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 Information About Ph+ CML

Is Ph+ CML a treatable disease?

Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) may be a disease you’ve never heard of, but remember:
you are not alone.

You may want to know more about the disease and what you can do about it. There are medications available to help treat Ph+ CML. You can also count on the healthcare providers who are treating you.

Did you know?

About 70,000 people in the United States are living with Ph+ CML.

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

What happens in Ph+ CML?

Watch this short video to learn more about what happens in your body when you have Ph+ CML.

 

Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML, is a kind of leukemia or cancer of the blood.

To help understand Ph+ CML, let’s first take a closer look at the blood flowing through our bodies.

Our blood is made up of many types of cells. These blood cells are made in the bone marrow which is the spongy center of our bones. There are 3 main types of cells and each type has a job to do.

Red blood cells help carry oxygen throughout the body.

Platelets are blood cells that help control bleeding.

White blood cells help your body fight infection.

Your bone marrow makes a certain number of each type of cell called a ‘count.’

Ph+ CML is a kind of leukemia or cancer of the blood. It causes white blood cells to behave differently.

When you have Ph+ CML, an abnormal protein in the bone marrow called BCR-ABL triggers the production of too many immature or damaged white blood cells to be produced.

These damaged white blood cells do not work properly and can crowd out the normal white blood cells, red blood cells, and platelets.

The decrease in normal white blood cells, red blood cells, and platelets may lead to many of the signs and symptoms of CML.

Did you know?

The Philadelphia chromosome is an abnormal chromosome that contains the BCR-ABL gene which can lead to the overproduction of white blood cells.

How is CML treated?

Not too long ago, people with CML had few treatment options.

Then, a whole new kind of therapy was introduced in the early 2000s. It’s called tyrosine kinase inhibitors (TKIs). TKIs work by blocking the
abnormal BCR-ABL protein from producing more abnormal white blood cells. TKIs have helped many people manage their disease.

What Are Some Signs and
Symptoms of Ph+ CML?

Some people may experience one or more of these symptoms before being diagnosed with Ph+ CML:

Feeling very tired

Feeling very tired

Weight loss

Weight loss for no known reason

Pain

Pain or a feeling of fullness below your ribs on the left side

Night sweats

Night sweats

Fever

Most people are diagnosed in the earliest phase, known as the chronic phase chronic phase the first phase of CML; it can last for months or years; most people are diagnosed with CML during this phase  . Symptoms are milder or not noticeable in the chronic phase compared with later phases.

These are not all the symptoms of Ph+ CML. You may experience others. Talk to your doctor if you have any questions or concerns.

What Are the Phases of Ph+ CML?

Each phase of Ph+ CML is defined by the percentage of blast cells, which are an abnormal type of immature white blood cell, in the blood
and bone marrow.

Chronic Phase
  • Less than 10% of blood cells in the bone marrow sample are blast cells
  • Most patients are diagnosed in this phase; can last for months or years
Accelerated Phase
Blast Phase
  • At least 20% or more blood cells in the bone marrow sample are blast cells
  • This is the most serious phase of Ph+ CML; Ph+ CML is more aggressive in this phase

The immediate goal of treatment is to reduce the number of leukemia cells being produced in your body.

What kind of help and support are available?

The best resource to answer any of your CML-related questions is a specialized healthcare team. Your oncologist and their team members can help you. They will talk about the disease and its treatment, and set a schedule for regular follow-ups.

What kind of help and support are available?

The best resource to answer any of your CML-related questions is a specialized healthcare team. Your oncologist and their team members can help you. They will talk about the disease and its treatment, and set a schedule for regular follow-ups.

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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
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healthcare provider
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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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