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.