FDA Warns About Serious Adverse Effect of AML Drug Enasidenib

Nick Mulcahy

November 29, 2018

The US Food and Drug Administration (FDA) says the life-threatening adverse effect known as differentiation syndrome is not being recognized by clinicians in patients receiving the acute myeloid leukemia (AML) drug enasidenib (Idhifa, Celgene).

Early recognition and aggressive management of differentiation syndrome are needed to lessen the likelihood of serious illness and death, according to the FDA. The syndrome has occurred as early as 10 days and up to 5 months after starting the medicine.

The symptoms of the syndrome include fever; cough; shortness of breath; swelling of the 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.

Patients are advised to contact their physician or go to the nearest hospital emergency room "right away" if any of these symptoms develop, especially unexplained respiratory distress. If the syndrome is suspected, treat promptly with oral or intravenous corticosteroids.

The enasidenib prescribing information and patient medication guide already contain a warning about differentiation syndrome and a symptoms list. The drug was approved in 2017, as reported by Medscape Medical News.

As standard practice, clinicians should describe to patients the symptoms of differentiation syndrome when starting the drug and at follow-up visits, and inform them to call their healthcare professional if such symptoms occur.

Earlier this year, a study indicated that "possible or probable" differentiation syndrome was seen in 33 (12%) of 281 patients with relapsed or refractory AML being treated with enasidenib ( JAMA Oncol. 2018;4:1106-1110).

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

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