Sprycel - Dasatinib Tablets

What is this medication?

DASATINIB (da SA ti nib) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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:

• Heart disease
• Immune system problems
• Irregular heartbeat or rhythm
• Liver disease
• Low levels of magnesium or potassium in the blood
• An unusual or allergic reaction to dasatinib, lactose, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Take products with aluminum or magnesium in them at a different time of day than this medication. Take antacids 2 hours BEFORE or 2 hours AFTER this medication.

Do not take this medication with grapefruit juice.

Handling this medication may be harmful. Wear gloves while touching the medication. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year 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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronaderone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Pimozide
• Posaconazole
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Antacids, vitamins, or other products that contain aluminum or magnesium
• Other medications that cause heart rhythm changes
• Stomach acid blockers, such as famotidine, omeprazole
• Supplements, such as St. John's wort

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work while taking this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

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

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 30 days after stopping therapy. A reliable form of contraception is recommended while taking this medication and for 30 days after stopping therapy. Talk to your care team about effective forms of contraception. Do not breast-feed while taking this medication and for 2 weeks after stopping therapy.

If you are pregnant or may get pregnant, do not handle broken or crushed tablets of this medication. If you are pregnant and come into contact with broken or crushed tablets, contact your care team. Exposure to whole tablets is not expected to cause harm as long as they are not swallowed.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pulmonary arterial hypertension (PAH)—shortness of breath, unusual weakness or fatigue, swelling of the ankles, hands, or feet, dizziness, feeling faint or lightheaded, chest pain, fast or irregular heartbeat, blue skin or lips
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

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

• Diarrhea
• Fatigue
• Headache
• Joint pain
• Muscle pain
• Nausea
• Skin rash

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.