Frequently Asked Questions About Ukoniq™ (umbralisib)

TraceyS

Generic Name: umbralisib
Trade Name: Ukoniq

For which conditions is UKONIQ approved for? UKONIQ is indicated for the treatment of adults with:

  • Marginal zone lymphoma (MZL) who have not responded or have stopped responding to at least one prior therapy.
  • Follicular lymphoma (FL) who have not responded or have stopped responding following at least three prior treatments.

UKONIQ was approved under accelerated approved based on overall response rate; continued approval may be contingent on additional efficacy data in ongoing clinical trials.

What is the mechanism of action? UKONIQ is a targeted kinase inhibitor. Kinase inhibitors work by blocking the action of enzymes, which are involved in many cell functions, including cell signaling, growth and division. These enzymes may be too active or found at high levels in some types of cancer cells and blocking them may help keep cancer cells from growing. Specifically, UKONIQ blocks the action of both P13K-Delta and CK1-Epsilon.

How is UKONIQ typically given (administered)? UKONIQ tablets are taken once a day with food at about the same time each day. The tablet must be swallowed whole with food and never opened, broken, or chewed. Talk to you doctor for instructions if you vomit or miss a dose of Ukoniq.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with UKONIQ. Blood may be drawn to check for side effects and to monitor functions of some organ systems. Patients may also undergo physical examinations or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with UKONIQ?

  • Thrombocytopenia (lower-than-normal number of platelets in the blood)
  • Changes in certain kidney function blood tests
  • Tiredness
  • Nausea
  • Muscle or bone pain
  • Anemia (lower-than-normal number of red blood cells)
  • Upper respiratory tract infection
  • Vomiting
  • Abdominal pain
  • Decreased appetite

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Take UKONIQ exactly as your healthcare provider tells you to take it. Tell your healthcare provider about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements. Drink plenty of fluids during treatment with UKONIQ to prevent dehydration from diarrhea.

Are there any special precautions patients should be aware of before starting treatment?

  • Talk to your healthcare provider about any medicines (prescription and over-the-counter), vitamins or herbal supplements that you are taking.

  • Tell your healthcare provider about all your medical conditions prior to starting treatment with UKONIQ including if you have infection, liver problems or if you have abdominal or intestinal problems.

  • Tell your healthcare provider if you are allergic to FD&C Yellow No. 5 or aspirin.

  • Talk to your doctor if you or your partner are pregnant or planning to become pregnant. UKONIQ can cause fetal harm. If a man’s sexual partner is not pregnant but could become pregnant, effective birth control should be used during treatment and for one month after treatment ends. Females should use an effective method of birth control during treatment and for one month after the last does of UKONIQ.

  • Do not breastfeed during treatment or for 1 month after the last dose of UKONIQ.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your healthcare provider right away if you experience:

  • Symptoms of infection: fever, chills, weakness, flu-like symptoms.
  • Symptoms of low white blood cell count: signs of infection
  • Symptoms of diarrhea or inflammation of your intestine (colitis): persistent or worsening diarrhea, mucus or blood in your stool, sever stomach pain.
  • Symptoms of liver problems: jaundice, dark or brown urine, upper right side abdomen pain, bleeding or bruising more easily than normal.
  • Symptoms of sever skin reactions: painful sores or skin ulcers, rash with blisters or peeling skin, rash with itching, or rash with fever.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Updated 4/21

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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CANCERCONNECT SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECT DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

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