Drug Safety Alerts

Ukoniq® (umbralisib) 200 mg tablets Product Withdrawal

6/1/2022

On June 1, 2022 the United States Food and Drug Administration (FDA) published a notice regarding the withdrawal of Ukoniq® (umbralisib) 200 mg tablets NDC # 73150-0200-12. Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). This withdrawal was issued because 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 on April 15, 2022 it was voluntarily withdrawing Ukoniq from the market for the approved uses in MZL and FL.

The FDA recommends that 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 (see www.fda.gov).

The FDA also recommends that health care professionals report side effects involving medicines to the FDA MedWatch program:

• Complete and submit the report online. 

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. 

CVS Caremark® Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information, please call TG Therapeutics at 1-877-848-9462 or visit www.tgtherapeutics.com.

You may also call the FDA at 1 888 INFO-FDA (1 888-463-6332) or visit https://www.fda.gov.