Warning: FDA Cautions Serious Adverse Event Related to Enasidenib

The U.S. Food and Drug Administration (FDA) released a warning that life-threatening symptoms of differentiation syndrome are not being recognized in patients receiving the enasidenib for acute myeloid leukemia (AML). The product’s prescribing information and patient medication guide contain a warning about differentiation syndrome; however, the agency has been made aware of cases of differentiation syndrome that are not being recognized and patients not receiving necessary treatment. 

Patients should contact their healthcare professional or go to the nearest emergency room if they are taking enasidenib and experience any of the following symptoms: 

  • Fever 
  • Cough 
  • Shortness of breath 
  • Swelling of arms and legs 
  • Swelling around the neck, groin, or underarm area 
  • Fast weight gain of more than 10 pounds within a week 
  • Bone pain 
  • Dizziness or feeling lightheaded 

Healthcare professionals should describe the symptoms of differentiation syndrome when patients start enasidenib and at all follow-up visits. Differentiation syndrome has occurred as early as 10 days after starting treatment, as well as up to 5 months later. Patients diagnosed with differentiation syndrome should be treated promptly with oral or intravenous corticosteroids, according to the FDA. 

Enasidenib was approved in August 2017 to treat IDH2-mutated AML. In the clinical trial for which the drug’s approval was based, at least 14% of patients experienced differentiation syndrome. The manufacturer’s safety report—which included data from May 1, 2018, to July 31, 2018—reported five deaths associated with differentiation syndrome. A study published in JAMA Oncology found that “possible or probable” differentiation syndrome was observed in 33 of 281 patients (12%) with relapsed/refractory AML who were treated with enasidenib. 

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Source: FDA