Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin Advanced Practice Nurse.
On November 29, 2018 FDA is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa, active ingredient enasidenib. The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, we have become aware of cases of differentiation syndrome not being recognized and patients not receiving the necessary treatment.
As a result, we are alerting health care professionals and patients about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. We are continuing to monitor this safety concern.
Health care professionals should describe to patients the symptoms of differentiation syndrome listed in the Medication Guide when starting Idhifa and at follow-up visits and inform them to call their health care professional if such symptoms occur. Differentiation syndrome has occurred as early as 10 days and up to 5 months after starting the medicine. If patients experience unexplained respiratory distress or other symptoms, consider a diagnosis of differentiation syndrome and treat promptly with oral or intravenous corticosteroids.
Idhifa was approved in August 2017 to treat patients with acute myeloid leukemia or AML with a specific genetic mutation called isocitrate dehydrogenase or IDH-2 whose disease has recurred or not improved after treatment with other chemotherapy medicines.
In the clinical trial conducted for Idhifa’s approval, at least 14 percent of patients experienced differentiation syndrome. The manufacturer’s safety report, for the period of May 1 to July 31 of 2018, reported five cases of death associated with differentiation syndrome in patients taking Idhifa. Another recently approved drug for AML with the specific genetic mutation called isocitrate dehydrogenase or IDH-1, Tibsovo, active ingredient ivosidenib, also carries a risk of differentiation syndrome. Health care professionals should also be vigilant in monitoring for differentiation syndrome when prescribing Tibsovo.
To help FDA track safety issues with medicines, side effects involving Idhifa, Tibsovo or other medicines should be reported to the FDA’s MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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- FDA Drug Safety Communication: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
- FDA Drug Safety Podcast: FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) (MP3 - 4.1MB)