Idelalisib

Idelalisib is used 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 idelalisib, but further studies are needed.

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

Follow all instructions 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 have severe or life-threatening diarrhea while taking idelalisib. Tell your doctor right away if your daily bowel movements increase by 6 or more.

You may need frequent medical tests to ensure 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.

Idelalisib can seriously harm your liver, lungs, or intestines. Some of these issues may result in life-threatening complications. Contact your doctor immediately if you experience: upper stomach pain, easy bruising or bleeding, dark urine, yellowing of your skin or eyes, cough, wheezing, shortness of breath, fever, chills, worsening stomach pain, or vomiting.

You may experience severe or life-threatening diarrhea while taking idelalisib. Inform your doctor right away if your daily bowel movements increase by 6 or more.

You may not be able to use idelalisib if you have ever had a serious skin reaction to any medicine.

Tell your doctor if you have ever had:

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

Idelalisib can harm an unborn baby if the mother or the father is using idelalisib.

• 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.

Do not breastfeed 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.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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.

Idelalisib may cause serious side effects. Call your doctor at once if you have:

• 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 of idelalisib 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.

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

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

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

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, 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.