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Patient Information Sheet
Dasatinib (marketed as Sprycel)
PDF Print Version
This is a summary of the most important information about Sprycel. For details, talk to
your healthcare professional.
What Is Sprycel?
Sprycel is a prescription medicine used to treat adults who:
- have chronic myeloid leukemia (CML)
- have acute lymphoblastic leukemia (ALL) called Philadelphia
chromosome positive or Ph+ALL
- are no longer benefiting from treatment with the current available therapies for
these diseases including a medicine called Gleevec (imatinib mesylate)
- experience severe side effects from Gleevec and are no longer able to take it
The long term benefits and toxicities are
currently still being studied.
Sprycel has not been studied in children.
Who Should Not Take Sprycel?
You should not take Sprycel if you:
- have not previously had a trial of Gleevec (imatinib mesylate)
- are pregnant or planning to become pregnant
What Are The Side Effects?
The following are the major side effects of Sprycel therapy. However, this list is not complete.
- Low Blood Counts. Sprycel may
cause low red blood cell counts (anemia), low white blood cell
counts (neutropenia), and low platelet counts (thrombocytopenia).
Your healthcare professional will monitor your blood counts
frequently after your start Sprycel, and may adjust your dose of
Sprycel or withhold the drug temporarily in the event your blood
counts drop too low. In some cases, you may need to receive
transfusions of red blood cells or platelets. Notify your
healthcare professional immediately if you develop a fever while
taking Sprycel.
- Bleeding: Sprycel may cause bleeding. The most serious
bleeding events observed in clinical studies included bleeding
into the brain leading to death in 1% of patients, and bleeding
from the gastrointestinal tract. Less
severe events included bleeding from the nose, the gums, bruising
of the skin, and excessive menstrual
bleeding. Notify your healthcare professional immediately if
you experience bleeding or easy bruising while taking Sprycel.
- Fluid Retention: Sprycel may cause fluid to accumulate in
your legs and around your eyes. In more severe cases, fluid may
accumulate in the lining of your lungs, the sac around your heart,
or your abdominal cavity. Notify your healthcare professional immediately if you experience swelling, weight
gain, or increasing shortness of breath while taking Sprycel.
- Some common side effects that may occur with Sprycel
include:
- diarrhea
- skin rash
- headache
- fatigue
- nausea
What Should I Tell My Healthcare Professional?
Before you start taking Sprycel, tell your healthcare professional if you:
- are pregnant or planning to become pregnant.
Sprycel may harm the fetus when given to a pregnant woman. Women should avoid becoming
pregnant while undergoing treatment with Sprycel. Tell your
healthcare professional immediately if you become pregnant or
plant to become pregnant while taking Sprycel.
- are breast-feeding.
It is not known if Sprycel can pass into your breast milk or if it
can harm your baby. Do not breast-feed if you are taking Sprycel.
- are a sexually active male.
Men who take Sprycel are advised to use a condom to avoid pregnancy in their partner.
- have a liver or heart problem.
- are lactose intolerant.
Can Other Medicines Or Food Affect Sprycel?
Sprycel and certain other medicines can interact with each other. Tell your
healthcare professional about all the medicines you take including
prescription and non-prescription medicines, vitamins, and herbal
supplements. Know the medicines you take. Keep a list of them with
you to show your healthcare professional.
Sprycel is eliminated
from your body through the liver. The use of certain other medicines
may alter the levels of Sprycel in your bloodstream. Likewise,
levels of other medicines in your bloodstream can be affected by
Sprycel. Such changes can increase the side effects, or reduce the
activity of the medicines you are taking, including Sprycel.
Especially tell your healthcare professional 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),
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 (rifampicin), and Luminal (Phenobarbital).
- medicines whose
blood levels might be altered by Sprycel, such as Sandimmune
(cyclosporine), Alfenta (alfentanil), fentanyl, Orap (pimozide),
Rapamune (sirolimus), Prograf (tacrolimus), and Ergomar
(ergotamine).
- medicines that
reduce stomach acid, such as Tagamet (cimetidine), Pepcid (famotidine),
Zantac (ranitidine), Prilosec (omeprazole), Protonix (pantoprazole),
Nexium (esomeprazole), Aciphex (rabeprazole), and Prevacid (lansoprazole).
- medicines that
neutralize stomach acid, such as Maalox (aluminum
hydroxide/magnesium hydroxide), Tums (calcium carbonate), Rolaids
(calcium carbonate and magnesia.
- medicines that thin
the blood, such as Coumadin (warfarin sodium) and aspirin.
How Should I Take Sprycel?
- The usual dose is 70 mg (one 70-mg
tablet) twice daily, once in the morning and once in the evening,
with or without a meal. Try to take Sprycel at the same time each
day.
- Take Sprycel whole. Do not break, cut,
or crush the tablets.
- Depending on your
response to treatment and any side effects that you may
experience, your healthcare professional
may adjust your dose of Sprycel upward or downward, or may
temporarily discontinue Sprycel.
- You should not change your dose or stop taking Sprycel
without first talking with your healthcare professional.
- 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. Call your
healthcare professional or pharmacist if you are not sure what to
do.
- If you accidentally
take more than the prescribed dose of Sprycel, call your
healthcare professional right away.
Regulatory history and labeling available through Drugs@FDA
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Date created: June 28, 2006
Date updated: August 15, 2006 |
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