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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 and 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 is an ongoing study 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:
    Yellowing of your skin or the white part of your eyes (jaundice)
    Dark or brown (tea colored) urine
    Pain in the upper right side of your stomach area (abdomen)
    Bleeding or bruising more easily than normal
  • Severe 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:
    Painful sores or ulcers on your skin, lips, or in your mouth
    Rash with blisters or peeling skin
    Rash with itching
    Rash with fever

    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:

    Have an infection
    Have abdominal or intestinal problems
    Have liver problems
    Are allergic to FD&C Yellow No. 5 (tartrazine) or aspirin. UKONIQ tablets contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.
    Are pregnant or plan to become pregnant. UKONIQ can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with UKONIQ.
    Females and males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with UKONIQ and for 1 month after the last dose of UKONIQ. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you or your partner become pregnant or think you are pregnant during treatment with UKONIQ.
    Are breastfeeding or plan to breastfeed. It is not known if UKONIQ passes into your breast milk. Do not breastfeed during treatment with UKONIQ and for 1 month after the last dose of UKONIQ.

    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:

    Changes in certain kidney function blood tests
    Tiredness
    Nausea
    Muscle or bone pain
    Low red blood cell count (anemia)
    Low platelet count
    Upper respiratory tract infection
    Vomiting
    Abdominal pain
    Decreased appetite

    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 full Product Information.
What is UKONIQ (umbralisib)?
  • 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 is an ongoing study to confirm the benefit of UKONIQ for these uses.

What to expect when taking UKONIQ

Talk to your doctor about how you’re feeling before, during, and after treatment

It’s important to talk to your doctor or nurse right away about anything you may be feeling or experiencing.

Woman taking oral medication

The most common side effects of UKONIQ include:

Changes in certain kidney function blood tests
Tiredness
Nausea
Muscle or bone pain
Low red blood cell count
(anemia)
Low platelet count
Upper respiratory
tract infection
Vomiting
Abdominal pain
Decreased appetite

Diarrhea is a common side effect of UKONIQ and can sometimes be serious. Guidelines to help manage diarrhea include:

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Drink plenty of fluids during treatment with UKONIQ to help prevent dehydration from diarrhea

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Tell your doctor if you have diarrhea that does not go away or gets worse, stool with mucus or blood, of if you have severe stomach area (abdominal) pain during treatment with UKONIQ

Icon of clipboard

Keep track of your stools using a written tracker or by downloading a stool tracker app on your smartphone

Icons showing string on a finger

Reminders:

Let your doctor and nurses know about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
Tell your doctor about all of your medical conditions, including if you: have an infection, have abdominal or intestinal problems, have liver problems, are allergic to FD&C Yellow No. 5 (tartrazine) or aspirin, are pregnant or plan to become pregnant, or are breastfeeding

What is UKONIQ (umbralisib)?

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 is an ongoing study 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:
    Yellowing of your skin or the white part of your eyes (jaundice)
    Dark or brown (tea colored) urine
    Pain in the upper right side of your stomach area (abdomen)
    Bleeding or bruising more easily than normal
  • Severe 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:
    Painful sores or ulcers on your skin, lips, or in your mouth
    Rash with blisters or peeling skin
    Rash with itching
    Rash with fever

    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:

    Have an infection
    Have abdominal or intestinal problems
    Have liver problems
    Are allergic to FD&C Yellow No. 5 (tartrazine) or aspirin. UKONIQ tablets contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.
    Are pregnant or plan to become pregnant. UKONIQ can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with UKONIQ.
    Females and males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with UKONIQ and for 1 month after the last dose of UKONIQ. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you or your partner become pregnant or think you are pregnant during treatment with UKONIQ.
    Are breastfeeding or plan to breastfeed. It is not known if UKONIQ passes into your breast milk. Do not breastfeed during treatment with UKONIQ and for 1 month after the last dose of UKONIQ.

    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:

    Changes in certain kidney function blood tests
    Tiredness
    Nausea
    Muscle or bone pain
    Low red blood cell count (anemia)
    Low platelet count
    Upper respiratory tract infection
    Vomiting
    Abdominal pain
    Decreased appetite

    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 full Product Information.