Duvelisib (doo-ve-LIS-ib)

Treats chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Brand Name(s):

Copiktra

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not break, chew, or open it.
• Your doctor may give you other medicines (including antivirals) to prevent infections and other unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and it is less than 6 hours from your usual dose, take the missed dose and go back to your regular schedule. If you miss a dose and it is more than 6 hours from your usual dose, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how duvelisib works. Tell your doctor if you are using etravirine, ketoconazole, midazolam, or rifampin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 month after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 1 month after the last dose.
• Tell your doctor if you have lung disease or breathing problems, any type of infection, or bowel problems.
• This medicine may cause the following problems:
  • Serious life-threatening side effects (including infections, diarrhea, skin reactions, pneumonitis), which can lead to death
  • Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis
  • Pneumonitis (swelling of the lungs)
  • Liver problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Severe bloody or watery diarrhea, stomach pain
• Trouble breathing, cough
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088