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Resistance and Intolerance in Chronic Myeloid Leukemia (CML) Treatment

If you’re like most people diagnosed with chronic myeloid leukemia (CML)  Chronic myeloid leukemia (CML): a slow-developing cancer of the blood in which the body produces uncontrolled numbers of abnormal blood cells  , your healthcare provider started treating you with Gleevec.

Gleevec works for many people with CML, but not everyone may have the same response.

Some people taking Gleevec may develop resistance  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  , or have certain side effects  Side effects: the undesired, usually negative, effects of a drug  that may lead to intolerance  Intolerance: when a person is unable to tolerate side effects caused by medication  .

What Is Resistance?

Sometimes cells that would normally be killed or slowed down by a certain drug actually survive and grow instead. This is called resistance. Resistance can happen when your disease does not respond to a drug from the beginning, or when your disease stops responding to your treatment over time.

If your doctor determines your CML is resistant to Gleevec, SPRYCEL® (dasatinib) may be an option for you.

What Is Intolerance?

Intolerance is the inability to tolerate a medication or its side effects.

Side effects from cancer medications are common, and in many cases they can be managed by your healthcare provider. Although it’s not common, some people have to stop taking a drug because of very bothersome or severe side effects.

Talk With Your Doctor

If your doctor decides you should stop taking Gleevec because of resistance or intolerance, SPRYCEL may be an option for you.

 

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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 can harm your unborn baby. Sexually
    active female patients of childbearing potential
    taking SPRYCEL should
    avoid pregnancy. 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-10881-800-FDA-1088.

Please read the Patient Information in the full Prescribing Information.

More Important Safety Information

 

SPRYCEL® (dasatinib) SELECTED IMPORTANT SAFETY
INFORMATION FOR PATIENTS

SPRYCEL may cause serious side effects, including low
blood cell counts, bleeding, fluid retention, heart problems, and pulmonary arterial
hypertension. Other common side effects of SPRYCEL include diarrhea, headache, cough, skin rash, fever, nausea, tiredness, vomiting, muscle pain,
weakness, and infections. This is not a complete list of all side effects recorded in clinical studies with SPRYCEL. Tell your healthcare provider if you
have any side effects while taking SPRYCEL.

Please read more information about potential side effects with SPRYCEL below.