SPRYCEL® (dasatinib) IMPORTANT SAFETY INFORMATION FOR PATIENTS

It is not known if SPRYCEL is safe and effective in children younger than 18 years old.

Before you take SPRYCEL, tell your healthcare provider if you:

  • have problems with your immune system
  • have liver problems
  • have heart problems
  • are lactose intolerant
  • have any other medical conditions
  • are pregnant or planning to become pregnant. SPRYCEL may harm your unborn baby. Women should not become pregnant while taking SPRYCEL.
    Talk to your healthcare provider right away if you are pregnant or plan to become pregnant
  • are breast-feeding or plan to breast-feed. It is not known if SPRYCEL passes into your breast milk or if it can harm your baby. You and your healthcare
    provider should decide if you will take SPRYCEL or breast-feed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, antacids,
and herbal supplements.

Especially tell your healthcare provider if you take:

  • medicines that increase the amount of SPRYCEL in your bloodstream, such as: Nizoral® (ketoconazole), Sporanox® (itraconazole),
    Norvir® (ritonavir), Reyataz® (atazanavir sulfate), Crixivan® (indinavir), Viracept® (nelfinavir), Nefazodone (serzone®, nefadar),
    Invirase® (saquinavir), Ketek® (telithromycin), E-mycin® (erythromycin), and Biaxin® (clarithromycin).
  • medicines that decrease the amount of SPRYCEL in your bloodstream, such as: Decadron® (dexamethasone), Dilantin® (phenytoin),
    Tegretol® (carbamazepine), Rimactane® (rifampin), and Luminal® (phenobarbital).
  • medicines whose blood levels might change by taking SPRYCEL, such as: Sandimmune® (cyclosporine), Alfenta® (alfentanil),
    Fentanyl® (fentanyl), Orap® (pimozide), Rapamune® (sirolimus), Prograf® (tacrolimus), and Ergomar® (ergotamine).

SPRYCEL is best absorbed from your stomach into your bloodstream in the presence of stomach acid. You should avoid taking
medicines that reduce stomach acid, such as:
Tagamet® (cimetidine), Pepcid® (famotidine), Zantac® (ranitidine), Prilosec® (omeprazole),
Protonix® (pantoprazole sodium), Nexium® (esomeprazole), AcipHex® (rabeprazole), and Prevacid® (lansoprazole).

Medicines that neutralize stomach acid, such as Maalox® (aluminum hydroxide/magnesium hydroxide), Tums® (calcium carbonate), or
Rolaids® (calcium carbonate and magnesia), may be taken up to 2 hours before or 2 hours after SPRYCEL.

Since SPRYCEL therapy may cause bleeding, tell your healthcare provider if you are using blood thinner medicine, such as
Coumadin® (warfarin sodium) or aspirin.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Take SPRYCEL exactly as prescribed by your healthcare provider

  • Take SPRYCEL with or without food. Try to take SPRYCEL at the same time each day
  • Swallow SPRYCEL tablets whole with water. Do not break, cut, or crush the tablets
  • You should not drink grapefruit juice while taking SPRYCEL
  • If you miss a dose of SPRYCEL, take your next scheduled dose at its regular time. Do not take two doses at the same time

SPRYCEL may cause serious side effects, including:
  • Low Blood Cell Counts: SPRYCEL may cause low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet
    counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with
    SPRYCEL. Call your healthcare provider right away if you have a fever or any signs of an infection while taking SPRYCEL
  • Bleeding: SPRYCEL may cause severe bleeding that can lead to death. Call your healthcare provider right away if you have:
    • -    unusual bleeding or bruising of your skin
    • -    bright red or dark, tar-like stools
    • -    a decrease in your level of consciousness, headache, or change in speech
  • Your body may hold too much fluid (fluid retention): In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or
    your stomach cavity. Call your healthcare provider right away if you get any of these symptoms during treatment with SPRYCEL:
    • -    swelling all over your body
    • -    weight gain
    • -    shortness of breath and cough
  • Heart problems: SPRYCEL may cause an abnormal heart rate, heart problems, or a heart attack that can lead to death. Your healthcare provider
    will monitor the potassium and magnesium levels in your blood and your heart function
  • Pulmonary Arterial Hypertension (PAH): SPRYCEL may cause high blood pressure in the vessels of your lungs. PAH may happen at any
    time during your treatment with SPRYCEL. Your healthcare provider should check your heart and lungs before and during your treatment with
    SPRYCEL. Call your healthcare provider right away if you have shortness of breath, tiredness, or swelling all over your body (fluid retention)

Other common side effects of SPRYCEL therapy include: diarrhea, headache, cough, skin rash, fever, nausea, tiredness, vomiting, muscle pain,
weakness, and infections.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of
SPRYCEL. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read the Patient Information in the full Prescribing Information.