L-glutamine

L-glutamine is an FDA-registered drug product whose active ingredient is L-GLUTAMINE. It is labelled by Camber Pharmaceuticals, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 31722-483, application ANDA219722, label effective 20260610. It is one of 2 FDA drug label records sharing the active ingredient L-GLUTAMINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing L-GLUTAMINE are most often described in connection with: l-glutamine oral, indicated reduce, acute complications, sickle cell, disease adult, pediatric patients, years age, powder amino. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE L-glutamine oral powder is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. L-glutamine oral powder is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION • 5 grams to 15 grams orally, twice daily based on body weight. ( 2 ) • Each dose of L-glutamine oral powder should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 oz. to 6 oz. of food before ingestion. ( 2 ) 2.1 Dosage Administer L-glutamine oral powder orally, twice per day at the dose based on body weight according to Table 1. Table 1. Recommended Dosing Weight in kilograms Weight in pounds Per dose in grams Per day in grams Packets per dose Packets per day less than 30 less than 66 5 10 1 2 30 to 65 66 to 143 10 20 2 4 greater than 65 greater than 143 15 30 3 6 2.2 Preparation of Product Mix L-glutamine oral powder immediately before ingestion with 8 oz. (240 mL) of cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. to 6 oz. of food such as applesauce or yogurt. Complete dissolution is not required prior to administration.

4 CONTRAINDICATIONS None None ( 4 )

6 ADVERSE REACTIONS Most common adverse reactions (incidence > 10%) are constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to L-glutamine in 187 patients, including 136 exposed for 6 months and 109 exposed for ≥1 year. L-glutamine was studied in 2 placebo-controlled clinical trials (a phase 3 study, n=230 and a phase 2 study, n=70). In these trials, patients with sickle cell anemia or sickle β o -thalassemia were randomized to receive L-glutamine (n=187) or placebo (n=111) orally twice daily for 48 weeks followed by 3 weeks of tapering. Both studies included pediatric and adult patients (5-58 years of age) and 54% were female. The majority of patients were black (97.3%), had a diagnosis of sickle cell anemia (89.9%) and were receiving hydroxyurea at baseline (63.4%). Treatment discontinuation due to adverse reactions was reported in 2.7% (n=5) of patients receiving L-glutamine. These adverse reactions included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash. Serious adverse reactions were reported in both treatment groups, more frequently in the placebo group, and were consistent with the underlying disease. Three deaths (3/187=1.6%) occurred during the study in the L-glutamine treatment group as compared to none in the placebo treatment group. None of the deaths were considered to be related to L-glutamine treatment. Adverse reactions occurring in greater than 10% of patients treated with L-glutamine are shown in Table 2 below. Table 2. Adverse Reactions Occurring at an Incidence > 10% in Clinical Studies of L-glutamine Adverse reaction L-glutamine N = 187 (%) Placebo N = 111 (%) Constipation 21 18 Nausea 19 14 Headache 18 15 Abdominal Pain 1 17 16 Cough 16 14 Pain in extremity 13 7 Back pain 12 5 Chest pain 12 8 1 Abdominal pain = abdominal pain and abdominal pain, upper

FDA lists 2 drug label records with L-GLUTAMINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is L-glutamine used for?
1 INDICATIONS AND USAGE L-glutamine oral powder is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. L-glutamine oral powder is an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ( 1 )

Who makes L-glutamine?
Camber Pharmaceuticals, Inc. is the labeler of record for L-glutamine. 2 FDA label records share the active ingredient L-GLUTAMINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does L-glutamine come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is L-glutamine prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing L-GLUTAMINE?
Yes. 2 FDA drug label records list L-GLUTAMINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has L-glutamine been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.