) 1 (11)
Infection 1 (7) 2 (13) 1 (11)
Sepsis 3 (20) 1 (6) 0 (0)
Body as a Whole: General Disorders 4 (27) 2 (13) 1 (11)
Fever 2 (13) 1 (6) 1 (11)
Fatigue 2 (13) 0 (0) 0 (0)
Respiratory System Disorders 2 (13) 4 (25) 1 (11)
Rhinitis 1 (7) 3 (19) 0 (0)
Laryngitis 0 (0) 0 (0) 1 (11)
Pharyngitis 0 (0) 0 (0) 1 (11)
Reproductive Disorders, Female 0 (0) 4 (25) 1 (11)
Vaginal Fungal Infection 0 (0) 0 (0) 1 (11)
Skin and Appendages Disorders 2 (13) 2 (13) 1 (11)
Rash 1 (7) 0 (0) 1 (11)
Musculoskeletal System Disorders 2 (13) 2 (13) 0 (0)
Arthralgia 2 (13) 2 (13) 0 (0)
Psychiatric Disorders 0 (0) 1 (6) 1 (11)
Depression 0 (0) 0 (0) 1 (11)
Insomnia 0 (0) 0 (0) 1 (11)
Urinary System Disorders 0 (0) 0 (0) 2 (22)
Pyelonephritis 0 (0) 0 (0) 1 (11)
Renal Calculus 0 (0) 0 (0) 1 (11)
Application Site Disorders 0 (0) 0 (0) 1 (11)
Injection Site Reaction 0 (0) 0 (0) 1 (11)
Liver and Biliary System Disorders 0 (0) 0 (0) 1 (11)
Hepatic Function Abnormal 0 (0) 0 (0) 1 (11)
Vascular Extracardiac Disorders 0 (0) 0 (0) 1 (11)
Vascular Disorder 0 (0) 0 (0) 1 (11)
Group A: rh-GH + SOD for 4 weeks followed by SOD for 12 weeks.
Group B: rh-GH + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks.
Group C: rh-GH placebo + SOD [GLN] for 4 weeks followed by SOD [GLN] for 12 weeks
1SOD[GLN] = Specialized Oral Diet supplemented with Glutamine; rhGH+SOD = Human Growth Hormone plus Specialized Oral Diet; rhGH + SOD [GLN] = Human Growth Hormone plus Specialized Oral Diet supplemented with Glutamine

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.

Read the entire FDA prescribing information for NutreStore (L-glutamine Powder for Oral Solution)

Related Resources for NutreStore

© NutreStore Patient Information is supplied by Cerner Multum, Inc. and NutreStore Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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