The letter U representing an abbreviation for Ukoniq

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Official logo of UKONIQ™ umbralisib 200 mg tablets
  • MZL: who have received at least 1 certain type of prior treatment

  • FL: who have received at least 3 prior treatments

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Pill bottle indication that UKONIQ is a tablet

Important product information

UKONIQ is a prescription medicine used to treat adults with:

  • Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least 1 certain type of prior treatment

  • Follicular lymphoma (FL) when the disease has come back or did not respond to treatment and who have received at least 3 prior treatments

It is not known if UKONIQ is safe and effective in children.

UKONIQ was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment. There are ongoing studies to confirm the benefit of UKONIQ for these uses.

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WHAT IS UKONIQ (UMBRALISIB)?


UKONIQ is a prescription medicine used to treat adults with:

It is not known if UKONIQ is safe and effective in children.

UKONIQ was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment. There are ongoing studies to confirm the benefit of UKONIQ for these uses.

IMPORTANT SAFETY INFORMATION

UKONIQ can cause serious side effects, including:

Infections. UKONIQ can cause serious infections that may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, flu-like symptoms, or any other signs of infection during treatment with UKONIQ.

Low white blood cell count (neutropenia). Neutropenia is common with UKONIQ treatment and can sometimes be serious. Your healthcare provider will check your blood counts regularly during treatment with UKONIQ. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with UKONIQ.

Diarrhea or inflammation of your intestine (colitis). Diarrhea is common during UKONIQ treatment and can sometimes be serious. Tell your healthcare provider right away if you have diarrhea that does not go away or worsening diarrhea, stool with mucus or blood, or if you have severe stomach area (abdominal) pain during treatment with UKONIQ. Drink plenty of fluids during treatment with UKONIQ to help prevent dehydration from diarrhea.

Liver problems. Abnormal liver function blood test results are common and can sometimes be serious. Your healthcare provider will do blood tests before and during your treatment with UKONIQ to check for liver problems. Tell your healthcare provider right away if you have any of the following symptoms of liver problems:


Skin reactions. Rashes and other skin reactions are common with UKONIQ treatment and can sometimes be severe and lead to death. Tell your healthcare provider right away if you get a new or worsening skin rash or other signs of a severe skin reaction during treatment with UKONIQ, including:


If you have any of the above serious side effects during treatment with UKONIQ, your doctor may completely stop your treatment, stop your treatment for a period of time, or change your dose of UKONIQ.

Before starting UKONIQ, tell your healthcare provider about all of your medical conditions, including if you:


Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of UKONIQ include:

These are not all the possible side effects with UKONIQ. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


For important risk and use information about UKONIQ, please see the Medication Guide and full Prescribing Information.

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