Idelalisib tablets

What is this medication?

IDELALISIB (eye del AL isib) treats chronic lymphocytic leukemia. It works by targeting proteins in cancer cells to stop the cancer cells from growing. It is not used as first-line therapy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZYDELIG

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• infection
• liver disease
• lung or breathing disease, like asthma
• skin conditions or sensitivity
• an unusual or allergic reaction to idelalisib, other medicines, foods, dyes, or preservative
• pregnant, or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 6 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• alfuzosin
• conivaptan
• eletriptan
• eplerenone
• flibanserin
• isavuconazonium
• ivabradine
• lurasidone
• naloxegol
• simvastatin
• tolvaptan
• triazolam
• ubrogepant

This medicine may also interact with the following medications:

• certain medicines for anxiety like midazolam
• certain medicines for fungal infections like ketoconazole
• certain medicines for heart disease or irregular heart beat
• certain medicines for blood pressure like amlodipine, felodipine, nifedipine
• certain medicines for cholesterol like atorvastatin, lovastatin
• certain medicines for depression or psychotic disturbances
• certain medicines for erectile dysfunction
• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• ergot alkaloids like dihydroergotamine, ergotamine
• rifampin
• narcotic medicines for pain

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular check on your progress. It may be some time before you see the benefit from this medication.

You may need blood work while you are taking this medication.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not become pregnant while taking this medication or for 1 month after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 3 months after stopping it. There is a potential for serious harm to an unborn child. Talk to your care team for more information. Do not breast-feed an infant while taking this medication and for 1 month after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching or hives, swelling of the face, lips, or tongue
• Cough
• Diarrhea
• Dizziness
• Fast heartbeat
• Infection—fever, chills, cough, sore throat, pain or trouble passing urine
• Liver injury—dark yellow or brown urine, general ill feeling or flu-like symptoms, loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Trouble breathing
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Nausea
• Tiredness
• Trouble sleeping
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 30 degrees C (68 and 86 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.