Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration&nbsp;(FDA)&nbsp;released a warning that&nbsp;life-threatening&nbsp;symptoms of&nbsp;differentiation syndrome are not being recognized in patients receiving the&nbsp;enasidenib for acute myeloid leukemia (AML).&nbsp;The product&rsquo;s&nbsp;prescribing information and patient&nbsp;medication&nbsp;guide contain a warning&nbsp;about differentiation syndrome;&nbsp;however,&nbsp;the agency has been made&nbsp;aware of cases of differentiation syndrome&nbsp;that are&nbsp;not being recognized and patients not receiving necessary treatment.&nbsp;Patients should contact&nbsp;their&nbsp;healthcare professional or go to the nearest emergency room&nbsp;if&nbsp;they are taking enasidenib and experience&nbsp;any of the following symptoms:&nbsp;<ul>
<li>Fever&nbsp;</li>
<li>Cough&nbsp;</li>
<li>Shortness of breath&nbsp;</li>
<li>Swelling of arms and legs&nbsp;</li>
<li>Swelling around the neck, groin, or underarm area&nbsp;</li>
<li>Fast weight gain of more than 10 pounds within a week&nbsp;</li>
<li>Bone pain&nbsp;</li>
<li>Dizziness or feeling lightheaded&nbsp;</li>
</ul><blockquote class="twitter-tweet" data-width="500" data-dnt="true">
How are people not recognizing differentiation syndrome? It's fairly well known by malignant heme clinicians&hellip; FDA Warns About Serious Adverse Effect of AML Drug Enasidenib <a href="https://t.co/2yPn0F2hME">https://t.co/2yPn0F2hME</a> via <a href="https://twitter.com/Medscape?ref_src=twsrc%5Etfw">@medscape</a>
&mdash; John Bossaer (@PharmDeetinib) <a href="https://twitter.com/PharmDeetinib/status/1068513441302937600?ref_src=twsrc%5Etfw">November 30, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Healthcare professionals should describe the symptoms of differentiation syndrome&nbsp;when patients start enasidenib&nbsp;and at&nbsp;all&nbsp;follow-up visits. Differentiation syndrome has occurred as early as 10 days&nbsp;after starting treatment, as well as&nbsp;up to 5 months&nbsp;later.&nbsp;Patients diagnosed with&nbsp;differentiation syndrome&nbsp;should be treated&nbsp;promptly with oral or intravenous corticosteroids, according to the FDA.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
<a href="https://twitter.com/hashtag/FDAOncology?src=hash&amp;ref_src=twsrc%5Etfw">#FDAOncology</a>'s @KellyNorsworth2 will discuss <a href="https://twitter.com/hashtag/ASH18?src=hash&amp;ref_src=twsrc%5Etfw">#ASH18</a> abstract 288: Incidence of Differentiation Syndrome with Ivosidenib &amp; Enasidenib for R/R IDH1/IDH2-Mutated AML on Sunday, Dec. 2, 8:45 am PCT in Seaport Ballroom F Manchester Grand Hyatt San Diego
&mdash; FDA Oncology (@FDAOncology) <a href="https://twitter.com/FDAOncology/status/1068584938365177858?ref_src=twsrc%5Etfw">November 30, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Enasidenib&nbsp;was approved in August 2017 to treat&nbsp;IDH2-mutated AML.&nbsp;In the clinical trial&nbsp;for which&nbsp;the drug&rsquo;s&nbsp;approval was based, at least 14%&nbsp;of patients experienced differentiation syndrome. The manufacturer&rsquo;s safety report&mdash;which included data from&nbsp;May 1, 2018, to July 31, 2018&mdash;reported five deaths&nbsp;associated with differentiation syndrome.&nbsp;A&nbsp;study&nbsp;published in&nbsp;JAMA Oncology&nbsp;found&nbsp;that &ldquo;possible or probable&rdquo;&nbsp;differentiation syndrome was&nbsp;observed&nbsp;in 33 of 281 patients&nbsp;(12%)&nbsp;with relapsed/refractory AML who were treated with enasidenib.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib) <a href="https://t.co/MH391SldGN">https://t.co/MH391SldGN</a> <a href="https://twitter.com/hashtag/aml?src=hash&amp;ref_src=twsrc%5Etfw">#aml</a> <a href="https://twitter.com/hashtag/leusm?src=hash&amp;ref_src=twsrc%5Etfw">#leusm</a> <a href="https://twitter.com/FDAOncology?ref_src=twsrc%5Etfw">@FDAOncology</a> <a href="https://twitter.com/hashtag/MedEd?src=hash&amp;ref_src=twsrc%5Etfw">#MedEd</a>
&mdash; Kelly Norsworthy, MD (@DrKNorsworthy) <a href="https://twitter.com/DrKNorsworthy/status/1068207054651879424?ref_src=twsrc%5Etfw">November 29, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><a href="https://proddocwire.wpengine.com/docwire-pick/postmenopausal-bleeding-endometrial-cancer/">Warning sign: Postmenopausal bleeding occurs in 91% of women with endometrial cancer.</a>&nbsp;&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/jury-awards-roundup/">A jury awards $289 million to a man who says Roundup caused his cancer.</a>&nbsp;Source:&nbsp;<a href="https://www.fda.gov/Drugs/DrugSafety/ucm626923.htm">FDA</a>

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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 ...

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