dasatinib (Rx)

Brand and Other Names:Sprycel
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 20mg
  • 50mg
  • 70mg
  • 80mg
  • 100mg
  • 140mg

Chronic Myeloid Leukemia

Also see Administration

Newly diagnosed

  • Indicated for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • Start 100 mg PO qDay (morning or evening)
  • May increase to 140 mg qDay if inadequate response

Advanced CML

  • Indicated for treatment of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
  • Start 140 mg PO qDay
  • May increase to 180 mg qDay if inadequate response

Acute Lymphoblastic Leukemia

Indicated for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy

Start 140 mg PO qDay

May increase to 180 mg PO qDay if inadequate response

Dosage Modifications

Hepatic Impairment

  • Mild-to-moderate (Child Pugh A to B): No dosage adjustment necessary
  • Severe (Child Pugh C): Decreases mean Cmax by 43% and in mean AUC by 28% compared to normal liver function subjects

Gastric acid reducing agents

  • Do not administer H2 antagonists or proton pump inhibitors with dasatinib; consider the use of antacids in place of H2 antagonists or proton pump inhibitors
  • Administer the antacid at least 2 hr prior to or 2 hr after dasatinib dose
  • Avoid simultaneous administration of dasatinib with antacids

Concomitant strong CYP3A4 inducers

  • Avoid use
  • If coadministration of strong CYP3A4 inducer is unavoidable, consider increasing dasatinib dose and monitor for toxicity

Concomitant strong CYP3A4 inhibitors

  • Avoid use
  • Recommend an alternate concomitant medication with no or minimal enzyme inhibition potential, if possible
  • Recommended dosage adjustment if concomitant strong CYP3A4 inhibitors must be administered
    • Patient currently taking 140 mg PO qDay: Decrease to 40 mg PO qDay
    • Patient currently taking 100 mg PO qDay: Decrease to 20 mg PO qDay
    • Patient currently taking 70 mg PO qDay: Decrease to 20 mg PO qDay
    • Patients currently taking 40 or 60 mg PO qDay: Hold treatment until inhibitor is discontinued
    • If therapy is not tolerated after dose reduction, either discontinue strong CYP3A4 inhibitor or interrupt dasatinib until inhibitor is discontinued; allow a washout period of ~1 week after inhibitor is stopped before increasing dose of dasatinib

Dose adjustments for neutropenia and thrombocytopenia

  • ANC <0.5 X 10^9 or platelets <10 X 10^9
  • Chronic Phase CML
    • Hold treatment until ANC ≥1.0 X 10^9/L and platelets ≥50 X 10^9/L
    • Resume treatment at original starting dose if recovery occurs in ≤7 days
    • If platelets <25 x 10^9/L or recurrence of ANC <0.5 x 10^9/L for >7 days, hold treatment until ANC ≥1.0 X 10^9/L and platelets ≥50 X 10^9/L and resume at a reduced dose of 80 mg PO qDay for second episode
    • For third episode, further reduce dose to 50 mg PO qDay (for newly diagnosed patients) or discontinue dasatinib (for patients resistant or intolerant to prior therapy including imatinib)
  • Accelerated phase CML, blast phase CML and Ph+ ALL
    • Check if cytopenia is related to leukemia (marrow aspirate or biopsy)
    • If cytopenia is unrelated to leukemia, hold dasatinib until ANC ≥1 X 10^9/L and platelets ≥20 X 10^9/L and resume at original starting dose
    • Recurrence of cytopenia, check if cytopenia is related to leukemia and resume dasatinib at a reduced dose of 100 mg PO qDay (second episode) or 80 mg PO qDay (third episode)
    • If cytopenia is related to leukemia, consider dose escalation to 180 mg PO qDay

Dosing Considerations

In clinical studies, dasatinib in adults, children, and adolescents patients was continued until disease progression or unacceptable toxicity

The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic response or major molecular response has not been established

Dosage Forms & Strengths

tablet

  • 20mg
  • 50mg
  • 70mg
  • 80mg
  • 100mg
  • 140mg

Acute Lymphoblastic Leukemia

Indicated for patients (≥1 year) with newly diagnosed Ph+ ALL in combination with chemotherapy

Begin therapy on or before day 15 of induction chemotherapy, when diagnosis is confirmed and continue for 2 years

Recommended initial dosage based on body weight

  • <10 kg: Not recommended
  • 10 to <20 kg: 40 mg PO qDay
  • 20 to <30 kg: 60 mg PO qDay
  • 30 to <45 kg: 70 mg PO qDay
  • ≥45 kg: 100 mg PO qDay

Chronic Myeloid Leukemia

Indicated for patients (≥1 year) with Ph+ CML in chronic phase

Recommended initial dosage based on body weight

  • <10 kg: Not recommended
  • 10 to <20 kg: 40 mg PO qDay
  • 20 to <30 kg: 60 mg PO qDay
  • 30 to <45 kg: 70 mg PO qDay
  • ≥45 kg: 100 mg PO qDay

Recommended dose escalation if hematological or cytogenetic response is not achieved

  • Starting dose 40 mg PO qDay: May increase 50 mg PO qDay
  • Starting dose 60 mg PO qDay: May increase 70 mg PO qDay
  • Starting dose 70 mg PO qDay: May increase 90 mg PO qDay
  • Starting dose 100 mg PO qDay: May increase 120 mg PO qDay

Also see Administration

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate (Child Pugh A to B): No dosage adjustment necessary
  • Severe (Child Pugh C): Decreases mean peak plasma concentration by 43% and in mean AUC by 28% compared to normal liver function subjects

Gastric acid reducing agents

  • Do not administer H2 antagonists or proton pump inhibitors with dasatinib; consider the use of antacids in place of H2 antagonists or proton pump inhibitors
  • Administer the antacid at least 2 hr prior to or 2 hr after dasatinib dose
  • Avoid simultaneous administration of dasatinib with antacids

Concomitant strong CYP3A4 inducers

  • Avoid use
  • If coadministration of strong CYP3A4 inducer is unavoidable, consider increasing dasatinib dose and monitor for toxicity

Concomitant strong CYP3A4 inhibitors

  • Avoid use
  • Recommend an alternate concomitant medication with no or minimal enzyme inhibition potential, if possible
  • Recommended dosage adjustment if concomitant strong CYP3A4 inhibitors must be administered
    • Patient currently taking 140 mg PO qDay: Decrease to 40 mg PO qDay
    • Patient currently taking 100 mg PO qDay: Decrease to 20 mg PO qDay
    • Patient currently taking 70 mg PO qDay: Decrease to 20 mg PO qDay
    • Patients currently taking 40 or 60 mg PO qDay: Hold treatment until inhibitor is discontinued
    • If therapy is not tolerated after dose reduction, either discontinue strong CYP3A4 inhibitor or interrupt dasatinib until inhibitor is discontinued; allow a washout period of ~1 week after inhibitor is stopped before increasing dose of dasatinib

Dose adjustments for neutropenia and thrombocytopenia

  • Cytopenia persists for >3 weeks, check if cytopenia is related to leukemia (marrow aspirate or biopsy)
  • Cytopenia is unrelated to leukemia, stop treatment until ANC ≥1 X 10^9/L and platelets ≥75 X 10^9/L and resume at original starting dose or at a reduced dose
  • Cytopenia recurs, repeat marrow aspirate/biopsy and resume at a reduced dose
  • Patients with chronic phase CML: If Grade ≥3 neutropenia or thrombocytopenia recurs during complete hematologic response (CHR), interrupt treatment and resume at a reduced dose; implement temporary dose reductions for intermediate degrees of cytopenia and disease response as needed
  • Patients with Ph+ ALL: Neutropenia and/or thrombocytopenia delays next block of treatment by > 14 days; interrupt dose and resume at the same dose level once the next block of treatment is started
  • Patients with Ph+ ALL: Neutropenia and/or thrombocytopenia persist and next block of treatment is delayed another 7 days; perform a bone marrow assessment to assess cellularity and percentage of blasts; if marrow cellularity <10%, interrupt treatment until ANC >500/mcL; if marrow cellularity >10%, consider resumption of treatment
  • One-level dose reduction
    • Starting dose 40 mg PO qDay: May increase 20mg PO qDay
    • Starting dose 60 mg PO qDay: May increase 40 mg PO qDay
    • Starting dose 70 mg PO qDay: May increase 60 mg PO qDay
    • Starting dose 100 mg PO qDay: May increase 80 mg PO qDay
  • Two-level dose reduction
    • Starting dose 40 mg PO qDay: Lower tablet dose not available
    • Starting dose 60 mg PO qDay: May increase 20 mg PO qDay
    • Starting dose 70 mg PO qDay: May increase 50 mg PO qDay
    • Starting dose 100 mg PO qDay: May increase 70 mg PO qDay

Dose adjustments for nonhematologic adverse reactions

  • Ph+ CML: Severe nonhematologic adverse reaction develops: Withhold treatment until the event resolves or improves; resume as appropriate at a reduced dose depending on severity and recurrence of the event
  • Ph+ ALL: Interrupt treatment for cases of Grade >3 nonhematologic adverse reactions with the exception of liver function test abnormalities, and resume at a reduced dose when resolved to Grade ≤1; if direct bilirubin is >5x ULN or AST/ALT >15x ULN, interrupt therapy until recovery to Grade ≤1 and then resume treatment at original starting dose or at a reduced dose for recurrent events
  • One-level dose reduction
    • Starting dose 40 mg PO qDay: May increase 20mg PO qDay
    • Starting dose 60 mg PO qDay: May increase 40 mg PO qDay
    • Starting dose 70 mg PO qDay: May increase 60 mg PO qDay
    • Starting dose 100 mg PO qDay: May increase 80 mg PO qDay
  • Two-level dose reduction
    • Starting dose 40 mg PO qDay: Lower tablet dose not available
    • Starting dose 60 mg PO qDay: May increase 20 mg PO qDay
    • Starting dose 70 mg PO qDay: May increase 50 mg PO qDay
    • Starting dose 100 mg PO qDay: May increase 70 mg PO qDay
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Interactions

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            Adverse Effects

            >10%

            Fluid retention, incl CHF, pulm edema, pleural effusion (50%)

            Diarrhea (49%)

            Headache (40%)

            Hemorrhage (40%)

            Fatigue (39%)

            Pyrexia (39%)

            Skin rash (35%)

            Infection (34%)

            Nausea (34%)

            Dyspnea (32%)

            Cough (28%)

            Pain (26%)

            Abdominal pain (25%)

            Vomiting (22%)

            Anorexia (19%)

            Arthralgia (19%)

            Asthenia (19%)

            Constipation (14%)

            Dizziness (14%)

            Musculoskeletal pain (14%)

            Weight loss (14%)

            Chest pain (13%)

            Neuropathy (13%)

            Myalgia (12%)

            Abdominal distention (11%)

            Arrhythmia (11%)

            Chills (11%)

            Pneumonia (11%)

            Pruritus (11%)

            Weight gain (11%)

            1-10% (selected)

            Anemia

            Febrile neutropenia

            Thrombocytopenia

            Mucosal inflammation

            Postmarketing Reports

            Cardiac disorders: Atrial fibrillation/atrial flutter

            Vascular disorders: Thrombosis/embolism (including pulmonary embolism, deep vein thrombosis)

            Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease, pulmonary arterial hypertension

            Dermatologic reactions: Stevens-Johnson syndrome, erythema multiforme

            Infections: Hepatitis B virus reactivation

            Renal and urinary disorders: Nephrotic syndrome

            Blood and lymphatic system disorders: Thrombotic microangiopathy

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            Warnings

            Contraindications

            None

            Cautions

            Use caution in hepatic impairment

            Use with caution in patients who have or may develop prolongation of QT interval; may increase risk of prolongation of QTc in patients including those with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking antiarrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy; correct hypokalemia or hypomagnesemia prior to and during therapy

            Cardiac adverse reactions were reported in 5.8% of 258 patients including cardiomyopathy (1.6%), congestive heart failure, diastolic dysfunction, fatal myocardial infarction, and left ventricular dysfunction; monitor patients for signs or symptoms and treat appropriately

            Tumor lysis syndrome reported; maintain adequate hydration and correct uric acid levels prior to initiating therapy; monitor electrolyte levels; patients with advanced-stage disease and/or high tumor burden may be at increased risk and should be monitored more frequently

            Risk of fluid retention and pleural/pericardial effusion; manage with supportive care measures and/or dose modification; evaluate patients who develop symptoms of pleural effusion or other fluid retention, such as new or worsened dyspnea on exertion or at rest, pleuritic chest pain, or dry cough, promptly with a chest x-ray or additional diagnostic imaging as appropriate; fluid retention events were typically managed by supportive care measures that may include diuretics or short courses of steroids; severe pleural effusion may require thoracentesis and oxygen therapy; consider dose reduction or treatment interruption

            Embryofetal toxicity reported (see Pregnancy)

            In pediatric trials of dasatinib in chronic phase CML after at least 2 years of treatment, adverse reactions associated with bone growth and development were reported, including epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia; monitor bone growth and development in pediatric patients

            Myelosuppression including severe thrombocytopenia, neutropenia and anemia

            • May manage by dose interruption, dose reduction, or discontinuation of therapy
            • Hematopoietic growth factor has been used with resistant myelosuppression

            Patients with chronic phase CML and pediatric Ph+ ALL

            • Perform complete blood cell counts (CBCs) every 2 weeks for 12 weeks, then q3Months thereafter, or as clinically indicated
            • Perform CBCs weekly for the first 2 months and then monthly thereafter, or as clinically indicated in patients with advanced phase CML or Ph+ ALL

            Pediatric patients with Ph+ ALL treated in combination with chemotherapy

            • Perform CBCs prior to start of each block of chemotherapy and as clinically indicated
            • During consolidation blocks of chemotherapy, perform CBCs every 2 days until recovery

            Bleeding

            • Can cause serious and fatal bleeding; incidence of Grade 3/4 hemorrhage, most commonly gastrointestinal, reported, requiring treatment interruptions and transfusions
            • Most bleeding events associated with severe thrombocytopenia; also shown to cause platelet dysfunction in vitro
            • Concomitant medications that inhibit platelet function or anticoagulants may increase risk of hemorrhage
            • Severe hemorrhage may require treatment interruption and transfusion

            Pulmonary arterial hypertension

            • Increased risk of developing pulmonary arterial hypertension (PAH)
            • May be reversible upon discontinuation of therapy
            • Evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to initiation and during treatment
            • If PAH confirmed permanently discontinue therapy

            Severe mucocutaneous dermatologic reactions

            • Cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, reported
            • Discontinue permanently in patients who experience severe mucocutaneous reaction during treatment if no other etiology can be identified

            Drug interactions overview

            • Avoid concomitant CYP3A4 inducers/inhibitors
            • If unavoidable, consider dose modification as appropriate (see Dosage Modifications)
            • Coadministration of dasatinib with a gastric acid reducing agent may decrease the concentrations of dasatinib and reduce efficacy (see Dosage Modifications)
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            Pregnancy & Lactation

            Pregnancy

            Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman; adverse pharmacologic effects (eg, hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia) have been reported with maternal exposure to dasatinib

            Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates; skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses; these findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib

            Advise a pregnant woman of the potential risk to a fetus

            Transplacental transfer of dasatinib has been reported

            Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 30 days after last dose

            Based on animal data, dasatinib may result in damage to female and male reproductive tissues

            Lactation

            No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production

            However, dasatinib is present in the milk of lactating rats

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Multi-kinase inhibitor that inhibits BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-Kit, EPHA2 and PDGFR-beta kinases; tyrosine kinase inhibition possibly blocks angiogenesis and cellular proliferation

            Absorption

            Peak plasma time: 0.5-6 hr

            Peak plasma concentration: 82.2 ng/mL (100 mg PO qDay)

            AUC: 397 ng/mL·hr (100 mg PO qDay)

            High-fat meal increased mean AUC of dasatinib following a single dose of 100 mg by 14%

            Distribution

            Protein Bound: 96% (dasatinib); 93% (active metabolites)

            Vd: 2505 L

            Metabolism

            Metabolism: extensively metabolized primarily by CYP3A4

            Enzymes inhibited: CYP3A4 (weak)

            Dasatinib is a P-gp substrate

            Elimination

            Half-Life: 3-5 hr

            Clearance: 363.8 l/hr

            Excretion: Feces (85%); urine (4%)

            Pharmacogenomics

            Tyrosine kinase inhibitors (TKIs) inhibit activity of BCR-ABL fusion protein, resulting in both hematologic response (ie, normal cell counts in the peripheral blood and normal bone marrow morphology), as well as cytogenetic response (ie, disappearance or reduction of the Philadelphia [Ph] chromosome)

            NCCN clinical practice guidelines recommends TKIs in CML with confirmed BCR-ABL transcripts in bone marrow or evidence of translocation on cytogenetics

            Genetic testing laboratories

            • The following companies currently offer FISH and/or transcript quantification testing for BCR-ABL
            • Asuragen (http://www.asuragen.com/)
            • Dako (http://www.dakousa.com/)
            • Invitrogen (http://www.invitrogen.com/)
            • Ipsogen (http://www.ipsogen.com)
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            Administration

            Oral Administration

            Take with or without meals, either in the morning or evening

            Swallow tablet whole; do not cut, crush, or chew

            Follow special handling and disposal procedures

            Personnel who are pregnant should avoid exposure to crushed or broken tablets

            Storage

            Tablets: Store at room temperature at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Sprycel oral
            -
            50 mg tablet
            Sprycel oral
            -
            20 mg tablet
            Sprycel oral
            -
            70 mg tablet
            Sprycel oral
            -
            140 mg tablet
            Sprycel oral
            -
            80 mg tablet
            Sprycel oral
            -
            100 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            dasatinib oral

            DASATINIB - ORAL

            (da-SA-ti-nib)

            COMMON BRAND NAME(S): Sprycel

            USES: This medication is used to treat certain types of cancer (chronic myeloid leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking dasatinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush, chew, or break the tablets.The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Children's dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.Avoid taking antacids (such as aluminum/magnesium hydroxide, calcium carbonate) within 2 hours before or after taking this medication because they will prevent your body from fully absorbing this drug.Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

            SIDE EFFECTS: See also Precautions section.Diarrhea, nausea/vomiting, muscle/joint pain, stomach/abdominal pain, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: dry cough, swelling/pain in the hands/ankles/feet, sudden/unexplained weight gain, shortness of breath.Get medical help right away if you have any very serious side effects, including: vomit that looks like coffee grounds, black/bloody stools, severe dizziness, fainting, fast/slow/irregular heartbeat, chest pain, confusion, weakness on one side of the body.Dasatinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking dasatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, current/recent infection, heart problems (such as irregular heartbeat), liver problems (such as hepatitis B).Dasatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using dasatinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dasatinib safely.Dasatinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using dasatinib before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This medication may affect a child's bone growth and development. Consult the doctor or pharmacist for more details.Older adults may be more sensitive to the side effects of this drug, especially diarrhea, swelling hands/ankles/feet, sudden/unexplained weight gain, unusual tiredness, shortness of breath, and QT prolongation (see above).Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using dasatinib. Dasatinib may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 30 days after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 30 days after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran), drugs that reduce stomach acid (for example, antacids, H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as omeprazole).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Other medications can affect the removal of dasatinib from your body, which may affect how dasatinib works. Examples include azole antifungals (such as itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (such as clarithromycin), rifamycins (such as rifampin, rifabutin), saquinavir, St. John's wort, telithromycin, among others.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as bone growth and development in children, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised November 2021. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.