Endari 5 g/1
Glutamine · POWDER, FOR SOLUTION · Emmaus Medical, Inc.
Endari is a powder, for solution containing glutamine at 5 g/1, taken oral. Manufactured by Emmaus Medical, Inc..
Key Facts
- Brand Name
- Endari
- Generic Name
- Glutamine
- NDC Code (Product)
42457-420- Manufacturer
- Emmaus Medical, Inc.
- Strength
- 5 g/1
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA208587
- Drug Class
- Amino Acid [EPC]
- Marketing Start
- 07/07/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. ENDARI 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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.
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
Drug Interactions No drug interaction studies have been conducted.
Adverse Reactions
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 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 d…
Frequently Asked Questions
What is Endari used for?
Endari contains Glutamine. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is Endari a controlled substance?
Endari is not classified as a controlled substance by the DEA.
What is the generic name for Endari?
The generic name for Endari is Glutamine. There are no other listed brand versions of Glutamine.
What is the NDC code for Endari 5 g/1?
The NDC (National Drug Code) for Endari 5 g/1 is 42457-420, listed by Emmaus Medical, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)