Sprycel

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Sprycel


Generic Name: Dasatinib Tablets (da-SA-ti-nib)
Brand Name: Sprycel

Sprycel is used for:

Treating certain types of leukemia that do not respond to imatinib or other therapy.

Sprycel is a tyrosine kinase inhibitor. It works by blocking proteins that cause the rapid growth of certain types of leukemia cells. This helps the bone marrow to start making normal blood cells again.

Do NOT use Sprycel if:

  • you are allergic to any ingredient in Sprycel
  • you are pregnant or planning to become pregnant
  • you have not previously taken imatinib
  • you are taking an H2 blocker (eg, famotidine), a proton pump inhibitor (eg, omeprazole), or St. John"s wort

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sprycel :

Some medical conditions may interact with Sprycel . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, other substances
  • if you are lactose intolerant or have blood problems (eg, anemia, low blood potassium or magnesium levels, low platelet levels, low white blood cell levels)
  • if you have a history of liver problems, heart problems, or irregular heartbeat (eg, prolonged QT interval)

Some MEDICINES MAY INTERACT with Sprycel . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin, heparin), antiplatelet medicines (eg, clopidogrel), or aspirin because the risk of bleeding problems may be increased
  • Anthracycline, antiarrhythmics (eg, amiodarone, quinidine), azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin, clarithromycin), nefazodone, HIV protease inhibitors (eg, ritonavir), or telithromycin because they may increase the risk of Sprycel "s side effects
  • Carbamazepine, dexamethasone, H2 blockers (eg, famotidine), phenobarbital, phenytoin, proton pump inhibitors (eg, omeprazole), rifampicin, rifampin, or St. John s wort because they may decrease Sprycel "s effectiveness
  • Alfentanil, astemizole, cisapride, cyclosporine, ergot derivatives (eg, ergotamine), fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or terfenadine because the risk of their side effects may be increased by Sprycel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sprycel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sprycel :

Use Sprycel as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Sprycel . Talk to your pharmacist if you have questions about this information.
  • Sprycel may be taken with or without food.
  • Swallow Sprycel whole. Do not break, crush, or chew before swallowing.
  • Do not take an antacid within 2 hours before or 2 hours after you take Sprycel .
  • Take Sprycel at the same time each day.
  • Do not change your dose or stop taking Sprycel without first talking with your doctor.
  • If you miss a dose of Sprycel , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Sprycel .

Important safety information:

  • Sprycel may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Sprycel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Women who may become pregnant should use effective birth control while taking Sprycel . Check with your doctor if you have questions about using birth control.
  • Men who take Sprycel should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Sprycel .
  • Women who are pregnant should avoid exposure to Sprycel if the tablet is accidentally crushed or broken.
  • If you experience nausea, vomiting, diarrhea, or loss of appetite, talk with your doctor about ways to lessen these effects.
  • Sprycel may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Sprycel may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Sprycel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sprycel . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Tell your doctor or dentist that you take Sprycel before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver and kidney function, blood electrolytes, and blood counts, may be performed while you use Sprycel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Sprycel should be used with extreme caution in CHILDREN younger than 18 years of age; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Sprycel if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Sprycel is found in breast milk. Do not breast-feed while taking Sprycel .

Possible side effects of Sprycel :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; breast enlargement; constipation; diarrhea; dizziness; drowsiness; fatigue; hair loss; headache; joint or muscle pain; loss of appetite; nausea; stomach pain; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit; change in the amount of urine; chest pain; confusion; depression; dry cough; fainting; irregular heartbeat; irritation or sores in the mouth; mood or mental changes; red, swollen, or blistered skin; ringing in the ears; seizures; severe or persistent diarrhea; shortness of breath; signs of bleeding in the brain (eg, slurred speech, one-sided weakness, muscle weakness, loss of consciousness); signs of infection (eg, fever, chills, sore throat); unusual bruising or bleeding; unusual numbness or tingling; unusual swelling or weight gain; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Sprycel :

Store Sprycel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sprycel out of the reach of children and away from pets.

General information:

  • If you have any questions about Sprycel , please talk with your doctor, pharmacist, or other health care provider.
  • Sprycel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sprycel . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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