Duvelisib

ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood. The FDA is notifying the public of these risks and is continuing to evaluate the safety of Copiktra. The FDA plans to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. The FDA will update the public when more information is available.

BACKGROUND: Copiktra was approved to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior therapies that did not work or stopped working.

Patients
• Patients should talk to your health care professional about the risks and benefits of receiving Copiktra for you. Discuss any questions or concerns you may have, including about possible alternative treatments.

Health Professionals
• Health care professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments. Advise patients receiving Copiktra of the possible increased risk of death and higher risk of serious adverse events.

Duvelisib may cause serious or life-threatening infections. Tell your doctor if you have an infection, or if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems). If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, shortness of breath, or other signs of infection.

Duvelisib may cause diarrhea or colitis (swelling of the large intestine). Tell your doctor if you have diarrhea or if you have ever had colitis or other conditions that affect your stomach or intestine. If you experience any of the following symptoms, call your doctor immediately: an increase in the number of bowel movements in a day, blood in your stool, or any stomach cramps or pain.

Duvelisib may cause serious or life-threatening skin reactions. If you experience any of the following symptoms, call your doctor immediately: new or worsening rash, rash with a fever, rash with itching, blisters or peeling skin, or painful sores or ulcers on your skin, lips, or in your mouth.

Duvelisib may cause serious or life-threatening pneumonitis (swelling of the lungs). Tell your doctor if you have lung disease or breathing problems. If you experience any of the following symptoms, call your doctor immediately: new or worsening cough, difficulty breathing, wheezing, or shortness of breath.

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

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with duvelisib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

🔔 Why is this medication prescribed?

Duvelisib is used to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes) that has returned or is unresponsive to at least two other treatments. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.

🔔 How should this medicine be used?

Duvelisib comes as a capsule to take by mouth. It is usually taken twice daily with or without food. Take duvelisib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take duvelisib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsule whole; do not open, chew, or break them.

Your doctor may decrease your dose of duvelisib or tell you to stop taking the medication for a time or permanently if you experience serious side effects during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take duvelisib even if you feel well. Do not stop taking duvelisib without talking to your doctor.

🔔 Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.