Copiktra is a prescription medicine used to treat adults with chronic lymphocytic leukemia or small lymphocytic leukemia.

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

It is not known if Copiktra is safe and effective in children less than 18 years of age.

Copiktra 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.

Before taking this medicine

To make sure Copiktra is safe for you, 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 this medicine 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 Copiktra.

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

Take Copiktra exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Copiktra with or without food.

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

Copiktra 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.

To make sure Copiktra is safe for you, 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 this medicine 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 Copiktra.

It is not safe to breast-feed a baby while you are using duvelisib. 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.

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 to Copiktra (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).

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 Copiktra side effects 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 interact with 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.