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Sprycel

Sprycel

(dasatinib)

Sprycel (Dasatinib) belongs to the class of medications called protein-tyrosine kinase inhibitors. Sprycel (Dasatinib) works by inhibiting the activity of proteins that are responsible for the uncontrolled growth of Leukemia cells.

Available form

Dosage

Tablet

20MG, 50MG, 70MG, 80MG, 100MG

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Sprycel information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

Treatment with Sprycel (Dasatinib) should be started under the direct supervision of a physician experienced in the treatment of the conditions Sprycel (Dasatinib) is used to treat.

For chronic myeloid leukemia (CML), the recommended starting dose of Sprycel (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 Sprycel (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.

Sprycel (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 Sprycel (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 Sprycel (Dasatinib) 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 Sprycel (Dasatinib) 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.

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 Sprycel (Dasatinib). If you are concerned about side effects, discuss the risks and benefits of Sprycel (Dasatinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Sprycel (Dasatinib). 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
fever and chills
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)
shortness of breath and fatigue
skin rash
symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
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:

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 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 Sprycel (Dasatinib).

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 Sprycel (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 Sprycel (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 Sprycel (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 Sprycel (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 Sprycel (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 Sprycel (Dasatinib). Nonmedicinal ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose; film coating: hypromellose, polyethylene glycol, and titanium dioxide.

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 Sprycel (Dasatinib).

Abnormal heart rhythm: Sprycel (Dasatinib) 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: Sprycel (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: Sprycel (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: Sprycel (Dasatinib) 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 Sprycel (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 Sprycel (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 Sprycel (Dasatinib) on male and female fertility are not known. Men and women should use adequate contraception while receiving Sprycel (Dasatinib). Talk to your doctor about what forms of contraception would be adequate.

Fluid retention: Sprycel (Dasatinib) 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 Sprycel (Dasatinib).

Grapefruit juice: Grapefruit juice can increase the blood levels of Sprycel (Dasatinib) and increase the risk of potentially serious side effects. Do not drink grapefruit juice while taking Sprycel (Dasatinib).

Hepatitis B Reactivation: Sprycel (Dasatinib) may cause hepatitis B infection that is dormant to become active again, which can result in further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how Sprycel (Dasatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, Sprycel (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: Sprycel (Dasatinib) contains lactose. If you have galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption, do not take Sprycel (Dasatinib).

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

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

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 Sprycel (Dasatinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sprycel (Dasatinib), and whether any special monitoring is needed.

Pregnancy: Sprycel (Dasatinib) 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 Sprycel (Dasatinib). If you become pregnant while taking Sprycel (Dasatinib), contact your doctor immediately.

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

Children: The safety and effectiveness of using Sprycel (Dasatinib) 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 Sprycel (Dasatinib).

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