[en Español]


Pronunciation: eye DEL a LIS ib

Brand: Zydelig


slide 1 of 1, Zydelig,

100 mg, oval, orange, imprinted with 100, GSI

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

You may have severe or life-threatening diarrhea while taking idelalisib. Idelalisib can also cause a perforation (a hole or tear) in your intestines. Call your doctor at once if you have diarrhea that is watery or bloody, if you have bloody or tarry stools, or if you cough up blood that looks like coffee grounds.

Idelalisib can cause serious harm to your liver, lungs, or intestines. Some of these conditions may lead to fatal complications. You will need frequent medical tests to be sure idelalisib is not causing harmful effects.

What is idelalisib?

Idelalisib is used together with rituximab (Rituxan) to treat chronic lymphocytic leukemia, and certain types of lymphoma.

Idelalisib is given after other cancer treatments did not work or have stopped working.

Idelalisib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Idelalisib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking idelalisib?

You should not use idelalisib if you have ever had a serious allergic reaction.

Tell your doctor if you have ever had:

  • liver disease;
  • an intestinal disorder such as ulcerative colitis; or
  • lung disease.

Do not use idelalisib if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.

Do not breast-feed while using this medicine, and for at least 1 month after your last dose.

Idelalisib is not approved for use by anyone younger than 18 years old.

How should I take idelalisib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take idelalisib with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Do not stop using idelalisib without your doctor's advice.

Store this medicine in the original container at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking idelalisib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of idelalisib?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Idelalisib can cause serious harm to your liver, lungs, or intestines. You may have severe or life-threatening diarrhea, or a perforation (a hole or tear) in your intestines. Some of these conditions may lead to fatal complications.

Call your doctor at once if you have:

  • severe diarrhea, increased number of stools per day;
  • bloody or tarry stools, vomit that looks like coffee grounds;
  • stomach pain with fever, chills, nausea, or vomiting;
  • cough with mucus, trouble breathing, chest pain;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • liver problems --upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
  • low white blood cell counts --fever, mouth sores, skin sores, sore throat.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, stomach pain, diarrhea;
  • fever, chills, cough;
  • tired feeling; or
  • breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect idelalisib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect idelalisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about idelalisib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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