Warning: FDA Cautions Serious Adverse Event Related to Enasidenib

By Kerri Fitzgerald - Last Updated: December 3, 2018

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. 

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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

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