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Zydelig

Generic Name: Idelalisib (eye del a LIS ib)
Brand Name: Zydelig

Warning

  • Very bad and sometimes deadly liver problems have happened with Zydelig (idelalisib). You will need to have your liver checked while you take this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • It is common to have loose stools (diarrhea) with this medicine. Sometimes, very bad or deadly diarrhea has happened with Zydelig. Call your doctor right away if you have very bad diarrhea or the number of bowel movements you have in a day goes up by 6 or more.
  • Very bad and sometimes deadly bowel problems have happened with this medicine. These are problems like swelling and tears in the bowel wall. Call your doctor right away if you are throwing up blood or you have throw up that looks like coffee grounds. Call your doctor right away if you have black, tarry, or bloody stools; fever or chills; upset stomach or throwing up; or stomach pain that is new or worse.
  • Very bad and sometimes deadly lung problems have happened with Zydelig. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
  • Very bad and sometimes deadly infections have happened in patients who take this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
  • Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.

Uses of Zydelig:

  • It is used to treat a type of leukemia.
  • It is used to treat a type of lymphoma.

What do I need to tell my doctor BEFORE I take Zydelig?

  • If you have an allergy to Zydelig or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Carbamazepine, phenytoin, rifampin, or St. John's wort.
  • If you are taking any drugs that can raise the chance of liver problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are taking any drugs that can cause loose stools (diarrhea). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding. Do not breast-feed while you take Zydelig.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Zydelig with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Zydelig?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are 65 or older, use Zydelig with care. You could have more side effects.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust during treatment and for 1 month after treatment ends.
  • If you get pregnant while taking this medicine or within 1 month after your last dose, call your doctor right away.

How is this medicine (Zydelig) best taken?

Use Zydelig (idelalisib) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Swallow whole. Do not chew, break, or crush.
  • Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it has been 6 hours or more since the missed dose, skip the missed dose and go back to your normal time.
  • Do not give 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of dehydration like dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast breathing; or confusion.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Mouth irritation or mouth sores.
  • Night sweats.
  • Swelling in the arms or legs.
  • 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.

What are some other side effects of Zydelig?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Headache.
  • Heartburn.
  • Joint pain.
  • Not hungry.
  • Feeling tired or weak.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Zydelig?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Zydelig is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Zydelig or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Zydelig. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017

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