FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

The U. S. Food and Drug Administration (FDA) is warning that signs of a life-threatening side impact called differentiation syndrome are not being recognized in patients getting the severe myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Treatment Guide already contain a warning about differentiation problem. However, we have identify cases of differentiation symptoms not being recognized and patients not getting the necessary treatment.

As a result, we are notifying health care professionals and patients about the need for early recognition and aggressive management of differentiation problem to lessen the possibility of severe illness and death. We are continuing to monitor this safety concern.

Health care professionals should describe to patients the symptoms of differentiation symptoms listed in the Treatment Guide when starting Idhifa and at follow-up visits, and inform them to call their health proper care professional if such symptoms occur. Differentiation syndrome has occurred as early as week and up to 5 months after starting the medicine. If patients experience unexplained respiratory problems or other symptoms, think about a diagnosis of differentiation symptoms and treat promptly with oral or intravenous corticosteroids (See Additional Information for Health Care Professionals).

Patients should contact your doktor or go to the nearest hospital emergency room immediately if you develop any of the next symptoms of differentiation syndrome while you are taking Idhifa:

• Fever
• Cough
•  Shortness of breath
• Inflammation of arms and hip and legs
• Swelling around the neck of the guitar, groin, or underarm area
• Fast fat gain of more than 10 pounds inside a week
• Bone pain
• Fatigue or feeling lightheaded

Idhifa was approved in August 2017 to treat patients with acute myeloid leukemia (AML) with a specific genetic mutation called isocitrate dehydrogenase (IDH)-2 whose disease has come back or has not improved after treatment with other radiation treatment medicines. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood tissue. Idhifa works by blocking several enzymes that promote this abnormal blood cell progress.

In the clinical demo conducted for Idhifa’s approval, at least 14 percent of patients experienced difference syndrome. The manufacturer’s protection report, which included the period of May 1, 2018 to July 31, 2018, reported five cases of death associated with differentiation syndrome in patients taking Idhifa (See Data Summary). Until Idhifa was approved, differentiation syndrome had recently been associated only with induction chemotherapy in patients with a rare form of malignancy called acute promyelocytic leukemia. Medical care professionals and patients may not recognize the indicators and symptoms of difference syndrome associated with Idhifa. Another recently approved medicine for AML with a specific genetic mutation called isocitrate dehydrogenase (IDH)-1, Tibsovo (ivosidenib), also carries a risk of differentiation syndrome. Wellness care professionals should also be vigilant in supervising for differentiation syndrome when prescribing Tibsovo and patients should alert their health care professional of any symptoms.

To help FOOD AND DRUG ADMINISTRATION track questions of safety with drugs, we urge patients and health care professionals to report side effects concerning Idhifa or other drugs to the FDA MedWatch program, using the data in the “Contact FDA” container at the bottom of the page.