Generic Name: idelalisib (eye-del-a-LIS-ib)
Brand Name: Zydelig
Severe and sometimes fatal liver problems have happened with Zydelig. You will need to have your liver checked while you take this drug. Call your doctor right away if you have symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, stomach pain, unusual bruising or bleeding, yellowing of the skin or eyes).
It is common to have loose stools (diarrhea) with Zydelig. Sometimes, severe or fatal diarrhea has happened with Zydelig. Call your doctor right away if you have moderate to severe diarrhea or the number of bowel movements you have in a day goes up by 6 or more.
Severe and sometimes fatal stomach or bowel problems (eg, colitis, tears in the bowel wall) have happened with Zydelig. Call your doctor right away if you vomit blood or you have vomit that looks like coffee grounds. Call your doctor right away if you have black, tarry, or bloody stools; fever or chills; nausea or vomiting; or stomach pain that is new or worse.
Severe and sometimes fatal lung problems have happened with Zydelig. Call your doctor right away if you have lung or breathing problems (eg, trouble breathing, shortness of breath, a cough that is new or worse).
Zydelig is used for:
Treating certain types of leukemia or lymphoma.
Zydelig is a phosphatidylinositol 3-kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Zydelig if:
- you are allergic to any ingredient in Zydelig
- you have ever had a severe allergic reaction (eg, severe skin rash) to any other medicine
- you are taking carbamazepine, phenytoin, rifampin, or St. John's wort
- you are taking any medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection). There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure if any of your medicines might harm the liver
- you are taking any medicines that may cause diarrhea. There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure if any of your medicines may cause diarrhea
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zydelig:
Some medical conditions may interact with Zydelig. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have liver problems, diarrhea, or lung or breathing problems
Some MEDICINES MAY INTERACT with Zydelig. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are not sure if any of your medicines might harm the liver
- Medicines that may cause diarrhea because the risk of severe diarrhea or bowel problems may be increased. Ask your doctor or pharmacist if you are not sure if any of your medicines may cause diarrhea
- Carbamazepine, phenytoin, rifampin, or St. John's wort because they may decrease Zydelig's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zydelig may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Zydelig:
Use Zydelig as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zydelig comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zydelig refilled.
- Take Zydelig by mouth with or without food.
- Swallow Zydelig whole. Do not break, crush, or chew before swallowing.
- Continue to take Zydelig even if you feel well. Do not miss any doses.
- If you miss a dose of Zydelig, take it as soon as possible. If it has been more than 6 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zydelig.
Important safety information:
- Tell your doctor or dentist that you take Zydelig before you receive any medical or dental care, emergency care, or surgery.
- Zydelig may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Zydelig may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- If you may become pregnant, you must use an effective form of birth control while you take Zydelig and for at least 1 month after you stop taking it. If you have questions about effective birth control, talk with your doctor.
- Lab tests may be performed while you use Zydelig. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Zydelig with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Zydelig may cause harm to the fetus. Do not become pregnant while you are using it or for at least 1 month after stopping treatment. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zydelig while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Zydelig.
Possible side effects of Zydelig:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; heartburn; joint pain; loss of appetite; tiredness; trouble sleeping; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth irritation or mouth sores; night sweats; swelling in the arms or legs; symptoms of bleeding (eg, coughing up blood, blood in the urine, bleeding from the gums, vaginal bleeding that is not normal, bruises without a reason or that get bigger, any bleeding that is severe or that you cannot stop); symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, anal itching or pain).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Zydelig:
Store Zydelig in the original container at room temperature, between 68 and 86 degrees F (20 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zydelig out of the reach of children and away from pets.
- If you have any questions about Zydelig, please talk with your doctor, pharmacist, or other health care provider.
- Zydelig is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Zydelig or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zydelig. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zydelig. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Zydelig.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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