Ibrutinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström’s macroglobulinemia. 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 may cause unwanted 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); chemotherapy

Generic and brand names: ibrutinib, oral; Imbruvica

What is this medicine used for?

This medicine is taken by mouth to treat:

• Chronic lymphocytic leukemia (CLL)
• Mantle cell lymphoma (MCL)
• Waldenström’s macroglobulinemia

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
• Bleeding problems
• Heart disease or an irregular heartbeat
• Liver or kidney problems

Also, tell your healthcare provider if you have recently had surgery or are scheduled to have surgery.

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. Do not become pregnant during treatment with this medicine. Talk with your healthcare provider about effective birth control methods. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine without your healthcare provider’s approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it for longer than prescribed. Taking too much increases the risk of serious side effects. Do not stop taking this medicine without your healthcare provider's approval.

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

Take this medicine 1 time per day at about the same time each day. Swallow the capsules whole with a full glass of water. Do not open, chew, or crush the capsules.

What if I miss a dose?

If you miss a dose, take it as soon as you remember on the same day. If you do not remember until the next day, skip the missed dose and take the next one as directed. 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 may include: severe diarrhea, nausea, vomiting, weakness, dizziness, headache, stomach pain.

What should I watch out for?

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

To help prevent kidney problems, your provider may suggest that you drink extra liquids while you taking this medicine. Talk with your provider about this.

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

This medicine may cause a serious problem called tumor lysis syndrome. Tumor lysis syndrome is caused by a fast breakdown of cancer cells. Talk with your healthcare provider about this.

This medicine may cause other types of cancer, including skin cancer. Talk with your 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; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): New or worsening shortness of breath; cough; chest pain; fever; severe or continued diarrhea; severe nausea or vomiting; unusual bruising or bleeding; bloody or black, tarry bowel movements; vomiting blood or vomit looks like coffee grounds; coughing up blood; yellowing of your skin or eyes; light-colored bowel movements; pink, brown, or dark urine; severe stomach pain; skin peeling or blistering; confusion; trouble talking; severe or continued headache; unusual dizziness, tiredness or weakness; decreased or problems urinating; unexplained swelling of the legs or feet.

Other: Diarrhea; constipation; loss of appetite; nausea; vomiting; mild rash; stomach pain; muscle or joint pain.

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:

• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), nefazodone, sertraline (Zoloft), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as haloperidol (Haldol) and iloperidone (Fanapt)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Aspirin and other salicylates
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), crizotinib (Xalkori), enzalutamide (Xtandi), imatinib (Gleevec), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• 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), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Live vaccines
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• St. John’s wort

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

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 in the original container 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.