Umbralisib Oral Tablets

What is this medication?

UMBRALISIB (um bra lis ib) targets proteins in cancer cells and stops the cancer cells from growing. It treats certain types of cancer. Some of the cancers treated are marginal zone lymphoma and follicular lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): UKONIQ

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• infection
• intestine problems
• liver disease
• an unusual or allergic reaction to umbralisib, aspirin, other medicines, foods, FD&C Yellow No. 5 (tartrazine), other dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. Take it with food. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Interactions have not been completed.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. It may be some time before you see the benefit from this medicine.

You may need blood work while you are taking this medicine.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 1 month after stopping it. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine and for 1 month after stopping it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• diarrhea
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• stomach pain

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone pain
• decreased appetite
• muscle pain
• nausea, vomiting
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired: take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location. If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.