Umbralisib is used to treat certain types of lymphoma in adults.

Umbralisib is given after other cancer treatments did not work or have stopped working.

Umbralisib may also be used for purposes not listed in this medication guide.

Umbralisib affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, or other flu-like symptoms

Get emergency medical help if you have signs of a severe skin reaction such as a fever with skin rash, itching, blistering, peeling, or sores on your skin or mouth.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food, at the same time each day.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking umbralisib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Umbralisib affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

You may be given other medications to help prevent serious infections. Keep using these medicines for as long as your doctor has prescribed.

Do not change your dose or stop using umbralisib without your doctor's advice.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Lymphoma:

800 mg orally once a day

Comments:
-Patients should be provided with prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment.
-Consideration should be given to provide prophylactic antivirals during treatment with to prevent cytomegalovirus (CMV) infection, including CMV reactivation.
-Treatment should be continued until disease progression or unacceptable toxicity.

Uses:
-For the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
-For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy

Usual Adult Dose for Follicular Lymphoma:

800 mg orally once a day

Comments:
-Patients should be provided with prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment.
-Consideration should be given to provide prophylactic antivirals during treatment with to prevent cytomegalovirus (CMV) infection, including CMV reactivation.
-Treatment should be continued until disease progression or unacceptable toxicity.

Uses:
-For the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
-For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy

Tell your doctor if you have and infection, or if you've ever had:

• a stomach or intestinal disorder;

• liver problems; or

• an allergy to aspirin or yellow food dye.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using umbralisib should use effective birth control to prevent pregnancy. Umbralisib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using umbralisib.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because umbralisib can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Umbralisib may cause serious side effects. Call your doctor at once if you have:

• a severe skin rash, or sores on your skin or mouth;

• severe or ongoing diarrhea, stools with mucus or blood, or severe stomach pain;

• liver problems--stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of umbralisib may include:

• low blood cell counts;

• nausea, vomiting, stomach pain, loss of appetite;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• muscle or bone pain;

• feeling tired; or

• abnormal kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect umbralisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to umbralisib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.