Imatinib Mesylate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain kinds of tumors, cancer, and blood marrow problems. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with many other medicines. 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); kinase inhibitor

Generic and brand names: imatinib mesylate, oral; Gleevec

What is this medicine used for?

This medicine is taken by mouth to treat:

• Acute lymphoblastic leukemia (ALL)
• Aggressive systemic mastocytosis (ASM)
• Chronic eosinophilic leukemia (CEL)
• Chronic myeloid leukemia (CML)
• Dermatofibrosarcoma protuberans (DFSP)
• Hypereosinophilic syndrome (HES)
• Myelodysplastic syndrome (MDS)
• Myeloproliferative disease (MPD)
• Metastatic malignant gastrointestinal stromal tumors (GIST)

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
• Any other blood disorder such as anemia or bleeding problems
• Edema (fluid buildup)
• Heart problems such as heart failure
• Kidney or liver disease
• Stomach problems or ulcers
• Thyroid 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. Do not become pregnant during treatment with this medicine. Use an effective birth control method while you are taking this medicine and for 14 days after you stop treatment. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Depending on your condition, your healthcare provider may adjust your daily dosage. Follow your healthcare provider's directions exactly. Treatment will be continued 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 1 year.

Take this medicine with a meal and a large glass of water. Do not crush or chew the tablets. Swallow them whole. Be careful not to touch crushed or broken tablets. If you accidentally touch a crushed or broken tablet, wash your skin with soap and water right away.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, 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: nausea, vomiting, diarrhea, rash, swelling, severe muscle cramps, unusual bruising or bleeding, headache, tiredness, stomach pain.

What should I watch out for?

This medicine can cause fluid buildup (edema) in your body. If you notice swelling of your hands or feet, around your eyes, or any unexplained swelling or rapid weight gain, contact your healthcare provider. Talk with your healthcare provider about this.

This medicine may cause blurred vision, dizziness, or drowsiness. Do not drive or operate machinery unless you are fully alert.

It is possible that this medicine may slightly limit growth in children. Talk to your healthcare provider about this.

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

You may bleed more easily or 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, rapid weight gain or any unexplained swelling, unusual bruising or bleeding, bloody or black tarry bowel movements, fever, cough, sore throat, unusual tiredness or weakness, yellowing of your skin or eyes, light-colored bowel movements, dark urine, severe nausea or vomiting, severe skin redness or rash, skin peeling or blisters, chest pain, fast or irregular heartbeat, severe dizziness or fainting, decreased urination, numbness or tingling in hands or feet, severe headache, vision changes, depression.

Other: Nausea, vomiting, diarrhea, constipation, tiredness, rash, hair loss, mild stomach pain, night sweats, joint or muscle pain, headache, trouble sleeping, dizziness, hoarseness, change in sense of taste.

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:

• Acetaminophen and medicines that contain acetaminophen
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), and diazepam (Valium)
• Antibiotics such as azithromycin (Zithromax, Zmax), 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), mirtazapine (Remeron), nefazodone, and vilazodone (Viibryd)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), clozapine (Clozaril, FazaClo), haloperidol (Haldol), lurasidone (Latuda), pimozide (Orap), and quetiapine (Seroquel)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Beta blockers such as bisoprolol (Zebeta), carvedilol (Coreg), and metoprolol (Lopressor, Toprol)
• 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 abiraterone (Zytiga), axitinib (Inlyta), bosutinib (Bosulif), cabozantinib (Cometriq), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), ibrutinib (Imbruvica), idelalisib (Zydelig), mitotane (Lysodren), olaparib (Lynparza), pazopanib (Votrient), and topotecan (Hycamtin)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Conivaptan (Vaprisol)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris), dexamethasone, and fluticasone (Flonase, Flovent, Veramyst)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Everolimus (Afinitor, Zortress)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), isosorbide (Dilatrate, Isordil, Monoket), propafenone (Rythmol), quinidine, and ranolazine (Ranexa)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), pimecrolimus (Elidel), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Iron supplements or multivitamins that contain iron, and iron medicines such as ferric carboxymaltose (Injectafer), ferric gluconate (Ferrlecit), ferumoxytol (Feraheme), and iron sucrose (Venofer)
• Ivacaftor (Kalydeco)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), dipyridamole (Persantine), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Narcotic pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), and oxycodone (OxyContin, Roxicodone)
• Natalizumab (Tysabri)
• Natural remedies such as ginseng and St. John’s wort
• Propranolol (Hemangeol, Inderal, InnoPran)
• Roflumilast (Daliresp)
• Salmeterol (Serevent)
• Simeprevir (Olysio)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tofacitinib (Xeljanz)
• Vaccines

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

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 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.