Idelalisib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain kinds of leukemia or lymphoma. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine can cause serious or life-threatening side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: idelalisib, oral; Zydelig

What is this medicine used for?

This medicine is taken by mouth to treat:

• Relapsed chronic lymphocytic leukemia
• Relapsed follicular B-cell non-Hodgkin lymphoma
• Relapsed small lymphocytic lymphoma

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease
• Lung disease or breathing problems

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 1 month after treatment. Talk with your healthcare provider about effective birth control methods. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine as your healthcare provider prescribes. Depending on your condition, your healthcare provider may adjust your daily dosage. Follow your healthcare provider's directions exactly.

Do not stop taking this medicine without your healthcare provider's approval. Treatment will continue for as long as you continue to benefit and can tolerate the side effects.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals and with a large glass of water may lessen the chance the drug will upset your stomach.

Do not crush or chew the tablets. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 6 hours of the next dose. In that case, skip that dose and take the next regular dose. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine can cause serious or life-threatening side effects. If you have any of these side effects, contact your healthcare provider right away:

• Severe stomach pain, fever, nausea and vomiting
• Yellowing of your skin or eyes, dark urine, light-colored bowel movements, unusual bruising or bleeding
• Severe diarrhea or if the number of bowel movements you have in a day increases by 6 or more. Diarrhea is common with this medicine. Do not treat your diarrhea with other medicines unless your healthcare provider approves.
• Trouble breathing, wheezing, or a new or worsening cough

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe stomach pain; fever; nausea and vomiting; yellowing of your skin or eyes; dark urine; light-colored bowel movements; unusual bruising or bleeding; severe diarrhea; trouble breathing; wheezing; new or worsening cough; peeling or blistering skin rash; painful sores or ulcers on your skin, lips, or in your mouth.

Other: Nausea, vomiting, diarrhea, tiredness, night sweats, joint or muscle pain, headache, trouble sleeping, dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antacids that contain magnesium, such as Gaviscon, Maalox, Mylanta, and Phillips' Chewable Tablets
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), and diazepam (Valium)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide, dofetilide (Tikosyn), dronedarone (Multaq), mexiletine, propafenone (Rythmol), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), nafcillin (Nallpen), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd) and vortioxetine (Trintellix)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend) and fosaprepitant (Emend)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as ado-trastuzumab (Kadcyla), axitinib (Inlyta), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), enzalutamide (Xtandi), erlotinib (Tarceva), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Colchicine (Colcrys)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris), dexamethasone, fluticasone (Flonase, Flovent, Veramyst), methylprednisolone, prednisolone (Omnipred, Orapred, Prelone), and prednisone (Prednisone Intensol)
• Darifenacin (Enablex)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Everolimus (Afinitor, Zortress)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), tipranavir (Aptivus), and zidovudine (Retrovir)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic) and temsirolimus (Torisel)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as salmeterol (Serevent), theophylline, and zileuton (Zyflo)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer) and macitentan (Opsumit)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Ranolazine (Ranexa)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.