Market withdrawal of Ukoniq tablets

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the market withdrawal of Ukoniq® 200 mg tablets on June 1, 2022.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the withdrawal and consider switching them to a clinically appropriate alternative.

The U.S. Food and Drug Administration (FDA) announced it has withdrawn its approval for Ukoniq due to safety concerns. Updated findings from a clinical trial showed a possible increased risk of death in patients using Ukoniq. As a result, the FDA determined the risks of treatment with Ukoniq outweigh its benefits. The drug manufacturer, TG Therapeutics, has voluntarily withdrawn the medication based on this determination.

Ukoniq is a cancer medication that was approved to treat two specific types of lymphoma: marginal zone lymphoma and follicular lymphoma.

Recommendations:

Visit the FDA website for specific details about the withdrawn medication.

To access Humana’s formulary drug list search for coverage information on alternative medications, go to: Humana.com/provider/pharmacy-resources/tools/humana-drug-lists.

Information for providers:1

  • We have sent a letter to your Humana-covered patients and asked them to stop taking the medication. Healthcare 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 medication.
    • In limited circumstances in which a patient may be receiving benefits from Ukoniq, TG Therapeutics plans to make it available under expanded access.
  • Patients should dispose of unused Ukoniq by taking it to a drug take-back location, such as one found in a pharmacy. If one is not available, they can dispose of Ukoniq in their household trash by doing the following:
    1. Mix the medication with an unappealing substance, such as dirt, cat litter or used coffee grounds; do not crush the tablets.
    2. Place the mixture in a container, such as a sealed plastic bag.
    3. Throw away the container in their home trash.
    4. Delete all personal information on the prescription labels of the empty medication bottles or packaging, then throw away or recycle them.
  • Healthcare providers and patients may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form.
      • Complete “Form FDA 3500B – Voluntary Reporting for Consumers” and submit it by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns,” U.S. Food and Drug Administration, last accessed June 6, 2022, www.fda.gov/drugs/drug-safety-and-availability/fda-approval-lymphoma-medicine-ukoniq-umbralisib-withdrawn-due-safety-concerns.