Dasatinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain kinds of leukemia. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• 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); kinase inhibitor

Generic and brand names: dasatinib, oral; Sprycel

What is this medicine used for?

This medicine is taken by mouth to treat chronic myeloid leukemia (CML), a cancer of the bone marrow. It may also be used to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

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 or to lactose
• Bleeding problems or blood disorders such as anemia (low red blood cells) or thrombocytopenia (low platelet cells)
• Edema (fluid buildup)
• Heart attack, heart failure, or other heart problems
• Liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Low levels of potassium or magnesium in your blood

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. 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.

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. Women who are pregnant should not handle crushed or broken tablets.

Treatment will be continued for as long as you continue to benefit and can tolerate the side effects.

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: unusual bruising or bleeding.

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.

This medicine can cause fluid buildup (edema) or high blood pressure in the arteries of the lungs. If you notice shortness of breath, unusual tiredness, swelling of your hands or feet, around your eyes, or any unexplained swelling, contact your healthcare provider right away.

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 or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Tell your healthcare provider if you have any signs of infection such as a fever, cough, or sore throat, or any unusual bruising or bleeding. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

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); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe stomach pain, severe diarrhea, unexplained swelling, unusual bruising or bleeding, fever, cough, sore throat, shortness of breath, severe confusion, unusual tiredness or weakness, rash or peeling skin, severe dizziness or fainting, chest pain, fast or irregular heartbeat, severe muscle pain.

Other: Nausea, vomiting, mild diarrhea, tiredness, night sweats, increased sweating, itching, rash, 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:

• Acetaminophen and medicines that contain acetaminophen
• Alfuzosin (Uroxatral)
• Anagrelide (Agrylin)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gatifloxacin (Zymaxid), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), nafcillin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), lithium (Lithobid), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Aspirin and other salicylates
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), degarelix (Firmagon), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), and simvastatin (Zocor)
• Conivaptan (Vaprisol)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), pantoprazole (Protonix), and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and vilanterol (Breo Ellipta)
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), apixaban (Eliquis), argatroban, bivalirudin (Angiomax), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), lepirudin (Refludan), rivaroxaban (Xarelto), tirofiban (Aggrastat), and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), granisetron (Sancuso), ondansetron (Zofran), and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze) and methadone (Dolophine, Methadose)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• St. John's wort
• Tetrabenazine (Xenazine)
• Vaccines

Do not drink alcohol while you are taking this medicine.

The effects of this medicine may be increased if you take it with grapefruit juice. Talk with your healthcare provider 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.