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Sprycel (dasatinib) is a cancer medicine that slows the growth and spread of cancer cells in the body.

Sprycel is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.

Sprycel may also be used for purposes not listed in this medication guide.

Important information

Sprycel is a cancer medication that slows the growth and spread of cancer cells in the body.

Sprycel can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Some people using Sprycel have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking Sprycel

Some people using Sprycel have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH occurs when blood pressure increases inside the arteries in your lungs. This makes it harder for your heart to pump blood through the lungs, which also weakens muscles in the heart. PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

To make sure Sprycel is safe for you, tell your doctor if you have:

  • a weak immune system (caused by disease or by using certain medicine);

  • liver disease;

  • heart disease;

  • a personal or family history of Long QT syndrome;

  • lung disease; or

  • low levels of potassium or magnesium in your blood.

Sprycel tablets contain lactose. Talk to your doctor before using this medicine if you are lactose-intolerant.

Do not use Sprycel if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving Sprycel, whether you are a man or a woman. Dasatinib use by either parent may cause birth defects. A man taking Sprycel should use a condom during any sexual activity.

Sprycel may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking Sprycel.

How should I take Sprycel?

Take Sprycel exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take the medicine with or without food. Take the medicine at the same time each day.

Do not crush, chew, or break a Sprycel tablet. Swallow it whole.

Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

Sprycel can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Do not change your dose or stop using Sprycel without your doctor"s advice.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Sprycel dosing information

Usual Adult Dose of Sprycel for Leukemia:

Chronic Phase CML:

100 mg orally once a day

Duration of therapy: Until disease progression or patient is intolerant.

Accelerated Phase CML, Myeloid or Lymphoid Blast Phase CML, Ph+ ALL:

140 mg orally once a day

Duration of therapy: Until disease progression or patient is intolerant

Comments:
-This drug should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize adverse effects.

-The effect of discontinuing therapy after complete cytogenetic response is achieved has not been investigated.

Uses: Chronic phase, accelerated phase, or myeloid or lymphoid blast phase Philadelphia chromosome-positive chronic myelogenous leukemia; Philadelphia chromosome-positive acute lymphoblastic leukemia

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Sprycel?

Grapefruit and grapefruit juice may interact with dasatinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Sprycel.

Avoid taking an antacid within 2 hours before or after you take Sprycel. Some antacids can make it harder for your body to absorb dasatinib.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Dasatinib can pass into body fluids (including urine, feces, vomit). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Sprycel side effects

Get emergency medical help if you have signs of an allergic reaction to Sprycel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:

  • feeling tired or short of breath (even with mild exertion);

  • swelling in your feet or lower legs;

  • blue-colored lips and skin; and

  • a light-headed feeling, like you might pass out.

Call your doctor at once if you have:

  • pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down);

  • pain in your chest, on your left side, or behind your breastbone;

  • rapid weight gain (especially in your face and midsection);

  • low platelets or red blood cells - pale skin, feeling light-headed, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • low white blood cell counts - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough; or

  • other signs of bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, confusion, headache, problems with speech, extreme weakness or drowsiness.

Common Sprycel side effects may include:

  • swelling, bleeding, blood cell disorders;

  • breathing problems;

  • headache, tiredness;

  • nausea, diarrhea; or

  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Sprycel?

Many drugs can interact with dasatinib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Sprycel, especially:

  • alfentanil or fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Subsys);

  • dexamethasone;

  • ergotamine;

  • nefazodone;

  • pimozide;

  • St. John"s wort;

  • an antibiotic - clarithromycin, rifampin, telithromycin;

  • antifungal medicine - itraconazole, ketoconazole;

  • a blood thinner - warfarin, Coumadin, Jantoven;

  • HIV/AIDS medication - atazanavir, indinavir, nelfinavir, ritonavir, saquinavir;

  • medicine to prevent organ transplant rejection - cyclosporine, sirolimus, tacrolimus;

  • seizure medication - carbamazepine, phenobarbital, phenytoin; or

  • stomach acid reducers - cimetidine, esomeprazole, famotidine, lansoprazole, omeprazole, ranitidine, Prevacid, Prilosec, Pepcid, Zantac, and others.

This list is not complete and many other drugs can interact with Sprycel. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.


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