Dasatinib oral tablet

What is this medication?

DASATINIB (da SA ti nib) is a medicine that targets specific proteins in cancer cells and stops the cancer cells from growing. It is used to treat chronic myeloid leukemia and acute lymphoblastic leukemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sprycel

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding problems
• heart disease
• immune system problems
• irregular heartbeat
• low levels of magnesium or potassium in the blood
• an unusual or allergic reaction to dasatinib, lactose, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Do not take with grapefruit juice. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice. Avoid taking antacids containing aluminum, calcium, or magnesium within 2 hours of taking this medicine. You can take such antacids up to 2 hours before or 2 hours after this medicine. Avoid taking all other medicines that reduce stomach acid.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year old for selected conditions, precautions do apply.

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 your next scheduled dose at its regular time. Do not take double or extra doses. Talk to your doctor if you are not sure what to do.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• fluconazole
• pimozide
• posaconazole
• saquinavir
• thioridazine

This medicine may also interact with the following medications:

• acetaminophen
• alfentanil
• antiviral medicines for HIV or AIDS
• aspirin
• carbamazepine
• certain antibiotics like clarithromycin, erythromycin, rifampin, rifabutin, rifapentine, telithromycin, troleandomycin
• certain medicines for cholesterol like atorvastatin
• certain medicines for fungal infections like itraconazole, ketoconazole, voriconazole
• certain medicines for stomach problems like cimetidine, famotidine, ranitidine, omeprazole
• certain medicines that treat or prevent blood clots like warfarin
• cyclosporine
• dexamethasone
• dofetilide
• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
• fentanyl
• NSAIDS, medicines for pain and inflammation, like ibuprofen, ketoprofen, naproxen
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• phenobarbital
• phenytoin
• sirolimus
• St. John's Wort
• tacrolimus
• ziprasidone

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?

Visit your health care provider for regular check ups on your progress. It may be some time before you see the benefit from this medicine.

You may need blood work done while you are taking this medicine.

This medicine may increase your risk of getting an infection. Call your health care provider 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.

This medicine may increase your risk to bruise or bleed. Call your health care provider if you notice any unusual bleeding.

Height and weight growth of a child taking this medicine will be monitored closely.

Do not become pregnant while taking this medicine or for 30 days after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 30 days after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine and for 2 weeks after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• bone pain
• breast enlargement in both males and females
• dry cough
• fast, irregular heartbeat
• heart attack (trouble breathing; pain or tightness in the chest, neck, back, or arms; unusually weak or tired)
• infection (fever, chills, cough, sore throat, pain or difficulty passing urine)
• low red blood cell counts (feeling faint; lightheaded, falls; unusually weak or tired)
• muscle cramps
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• slow growth in children
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• swelling of the legs or ankles, or other parts of the body
• sudden weight gain

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

• constipation
• decreased appetite
• diarrhea
• headache
• muscle pain
• nausea
• stomach pain
• vomiting

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 at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine 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.