Duvelisib

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 reasons not mentioned in this medication guide.

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.

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

Tell your doctor if you have ever had:

• an intestinal disorder such as ulcerative colitis;
• lung disease; or
• liver disease.

Both men and women taking duvelisib should use effective birth control to prevent pregnancy. Duvelisib can harm an unborn baby or cause birth defects if either the mother or father is using this medicine.

Continue using birth control for at least 1 month after your last dose. Inform your doctor immediately 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.

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

Duvelisib may cause serious side effects. Contact your doctor immediately if you experience:

• severe diarrhea (more than 6 bowel movements in 1 day);
• severe stomach pain, new or worsening diarrhea that has 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 stopped permanently 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 like stuffy nose, sneezing, sore throat.

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

Usual Adult Dose for Chronic Lymphocytic Leukemia:

25 mg orally 2 times a day in 28-day cycles until unacceptable toxicity or progressive diseaseComments:-If a dose is missed by fewer than 6 hours, take the missed dose right awayand take the next dose as usual. If a dose is missed by more than 6 hours, waitand 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

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.

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

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

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 begin or stop using.

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