This is a summary of important information that patients need to know about SPRYCEL. Your healthcare team can work with you to help answer any questions you may have about SPRYCEL.
Keep this document in a safe place, so you can refer to it before and during treatment.
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Example SPRYCEL tablet. Tablet is not actual size.
Tablets are white to off-white, with “BMS” appearing on one side. These letters may be followed by a number indicating the strength of the tablet, in milligrams. In addition, an identification number will be marked on the other side. Size and shape may vary by dose.
Tablets are taken by mouth.
What are the possible side effects of SPRYCEL® (dasatinib)?
Serious side effects
SPRYCEL may cause serious side effects, including those listed below.
Call your healthcare provider right away if you have any symptoms of the side effects below, or any other concerns about these side effects:
- Low blood cell counts: Low blood cell counts are common with SPRYCEL and can be severe, including 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 any of these symptoms during treatment with SPRYCEL:
- fever
- any signs of infection
- Low blood cell counts: Low blood cell counts are common with SPRYCEL and can be severe, including 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 any of these symptoms during treatment with SPRYCEL:
- fever
- any signs of infection
- Bleeding problems: Bleeding problems are common with SPRYCEL. Sometimes these bleeding problems can be serious and 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
- decreased alertness, headache,
or change in speech
- Bleeding problems: Bleeding problems are common with SPRYCEL. Sometimes these bleeding problems can be serious and 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
- decreased alertness, headache, or change in speech
- Your body may hold too much fluid (fluid retention): Fluid retention is common with SPRYCEL and can sometimes be severe. 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 have any of these symptoms during treatment with SPRYCEL:
- swelling all over your body
- shortness of breath,
especially if this happens with low
levels of physical activity or at rest
- dry cough
- chest pain when taking a deep breath
- Your body may hold too much fluid (fluid retention): Fluid retention is common with SPRYCEL and can sometimes be severe. 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 have any of these symptoms during treatment with SPRYCEL:
- swelling all over your body
- weight gain
- shortness of breath, especially if this happens with low levels of physical activity or at rest
- dry cough
- chest pain when taking a deep breath
- Heart problems: SPRYCEL may cause an abnormal heart rate, heart problems, or a heart attack. Your healthcare provider will monitor the potassium and magnesium levels in your blood, and your heart function
- Heart problems: SPRYCEL may cause an abnormal heart rate, heart problems, or a heart attack. 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 any of these symptoms:
- shortness of breath
- tiredness
- swelling all over your body
(fluid retention)
- 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 any of these symptoms:
- shortness of breath
- tiredness
- swelling all over your body (fluid retention)
- Severe skin reactions: SPRYCEL may cause skin reactions that can sometimes be severe. Get medical help right away if you have any of these symptoms:
- skin reaction with fever
- sore mouth or throat
- blistering or peeling of your
skin or in the mouth
- Severe skin reactions: SPRYCEL may cause skin reactions that can sometimes be severe. Get medical help right away if you have any of these symptoms:
- skin reaction with fever
- sore mouth or throat
- blistering or peeling of your skin or in the mouth
- Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause kidney failure and an abnormal heartbeat. Kidney failure may require the need for dialysis treatment. Your healthcare provider may do blood tests to check you for TLS
- Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause kidney failure and an abnormal heartbeat. Kidney failure may require the need for dialysis treatment. Your healthcare provider may do blood tests to check you for TLS
- Slowing of growth and development in children: Effects on bone growth and development in children with chronic phase CML have happened with SPRYCEL and can sometimes be severe
- Slowing of growth and development in children: Effects on bone growth and development in children with chronic phase CML have happened with SPRYCEL and can sometimes be severe
Most common side effects
The most common side effects of SPRYCEL® (dasatinib) in adults include:
- diarrhea
- shortness of breath
- muscle pain
The most common side effects of SPRYCEL in children include:
- headache
- pain in hands or feet
(extremities)
- skin rash
- stomach (abdomen) pain
- diarrhea
- headache
- skin rash
- shortness of breath
- tiredness
- nausea
- muscle pain
The most common side effects of SPRYCEL in children include:
- headache
- nausea
- pain in hands or feet (extremities)
- diarrhea
- skin rash
- stomach (abdomen) pain
SPRYCEL may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of SPRYCEL. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your healthcare provider for medical advice about side effects.
You may report side effects to the FDA by calling 1-800-FDA-1088.
How do I store SPRYCEL?
SPRYCEL tablets should be stored at room temperature between 68°F to 77°F (20°C to 25°C).
Ask your healthcare provider or pharmacist about the right way to throw away outdated or unused SPRYCEL.
Wear latex or nitrile gloves when handling tablets that have accidentally been crushed or broken.
Females who are pregnant should not handle crushed or broken SPRYCEL tablets.
Keep SPRYCEL and all medicines out of the reach of children.
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