Drug Safety Conversation (PDF – 197 KB)
6-1-2022 Food and drug administration Drug Security Communication
Due to safety considerations, the U.S. Food and Drug Administration (Fda) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was authorized to handle two unique types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Up-to-date conclusions from the UNITY-CLL medical trial continued to show a achievable greater threat of loss of life in patients obtaining Ukoniq. As a result, we established the hazards of cure with Ukoniq outweigh its benefits. Primarily based upon this dedication, the drug’s maker, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the accepted employs in MZL and FL.
Wellness treatment experts must end prescribing Ukoniq and switch patients to alternate remedies. Advise individuals presently getting Ukoniq of the greater hazard of death seen in the clinical demo and recommend them to end using the medicine. In constrained conditions in which a affected person may be acquiring advantage from Ukoniq, TG Therapeutics options to make it available under expanded accessibility.
Clients really should talk to your health treatment pros about option therapies and cease using Ukoniq. It is best to dispose of unused Ukoniq using a drug take-back site these kinds of as in a pharmacy, but if one particular is not accessible, you can dispose of Ukoniq in your home trash by carrying out the subsequent:
- Mix the medication with an unappealing compound these kinds of as grime, cat litter, or used espresso grounds do not crush them.
- Spot the mixture in a container such as a sealed plastic bag.
- Toss absent the container in your household trash.
- Delete all private facts on the prescription labels of vacant medicine bottles or packaging, then throw absent or recycle them.
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