Idelalisib Tablets

What is this medication?

IDELALISIB (eye DEL a LIS ib) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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:

• History of cytomegalovirus (CMV) infection
• Infection
• Liver disease
• Lung disease
• An unusual or allergic reaction to idelalisib, other medications, foods, dyes, or preservative
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Keep taking it unless your care team tells you to stop.

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 care team about the use of this medication 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 the normal time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Conivaptan
• Eletriptan
• Eplerenone
• Flibanserin
• Isavuconazonium
• Ivabradine
• Lurasidone
• Naloxegol
• Simvastatin
• Tolvaptan
• Triazolam
• Ubrogepant

This medication may also interact with the following:

• Certain medications for anxiety, such as midazolam
• Certain medications for blood pressure, such as amlodipine, felodipine, nifedipine
• Certain medications for cholesterol, such as atorvastatin, lovastatin
• Certain medications for depression or mental health conditions
• Certain medications for erectile dysfunction
• Certain medications for fungal infections, such as ketoconazole
• Certain medications for heart disease or irregular heart beat
• Certain medications that prevent or treat blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban
• Ergot alkaloids, such as dihydroergotamine, ergotamine
• Opioid medications for pain
• Rifampin

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?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication 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. You may also 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.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 month after the last dose.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose.

Do not breastfeed while taking this medication and for 1 month after the last dose.

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, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Severe or prolonged diarrhea
• Stomach pain that is severe, does not go away, or gets worse
• Unusual bruising or bleeding

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

• Fatigue
• Loss of appetite
• Nausea
• Stomach pain
• Trouble sleeping

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 medication in the original container. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer wanted or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.