Sprycel is a brand-name prescription medication. It’s FDA-approved to treat certain types of leukemia in adults and children. Leukemia is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

Sprycel contains the active drug dasatinib. Sprycel belongs to a class of drugs called tyrosine kinase inhibitors. (A class of drugs is a group of medications that work in a similar way.)

Sprycel comes as a tablet that you swallow. The drug is available in these strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. Adults and children will typically take Sprycel once a day.

Sprycel for adults

Sprycel is used for adults with:

  • A new diagnosis of chronic myeloid leukemia in the chronic phase that’s Philadelphia chromosome-positive. Chronic myeloid leukemia (CML) starts in blood cells of the bone marrow called myeloid blood cells. Philadelphia chromosome-positive (Ph+) refers to a gene mutation that causes even more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.) Sprycel is used to treat Ph+ CML that’s in the chronic (first) phase. This is when there’s a low amount of cancer in the blood or bone marrow.
  • Ph+ CML in any phase that hasn’t responded to treatment. Sprycel is used to treat Ph+ CML that’s in the chronic, accelerated (second), or blast (most advanced) phase. (For details on the phases, see the “Sprycel uses” section below.) Adults must have already tried medication including imatinib (Gleevec), but it didn’t work for them or they couldn’t tolerate the drug. This is what “hasn’t responded to treatment” means.
  • Acute lymphoblastic leukemia that’s Ph+ and hasn’t responded to treatment. Acute lymphoblastic leukemia (ALL) starts in blood cells of the bone marrow called lymphoid blood cells. Adults must have already tried treatment that didn’t work for them or that they couldn’t tolerate.

Sprycel for children

Sprycel is used for children ages 1 year and older with:

  • Ph+ CML in the chronic phase. Sprycel is used to treat Ph+ CML that’s in the chronic phase.
  • A new diagnosis of Ph+ ALL when used with chemotherapy. Sprycel is used with chemotherapy to treat Ph+ ALL.

Effectiveness

For information on the effectiveness of Sprycel in treating the conditions mentioned above, please see the “Sprycel uses” section below.

Sprycel is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Sprycel contains the active drug ingredient dasatinib. Sprycel belongs to a class of drugs called tyrosine kinase inhibitors (TKIs).

Sprycel can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Sprycel. This list doesn’t include all possible side effects.

For more information on the possible side effects of Sprycel, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Sprycel, you can do so through MedWatch.

More common side effects

Side effects of Sprycel can vary by the age of the person taking the drug and the condition being treated.

Side effects in adults or children

The more common side effects of Sprycel when used by itself in children or adults include:

Side effects in children treated for Ph+ ALL

Sprycel is approved to treat acute lymphoblastic leukemia (ALL) that’s Philadelphia chromosome-positive (Ph+) in adults and children ages 1 year and older. Ph+ refers to a gene mutation that causes more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.)

When Sprycel is used for Ph+ ALL in children, the drug is used with chemotherapy.

The more common side effects of Sprycel when used with chemotherapy in children include:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Sprycel aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Low blood cell counts, including low levels of red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia). Symptoms can include:
    • chills
    • dizziness
    • trouble breathing
    • bruising
    • small red or purple spots on skin
  • Bleeding easily. Symptoms can include:
    • bleeding or bruising of the skin
    • blood in stool that’s bright red or black
    • headache
    • change in speech pattern
  • Severe fluid retention. Symptoms can include:
    • swelling all over your body
    • weight gain
    • trouble breathing, especially during low activity or at rest
    • dry cough
    • chest pain when you take deep breaths
  • Heart problems, such as heart attack, arrhythmia (abnormal heart rhythm), or long QT syndrome (abnormal electrical activity in your heart). Symptoms can include:
    • chest pain, pressure, or tightness
    • lightheadedness or dizziness
    • rapid heartbeat or chest pounding
  • Pulmonary hypertension (high blood pressure inside your lungs). Symptoms can include:
    • trouble breathing
    • tiredness or weakness
    • swelling all over your body
  • Serious skin reactions, including Stevens-Johnson syndrome. Symptoms can include:
    • redness or reddish spots
    • fever
    • sore mouth or throat
    • open blisters or sores on skin or mouth
  • Tumor lysis syndrome (a condition in which cancer cells release harmful chemicals into your blood). Symptoms can include:
    • weakness
    • swelling
    • trouble breathing
    • muscle cramps
  • Slowed growth in children. Symptoms can include:
    • growing at a slower-than-average rate
    • being a smaller size than other children their age

Other serious side effects, explained in more detail below in “Side effect details,” include:

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Sprycel. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

In clinical studies, children with acute lymphoblastic leukemia (ALL) that’s Philadelphia chromosome-positive (Ph+) who took Sprycel with chemotherapy had allergic reactions. Ph+ refers to a gene mutation that causes even more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.)

In this group, 36% of children had some type of allergic reaction and 20% had serious allergic reactions. Sprycel wasn’t compared with a different drug or a placebo (treatment with no active drug).

Other clinical studies looked at adults and children with Ph+ chronic myeloid leukemia (CML) in the chronic phase.Researchers also looked at children with a new diagnosis of Ph+ ALL who took Sprycel with chemotherapy.

Severe allergic skin reactions were seen in up to 2% of adults or children who took only Sprycel and in 7% of children who took Sprycel with chemotherapy. However, it’s not known whether the skin reactions were caused by Sprycel or chemotherapy. Sprycel wasn’t compared with a different drug or a placebo.

Symptoms of a severe allergic reaction

Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • trouble breathing or speaking
  • fever
  • sore mouth or throat
  • open blisters or sores on skin or mouth

Call your doctor right away if you have a severe allergic reaction to Sprycel. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Long-term side effects

Most of Sprycel’s side effects usually don’t last long. However, some side effects may be long term or even permanent. This can include heart damage from a heart attack or lung damage from pulmonary hypertension, which is high blood pressure inside your lungs.

If you’re concerned about long-term side effects while taking Sprycel and what treatment would involve, talk with your doctor.

Rash

Rashes can occur with Sprycel use as part of an allergic reaction. For more information about rashes and allergic reactions, see the “Allergic reaction” section above.

Headache

In clinical studies, headache was one of the more common side effects of Sprycel. In adults who took only Sprycel for Ph+ CML in the chronic phase and had previous treatment with imatinib (Gleevec), up to 33% of them had headaches. In children with Ph+ ALL who took Sprycel with chemotherapy, 77% of them had headaches. Sprycel wasn’t tested against another treatment or a placebo.

If you develop headaches while taking Sprycel, talk with your doctor. They can suggest ways to help treat this side effect.

Fatigue

Fatigue, which is a lack of energy, is also a common side effect of Sprycel. In clinical studies of adults who took only Sprycel for Ph+ CML in the chronic phase and had previous treatment with imatinib, up to 19% of them had fatigue. And 59% of children with Ph+ ALL who took Sprycel with chemotherapy reported fatigue. Sprycel wasn’t tested against another treatment or a placebo.

Cancer itself can also cause fatigue. It can take a lot of work for your body to fight the cancer, so you may have less energy than usual.

If you have fatigue while taking Sprycel, talk with your doctor. They can suggest ways to help you feel better.

Hair loss

Hair loss is a possible side effect of Sprycel. Individual clinical studies didn’t report how often hair loss occurred. However, combined data across studies of chronic myeloid leukemia (CML) and ALL estimated hair loss to affect 1% to 10% of people who took only Sprycel.

If you’re concerned about hair loss while taking Sprycel, talk with your doctor. They may be able to suggest ways to help you manage this side effect. Sprycel wasn’t tested against another treatment or a placebo.

Side effects in children

Clinical trials looked at children with Ph+ CML in the chronic phase who took only Sprycel for 2 years. Researchers found that 5.2% of these children had problems with bone growth and development. Problems included brittle bones and slowed growth of bones.

Your child’s doctor will monitor your child’s growth and development during Sprycel treatment.

For more information on Sprycel side effects in children, see the “More common side effects,” “Serious side effects,” and “Side effect details” sections above.

If you have any concerns about possible side effects of Sprycel in children, talk with your child’s doctor. They can review the risk and benefits of the drug with you.

The Sprycel dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Sprycel to treat
  • your age
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Sprycel comes as a tablet that you swallow. The drug is available in these strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Dosage for chronic myeloid leukemia (CML)

The Sprycel dosage for adults with chronic myeloid leukemia (CML) in the chronic phase that’s Philadelphia chromosome-positive (Ph+) is 100 mg once a day.

The Sprycel dosage for adults with Ph+ CML in the accelerated (second) or blast (most advanced) phase is 140 mg once a day.

Dosage for acute lymphoblastic leukemia (ALL)

The Sprycel dosage for adults with acute lymphoblastic leukemia (ALL) is 140 mg once a day.

Pediatric dosage

In children with Ph+ CML or Ph+ ALL, Sprycel is used with chemotherapy. The Sprycel dose is based on your child’s body weight:

  • 10 to 20 kg: 40 mg once a day
  • 20 to 30 kg: 60 mg once a day
  • 30 to 45 kg: 70 mg once a day
  • 45 kg or more: 100 mg once a day

Keep in mind that 1 kg is about 2.2 lb. Your child’s doctor should check the dose every 3 months and update it as needed for any change in weight.

What if I miss a dose?

If you miss a dose of Sprycel, take the next scheduled dose at the regular time. Don’t take two doses to make up for a missed dose.

Will I need to use this drug long term?

Sprycel is meant to be used as a long-term treatment. If you and your doctor determine that Sprycel is safe and effective for you, you’ll likely take it long term. However, if the side effects become severe or if your condition worsens, your doctor may have you stop taking Sprycel.

As with all medications, the cost of Sprycel can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Sprycel at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Your insurance plan may require you to get prior authorization before approving coverage for Sprycel. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Sprycel.

If you’re not sure if you’ll need to get prior authorization for Sprycel, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Sprycel, help is available. Bristol-Myers Squibb, the manufacturer of Sprycel, offers a program called Sprycel Assist. For more information and to find out if you’re eligible for support, call 855-SPRYCEL (855-777-9235), or visit the program website.

The Food and Drug Administration (FDA) approves prescription drugs such as Sprycel to treat certain conditions. Sprycel may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Sprycel is used to treat certain types of leukemia. This is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

Sprycel for chronic myeloid leukemia (CML)

Chronic myeloid leukemia (CML) starts in blood cells of the bone marrow called myeloid blood cells. It’s called chronic because it develops more slowly than the acute kind of leukemia. CML is more common in adults than in children.

Most cancers are described by their size or how far they have spread. But because CML is a disease of the bone marrow, it’s described by stages. These stages are known as phases, and they refer to the amount of cancer in the bone marrow. CML has three phases:

  • Chronic phase: This is stage 1 of CML. There’s a low amount of cancer, called blasts, in the blood or bone marrow. There may be few to no visible symptoms of CML.
  • Accelerated phase: This is stage 2 of CML. Your blood has 15% to 30% blasts, or you have abnormal levels of blood cells.
  • Blast phase: This is stage 3 of CML. It also may be called the myeloid or lymphoid blast phase. Myeloid blasts are cells that should develop into red blood cells, platelets (blood cells that help your blood clot), and certain white blood cells, but don’t. Lymphoid blasts are cells that should develop into specialized white blood cells that help the immune system (your body’s defense against infection), but don’t. In the blast phase, your blood has at least 20% blasts. These blasts can spread to any organ in the body, such as your liver. Symptoms of leukemia are very noticeable and may include:
    • loss of appetite or weight loss

What Sprycel is used for in CML

Sprycel is FDA-approved for use in adults with a new diagnosis of CML in the chronic phase that’s Philadelphia chromosome-positive (Ph+). Ph+ refers to a gene mutation that causes even more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.)

Sprycel is also approved for use in adults with Ph+ CML in any phase that hasn’t responded to treatment. You must have already tried medication including imatinib (Gleevec), but it didn’t work for you or you couldn’t tolerate the drug. This is what “hasn’t responded to treatment” means. Sprycel is used to treat Ph+ CML that’s in the chronic, accelerated, or blast phase.

In addition, Sprycel is approved for use in children ages 1 year and older with Ph+ CML in the chronic phase.

Effectiveness

Various studies have looked at how effective Sprycel is in treating Ph+ CML.

A study of newly diagnosed Ph+ CML in the chronic phase

To measure the effectiveness of Sprycel, researchers counted the number of cancer cells that remained in bone marrow after treatment.

There were two types of results, which were called responses. One was a complete cytogenetic response (CCyR), which looked at bone marrow cells. The other type of result was called a major molecular response (MMR). It looked at bone marrow at the genetic level, and it’s more specific than a CCyR.

An MMR was defined as having a level of cells with the Ph+ gene mutation that was at least 1,000 times lower than the level of someone with CML who wasn’t treated. A CCyR was defined as having no cells that were Ph+.

A clinical study of adults with newly diagnosed Ph+ CML in the chronic phase looked at treatment with Sprycel or imatinib. At 12 months, 76.8% of people who took only Sprycel had a CCyR. In comparison, 66.2% of people who took imatinib had a CCyR.

Also, 52.1% of people who took only Sprycel had an MMR at 12 months, and 76.4% had an MMR at 60 months. In comparison, 33.8% of people who took imatinib had an MMR at 12 months, and 64.2% had an MMR at 60 months.

The study results show that Sprycel was more effective in treating Ph+ CML than imatinib.

A study of Ph+ CML in the chronic phase after a previous treatment didn’t work

Another clinical study looked at adults with Ph+ CML in the chronic phase. They had tried imatinib, but the drug didn’t work for them. Researchers gave the adults 100-mg doses of Sprycel. Results showed that an MMR was seen in:

  • 34% of people at 2 years
  • 43% of people at 5 years
  • 44% of people at 7 years

A study of Ph+ CML in more advanced phases and Ph+ ALL

A different study looked at adults with Ph+ CML in the more advanced phases and adults with Ph+ ALL. They took Sprycel for 2 years. Researchers found that according to lab tests, the drug worked for most people, and there was no evidence of leukemia. At 2 years, the study looked at whether people had a major hematologic response. (This refers to having normal levels of blood cells and no signs of cancer within the blood or bone marrow.)

A major hematologic response was seen in:

  • 66% of people with Ph+ CML in the accelerated phase (See above for definitions of the blast phases.)
  • 28% of people with Ph+ CML in the myeloid blast phase
  • 42% of people with Ph+ CML in the lymphoid blast phase
  • 38% of people with Ph+ ALL

Sprycel for acute lymphoblastic leukemia (ALL)

Acute lymphoblastic leukemia (ALL) starts in blood cells of the bone marrow called lymphoid blood cells. It develops quickly and is more common in children than in adults.

What Sprycel is used for in ALL

Sprycel is FDA-approved for use in adults with acute lymphoblastic leukemia that’s PH+ and hasn’t responded to treatment. This means that you must have already tried treatment that didn’t work for you or that you couldn’t tolerate.

Sprycel is also approved for use in children ages 1 year and older who have a new diagnosis of Ph+ ALL. Sprycel will be used with chemotherapy.

Effectiveness

The effectiveness of Sprycel in treating adults with Ph+ ALL was examined in a clinical study that also looked at adults with Ph+ CML. For details, see the “A study of Ph+ CML in more advanced phases and Ph+ ALL” section above.

Off-label uses for Sprycel

In addition to the uses listed above, Sprycel may be used off-label for other uses. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved. Below are examples of off-label uses for Sprycel.

Sprycel for CML after a hematopoietic stem cell transplant

Sprycel isn’t FDA-approved for CML after a hematopoietic stem cell transplant (HSCT). This is a type of cancer treatment. However, according to one study, researchers have looked at the use of Sprycel for CML after an HSCT. Your doctor may consider using Sprycel off-label to treat CML after an HSCT.

If you’d like to learn more about Sprycel and HSCTs, talk with your doctor.

Sprycel for CML after no response with multiple tyrosine kinase inhibitors

Drugs called tyrosine kinase inhibitors (TKIs) are sometimes used to treat CML. Sprycel isn’t FDA-approved to treat CML after multiple TKIs have been tried but didn’t work. (This is referred to as “no response.”) However, according to a small study, researchers have looked at the use of Sprycel for this use. Your doctor may consider using Sprycel off-label to treat CML after multiple TKIs have been tried but didn’t work.

For more information on Sprycel use after trying TKIs, talk with your doctor.

Sprycel as first-line treatment for adults with ALL

Sprycel isn’t FDA-approved as the first-line treatment for Ph+ ALL in adults. (“First-line” refers to the first treatment used for a condition.) However, according to the National Comprehensive Cancer Network (NCCN) guidelines, Sprycel may be prescribed off-label for this use.

If you’d like to learn more about Sprycel in treating Ph+ ALL, talk with your doctor.

Sprycel for gastrointestinal stromal tumor (GIST) (under study)

Sprycel isn’t FDA-approved to treat a rare cancer of the stomach and intestines called gastrointestinal stromal tumor (GIST). However, researchers are studying the drug as a first-line treatment for GIST or after use with imatinib. Your doctor may consider using Sprycel off-label for this use.

To learn more about Sprycel and GIST, talk with your doctor.

Sprycel for children

For information on Sprycel’s uses in children, please see the “Sprycel for chronic myeloid leukemia (CML)” and “Sprycel for acute lymphoblastic leukemia (ALL)” sections above.

Effectiveness

Two clinical studies looked at children with Ph+ CML in the chronic phase. Researchers examined whether the children had a response to treatment, defined as CCyR. (For more about CCyR, see the “Sprycel for chronic myeloid leukemia (CML)” section above.)

After 2 years of taking only Sprycel, a CCyR was seen in:

  • 96.1% of children who were newly diagnosed with Ph+ CML
  • 82.6% of children who had been previously treated for Ph+ CML

Another clinical study looked at children with Ph+ ALL who were treated with Sprycel and chemotherapy over 3 years. Researchers found that 64.1% of the children survived without any further worsening of leukemia. The Sprycel and chemotherapy treatment wasn’t compared with a different treatment or a placebo.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Sprycel, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for chronic myeloid leukemia (CML)

Examples of other drugs that may be used to treat chronic myeloid leukemia (CML) include:

  • tyrosine kinase inhibitors (TKIs), such as:
  • chemotherapies, such as:
    • hydroxyurea (Hydrea)
    • omacetaxine (Synribo)
    • cytarabine (Ara-C)
    • busulfan (Busulfex)
    • cyclophosphamide
    • vincristine
  • interferon alpha (Alferon, Infergen, others)

Alternatives for acute lymphoblastic leukemia (ALL)

Examples of other drugs that may be used to treat acute lymphoblastic leukemia (ALL) include:

  • TKIs, such as:
    • imatinib (Gleevec)
    • nilotinib (Tasigna)
    • bosutinub (Bosulif)
    • ponatinib (Iclusig)
  • chemotherapies, such as:
    • vincristine or liposomal vincristine (Marqibo)
    • daunorubicin (Cerubidine)
    • doxorubicin (Adriamycin)
    • cytarabine (Ara-C)
    • L-asparaginase or PEG-L-asparaginase (Oncaspar)
    • 6-mercaptopurine (6-MP)
    • methotrexate (Otrexup, Rasuvo, Trexall, others)
    • cyclophosphamide
    • nelarabine (Arranon)
  • immunotherapies, such as:
    • blinatumomab (Blincyto)
    • inotuzumab ozogamcin (Besponsa)

You may wonder how Sprycel compares to other medications that are prescribed for similar uses. Here we look at how Sprycel and Gleevec are alike and different.

Ingredients

Sprycel contains the active drug dasatinib. Gleevec contains the active drug imatinib. Both Sprycel and Gleevec are both in the same class of medications: tyrosine kinase inhibitors (TKIs). This means that they work in similar ways.

Uses

The Food and Drug Administration (FDA) has approved Sprycel and Gleevec to treat certain types of leukemia in adults and children. Leukemia is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

Sprycel and Gleevec are used in adults to treat:

  • A new diagnosis of chronic myeloid leukemia in the chronic phase that’s Philadelphia chromosome-positive. Chronic myeloid leukemia (CML) starts in blood cells of the bone marrow called myeloid blood cells. Philadelphia chromosome-positive (Ph+) refers to a gene mutation that causes even more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.) The drugs are used to treat Ph+ CML that’s in the chronic (first) phase. This is when there’s a low amount of cancer in the blood or bone marrow.
  • Ph+ CML in any phase that hasn’t responded to treatment.* The drugs are used to treat Ph+ CML that’s in the chronic, accelerated (second), or blast (most advanced) phase. (For details on the phases, see the “Sprycel uses” section above.)
  • Acute lymphoblastic leukemia that’s PH+ and hasn’t responded to treatment. Acute lymphoblastic leukemia (ALL) starts in blood cells of the bone marrow called lymphoid blood cells. Adults must have already tried treatment that didn’t work for them or that they couldn’t tolerate.

Sprycel and Gleevec are used in children** with:

  • Ph+ CML in the chronic phase. Sprycel is used to treat Ph+ CML that’s in the chronic phase.
  • A new diagnosis of Ph+ ALL when used with chemotherapy. Sprycel is used with chemotherapy to treat Ph+ ALL.

* For Sprycel, “responded to treatment” means that you must have already tried medication including Gleevec, but it didn’t work for you or you couldn’t tolerate the drug. For Gleevec, it means that you must have already tried interferon, but it didn’t work for you or you couldn’t tolerate the drug.

** Sprycel is approved for use in children ages 1 year and older. Gleevec is approved for use in children of all ages. (Sprycel hasn’t been studied in children younger than age 1 year.)

Gleevec is also approved to treat:

  • myelodysplastic/myeloproliferative diseases
  • aggressive systemic mastocytosis
  • hypereosinophilic syndrome and/or chronic eosinophilic leukemia
  • metastatic dermatofibrosarcoma protuberans
  • Kit-positive (Kit+) gastrointestinal stromal tumor (GIST)
  • adjuvant treatment of GIST

Drug forms and administration

Sprycel and Gleevec both come as tablets that you swallow. You’ll usually take Sprycel once a day. And you’ll typically take Gleevec once or twice a day.

Side effects and risks

Sprycel and Gleevec are both in the same drug class, so they act in similar ways within the body. Because of this, they cause very similar side effects, but some different ones as well. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Sprycel, with Gleevec, or with both drugs (when taken individually):

Serious side effects

These lists contain examples of serious side effects that can occur with Sprycel, with Gleevec, or with both drugs (when taken individually).

Effectiveness

Sprycel and Gleevec have different FDA-approved uses, but they’re both used to treat Ph+ CML and Ph+ ALL.

The use of Sprycel and Gleevec in treating a new diagnosis of Ph+ CML in the chronic phase in adults has been directly compared in a clinical study. At 12 months, the results showed that 76.8% of people who took only Sprycel had had no Ph+ cells. This was compared with 66.2% of people who took Gleevec.

Also at 12 months, 52.1% of people who took only Sprycel had few or no cancer cells in their blood or bone marrow. This was compared with 33.8% of people who took Gleevec.

At 60 months, 76.4% of people who took only Sprycel had few or no cancer cells in their blood or bone marrow. This was compared with 64.2% of people who took Gleevec.

These drugs haven’t been directly compared in clinical studies for their other uses, but studies have found both Sprycel and Gleevec to be effective for treating Ph+ CML and Ph+ ALL.

National Comprehensive Cancer Network guidelines

According to National Comprehensive Cancer Network (NCCN) guidelines, Gleevec is typically used as the first treatment option before Sprycel. If Gleevec doesn’t work, Sprycel can be used. However, in some cases, Sprycel may be used off-label as the preferred first treatment option. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved.

Costs

Sprycel and Gleevec are both brand-name drugs. Sprycel isn’t currently available in generic form.

But Gleevec is available in a generic form, and it’s called imatinib. Brand-name medications usually cost more than generics.

Sprycel costs significantly more than Gleevec and its generic form (imatinib). The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Like Gleevec (above), the drug Tasigna has uses similar to those of Sprycel. Here’s a comparison of how Sprycel and Tasigna are alike and different.

Ingredients

Sprycel contains the active drug dasatinib. Tasigna contains the active drug nilotinib. Both Sprycel and Tasigna are in the same class of medications: tyrosine kinase inhibitors (TKIs). This means that they work in similar ways.

Uses

The Food and Drug Administration (FDA) has approved Sprycel and Tasigna to treat certain types of leukemia in adults and children. Leukemia is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

What Sprycel is used for

Sprycel is approved for use in adults with:

  • A new diagnosis of chronic myeloid leukemia in the chronic phase that’s Philadelphia chromosome-positive. Chronic myeloid leukemia (CML) starts in blood cells of the bone marrow called myeloid blood cells. Philadelphia chromosome-positive (Ph+) refers to a gene mutation that causes even more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.) Sprycel is used to treat Ph+ CML that’s in the chronic (first) phase. This is when there’s a low amount of cancer in the blood or bone marrow.
  • Ph+ CML in any phase that hasn’t responded to treatment. Sprycel is used to treat Ph+ CML that’s in the chronic, accelerated (second), or blast (most advanced) phase. (For details on the phases, see the “Sprycel uses” section above.) Adults must have already tried medication including imatinib (Gleevec), but it didn’t work for them or they couldn’t tolerate the drug. This is what “hasn’t responded to treatment” means.
  • Acute lymphoblastic leukemia that’s PH+ and hasn’t responded to treatment. Acute lymphoblastic leukemia (ALL) starts in blood cells of the bone marrow called lymphoid blood cells. Adults must have already tried treatment that didn’t work for them or that they couldn’t tolerate.

Sprycel is approved for use in children ages 1 year and older with:

  • Ph+ CML in the chronic phase. Sprycel is used to treat Ph+ CML that’s in the chronic phase.
  • A new diagnosis of Ph+ ALL when used with chemotherapy. Sprycel is used with chemotherapy to treat Ph+ ALL.

What Tasigna is used for

Tasigna is approved for use in adults with:

  • A new diagnosis of Ph+ CML that’s in the chronic phase.
  • Ph+ CML that’s in the chronic or accelerated phase. They must have already tried medication including imatinib, but it didn’t work for them or they couldn’t tolerate the drug.

Tasigna is approved for use in children ages 1 year and older with:

  • A new diagnosis of Ph+ CML that’s in the chronic phase.
  • Ph+ CML that’s in the chronic phase. They must’ve already tried a TKI drug, but it didn’t work for them or they couldn’t tolerate the drug.

Drug forms and administration

Sprycel comes as a tablet that you swallow. You’ll typically take it once a day.

Tasigna comes as a capsule that you swallow or open and mix with applesauce to swallow. You’ll usually take it twice a day.

Side effects and risks

Sprycel and Tasigna are both from the same class of drugs and act in similar ways within the body. Because of this, they cause very similar side effects, but some different ones as well. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Sprycel, with Tasigna, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Sprycel, with Tasigna, or with both drugs (when taken individually).

* Tasigna has boxed warnings for the risk of sudden death related to QT prolongation (a heart condition in which your heartbeat is uneven) or low potassium or magnesium. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Effectiveness

These drugs haven’t been directly compared in clinical studies, but studies have found both Sprycel and Tasigna to be effective for treating Ph+ CML.

Costs

Sprycel and Tasigna are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Sprycel and Tasigna costs will vary depending on what condition the drug is treating and your dosing schedule. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Sprycel is sometimes used with chemotherapy to treat a certain type of leukemia in children ages 1 year and older. Leukemia is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

Sprycel is used to treat a new diagnosis of acute lymphoblastic leukemia (ALL) that’s Philadelphia chromosome-positive (Ph+). Ph+ refers to a gene mutation that causes more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.)

Chemotherapies are traditional cancer drugs that attack fast-growing cells such as cancer cells. Sprycel is a type of targeted therapy, which attacks certain kinds of cancer cells that have very specific gene mutations. When used together, chemotherapies and targeted therapies often treat cancer better than if the drugs were used separately.

Examples of chemotherapies used with Sprycel include:

  • vincristine or liposomal vincristine (Oncovin, Marqibo)
  • daunorubicin (Cerubidine)
  • doxorubicin (Adriamycin)

For other types of chemotherapies used with Sprycel, see the “Alternatives to Sprycel” section above.

There are no known interactions between Sprycel and alcohol at this time.

Sprycel can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Sprycel and other medications

Below is a list of medications that can interact with Sprycel. This list doesn’t contain all drugs that may interact with Sprycel.

Before taking Sprycel, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Drugs that can increase the effects of Sprycel

Taking Sprycel with certain medications may increase the level of Sprycel in your body. This can increase your risk for side effects. (For more about the side effects of Sprycel, see the “Sprycel side effects” section above.)

Examples of these medications include:

  • certain antimicrobials, such as:
    • clarithromycin (Biaxin)
    • fluconazole (Diflucan)
    • itraconazole (Sporanox)
    • ketoconazole (Nizoral, Extina, others)
  • certain HIV medications, such as:
    • ritonavir (Norvir)
    • saquinavir (Invirase)
  • certain heart medications, such as:
    • diltiazem (Cartia, Diltzac, others)
    • verapamil (Calan, Isoptin)
    • amiodarone (Nexterone, Pacerone)
  • other medications, such as:
    • tamoxifen (Soltamox)

If you’re taking any of these drugs, tell your doctor before you start using Sprycel. They may suggest different medications.

Drugs that can decrease the effects of Sprycel

Taking Sprycel with certain medications may decrease the level of Sprycel in your body. This may make Sprycel less effective in treating your condition.

Examples of these medications include:

If you’re taking any of the acid reflux medications listed above, ask your doctor if you can use an antacid instead. Keep in mind that you’ll have to take the antacid at least 2 hours before or after your dose of Sprycel. Otherwise, the antacid may affect how well Sprycel works, and Sprycel won’t be as effective in treating your condition.

And if you’re using any of the other medications mentioned above, tell your doctor before you start taking Sprycel. They may suggest different treatments for you.

Drugs that can increase your risk for bleeding

Sprycel may lower your level of platelets (blood cells that help your blood clot), which can make you bleed more easily. Medications that prevent or treat blood clots can also make you bleed more easily. So taking Sprycel with these medications can increase your risk for serious bleeding.

Examples of these drugs include antiplatelet medications, such as:

If you’re taking any of these drugs, tell your doctor before you start using Sprycel. They may recommend different treatments for you.

Sprycel and Tylenol (not an interaction)

There are no known interactions between Sprycel and acetaminophen (Tylenol) at this time.

If you have any questions about taking Tylenol during your Sprycel treatment, ask your doctor.

Sprycel and herbs and supplements

Avoid taking St. John’s wort while using Sprycel. St. John’s wort is a common herbal supplement that can make Sprycel less effective.

If you’re taking St. John’s wort, tell your doctor before you start your Sprycel treatment. They may be able to suggest a treatment other than St. John’s wort.

And be sure to tell your doctor or pharmacist about other herbs or supplements you’re taking before you start to use Sprycel.

Sprycel and foods

Avoid consuming grapefruit and grapefruit juice while taking Sprycel because they can raise the level of Sprycel in your body. This can increase your risk for side effects. (To learn more about the side effects of Sprycel, see the “Sprycel side effects” section above.)

You should take Sprycel according to your doctor’s or healthcare provider’s instructions.

Sprycel comes as a tablet that you swallow.

When to take

You can take Sprycel in the morning or at night. You should take it once a day, at the same time each day.

Taking Sprycel with food

You can take Sprycel with or without food.

Can Sprycel be crushed, split, or chewed?

No. Don’t crush, cut, or chew Sprycel tablets. You should swallow them whole.

Sprycel is used to treat certain types of leukemia. This is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

Chronic myeloid leukemia (CML) starts in blood cells of the bone marrow called myeloid blood cells. It’s called chronic because it develops more slowly than the acute kind of leukemia. CML is more common in adults than in children.

Most cancers are described by their size or how far they spread. But because CML is a disease of the bone marrow, it’s described by stages. These stages are known as phases, and they refer to the amount of cancer in the bone marrow. CML has three phases:

  • Chronic phase: This is stage 1 of CML. There’s a low amount of cancer, called blasts, in the blood or bone marrow. There may be few to no visible symptoms of CML.
  • Accelerated phase: This is stage 2 of CML. Your blood has 15% to 30% blasts, or you have abnormal levels of blood cells.
  • Blast phase: This is stage 3 of CML. It also may be called the myeloid or lymphoid blast phase. Myeloid blasts are cells that should develop into red blood cells, platelets (blood cells that help your blood clot), and certain white blood cells, but don’t. Lymphoid blasts are cells that should develop into specialized white blood cells that help the immune system (your body’s defense against infection), but don’t. In the blast phase, your blood has at least 20% blasts. These blasts can spread to any organ in the body, such as your liver. Symptoms of leukemia are very noticeable and may include:
    • loss of appetite or weight loss

Acute lymphoblastic leukemia (ALL) starts in blood cells of the bone marrow called lymphoid blood cells. It develops quickly and is more common in children than in adults.

Sprycel is used to treat CML and ALL that are Philadelphia chromosome-positive (Ph+). Ph+ refers to a gene mutation that causes even more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.)

What Sprycel does

Sprycel belongs to a class of drugs called tyrosine kinase inhibitors (TKIs). A class of drugs is a group of medications that work in a similar way. TKIs help prevent a type of protein called an enzyme from sending messages that cause cancer cells to grow and spread. The particular enzyme that TKIs affect is known as a kinase. To be more specific, Sprycel blocks the BCR-ABL kinase, which helps CML and ALL cancer cells spread.

How long does it take to work?

In clinical studies of CML and AML, a response to treatment was seen as early as a couple months based on blood tests. But you may start to notice improvements in your symptoms even sooner. A response to treatment is measured by the amount of cancer cells within your bone marrow or blood.

You shouldn’t take Sprycel during pregnancy. Based on clinical studies, Sprycel can cause birth defects when the mother is treated with this drug while pregnant. Animal studies have also shown that Sprycel can cause birth defects when given during pregnancy.

Before you start taking Sprycel, your doctor will give you a pregnancy test to make sure you’re not pregnant. It’s recommended that you use birth control during treatment with the drug. And you should continue to use birth control for at least 30 days after your last dose of Sprycel.

If you’re pregnant or are planning to become pregnant, tell your doctor before you use Sprycel. They’ll likely recommend a different treatment.

You shouldn’t take Sprycel during pregnancy because the drug can cause birth defects.

Before you start taking Sprycel, your doctor will give you a pregnancy test to make sure you’re not pregnant. It’s recommended that you use birth control during treatment with the drug. And you should continue to use birth control for at least 30 days after your last dose of Sprycel.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Sprycel.

You shouldn’t breastfeed during Sprycel treatment because it isn’t known if the drug passes into breast milk. You should also avoid breastfeeding for at least 2 weeks after your last dose of Sprycel.

If you’re breastfeeding or are planning to breastfeed, tell your doctor before taking Sprycel. They may recommend a different medication.

Here are answers to some frequently asked questions about Sprycel.

Is Sprycel a form of chemotherapy?

No, Sprycel isn’t a chemotherapy drug. Chemotherapy medications usually affect all cells in your body that are multiplying quickly, not just cancer cells. This means that chemotherapy may cause a number of side effects.

Sprycel, on the other hand, is a targeted therapy. Targeted therapies work on specific cells to treat cancer, so there are typically fewer side effects than with chemotherapy. (For more information on the side effects of Sprycel, see the “Sprycel side effects” section above.)

How do I take Sprycel?

Sprycel comes as a tablet that you swallow. You’ll take it once a day in the morning or at night, as long as you take it at the same time each day. You can take Sprycel with or without food. Be sure to swallow the tablet whole. Don’t crush, cut, or chew Sprycel.

If you have any concerns about how to take Sprycel, talk with your doctor.

Can I use antacids while taking Sprycel?

Yes, you can take an antacid while using Sprycel. However, you’ll need to take the antacid at least 2 hours before or after your dose of Sprycel. Otherwise, the antacid may affect how well Sprycel works, and Sprycel won’t be as effective in treating your condition.

If you have any questions about using antacids during your Sprycel treatment, talk with your doctor.

Have side effects from Sprycel ever led to death?

It’s very rare, but there’s been at least one reported death related to Sprycel in clinical studies. The drug may cause serious side effects that include bleeding more easily than usual, heart problems such as heart attack or arrhythmia (abnormal heart rhythm), and allergic reactions. If these serious side effects aren’t treated and become more severe, they can become life threatening.

For more information on side effects of Sprycel, see the “Sprycel side effects” section above. You can also talk with your doctor.

Is Sprycel ever used with any other drugs?

Yes. Sprycel is sometimes used with chemotherapy to treat a certain type of leukemia in children ages 1 year and older. Leukemia is a form of cancer that affects the blood or bone marrow (the tissue inside bones that makes blood cells).

Sprycel is used to treat a new diagnosis of acute lymphoblastic leukemia (ALL) that’s Philadelphia chromosome-positive (Ph+). Ph+ refers to a gene mutation that causes more leukemia cells to grow. (A gene mutation is an abnormal, permanent change to a gene.)

For more information on Sprycel and chemotherapy, see the “Sprycel use with other drugs” section above. You can also talk with your child’s doctor.

Before taking Sprycel, talk with your doctor about your health history. Sprycel may not be right for you if you have certain medical conditions. These include:

  • Heart disease. If you have heart disease or other heart-related problems such as an arrhythmia (abnormal heart rhythm), taking Sprycel may worsen your condition. The drug itself can result in an abnormal heart rhythm and cause your body to retain water, which can weaken or damage your heart. If this occurs, you may need to stop taking Sprycel. Talk with your doctor about any heart-related problems before starting to use this medication. They may recommend a drug other than Sprycel.
  • Low levels of potassium or magnesium. Low levels of potassium and magnesium can affect your heart rate. Sprycel can also cause an abnormal heart rhythm, which can weaken or damage your heart. So if you have low levels of potassium and magnesium, tell your doctor before you start taking Sprycel. They may want you to have lab tests to check your potassium and magnesium levels or may recommend a drug other than Sprycel.
  • Lactose intolerance. Sprycel contains lactose (a sugar in milk). So if you’re lactose intolerant and take Sprycel, you may have side effects of lactose intolerance. Before you take Sprycel, tell your doctor if you’re lactose intolerant. They may work with you to help ease any side effects or recommend a drug other than Sprycel.
  • Young age. A possible side effect of Sprycel in children is slowed growth and development. So taking Sprycel at an early age may cause problems for children growing up, including bone growth and height issues. To learn more, talk with your child’s doctor. They can review the risks and benefits of Sprycel before your child starts treatment.
  • Pregnancy and breastfeeding. You shouldn’t take Sprycel during pregnancy or while breastfeeding. For more information, see the “Sprycel and pregnancy” and “Sprycel and breastfeeding” sections above.

Note: For more information about the potential negative effects of Sprycel, see the “Sprycel side effects” section above.

Using more than the recommended dosage of Sprycel can lead to serious side effects. Don’t use more Sprycel than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

Also, animal studies found that overdosages of Sprycel caused heart damage.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Sprycel from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store Sprycel tablets at room temperature between 68°F and 77°F (20°C and 25°C). But you can keep them between 59°F and 86°F (15°C and 30°C) for a short period of time, if needed.

Disposal

If you no longer need to take Sprycel, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

Since Sprycel is an anticancer drug, it needs to be treated and disposed of as hazardous waste. You should wear gloves when handling tablets that are crushed or broken to avoid contact with your skin. Talk with your doctor about how to dispose of the medication if you’re no longer taking it. You can find useful tips on medication disposal here.

The following information is provided for clinicians and other healthcare professionals.

Indications

Sprycel is FDA-approved to treat:

  • adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase
  • adults with Ph+ CML with resistance or intolerance to previous treatment including imatinib
  • adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to previous treatment
  • pediatrics at least 1 year of age with Ph+ CML in the chronic phase
  • pediatrics at least 1 year of age with newly diagnosed Ph+ ALL in combination with chemotherapy

Mechanism of action

Sprycel inhibits many kinases, including BCR-ABL, which is overexpressed in CML and ALL cell lines. This inhibition blocks signaling pathways for the growth and proliferation of cancer cells.

Pharmacokinetics and metabolism

After oral administration, the maximum concentration of Sprycel occurs between 0.5 and 6 hours. Taking 100 mg of Sprycel daily yields a steady state maximum concentration of 82.2 ng/mL. Its mean terminal half-life is 3 to 5 hours.

Sprycel gets metabolized by the enzyme CYP3A4. Sprycel forms an active metabolite after being metabolized and accounts for 5% of the area under the curve (AUC). Sprycel is 85% eliminated in the feces.

Contraindications

There are no contraindications for Sprycel at this time.

Storage

Sprycel should be stored at 68°F to 77°F (20°C to 25°C). But the drug can be kept between 59°F and 86°F (15°C and 30°C) for brief periods, if necessary.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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