INDICATIONS AND USAGE

SPRYCEL® (dasatinib) is a prescription medicine used to treat:

  • adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including GLEEVEC® (imatinib mesylate)
  • adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment
  • children with Ph+ CML in chronic phase

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I've Got Study Data

Has SPRYCEL® (dasatinib)
been studied in adults in clinical trials?

Your doctor has chosen SPRYCEL because he or she believes it is the right treatment for you.

SPRYCEL is approved for use in newly diagnosed adult patients with Ph+ CML in chronic phase based on a head-to-head clinical trial of SPRYCEL compared to imatinib.

How many patients
have
been treated with SPRYCEL?

Since its introduction in 2006, more than
20,000 adult patients have been treated
with SPRYCEL.*

*SPRYCEL received initial approval in June 2006 for treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including imatinib; the effectiveness of SPRYCEL was based on treatment response that was seen in both the blood and bone marrow. SPRYCEL also received approval at that time for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

How was SPRYCEL studied?

SPRYCEL was studied in people who were newly diagnosed with Ph+ CML in chronic phase—in direct comparison with another TKI called imatinib.

Image of numbers from the trial – 519 adults in the trial, 259 patients on SPRYCEL and 260 patients on imatinib. Image of numbers from the trial – 519 adults in the trial, 259 patients on SPRYCEL and 260 patients on imatinib.

The main goal of the trial was to see the effect of SPRYCEL and imatinib on cCCyR by one year.
Another goal of the study was to measure MMR.

  • Confirmed Complete Cytogenetic Response (cCCyR)

    A cytogenetic response can occur in the bone marrow, as well as in the blood. A confirmed Complete Cytogenetic Response means that there were no signs of bad cells in 2 bone marrow tests.
  • Major Molecular Response (MMR)

    This is a very sensitive test that can detect other bad cells in the bone marrow. A Major Molecular Response means that the amount of BCR-ABL protein is very low.

More people who took SPRYCEL achieved both a confirmed CCyR and MMR than people who took imatinib.

cCCyR*
by 1 Year

Image of multiple silhouettes of people's heads talking.Image of multiple silhouettes of people's heads talking.

MMR
at 1 Year

Image of multiple silhouettes of people's heads talking.Image of multiple silhouettes of people's heads talking.
Bleeding problems icon

*A confirmed Complete Cytogenetic Response (cCCyR) means that there were no signs of bad cells in 2 bone marrow tests.

A Major Molecular Response (MMR) means that the amount of BCR-ABL protein is very low.

Results showed that more people who took SPRYCEL were able to achieve a confirmed CCyR and MMR at the end of the 5-year study.

cCCyR*
by Year 5

Image of multiple silhouettes of people's heads talking.Image of multiple silhouettes of people's heads talking.

MMR
at Year 5

Image of multiple silhouettes of people's heads talking.Image of multiple silhouettes of people's heads talking.
Bleeding problems icon

*A confirmed Complete Cytogenetic Response (cCCyR) means that there were no signs of bad cells in 2 bone marrow tests.

A Major Molecular Response (MMR) means that the amount of BCR-ABL protein is very low.

Did SPRYCEL help patients achieve cCCyR earlier than 1 year?

The main goal of the study was to achieve cCCyR by 1 year.

Patients were followed up after 5 years for patients who achieved CCyR. For those patients who achieved a cCCyR, the median time to cCCyR was 3.1 months for those who took SPRYCEL, and 5.8 months for those who took imatinib.

Bleeding problems icon

Median means the middle of the different times to this response.

What are the side effects?

What are the side effects?

Medications like SPRYCEL can cause side effects, or undesired effects that people may experience. For instance, people may experience diarrhea, cramping, or fatigue—it can vary from person to person. Be sure to tell your doctor if you think you’re having a side effect with SPRYCEL.

Try to talk to your doctor soon, even if the side effect is minor. Your doctor may be able to help.

Bleeding problems icon

Side effects reported in at least 10% of newly-diagnosed adult patients taking SPRYCEL or imatinib

*A side effect of special interest that was reported in less than 10% of patients.

Be sure to tell your doctor if you think you’re having a side effect with SPRYCEL. Your doctor will perform routine blood tests to see how you are doing while on SPRYCEL. This is a chart of serious abnormal test results from this trial of adult patients.

Bleeding problems icon

Serious abnormal test results

Talk to your doctor if you have any side effects. Don’t wait until your symptoms get worse.

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SPRYCEL® (dasatinib) SELECTED IMPORTANT SAFETY INFORMATION FOR PATIENTS

SPRYCEL may cause serious side effects, including low blood cell counts, bleeding problems, fluid retention, heart problems, pulmonary arterial hypertension, severe skin reactions, tumor lysis syndrome, and slowing of growth and development in children. Side effects of SPRYCEL that are considered most common in adults include: diarrhea, headache, skin rash, shortness of breath, tiredness, nausea, and muscle pain. Side effects of SPRYCEL that are considered most common in children include: headache, nausea, pain in hands or feet (extremities), diarrhea, skin rash, and stomach (abdomen) pain. This is not a complete list of all side effects 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.

 
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Important Facts About SPRYCEL® (dasatinib)

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.

Look out for the following
icons as you read:
Talk to your
healthcare provider
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provider right away
Helpful information
to remember

What is SPRYCEL?

SPRYCEL® (dasatinib) is a prescription medicine used to treat:

  • Adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP)
  • Adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including GLEEVEC® (imatinib mesylate)
  • Adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment
  • Children with Ph+ CML in chronic phase

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 should I discuss with my healthcare provider before starting SPRYCEL?

Talk to your healthcare provider about all of your medical conditions, including if you have any of these medical conditions:
  • problems with your
    immune system
  • heart problems, including a
    condition called congenital
    long QT syndrome
  • low potassium or low
    magnesium levels in your blood
  • lactose (milk sugar) intolerance
  • problems with your immune system
  • heart problems, including a condition called congenital long QT syndrome
  • low potassium or low magnesium levels in your blood
  • lactose (milk sugar) intolerance
Tell your healthcare provider if you are:
  • Pregnant or plan to become pregnant. SPRYCEL® (dasatinib) can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 30 days after your final dose of SPRYCEL. If you become pregnant or think you may be pregnant during treatment with SPRYCEL, talk to your healthcare provider right away.
  • Breastfeeding or plan to breastfeed. It is not known if SPRYCEL passes into your breast milk. You should not breastfeed during treatment and for 2 weeks after your final dose of SPRYCEL.
Females who are pregnant should not handle crushed or broken SPRYCEL tablets.

Tell your healthcare provider about all the medicines you take, including:

  • prescription and
    over-the-counter medicines
  • vitamins
  • herbal supplements
  • antacids

If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of SPRYCEL.

 

SPRYCEL may interact with other medicines you are taking. This can change the relative effectiveness of SPRYCEL, or cause unwanted side effects.

During treatment with SPRYCEL, make sure you also talk to your healthcare provider before you begin to take anything new. Your healthcare provider can help identify any potential interactions and help find alternatives.

Tell your healthcare provider about all the medicines you take, including:
  • prescription and over-the-counter
    medicines
  • vitamins
  • antacids
  • herbal supplements

If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of SPRYCEL.

 

SPRYCEL may interact with other medicines you are taking. This can change the relative effectiveness of SPRYCEL, or cause unwanted side effects.

During treatment with SPRYCEL, make sure you also talk to your healthcare provider before you begin to take anything new. Your healthcare provider can help identify any potential interactions and help find alternatives.


How should SPRYCEL be taken?

Take SPRYCEL exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose of SPRYCEL or temporarily stop treatment with SPRYCEL. Do not change your dose or stop taking SPRYCEL without first talking to your healthcare provider.
  • Do take SPRYCEL one (1) time a day
  • Do take SPRYCEL with or without food, either in the morning or in the evening, at the same time each day*
  • Do swallow SPRYCEL tablets whole with water

*Setting an alarm clock or calendar notification is a great way to remember to take medication.

  • Do not cut, crush, or chew the tablets
  • Do not drink grapefruit juice during treatment with SPRYCEL
  • Do not take St. John’s wort during treatment with SPRYCEL

*Setting an alarm clock or calendar notification is a great way to remember to take medication.

What if I miss a dose of SPRYCEL?

If you miss a dose of SPRYCEL, take your next scheduled dose at your regular time. Do not take two doses at the same time. Call your healthcare provider or your pharmacist if you are not sure what to do.

 

What if I take too much SPRYCEL?

Call your healthcare provider or go to the nearest hospital emergency room right away.

 


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
    • weight gain
  • 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
  • headache
  • tiredness
  • skin rash
  • nausea

The most common side effects of SPRYCEL in children include:

  • headache
  • pain in hands or feet
    (extremities)
  • skin rash
  • stomach (abdomen) pain
  • nausea
  • diarrhea
  • 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.


This document has summarized the most important safety information for SPRYCEL. For more in-depth safety information,
please read the Patient Information in the full Prescribing Information.

Information provided in this website is not a substitute for talking to your healthcare provider, who is your best source of information about your disease.

729US1502955-11-01 08/18

729US1502955-10-01 6/18

729US1502955-05-01 01/17

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