Serious side effects

Like all prescription medicines, ZYDELIG may cause side effects. Side effects can occur at any time. Some of the most important side effects for you to be aware of and discuss with your doctor or nurse are shown below. If you have these serious side effects while taking ZYDELIG, your doctor may completely stop your treatment, stop your treatment for a period of time, or change your dose of 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 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)
  • bleeding or bruising more easily than normal

Severe diarrhea

Diarrhea is common during treatment with ZYDELIG and can sometimes be severe. Diarrhea can happen anytime, even several months after you begin treatment. Tell your doctor right away if the number of bowel movements you have in a day increases by 6 or more.

Ask your doctor about medicines you can take to treat your diarrhea.

Lung problems (pneumonitis)

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
  • wheezing

Your doctor may treat you with a steroid if you develop lung problems.

Infections

ZYDELIG can cause serious infections that may lead to death. Tell your doctor right away if you have a fever or any signs of an infection while taking ZYDELIG.

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
  • vomiting

Severe skin reactions

Tell your doctor 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
  • a rash with itching

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.

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).

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ZYDELIG patient brochure

The ZYDELIG patient brochure was created to provide tips on managing treatment and information about what to expect with ZYDELIG

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Patient & caregiver resources

Find downloadable resources to help you get and stay informed about your disease and treatment

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Financial information & nurse support

Learn more about the financial information and nurse support offerings that may be available to you while on ZYDELIG treatment

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Reference:

  1. ZYDELIG® (idelalisib) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; rev January 2018.