FDA Evaluating Possible Serious Risks From Umbralisib.

Abstract

Initial clinical trial data for umbralisib (Ukoniq), a drug currently approved to treat relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma, indicate that umbralisib may increase the risk of death or serious adverse effects when given with a specific monoclonal antibody to treat chronic lymphocytic leukemia.Patients receiving umbralisib to treat lymphomas should be evaluated closely for adverse effects. Nurses and other health care providers should report any of these adverse effects to the Food and Drug Administration's MedWatch program.

• Authors: Diane S Aschenbrenner
• Journal: The American journal of nursing (Am J Nurs) Vol. 122 Issue 6 Pg. 23 (06 01 2022) ISSN: 1538-7488 [Electronic] United States
• PMID: 35617560 (Publication Type: Journal Article)
• Copyright: Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• Heterocyclic Compounds, 4 or More Rings
• umbralisib

Topics

• Antibodies, Monoclonal (therapeutic use)
• Clinical Trials as Topic
• Heterocyclic Compounds, 4 or More Rings (adverse effects)
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)
• Lymphoma (drug therapy)
• United States
• United States Food and Drug Administration