ENDARI SIDE EFFECTS

  • Generic Name: l-glutamine oral powder
  • Brand Name: Endari
  • Drug Class: Nutritionals, Other
Last updated on MDtodate: 10/05/2022

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

Adverse reaction Endari
N = 187
%
Placebo
N = 111
%
Constipation 21 18
Nausea 19 14
Headache 18 15
Abdominal Pain1 17 16
Cough 16 14
Pain in extremity 13 7
Back pain 12 5
Chest pain 12 8
1Abdominal pain = abdominal pain and abdominal pain, upper

 

SRC: NLM .