Endari (L-Glutamine)

Brand Name

Endari

Generic Name

L-Glutamine

View Brand Information

FDA approval date: July 07, 2017

Classification: Amino Acid

Form: Powder

What is Endari (L-Glutamine)?

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.

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Brand Information

Endari (Glutamine)

1INDICATIONS 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.

2DOSAGE FORMS AND STRENGTHS

Oral powder: 5 grams of L–glutamine as a white crystalline powder in paper-foil-plastic laminate packets

3CONTRAINDICATIONS

None

4OVERDOSAGE

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.

5DESCRIPTION

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

Endari is formulated as a white crystalline powder and is packaged as 5 grams in a paper-foil-plastic laminate packet for oral administration.

6Clinical Studies

The efficacy of Endari in sickle cell disease was evaluated in a randomized, double-blind, placebo-controlled, multi-center clinical trial entitled "A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle β

The clinical trial evaluated the efficacy and safety of Endari in 230 patients (5 to 58 years of age) with sickle cell anemia or sickle β

The recurrent crisis event time analysis (Figure 1) yielded an intensity rate ratio (IRR) value of 0.75 with 95% CI= (0.62, 0.90) and (0.55, 1.01) based on unstratified models using the Andersen-Gill and Lin, Wei, Yang and Ying methods, respectively in favor of Endari, suggesting that over the entire 48-week period, the average cumulative crisis count was reduced by 25% from the Endari group over the placebo group.

7HOW SUPPLIED/STORAGE AND HANDLING

Endari is supplied in paper-foil-plastic laminate packets containing 5 grams of L-glutamine white crystalline powder.

Carton of 60 packets: NDC 42457-420-60

8PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

9INSTRUCTIONS FOR USE

ENDARI

Read this Instructions for Use before you start taking Endari and each time you get a refill. There may be new information. This Instructions for Use does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about Endari before you start taking it and at regular checkups.

Endari is usually taken 2 times a day. Take Endari as prescribed by your healthcare provider.

If you miss a dose of Endari, take the missed dose as soon as you remember.

How should I store Endari?

Store Endari at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Endari away from direct sunlight.

Keep Endari and all medicines out of the reach of children.

Manufactured for:

For more information got to www.EnadriRx.com or call 1-877-420-6493.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 04/2020

10PRINCIPAL DISPLAY PANEL - 5 gram Packet Carton

NDC: 42457-420-60

ENDARI™
(L-glutamine oral powder)

Contents: 60 Packets (5 grams/packet)

Directions: Mix the contents of each packet with cold or room temperature beverage or food

Administer the prescribed amount orally, twice daily, taking no more than 6 packets per day.

Package is not child resistant. Keep this and all drugs out of reach of children.

Store at 20°C to 25°C (68°F to 77°F) away from direct sunlight.

Rx Only

LOT XX XXX XX XX

Manufactured for Emmaus Medical, Inc.

PRINCIPAL DISPLAY PANEL - 5 gram Packet Carton