Duvelisib is used to treat adults with chronic lymphocytic leukemia or small lymphocytic leukemia. Duvelisib is also used to treat follicular lymphoma.

Duvelisib is given after at least two other cancer treatments did not work or have stopped working.

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

Duvelisib can cause serious or fatal side effects, including serious infections, severe diarrhea, or a life-threatening skin rash.

Call your doctor right away if you have symptoms such as:

• fever, chills, cough, breathing problems;

• severe stomach pain, diarrhea with blood or mucus; o

• painful mouth sores, or a skin rash with blistering or peeling.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take duvelisib with or without food.

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

Duvelisib can cause severe diarrhea, which can be life-threatening. You may need to take medication to prevent or quickly treat diarrhea.

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

Your doctor will need to check your progress on a regular basis, and you will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Store capsules in the blister pack at room temperature, away from moisture and heat.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

25 mg orally 2 times a day in 28-day cycles until unacceptable toxicity or progressive disease

Comments:
-If a dose is missed by fewer than 6 hours, take the missed dose right away
and take the next dose as usual. If a dose is missed by more than 6 hours, wait
and take the next dose at the usual time.
-Provide prophylaxis for Pneumocystis jirovecii (PJP) during therapy with this drug.
-Withhold therapy in patients with suspected PJP of any Grade and discontinue if PJP is confirmed.
-Consider prophylactic antivirals during therapy to prevent cytomegalovirus
(CMV) infection/reactivation.

Uses: For the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies

Tell your doctor if you have ever had:

• an intestinal disorder such as ulcerative colitis;

• lung disease; or

• liver disease.

Both men and women using duvelisib should use effective birth control to prevent pregnancy. Duvelisib can harm an unborn baby or cause birth defects 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 duvelisib.

It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 1 month after your last dose.

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take 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).

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

• severe diarrhea (more than 6 bowel movements in 1 day);

• severe stomach pain, new or worsening diarrhea with blood or mucus;

• liver problems--stomach pain (upper right side), dark urine, 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.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of duvelisib may include:

• diarrhea, nausea;

• low blood cell counts;

• bone pain, muscle pain;

• fever, cough, tiredness; or

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

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect duvelisib, 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.

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.