idelalisib

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

You may have severe or life-threatening diarrhea while taking idelalisib. Tell your doctor at once if your daily bowel movements increase by 6 or more.

What is idelalisib?

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

Idelalisib is sometimes given after at least two 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 to treat lymphoma. 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?

Tell your doctor if you have ever had:

• liver disease;
• lung disease; or
• a perforation (a hole or tear) in your intestines.

• If you are a woman, do not use idelalisib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using idelalisib.

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.

You may have severe or life-threatening diarrhea while taking idelalisib. Tell your doctor at once if your daily bowel movements increase by 6 or more.

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.

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?

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?

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.

• severe diarrhea, increased number of stools per day;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• intestinal problems --worsening stomach pain, fever, chills, vomiting;
• liver problems --upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• lung problems --worsening cough, wheezing, cough with mucus, or shortness of breath;
• 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, cough, lung problems;
• low white blood cells;
• abnormal liver function tests;
• rash; or
• feeling tired.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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