ZYDELIG and Relapsed Follicular B‑cell non-Hodgkin Lymphoma (FL)

ZYDELIG is a prescription medicine used to treat adults with Follicular B-cell non-Hodgkin Lymphoma (FL) when the disease worsens after treatment with at least 2 prior medicines. ZYDELIG was approved based on response rates. Data are not yet available to show if ZYDELIG improves symptoms or survival.

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ZYDELIG and Relapsed Chronic Lymphocytic Leukemia (CLL)

ZYDELIG 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 when Rituxan treatment alone may be used due to other health problems.                                                                 

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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. Your doctor will do blood tests before and during your treatment with ZYDELIG to check for liver problems. Tell your doctor 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 with ZYDELIG and can sometimes be severe. Tell your doctor right away if the number of bowel movements you have in a day increases by six or more. Ask your doctor about medicines you can take to treat your diarrhea.

Lung or breathing problems. Your doctor may do tests to check your lungs if you have breathing problems during treatment with ZYDELIG. Tell your doctor right away if you get new or worsening cough, shortness of breath, difficulty breathing, or wheezing.

Tear in intestinal wall (perforation). Tell your doctor or get medical help right away if you get new or worsening stomach area (abdomen) pain, chills, fever, nausea, or vomiting.

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

Who should not take ZYDELIG?

  • If your doctor determines you have a history of serious allergic or skin reactions.

What are the other possible side effects of ZYDELIG? ZYDELIG can cause serious side effects, including:

  • Severe skin reactions. Tell your doctor if you get painful sores or ulcers on your skin, lips, or in your mouth, or severe rash with blisters or peeling skin.
  • Serious allergic reactions (anaphylaxis). Tell your doctor or get medical help right away if you have a serious allergic reaction.
  • Low white blood cell count (neutropenia). Your doctor will check your blood counts regularly during treatment with ZYDELIG. Tell your doctor right away if you have a fever or any signs of an infection.

The most common side effects of ZYDELIG include fever, feeling tired, nausea, cough, stomach area (abdomen) pain, and chills.

What should I tell my doctor before taking ZYDELIG?

  • All of your medical conditions, including if you have liver, lung, or breathing problems.
  • If you are pregnant or plan to become pregnant. ZYDELIG may harm your unborn baby. Women who are able to become pregnant should use effective birth control (contraception) during treatment with ZYDELIG and for 1 month after stopping treatment. Talk to your doctor about birth control methods. Tell your doctor right away if you become pregnant during treatment with ZYDELIG.
  • If you are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take ZYDELIG or breastfeed. You should not do both.
  • 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. You can also call 1‑800‑GILEAD‑5 (1‑800‑445‑3235).

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

Rituxan® is a registered trademark of Biogen Idec, Inc.
Gilead, the Gilead logo, Zydelig, and the Zydelig logo are trademarks of Gilead Sciences, Inc., or one of its related companies.
© 2015 Gilead Sciences, Inc. All rights reserved. ZYDC0030 (07/15)