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Sprycel

(dasatinib)

How does this medication work? What will it do for me?

Dasatinib belongs to the class of medications called protein-tyrosine kinase inhibitors. Dasatinib works by inhibiting the activity of proteins that are responsible for the uncontrolled growth of leukemia cells. By inhibiting these proteins, dasatinib kills the leukemia cells in the bone marrow and allows normal blood cells to be produced.

It is used to treat adults with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). It is also used to treat adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who have not responded or tolerated other treatments.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

Treatment with dasatinib should be started under the direct supervision of a physician experienced in the treatment of the conditions this medication is used to treat.

For chronic myeloid leukemia (CML), the recommended starting dose of dasatinib is 100 mg once daily, either in the morning or in the evening.

For accelerated or blast crisis CML or for Ph+ acute lymphoblastic leukemia (ALL), the recommended starting dose of dasatinib is 140 mg once daily, either in the morning or in the evening.

Your dose may be adjusted depending on your response to the medication and on the side effects you experience.

Dasatinib may be taken with or without food. The tablets should be swallowed whole and should not be crushed or cut. Try to take the medication at the same time each day. Avoid drinking grapefruit juice, as it may increase the blood levels of dasatinib and increase the risk of side effects.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, take your next scheduled dose at its regular time. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

20 mg
Each white-to-off-white, biconvex, round, film-coated tablet with "BMS" debossed on one side and "527" on the other contains 20 mg of dasatinib. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

50 mg
Each white-to-off-white, biconvex, oval, film-coated tablet with "BMS" debossed on one side and "528" on the other contains 50 mg of dasatinib. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

70 mg
Each white-to-off-white, biconvex, round, film-coated tablet with "BMS" debossed on one side and "524" on the other contains 70 mg of dasatinib. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

80 mg
Each white-to-off-white, biconvex, triangular, film-coated tablet with "BMS" over "80" debossed on one side and "855" on the other side contains 80 mg of dasatinib. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

100 mg
Each white-to-off-white, biconvex, oval, film-coated tablet with "BMS 100" debossed on one side and "852" on the other side contains 100 mg of dasatinib. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

140 mg
Each white-to-off-white, biconvex, round, film-coated tablet with "BMS" over "140" debossed on one side and "857" on the other side contains 140 mg of dasatinib. Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you are allergic to dasatinib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • cough
  • diarrhea
  • fatigue
  • fever
  • headache
  • inflammation of mucous membranes (e.g., inside the mouth)
  • muscle, joint, or bone pain
  • nausea
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • dizziness or feeling faint
  • signs of anemia (low red blood cells; e.g., dizziness, fatigue, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of bleeding (e.g., unusual nosebleeds, bruising, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of fluid retention (rapid weight gain, swelling, increasing shortness of breath)
  • signs of infection (fever, severe chills, sore throat, or mouth ulcers)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of muscle damage (e.g., unexpected muscle pain or aches, weakness, dark urine)
  • skin rash
  • symptoms of low blood pressure (dizziness, lightheadedness)
  • unexpected bleeding or bruising without suffering from any injury

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • dizziness, irregular, or forceful heartbeat
  • fainting
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of a stroke (sudden and severe headache, vision changes, difficulty speaking, dizziness, weakness, or numbness)
  • symptoms of an allergic reaction (hives; difficulty breathing; wheezing; swelling of lips, mouth, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: This medication can cause abnormal heart rhythms, especially for people who have certain heart problems (e.g., congenital long QT syndrome), who are taking medication(s) to control heart rhythm (e.g., amiodarone, disopyramide, quinidine, sotalol), who have received high doses of anthracycline chemotherapy (e.g., daunorubicin, doxorubicin, mitoxantrone), or who are prone to low potassium and magnesium blood levels. Your doctor can assess your risk by reviewing your medications and checking your blood and electrocardiogram (ECG).

Anemia: Dasatinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, and adjust your dose or temporarily stop it. In severe cases, you may need to receive transfusions of red blood cells.

Bleeding: Dasatinib may cause bleeding from various sources. The most serious bleeding may occur in the stomach and the brain. If you experience signs of stomach bleeding (severe stomach pain, black stools, vomiting blood, dizziness) or bleeding into the brain (severe and sudden headache, dizziness, trouble speaking, numbness, or weakness), get immediate medical attention.

Blood counts: This medication can decrease the number of red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia). Your doctor will do blood tests to monitor for this and adjust your dose of dasatinib or temporarily stop it if your blood counts are too low. If you develop a fever while your blood cell counts are low, contact your doctor immediately.

Congestive heart failure: People taking dasatinib have experienced congestive heart failure (the heart is not able to pump blood efficiently). This is usually accompanied by fluid retention (see below) or fluid in the lungs (pulmonary edema). If you experience shortness of breath, swelling, or rapid weight gain, contact your doctor immediately.

Fertility: The effects of dasatinib on male and female fertility are not known. Men and women should use adequate contraception while receiving dasatinib. Talk to your doctor about what forms of contraception would be adequate.

Fluid retention: This medication can cause serious fluid retention. Contact your doctor immediately if you experience swelling in your feet, ankles, lower legs, or hands; weight gain; or increasing shortness of breath. Your doctor will weigh and monitor you regularly for signs of fluid retention while you are taking this medication.

Grapefruit juice: Grapefruit juice can increase the blood levels of dasatinib and increase the risk of potentially serious side effects. Do not drink grapefruit juice while taking this medication.

Infection: As well as killing cancer cells, dasatinib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of white blood cells in your blood and adjust the dose or temporarily stop it if your blood counts are too low.

Lactose: This medication contains lactose. If you have galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption, do not take dasatinib.

Liver function: Liver problems such as inflammation and increased liver enzyme levels in the blood have occurred in people taking dasatinib. Your doctor may monitor your liver function regularly while taking this medication. If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pulmonary hypertension: There have been rare reports of pulmonary hypertension. Pulmonary hypertension is an increased blood pressure in the pulmonary arteries, the blood vessels that carry blood from the heart to the lungs. If you experience shortness of breath and fatigue, contact your doctor as soon as possible. If you have a heart problem or lung disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy or by women who are planning to become pregnant. If it is taken by a woman who is pregnant, it may harm the developing baby. Women should avoid becoming pregnant while taking dasatinib. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dasatinib passes into breast milk. Due to the potential for serious harm to a baby if they are exposed to this medication, breast-feeding must be stopped before starting this medication.

Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.

Seniors: People over the age of 65 years may be more at risk of side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between dasatinib and any of the following:

  • abiraterone
  • acetaminophen
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amiodarone
  • antacids containing aluminum or magnesium
  • anti-cancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aprepitant
  • anagrelide
  • apixaban
  • ASA
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • bicalutamide
  • bisoprolol
  • boceprevir
  • bosentan
  • bromocriptine
  • buprenorphine
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • chloroquine
  • cilostazol
  • clopidogrel
  • conivaptan
  • cyclosporine
  • dabigatran
  • dantrolene
  • dapsone
  • darifenacin
  • deferasirox
  • dexamethasone
  • digoxin
  • disopyramide
  • dofetilide
  • domperidone
  • dronedarone
  • droperidol
  • echinacea
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • ethosuximide
  • everolimus
  • fingolimod
  • flecainide
  • flutamide
  • fusidic acid
  • "gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
  • grapefruit juice
  • H2-antagonists (e.g., cimetidine, ranitidine, famotidine, nizatidine)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • heparin
  • hydrocodone
  • indacaterol
  • leflunomide
  • lidocaine
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • lomitapide
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maraviroc
  • mefloquine
  • mestranol
  • methadone
  • metronidazole
  • mifepristone
  • mirtazapine
  • modafinil
  • montelukast
  • natalizumab
  • nateglinide
  • nefazodone
  • nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • ondansetron
  • oxcarbazepine
  • oxycodone
  • phenytoin
  • pimecrolimus
  • pimozide
  • prasugrel
  • praziquantel
  • primaquine
  • primidone
  • procainamide
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • other protein kinase inhibitors (e.g., bosutinib, nilotinib, imatinib)
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • proton pump inhibitors (e.g., omeprazole, rabeprazole, pantoprazole)
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • repaglinide
  • rifabutin
  • rifampin
  • rilpivirine
  • rivaroxaban
  • roflumilast
  • romidepsin
  • salmeterol
  • St. John’s wort
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
  • sildenafil
  • siltuximab
  • simeprevir
  • sirolimus
  • sotalol
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • tamoxifen
  • temsirolimus
  • teniposide
  • telaprevir
  • tetrabenazine
  • tetracycline
  • theophylline
  • ticagrelor
  • ticlopidine
  • tocilizumab
  • tolterodine
  • tolvaptan
  • trabectedin
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • vaccines
  • warfarin
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sprycel

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