Glossary

Accelerated phase CML: the second phase of CML; leukemic cells grow more quickly and symptoms such as poor appetite, fever, and weight loss may occur

Anemia: see Red blood cells

BCR-ABL: an abnormal protein that causes out-of-control production of CML cells

Blast cells: immature white blood cells found in abnormally large numbers in CML patients

Blast phase CML: the final and most serious phase of CML; symptoms become more severe and are more difficult to treat

Bone marrow: the soft tissue inside bones that produces blood cells

Chromosome: a part of a cell that contains genes, the basic units that carry hereditary information. An individual chromosome can contain hundreds or thousands of genes

Chronic myeloid leukemia (CML): a slow-developing cancer of the blood in which the body produces uncontrolled numbers of abnormal blood cells

Chronic phase CML: the first phase of CML; it can last for months or years; most people are diagnosed with CML during this phase

Complete cytogenetic response (CCyR): when cells carrying the Philadelphia chromosome are undetectable

Confirmed CCyR (cCCyR): when cells carrying the Philadelphia chromosome are undetectable based on 2 consecutive measurements that are taken at least 28 days apart

Hematologic test: test that can detect the number of white blood cells, red blood cells, and platelets in the blood

Intolerance: when a person is unable to tolerate side effects caused by medication

Leukemia: several acute (progresses quickly) or chronic (takes a longer time to progress) diseases of the blood and bone marrow; characterized by an abnormal increase in blood cells

Major cytogenetic response (MCyR): when the percentage of cells carrying the Philadelphia chromosome is 0% to 35% (this combines both complete [0%] and partial [1% to 34%] responses)

Major molecular response (MMR): when testing reveals that the extent of the BCR-ABL found in the patient's blood is very small.

Musculoskeletal: referring to the muscles, tendons, ligaments, joints, or bones.

Neutropenia: see White blood cells

Philadelphia chromosome (or Ph chromosome): the chromosome abnormality that causes CML; pieces from 2 different chromosomes break off and fuse together to create this new abnormal chromosome

Platelets: blood cells that help stop bleeding. When platelet levels are lower than normal, it is called thrombocytopenia

Red blood cells: blood cells that carry oxygen to all parts of the body. When red blood cell levels are lower than normal, it is called anemia

Resistance: when cells are able to survive and grow, even when they are exposed to drugs that would normally kill them or limit their growth

Side effects: the undesired negative effects of a drug

Signs: abnormalities in the body that others can see

Symptoms: a signal of illness or disease in the body that you can feel or notice, but others may not easily see

Thrombocytopenia: see Platelets

White blood cells: blood cells that help fight infections. When the level of a certain type of white blood cell is lower than normal, it is called neutropenia

Important Safety Information about
SPRYCEL® (dasatinib)

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)
    Biaxin® (clarithromycin)
  • medicines that decrease the amount of SPRYCEL in your bloodstream, such as:
    • Decadron® (dexamethasone)
    Dilantin® (phenytoin)
    Tegretol® (carbamazepine)
    Rimactane® (rifampin)
    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)
    Ergomar® (ergotamine)

SPRYCEL® (dasatinib) 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)
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

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® (dasatinib) 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
  • 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.