What is the most important information I should know about idelalisib?
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.
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.
What is idelalisib?
Idelalisib is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Idelalisib is used together with rituximab (Rituxan) to treat chronic lymphocytic leukemia that has relapsed.
Idelalisib is also used to treat certain types of lymphoma that have relapsed or have not responded to other treatments.
Idelalisib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. Patients in clinical studies responded to this medicine. However, it has not been shown that idelalisib can improve symptoms or lengthen survival time.
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.
To make sure idelalisib is safe for you, tell your doctor if you have:
- liver disease;
- an intestinal disorder such as ulcerative colitis; or
- lung disease.
FDA pregnancy category D. Do not use idelalisib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 1 month after your treatment ends.
It is not known whether idelalisib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medicine to anyone under 18 years old without medical advice.
How should I take idelalisib?
Idelalisib is usually taken twice per day. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
You may take idelalisib with or without food.
Do not crush, chew, or break an idelalisib tablet. Swallow it whole.
While using idelalisib, you will need frequent medical tests to be sure idelalisib is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.
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 missed dose as soon as you remember. If you are more than 6 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Idelalisib can cause serious harm to your liver, lungs, or intestines. Some of these conditions may lead to fatal complications. 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:
- severe or ongoing diarrhea, increased number of stools per day;
- diarrhea that is watery or bloody;
- stomach pain with fever, chills, nausea, or vomiting;
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- fever, easy bruising or bleeding, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
-
liver problems --nausea, upper stomach pain, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
signs of pneumonia (lung infection) --fever, chills, stabbing chest pain, wheezing, trouble breathing, cough with yellow or green mucus; or
-
severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
- nausea, stomach pain, diarrhea;
- fever, chills, cough;
- tired feeling; or
- lung infection.
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?
Other drugs may interact with idelalisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your 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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