Idhifa Safety Alert Warns of Differentiation Syndrome

November 29, 2018 – The U.S. FDA has issued a safety communication for Idhifa® (enasidenib), saying that the signs and symptoms of differentiation syndrome are not being recognized in patients who receive the drug. Differentiation syndrome is a potentially life-threatening condition that occurs when the body overproduces cytokine proteins that signal inflammatory responses.

Although Idhifa already bears a black box warning for differentiation syndrome, the FDA has been made aware that in some cases, the condition has not been recognized and patients have consequently not received the appropriate treatment. To address this issue, the FDA is reminding patients and healthcare professionals of the need for early diagnosis and treatment of differentiation syndrome to reduce the risk of serious illness or death.

Idhifa’s Medication Guide describes the symptoms of differentiation syndrome, and healthcare providers should review this with patients when starting Idhifa and during follow-up visits. The condition can occur within 10 days of beginning Idhifa, and has been known to happen up to five months into treatment. Patients on Idhifa should seek medical assistance immediately if they experience the following symptoms:

The FDA granted approval to Idhifa in 2017 for the treatment of acute myeloid leukemia (AML) in patients who have an isocitrate dehydrogenase (IDH)-2 genetic mutation and who have relapsed or not improved following treatment with other chemotherapy medicines. The product is manufactured by Celgene.