Glossary

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B cells - B cells are a type of white blood cell that forms part of the body's natural defense system. Their role in this system is to make antibodies. B cells are sometimes also called B lymphocytes.¹

Chemotherapy - A type of drug used for the treatment of cancer.¹

CLL - The abbreviation for chronic lymphocytic leukemia, a type of cancer where the body contains too many "immature" white blood cells (white blood cells are part of the body's natural defense system). These immature white blood cells mostly collect in the blood and bone marrow.¹

Complete Remission - Disappearance of all signs and symptoms of cancer, although cancer may still be in the body. Also called complete response.¹

Diarrhea - Frequent, watery bowel movements.¹

Fatigue - Feeling extreme tiredness, and not able to do everyday things due to lack of energy.¹

Indolent - A type of cancer that grows slowly.¹

Neutropenia - A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).¹

Non-Hodgkin Lymphoma - Also called NHL. Any of a large group of cancers of lymphocytes. NHLs are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of NHL. These types can be divided into aggressive (fast-growing) and indolent (slow-growing) types, and they can be formed from either B cells or T cells. Indolent types of NHL may be referred to as iNHL.¹

Partial Remission - A decrease in the extent of cancer in the body or tumor size in response to treatment. Also called partial response.¹

PI3-Kinase, or PI3K - Short for phosphatidylinositol 3-kinase, a protein found inside a B cell. It is one of the molecules that plays a part in the growth of cancerous B cells and normal B cells. The expansion of cancerous B cells leads to the development of chronic lymphocytic leukemia (CLL). PI3Kδ is a specific type of PI3K found in B cells.^1,2

Placebo - A treatment that does not contain any active ingredients, but looks the same, and is taken in the same way as a real medicine or treatment.¹

Primary Endpoint - The main goal or purpose of a study designed to test whether a treatment does what it is intended to.¹

Progression - In terms of cancer, progression means either the spreading of cancer to other areas of the body or when the cancer becomes worse.¹

Progression-Free Survival (PFS) - In clinical trials, progression-free survival is the duration of time that patients remain alive without their disease becoming any worse.¹

Relapse - The return of the signs and symptoms of a patient's disease following a period of improvement.¹

Remission - A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some signs and symptoms of cancer have disappeared. In complete remission, all signs and symptoms of cancer have disappeared, although cancer still may be in the body.¹

Severe Diarrhea - 6 or more bowel movements more than the patient typically experienced before starting treatment.³

Side Effect - A health problem that occurs when a treatment a patient is taking to help fight their disease also has an unwanted effect on their body.¹

PI3Kδ=phosphatidylinositol 3-kinase.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZYDELIG?

ZYDELIG can cause serious side effects that can lead to death, including:

Liver problems. Abnormal liver blood test results are common during treatment with ZYDELIG. ZYDELIG can cause severe liver problems. Your healthcare provider will do blood tests before and during your treatment with ZYDELIG to check for liver problems. Tell your healthcare provider right away if you get yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain in the upper right side of your stomach area (abdomen), or bleeding or bruising more easily than normal.
Severe diarrhea. Diarrhea is common during treatment with ZYDELIG and can sometimes be severe. Tell your healthcare provider right away if the number of bowel movements you have in a day increases by 6 or more. Ask your healthcare provider about medicines you can take to treat your diarrhea.
Lung problems (pneumonitis). Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with ZYDELIG. Tell your healthcare provider right away if you get new or worsening cough, shortness of breath, difficulty breathing, or wheezing. Your healthcare provider may treat you with a steroid if you develop lung problems.
Infections. Tell your healthcare provider right away if you have a fever or any signs of an infection while taking ZYDELIG.
Tear in intestinal wall (perforation). Tell your healthcare provider or get medical help right away if you get new or worsening stomach area (abdomen) pain, chills, fever, nausea, or vomiting.
Severe skin reactions. Tell your healthcare provider right away if you get painful sores or ulcers on your skin, lips, or in your mouth; a severe rash with blisters or peeling skin, or itching, or if you have a fever or enlarged lymph nodes.

If you have any of the above serious side effects during treatment with ZYDELIG, your healthcare provider may completely stop your treatment, stop your treatment for a period of time, or change your dose of ZYDELIG.

Who should not take ZYDELIG?

Those who have had a serious allergic reaction to ZYDELIG or have had a severe skin reaction to any drug, as determined by a healthcare provider.

What are the other possible side effects of ZYDELIG?

ZYDELIG can cause serious side effects, including:

Serious allergic reaction, including a severe reaction known as anaphylaxis. Tell your healthcare provider or get medical help right away if you have swelling of the face, lips, or tongue; trouble breathing or swallowing; feeling dizzy or faint; rash or hives; cough; or a fast heartbeat.
Low white blood cell count (neutropenia). Neutropenia is common during treatment with ZYDELIG and can sometimes be severe. Your healthcare provider will check your blood counts regularly during treatment with ZYDELIG. Tell your healthcare provider right away if you have a fever or any signs of an infection.

The most common side effects of ZYDELIG when used in combination with Rituxan include pneumonia, fever, feeling tired, rash, cough, and nausea.

What should I tell my healthcare provider before taking ZYDELIG?

All of your medical conditions, including if you have liver, lung, or breathing problems or an infection.
If you are pregnant or plan to become pregnant. ZYDELIG may harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with ZYDELIG and should use effective birth control (contraception) during treatment with ZYDELIG and for 1 month after the last dose of ZYDELIG. Talk to your healthcare provider about birth control methods. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ZYDELIG. Males with female partners who are able to become pregnant should use effective birth control during treatment with ZYDELIG and for 3 months after the last dose.
If you are breastfeeding or plan to breastfeed. Do not breastfeed during your treatment with ZYDELIG and for 1 month after the last dose.
All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZYDELIG and certain other medicines may affect each other.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide with important warnings.

INDICATION

What is ZYDELIG?

ZYDELIG (idelalisib) is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL), in combination with Rituxan® (rituximab), when CLL comes back after prior cancer treatment and when Rituxan treatment alone may be used due to other health problems.

ZYDELIG should not be used as the first medicine to treat anyone, including people with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other slow growing (indolent) non-Hodgkin lymphomas.

ZYDELIG should not be used in combination with bendamustine and Rituxan, or in combination with Rituxan to treat people with FL, SLL, and other indolent non-Hodgkin lymphomas.

References:

NCI dictionary of cancer terms. National Institute of Health. Accessed September 14, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms
Robak P, Robak T. The emerging role of ibrutinib and idelalisib in the treatment of chronic lymphocytic leukemia. J Hematol Transfus. 2013;1(1):1001.
Common terminology criteria for adverse events (CTCAE), Version 5.0. US Department of Health and Human Services. Published November 27, 2017. Accessed September 14, 2023. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf

Glossary

About ZYDELIG

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