[Posted 06/01/2022]
Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns
AUDIENCE: Oncology, Patient, Health Professional, Pharmacy
ISSUE: Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).
Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, the FDA determined the risks of treatment with Ukoniq outweigh its benefits. Based upon this determination, the drug's manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in marginal zone lymphoma and follicular lymphoma.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma and follicular lymphoma.
RECOMMENDATIONS:
Health care professionals should stop prescribing Ukoniq and switch patients to alternative treatments. Inform patients currently taking Ukoniq of the increased risk of death seen in the clinical trial and advise them to stop taking the medicine. In limited circumstances in which a patient may be receiving benefit from Ukoniq, TG Therapeutics plans to make it available under expanded access.
Patients should talk to your health care professionals about alternative treatments and stop taking Ukoniq. It is best to dispose of unused Ukoniq using a drug take-back location such as in a pharmacy, but if one is not available, you can dispose of Ukoniq in your household trash by doing the following:
• Mix the medicine with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
• Place the mixture in a container such as a sealed plastic bag.
• Throw away the container in your home trash.
• Delete all personal information on the prescription labels of empty medicine bottles or packaging, then throw away or recycle them.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/k1Dyo9
Ukoniq原核准用於治療兩種特定類型的淋巴瘤：邊緣區型淋巴瘤(marginal zone lymphoma)和濾泡型淋巴瘤(follicular lymphoma)。根據UNITY-CLL臨床試驗的最新結果持續顯示使用Ukoniq的病人死亡風險可能增加。美國FDA評估使用Ukoniq治療的風險大於其益處。出於安全性的考量，美國FDA已取消核准癌症藥物 Ukoniq (umbralisib)。基於此決定，該藥物的製造商TG Therapeutics宣布自願將用於邊緣區型淋巴瘤(marginal zone lymphoma)和濾泡型淋巴瘤(follicular lymphoma)之Ukoniq下市。
醫療專業人員應停止開立Ukoniq的處方，使用中病人需改用其他替代療法治療，並告知Ukoniq在臨床試驗中觀察到死亡風險增加，故建議他們停止服用該藥。若病人在特殊情況下使用Ukoniq可能有益，TG Therapeutics藥廠計劃用恩慈療法的方式提供這類病人使用。
病人應與醫療專業人員討論替代療法並停止服用Ukoniq。最好在藥局等可藥物回收地點丟棄未使用的Ukoniq，若無可回收地點，可依以下操作丟棄於居家垃圾中：
• 將藥品與泥土、貓砂或用過的咖啡渣等物質混合；不要壓碎。
• 將上述混合物放入容器，例如密封塑膠袋中。
• 將密封好的容器/塑膠袋丟棄於家庭垃圾中。
• 空藥瓶或包裝的藥袋上若有個人資訊，請記得先移除再丟棄或回收。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/k1Dyo9
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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