endari
Endari (L-Glutamine) is a medication supplied as a powder, for solution.
L-Glutamine · by Emmaus Medcl
Available as a generic: L-Glutamine
Key facts
- Active ingredient
- L-Glutamine
- Form
- Powder
- Strength
- L-GLUTAMINE 5GM/PACKET
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Emmaus Medcl
- FDA application
- NDA208587
What is Endari?
From the FDA label:Endari (L-glutamine) is an amino acid. L-glutamine is designated chemically as (S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, or (S)-2,5-diamino-5-oxopentanoic acid. The molecular formula is C 5 H 10 N 2 O 3 with the molecular weight of 146.15 g/mol and the following structural formula: Endari is formulated as a white crystalline powder and is packaged as 5 grams in a paper-foil-plastic laminate packet for oral administration. Chemical Structure
How to use
5 grams to 15 grams orally, twice daily based on body weight. ( 2 ) Each dose of Endari 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 Endari 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 Endari 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. Dosage and Administration Advise patient to take a missed dose as soon as they remember. Patient should not double the dose that they take . Instruct patient to mix each dose in 8 oz. (240 mL) of cold or room temperature beverage or 4 to 6 oz. of food. Advise patient that complete dissolution is not required prior to administration.
Side effects
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 Emmaus Medical, Inc. at 1-877-420-6493 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 Endari in 187 patients, including 136 exposed for 6 months and 109 exposed for ≥1 year. Endari 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 0 -thalassemia were randomized to receive Endari (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 Endari. These adverse…
Who should not take Endari
None None ( 4 )
Overdose — what happens if you take too much
Single oral doses of L-glutamine at about 20 g/kg to 22 g/kg, 8 g/kg to 11 g/kg, and 19 g/kg were lethal in mice, rats, and rabbits, respectively. Supportive measures should be undertaken in the event of overdose of Endari.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No drug interaction studies have been conducted.
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Endari?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Endari. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Endari?
- Endari is marketed by Emmaus Medcl. You can see Emmaus Medcl's full profile, rating, and other products on pharmaranks.
- Is Endari a brand-name or generic drug?
- Endari is a brand-name product with the active ingredient L-Glutamine. Lower-cost generic equivalents containing L-Glutamine are available — ask your pharmacist.
- Is Endari available over the counter?
- No. Endari is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Endari come in?
- Endari is currently marketed as powder, per the FDA's National Drug Code Directory.
- Is Endari FDA-registered?
- Endari is on record with the U.S. FDA under application number NDA208587. You can verify this on its official FDA label.
- Is Endari safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Endari. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Endari?
- Endari's side effects are taken directly from its FDA label. From the label: 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 Emmaus Medical, Inc.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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