Umbralisib (um-bra-LIS-ib)

Treats marginal zone lymphoma (MZL) and follicular lymphoma (FL). This medicine was withdrawn from the U.S. market on June 1, 2022.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, cut, or chew it.
• It is best to take this medicine with food or milk. Take the medicine at the same time each day.
• You may also receive medicines to help prevent infections during treatment with this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is more than 12 hours until your next scheduled dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 12 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• If you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular scheduled time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 month after the last dose.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, stomach or bowel problems, or any type of infection.
• This medicine may cause the following problems:
  • Increased risk of serious infection (including pneumonia, sepsis, urinary tract infection)
  • Liver problems
  • Serious skin reactions (including exfoliative dermatitis)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may cause diarrhea. Drink plenty of water to help avoid dehydration.
• This medicine could cause infertility in some men. Talk with your doctor before using this medicine if you plan to have children.
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Change in how much or how often you urinate, lower back or side pain
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea that may contain blood
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Muscle or bone pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088