Important Safety Information | ZYDELIG® (idelalisib) Tablets

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.

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.