INDICATIONS AND USAGE

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

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

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Monitoring Philadelphia Chromosome-positive Chronic Myeloid Leukemia

Your healthcare provider may perform tests of your blood and bone marrow Bone marrow: the soft tissue inside bones that produces blood cells  at various time points after starting treatment. These tests may be scheduled at 3 months, 6 months, 12 months, and beyond. Your testing schedule (how often you will have tests performed in the future) will be determined by your healthcare provider.

What Tests Are Used To Evaluate and Monitor Ph+ CML?

Test Type What the Test Measures Sample Required for Test
Hematological Hematological: test that can detect the number of white blood cells, red blood cells, and platelets in the blood 
Complete blood count (CBC)
White blood cells White blood cells : blood cells that help fight infections. When the level of a certain type of white blood cell is lower than normal, it is called neutropenia , red blood cells Red blood cells: blood cells that carry oxygen to all parts of the body. When red blood cell levels are lower than normal, it is called anemia  , platelets Platelets: cell fragments that help stop bleeding. When platelet levels are lower than normal, it is called thrombocytopenia  , and other blood components Blood sample
Cytogenetic
Fluorescence in situ hybridization (FISH)
Cells carrying Philadelphia (Ph) chromosome Philadelphia (Ph) chromosome: the chromosome abnormality that causes CML; pieces from 2 different chromosomes break off and fuse together to create this new abnormal chromosome   Blood or bone marrow sample
Cytogenetic
Conventional cytogenetic
Cells carrying Ph chromosome  Ph chromosome: the chromosome abnormality that causes CML; pieces from 2 different chromosomes break off and fuse together to create this new abnormal chromosome   Blood or bone marrow sample
Molecular*
Reverse transcriptase polymerase chain reaction (RT-PCR)
BCR-ABL BCR-ABL: an abnormal protein that causes out-of-control production of CML cells  transcripts Blood or bone marrow sample

*The approval of SPRYCEL for Ph+ CML patients who are no longer benefiting from, or cannot tolerate, current treatment, including GLEEVEC® (imatinib mesylate), was not based on results of this kind of testing.

Why Is Ongoing Testing and Monitoring Important?

Ongoing testing and monitoring is very important to help you and your doctor understand if your Ph+ CML is being controlled appropriately over the long term. The goal of testing is to determine if your blood counts are improving and the number of leukemia cells is decreasing. These tests can also tell your doctor whether your Ph+ CML may be resistant to your medicine.

A complete cytogenetic response (CCyR) is an important treatment milestone that means there are no Philadelphia chromosome-positive (Ph+) cells detected within your blood or bone marrow sample. If you achieve and maintain a CCyR, this means your Ph+ CML is responding to your medicine. It is important to remember that achieving a CCyR does not mean that your Ph+ CML is cured, only that leukemia cells can’t be detected. It is important to continue taking your medication as directed.

If your Ph+ CML is resistant to medicine and you are not able to achieve or maintain a CCyR, your doctor may decide to change your treatment.

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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, and tumor lysis syndrome. Side effects of SPRYCEL which are considered common include: diarrhea, headache, tiredness, nausea, shortness of breath, skin rash, muscle pain, fever, and fluid retention. 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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SPRYCEL® (dasatinib) IMPORTANT SAFETY INFORMATION FOR PATIENTS

Important Safety Information about SPRYCEL

It is not known if SPRYCEL is safe and effective in children younger than 18 years old.

Before taking SPRYCEL, tell your healthcare provider about all of your medical conditions, including if you:

  • have problems with your immune system
  • have liver problems
  • have heart problems, including a condition called congenital long QT syndrome
  • have low potassium or low magnesium levels in your blood
  • are lactose (milk sugar) intolerant
  • are pregnant or plan to become pregnant. SPRYCEL 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. Talk to your healthcare provider right away if you become pregnant during treatment with SPRYCEL
  • are 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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, antacids, and herbal supplements. If you take an antacid medicine, take it 2 hours before or 2 hours after your dose of SPRYCEL.

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
  • Take SPRYCEL one (1) time a day
  • Take SPRYCEL with or without food, either in the morning or in the evening
  • Swallow SPRYCEL tablets whole with water. Do not cut or crush the tablets
  • You should not drink grapefruit juice during treatment with 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
  • If you take too much SPRYCEL, call your healthcare provider or go to the nearest hospital emergency room right away

SPRYCEL may cause serious side effects, including:

  • 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 a fever or any signs of an infection during treatment with SPRYCEL
  • Bleeding problems: SPRYCEL 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
    • 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 get any of these symptoms during treatment with SPRYCEL:
    • swelling all over your body
    • weight gain
    • shortness of breath and cough, especially if this happens with low levels of physical activity or at rest
    • chest pain when taking a deep breath
  • 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)
  • Severe skin reactions: SPRYCEL may cause skin reactions that can sometimes be severe. Get medical help right away if you get a skin reaction with fever, sore mouth or throat, or 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 heart beat. Kidney failure may require the need for dialysis treatment. Your healthcare provider may do blood tests to check you for TLS

Side effects of SPRYCEL which are considered common include: diarrhea, headache, tiredness, nausea, shortness of breath, skin rash, muscle pain, and fever.

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.

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.

729US1502955-03-01 12/16

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