Endari

Last updated on RxList: 11/9/2020
Endari Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Endari?

Endari (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.

What Are Side Effects of Endari?

Common side effects of Endari include:

Dosage for Endari

The dose of Endari is 5 to 15 grams orally, twice daily based on body weight. Each dose of Endari should be mixed in 8 oz. (240 mL) of cold or room temperature beverage or 4 to 6 oz. of food before ingestion.

What Drugs, Substances, or Supplements Interact with Endari?

Endari may interact with other drugs. Tell your doctor all medications and supplements you use.

Endari During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Endari; it is unknown how it may affect a fetus. It is unknown if Endari passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Endari (L-glutamine oral powder) 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.

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Endari Professional Information

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SIDE EFFECTS

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 β0-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 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 Endari treatment group as compared to none in the placebo treatment group. None of the deaths were considered to be related to Endari treatment. Adverse reactions occurring in greater than 10% of patients treated with Endari are shown in Table 2 below.

Table 2. Adverse Reactions Occurring at an Incidence > 10% in Clinical Studies of Endari

Adverse reactionEndari
N = 187
%
Placebo
N = 111
%
Constipation2118
Nausea1914
Headache1815
Abdominal Pain11716
Cough1614
Pain in extremity137
Back pain125
Chest pain128
1Abdominal pain = abdominal pain and abdominal pain, upper

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

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

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