Treating Relapsed/Refractory Follicular Lymphoma and Chronic Lymphocytic Leukemia: Side Effects of PI3K Inhibitors

This article is for people who have relapsed or refractory follicular lymphoma (FL), or relapsed or refractory chronic lymphocytic leukemia (CLL), or anyone who wants to learn more about relapsed or refractory FL or relapsed or refractory CLL. The goal of this patient education activity is to provide patients and their caregivers information about the possible side effects of PI3K inhibitors and strategies to help manage the side effects.

You will learn:

• What "relapsed" and "refractory" mean

• Treatment options for relapsed and refractory FL and CLL

• The benefits of PI3K inhibitors

• The possible side effects of PI3K inhibitors

• Ways to manage side effects of PI3K inhibitors

• Questions to ask your healthcare team

Relapsed means that the cancer has come back after a period of remission. You received treatment before, and the cancer went away; now, it's come back.

Refractory means that even though you are being treated, the cancer has not gone away or has gotten worse. You've received multiple treatments and still haven't had the success that you and your doctor want for your health.

Whether you have relapsed FL or CLL or refractory FL or CLL, your doctor will likely recommend additional treatment.

Yes. There are medicines called PI3K inhibitors that can treat relapsed or refractory FL or CLL. A PI3K inhibitor works by blocking some functions of cell growth, which may stop or slow the progression of FL and CLL.

There are 3 PI3K inhibitors:

• Copanlisib: can treat FL

• Duvelisib: can treat FL and CLL

• Idelalisib: can treat FL and CLL

Do not take any PI3K inhibitor if you are pregnant, trying to get pregnant, or are breastfeeding. Everyone -- men or women -- receiving a PI3K inhibitor should use birth control to avoid pregnancy.

Copanlisib is given through a 1-hour intravenous (IV) infusion on days 1, 8, and 15 of a 28-day treatment cycle. You will have to go to a medical facility to receive it. It can treat:

• Relapsed FL in patients who have received 2 prior systemic (medicine) treatments

Duvelisib is a pill taken by mouth twice a day that can treat:

• Relapsed or refractory FL after at least 2 prior systemic therapies

• Relapsed or refractory CLL after at least 2 prior therapies

Idelalisib is a pill taken by mouth twice a day that can treat:

• Relapsed FL in patients who have received 2 prior systemic treatments

• Relapsed CLL with an additional medicine (rituximab)

Relapsed or refractory CLL and FL are hard to treat since a number of medicines have been tried already.

Although PI3K inhibitors are a relatively new type of treatment, they can increase the amount of time that the cancer stops growing (progression-free survival).

Yes. If you are taking pills (idelalisib or duvelisib), contact your doctor immediately if you experience:

• Fever or chills (possible infection)

• Yellow skin or eyes (possible jaundice)

• Rash or other skin reaction

• Severe diarrhea or abdominal pain (possible colitis)

• Cough, shortness of breath, or other breathing problem (possible pneumonitis)

Idelalisib and duvelisib have black box warnings from the FDA. This means that the side effects can be very serious. It is very important to talk with your doctor about the possible side effects of these medicines.

If you are receiving an IV (copanlisib), contact your doctor immediately if, after you've gone home you experience:

• Fever or chills (possible infection)

• Extreme hunger/thirst, headache, frequent urination, signs of high blood sugar

• Cough, shortness of breath, or other breathing problem (possible pneumonitis)

Another side effect is high blood pressure.

In addition to monitoring the physical symptoms of your side effects, you will need lab work to identify side effects that you cannot feel.

Because PI3K inhibitors can affect your liver enzymes and your blood counts, you will need regular bloodwork done to make sure your levels are within acceptable ranges.

If you are taking copanlisib, you will be tested to make sure you do not have high blood sugar prior to or during treatment.

There are some ways to help minimize your chance of having a side effect or help monitor side effects.

Your doctor may give you steroids to help lower your chance of getting pneumonitis, which is lung inflammation that makes it difficult to breathe.

You may also be given an antiviral medicine to help prevent a cytomegalovirus (CMV) infection.

If you have side effects such as mild rash or diarrhea, or minimal high blood pressure, your doctor may want to follow you closely so you do not get worse.

If you have serious side effects, you may be given additional medicines and your doctor may tell you to stop taking your PI3K inhibitor until side effects resolve, or to stop taking your PI3K inhibitor treatment altogether.

In emergency situations, you may need to go to the hospital.

Side effects can occur at any time during treatment. Some side effects may occur right after you start your treatment. Others may occur after you have been on treatment for a while.

Regardless of when they occur, always tell your doctor if you have a side effect so it can be observed or treated as soon as possible. Do not stop taking your medicine unless your doctor tells you to.

• Why are you recommending this treatment?

• What are the side effects of the medicine?

• What is a black box warning?

• How will you monitor for me for side effects?

• What should I do if I have a side effect?

• How can the chance of me having side effects be reduced?

• How will side effects be managed?

Congratulations!

You have successfully completed the program: Treating Relapsed/Refractory Follicular Lymphoma and Chronic Lymphocytic Leukemia: Side Effects of PI3K Inhibitors