Dasatinib (Systemic)

Brand names: Sprycel
Drug class: Antineoplastic Agents

Usage of Dasatinib (Systemic)

Chronic Myelogenous Leukemia (CML)

Treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) CML in adults who are in the chronic phase of the disease.

Treatment of Ph+ CML in adults who are in myeloid or lymphoid blast crisis, in the accelerated phase, or in the chronic phase of the disease, after failure (secondary to resistance or intolerance) of prior therapy including Imatinib.

Treatment of Ph+ CML in pediatric patients ≥1 year of age who are in the chronic phase of the disease.

Designated an orphan drug by FDA for use in the treatment of CML.

Acute Lymphocytic (Lymphoblastic) Leukemia (ALL)

Treatment of Philadelphia chromosome-positive (Ph+) ALL in adults following failure (secondary to resistance or intolerance) of prior therapy.

In combination with chemotherapy for the treatment of newly diagnosed Ph+ ALL in pediatric patients ≥1 year of age.

Designated an orphan drug by FDA for use in the treatment of acute ALL.

Other Uses

Has been used for the treatment of Noonan-syndrome† [off-label] associated with hypertrophic cardiomyopathy. Designated an orphan drug by FDA for use in this condition.

Has been used for the treatment of gastrointestinal stromal tumors (GIST)† [off-label].

Relate drugs

How to use Dasatinib (Systemic)

General

Pretreatment Screening

  • Complete blood cell count (CBC).
  • Correct electrolyte abnormalities (e.g. hypokalemia, hypomagnesemia) prior to initiating therapy.
  • Correct uric acid levels prior to initiating therapy.
  • Monitor transaminases at baseline.

    • Patient Monitoring

    Adult Patients
  • Adults with CML in chronic phase: Monitor CBC every 2 weeks during the first 3 months of therapy and then every 3 months (or as clinically indicated) thereafter.
  • Adults with accelerated phase CML or Ph+ ALL: Monitor CBC weekly during the first 2 months of therapy and monthly (or as clinically indicated) thereafter.
  • Monitor electrolytes, particularly potassium and magnesium, periodically during therapy.
  • Monitor for signs and symptoms of cardiac toxicity.
  • Monitor transaminases monthly or as clinically indicated during therapy.
    • Pediatric Patients
  • Pediatric patients with CML in chronic phase: Monitor CBC every 2 weeks during the first 3 months of therapy and then every 3 months (or as clinically indicated) thereafter.
  • Pediatric patients with Ph+ ALL: Monitor CBC as clinically indicated; during consolidation chemotherapy, obtain CBC every 2 days until recovery.
  • Monitor electrolytes, particularly potassium and magnesium, periodically during therapy.
  • Monitor for signs and symptoms of cardiac toxicity.
  • Monitor bone growth and development.
  • Monitor transaminases monthly or as clinically indicated during therapy.

    • Dispensing and Administration Precautions

    Handling and Disposal
  • Consult specialized references for procedures for proper handling (e.g., use of gloves) and disposal of antineoplastics.
  • Dasatinib may cause fetal harm; pregnant females should not handle crushed or broken dasatinib tablets.
  • Based on the Institute for Safe Medication Practices (ISMP), dasatinib is a high-alert medication that has a heightened risk of causing significant patient harm when used in error.

    • Other General Considerations

  • Maintain adequate hydration throughout therapy.

    • Administration

    Oral Administration

    Administer orally once daily (morning or evening) without regard to meals.

    Administer at the SAMe time each day.

    Swallow tablets whole; do not cut, chew, or crush.

    If a dose is missed, take the next dose at its regular time. Do not take two doses at the same time.

    Dosage

    Pediatric Patients

    CML Chronic Phase Oral

    ≥1 year of age: Dosage is based on body weight as described in Table 1. Recalculate dosage every 3 months or more frequently if necessary to account for changes in body weight.

    Tablet dosing not recommended in pediatric patients weighing <10 kg.

    Table 1. Dasatinib Dosing in Pediatric Patients with Chronic Phase CML1

    Body Weight (kg)

    Recommended Starting Dosage

    10 to <20

    40 mg once daily

    20 to <30

    60 mg once daily

    30 to <45

    70 mg once daily

    ≥45

    100 mg once daily

    In patients who do not achieve a hematologic or cytogenetic response at the recommended initial dosage, increase dasatinib dosage as described in Table 2.

    Table 2. Dasatinib Dosage Escalation in Pediatric Patients with Chronic Phase CML1

    Starting Dosage

    Escalated Dosage

    40 mg once daily

    50 mg once daily

    60 mg once daily

    70 mg once daily

    70 mg once daily

    90 mg once daily

    100 mg once daily

    120 mg once daily

    Systemic exposure of dasatinib following administration of dasatinib tablets dispersed in juice was 36% lower compared to intact tablets in 5 patients 2–10 years of age with Ph+ ALL. Efficacy and safety of dispersing dasatinib tablets not established.

    Continue treatment until evidence of disease progression or until no longer tolerated by the patient.

    Optimal duration of therapy has not been clearly established.

    ALL Oral

    ≥1 year of age (in combination with chemotherapy): Dosage is based on body weight as described in Table 3. Recalculate dosage every 3 months or more frequently if necessary to account for changes in body weight. Continue therapy for 2 years.

    Initiate therapy on or before day 15 of induction chemotherapy. Dosage escalations are not recommended for pediatric Ph+ ALL since dasatinib is administered in combination with chemotherapy.

    Tablet dosing not recommended in pediatric patients weighing <10 kg.

    Table 3. Dasatinib Dosing in Pediatric Patients with Ph+ ALL1

    Body Weight (kg)

    Recommended Starting Dosage

    10 to <20

    40 mg once daily

    20 to <30

    60 mg once daily

    30 to <45

    70 mg once daily

    ≥45

    100 mg once daily

    Systemic exposure of dasatinib following administration of dasatinib tablets dispersed in juice was 36% lower compared to intact tablets in 5 patients 2–10 years of age with Ph+ ALL. Efficacy and safety of dispersing dasatinib tablets not established.

    Dosage Modification Nonhematologic Adverse Effects Oral

    If a severe nonhematologic adverse Reaction occurs, withhold dasatinib until the toxicity has resolved or improved. Thereafter, resume therapy, as appropriate, at a reduced dosage Depending on the initial severity of the event.

    In pediatric patients with Ph+ ALL, temporarily interrupt therapy if grade 2 nonhematologic toxicity occurs; when the toxicity improves to grade 1 or less, resume therapy at original dosage or reduce dosage (following a subsequent episode) as described in Table 4. If grade 3 nonhematologic toxicity occurs, temporarily interrupt therapy; when toxicity resolves to grade 1 or less, resume therapy at a reduced dosage as described in Table 4.

    If elevated direct bilirubin concentrations >5 times the ULN or AST/ALT concentration >15 times the ULN occurs, temporarily interrupt therapy; when toxicity resolves to grade 1 or less, resume therapy at the original dosage or reduce dosage (following a subsequent episode) as described in Table 4.

    Table 4. Dasatinib Dosage Adjustment for Nonhematologic Toxicities in Pediatric Patients1

    Original Starting Dosage

    One-level Dosage Reduction

    Two-level Dosage Reduction

    40 mg

    20 mg

    Lower tablet strength not available

    60 mg

    40 mg

    20 mg

    70 mg

    60 mg

    50 mg

    100 mg

    80 mg

    70 mg

    Hematologic Adverse Effects Oral

    In patients in the chronic phase of CML experiencing grade 3 or higher Neutropenia or thrombocytopenia during complete hematologic response, temporarily withhold therapy. May resume dasatinib therapy at a reduced dosage. Temporary dosage reductions may be necessary for intermediate degrees of neutropenia and thrombocytopenia and disease response.

    In patients with Ph+ ALL experiencing persistent (>3 weeks) neutropenia or thrombocytopenia unrelated to ALL (as determined by bone marrow aspirate or biopsy). Treatment may be resumed at the original starting dosage or at a reduced dosage as described in Table 5 when ANC resolves to ≥1000/mm3 and platelet counts resolve to ≥75,000/mm3. If neutropenia or thrombocytopenia recurs, repeat bone marrow aspirate or biopsy and resume dasatinib at a reduced dosage (Table 5). If neutropenia and/or thrombocytopenia delay the next cycle by >14 days, interrupt dasatinib therapy and resume at the same dosage once the next cycle starts. If neutropenia and/or thrombocytopenia persist and the next cycle is further delayed by 7 days, perform a bone marrow assessment to assess cellularity and percentage of blasts. If bone marrow cellularity is <10%, interrupt treatment with dasatinib until ANC >500/mm3. If neutropenia and/or thrombocytopenia recur and delay the next cycle by 7 days, repeat bone marrow aspirate or biopsy. If marrow cellularity is less than 10%, treatment may be resumed at the full dosage once ANC exceeds 500/mm3. If bone marrow cellularity is greater than 10%, consider resuming therapy.

    Table 5. Dasatinib Dosage Adjustment for Neutropenia or Thrombocytopenia in Pediatric Patients with Ph+ ALL1

    Original Starting Dosage

    One-level Dosage Reduction

    Two-level Dosage Reduction

    40 mg

    20 mg

    Lower tablet strength not available

    60 mg

    40 mg

    20 mg

    70 mg

    60 mg

    50 mg

    100 mg

    80 mg

    70 mg

    Adults

    CML Chronic Phase Oral

    100 mg once daily. If hematologic or cytogenetic response is not achieved, increase dosage to 140 mg once daily.

    Continue treatment until evidence of disease progression or until no longer tolerated by the patient.

    Optimal duration of therapy has not been clearly established.

    Accelerated Phase or Blast Crisis Oral

    140 mg once daily. If hematologic or cytogenetic response is not achieved, increase dosage to 180 mg once daily.

    Continue treatment until evidence of disease progression or until no longer tolerated by the patient.

    Optimal duration of therapy has not been clearly established.

    ALL Oral

    140 mg once daily. If hematologic or cytogenetic response is not achieved, increase dosage to 180 mg once daily.

    Continue treatment until evidence of disease progression or until no longer tolerated by the patient.

    Optimal duration of therapy has not been clearly established.

    Dosage Modification for Toxicity Nonhematologic Adverse Effects Oral

    If a severe nonhematologic adverse reaction occurs, withhold dasatinib until the toxicity has resolved or improved. Thereafter, resume therapy, as appropriate, at a reduced dosage depending on the initial severity of the event.

    Adverse Hematologic Effects Oral

    Temporary interruption, dosage reduction, or discontinuance is indicated in patients experiencing severe neutropenia and/or thrombocytopenia (see Tables 6 and 7). Hematopoietic growth factor has been used in patients with resistant myelosuppression.

    Table 6. Chronic Phase CML: Dosage Adjustments for Neutropenia and Thrombocytopenia1

    Initial Dosage

    Episode of Neutropenia or Thrombocytopenia (Hematologic Measurements)

    Dosage Adjustment

    100 mg once daily

    First episode (ANC <500/mm3 or platelets <50,000/mm3)

    Withhold dasatinib; may resume at original dosage (100 mg once daily) if ANC reaches ≥1000/mm3 and platelets reach ≥50,000/mm3 within 7 days

    Second episode (ANC <500/mm3 lasting >7 days or platelets <25,000/mm3)

    Withhold dasatinib; may resume at reduced dosage of 80 mg once daily when ANC reaches ≥1000/mm3 and platelets reach ≥50,000/mm3

    Third episode (ANC <500/mm3 lasting >7 days or platelets <25,000/mm3)

    Patients receiving dasatinib for newly diagnosed disease: Withhold dasatinib; may resume at reduced dosage of 50 mg once daily when ANC reaches ≥1000/mm3 and platelets reach ≥50,000/mm3

    Patients receiving dasatinib following failure of prior therapy: Discontinue drug

    Table 7. Accelerated Phase or Blast Phase CML and Ph+ ALL: Dosage Adjustments for Neutropenia and Thrombocytopenia1

    Initial Dosage

    Hematologic Measurements

    Dosage Adjustment

    140 mg once daily

    ANC <500/mm3 or platelets <10,000/mm3

    1. If cytopenia is unrelated to leukemia (as determined by marrow aspirate or biopsy), discontinue dasatinib until ANC ≥1000/mm3 and platelets ≥20,000/mm3

    2. Resume treatment at original dosage (140 mg once daily)

    3. If recurrence of ANC <500/mm3 or platelets <10,000/mm3 occurs, repeat step 1 and resume therapy at a reduced dosage of 100 mg once daily (following a second episode) or 80 mg once daily (following a third episode)

    4. If cytopenia is related to leukemia (as determined by marrow aspirate or biopsy), consider increasing dosage to 180 mg once daily

    Special Populations

    Hepatic Impairment

    No special dosage recommendations at this time.

    Renal Impairment

    No special dosage recommendations at this time.

    Geriatric Patients

    No special dosage recommendations at this time.

    Warnings

    Contraindications

  • No known contraindications.

    • Warnings/Precautions

    Hematologic Effects

    Myelosuppression (principally severe neutropenia, anemia, and thrombocytopenia) occurs commonly and is usually reversible; more frequent in patients in the accelerated or blast phase of CML and in those with Ph+ ALL than in patients in the chronic phase of CML.

    Temporary suspension of therapy or dosage reduction may be required if hematologic toxicity occurs.

    In patients with chronic phase CML, perform CBC every 2 weeks during the first 3 months of therapy and then every 3 months (or as clinically indicated) thereafter. In patients with advance phase CML or Ph+ ALL, perform CBCs weekly during the first 2 months of therapy and monthly (or as clinically indicated) thereafter.

    In pediatric patients with Ph+ ALL, perform CBC prior to the start of each block of chemotherapy and as clinically indicated; during consolidation blocks of chemotherapy, perform CBC every 2 days until recovery.

    Hemorrhage

    Risk of severe hemorrhage, including potentially fatal CNS or GI hemorrhage; usually associated with severe thrombocytopenia.

    Severe hemorrhage may require treatment interruption and transfusions.

    Use with caution in patients receiving anticoagulants or drugs that inhibit platelet function.

    Fluid Retention

    Risk of potentially severe fluid retention (i.e., pleural effusion, pericardial effusion, pulmonary edema, ascites, generalized edema).

    Fluid retention generally managed with supportive care (e.g., diuretics, short course of corticosteroids).

    Evaluate symptoms suggestive of pleural effusion or other fluid retention (e.g., new or worsening dyspnea on exertion or at rest, dry cough, pleuritic chest pain) by chest radiograph. Severe pleural effusion may require thoracentesis and oxygen therapy. Consider dosage reduction or interruption of therapy if fluid retention occurs.

    Cardiac Effects

    May cause cardiac dysfunction or prolongation of the QT interval.

    Use with caution in patients who have or may develop prolongation of the QT interval (e.g., hypokalemia, hypomagnesemia, congenital long QT syndrome, use of drugs known to prolong QT interval, cumulative high-dose anthracycline therapy). Correct hypokalemia or hypomagnesemia prior to administration of dasatinib.

    Pulmonary Arterial Hypertension (PAH)

    May increase risk for development of PAH. May occur at any time after initiation of therapy (e.g., 8–60 months); reported most often in patients with comorbidities or receiving other drugs concomitantly. May be reversible upon discontinuance of dasatinib.

    Evaluate patient for manifestations of cardiopulmonary disease before and during dasatinib therapy. Consider PAH in any patient with dyspnea, fatigue, hypoxia, and fluid retention; however, exclude other etiologies of dyspnea prior to initiating invasive diagnostic procedures for PAH.

    Interruption of therapy accompanied by monitoring for improvement may be considered if PAH is suspected. If PAH is cOnfirmed (e.g., by cardiac catheterization), permanently discontinue the drug.

    Severe Dermatologic Reactions

    May cause severe dermatological reactions, including Stevens-Johnson syndrome and erythema multiforme.

    Permanently discontinue in patients experiencing a severe dermatological reaction during treatment and no other etiology for the reaction can be identified.

    Tumor Lysis Syndrome

    May increase risk of tumor lysis syndrome, generally in patients with imatinib-resistant disease in an advanced phase.

    Due to potential for tumor lysis syndrome, maintain adequate hydration, correct uric acid levels prior to initiating therapy with dasatinib, and monitor electrolyte levels during therapy. Patients with advanced phase disease and/or high tumor burden may be at an increased risk of tumor lysis syndrome and should be monitored more frequently.

    Fetal/Neonatal Morbidity and Mortality

    May cause fetal harm; embryofetal toxicity and teratogenicity have been reported in humans. Avoid pregnancy during therapy. If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.

    Females of reproductive potential and males with such female partners should use effective forms of contraception during therapy and for 30 days after the last dose.

    Females who are pregnant should not handle crushed or broken dasatinib tablets.

    Effects on Growth and Development of Pediatric Patients

    May affect bone growth and development in pediatric patients.

    Monitor bone growth and development during therapy in pediatric patients.

    Hepatotoxicity

    Hepatotoxicity with increases in bilirubin, AST, ALT, and alkaline phosphatase reported. Monitor transaminases at baseline and monthly or as clinically indicated during therapy. Reduce or withhold the dasatinib dose or permanently discontinue therapy based on hepatotoxicity severity. When administered with chemotherapy, transaminase elevations and hyperbilirubinemia reported. Monitor hepatic function when dasatinib is used in combination with chemotherapy.

    Lactose-intolerant Patients

    140-mg daily dosage contains 189 mg of lactose monohydrate; 100-mg daily dosage contains 135 mg of lactose monohydrate.

    Specific Populations

    Pregnancy

    May cause fetal harm.

    Lactation

    Not known whether dasatinib is distributed into human milk. Discontinue nursing because of potential risk to nursing infants.

    Pediatric Use

    Monitor bone growth and development in pediatric patients.

    Safety and efficacy not established in patients <18 years of age with previously treated Ph+ accelerated or myeloid or lymphoid blast phase CML.

    Safety and efficacy of dasatinib monotherapy evaluated in pediatric patients ≥1 year of age with newly diagnosed chronic phase CML. Safety and efficacy also has been demonstrated in pediatric patients ≥1 year of age with newly diagnosed Ph+ ALL. No data in pediatric patients <1 year of age.

    Adverse effects on bone growth and development and grade 1 osteopenia reported in pediatric patients. Overall, safety profile in pediatric patients is comparable to that reported in adult patients.

    Systemic exposure of dasatinib following administration of dasatinib tablets dispersed in juice was 36% lower compared to intact tablets in 5 patients 2–10 years of age with Ph+ ALL. Efficacy and safety of dispersing dasatinib tablets not been established.

    Geriatric Use

    No substantial difference in efficacy relative to younger adults, but patients ≥65 years of age are more likely to experience toxicity.

    Hepatic Impairment

    Not studied in patients with hepatic impairment (ALT and/or AST >2.5 times ULN and/or total bilirubin >2 times ULN); however the drug is metabolized extensively in the liver.

    Renal Impairment

    Renal impairment not expected to decrease dasatinib clearance.

    Creatinine clearance of 21.6 mL/minute had no clinically relevant effect on the pharmacokinetics of dasatinib.

    Common Adverse Effects

    Adverse effects reported in 15% or more of patients receiving dasatinib as monotherapy myelosuppression, fluid retention, diarrhea, headache, rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

    Adverse effects reported in 30% or more of pediatric patients receiving dasatinib in combination with chemotherapy include mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infection, hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.

    What other drugs will affect Dasatinib (Systemic)

    Metabolized principally by CYP3A4; weak inhibitor of CYP3A4.

    Does not inhibit CYP isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 2E1; does not induce human CYP isoenzymes.

    Drugs Affecting Hepatic Microsomal Enzymes

    Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma dasatinib concentrations). Consider alternative drugs with no or less enzyme inhibition potential. If concomitant use with a potent CYP3A4 inhibitor cannot be avoided, consider reducing dasatinib dosage to 20 mg daily (if current dosage is 70 or 100 mg daily) or to 40 mg daily (if current dosage is 140 mg daily) based on pharmacokinetic considerations (no clinical data with these dosage adjustments available). Consider stopping dasatinib 40 or 60 mg if a CYP3A4 inhibitor is necessary. If dasatinib is not tolerated following dosage reduction, discontinue the CYP3A4 inhibitor or interrupt dasatinib therapy until treatment with the CYP3A4 inhibitor is completed. Upon discontinuance of a potent CYP3A4 inhibitor, allow approximately 1 week to elapse before increasing dasatinib dosage.

    Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma dasatinib concentrations). Avoid concomitant use of potent CYP3A4 inducers; consider alternative drugs with no or less enzyme induction potential. If concomitant therapy cannot be avoided, consider increase in dasatinib dosage and closely monitor patient for toxicity.

    Drugs Affecting Coagulation

    Potential for bleeding; use anticoagulants and drugs that inhibit platelet function concomitantly with caution.

    Drugs Metabolized by Hepatic Microsomal Enzymes

    Substrates of CYP3A4: Potential pharmacokinetic interaction (increased plasma substrate concentrations).

    Specific Drugs and Foods

    Drug or Food

    Interaction

    Comments

    Antacids (e.g., Calcium carbonate, aluminum and magnesium hydroxides)

    Possible decreased plasma dasatinib concentrations, secondary to apparent pH-dependence of dasatinib solubility Dasatinib AUC unchanged when administered 2 hours after antacid (aluminum and magnesium hydroxides) but decreased 55% when administered concomitantly with antacid

    Administer antacids ≥2 hours before or ≥2 hours after a dose of dasatinib

    Anticoagulants (e.g., warfarin)

    Possible increased risk of hemorrhage

    Use concomitantly with caution

    Antifungals, azoles (i.e., itraconazole, ketoconazole, voriconazole)

    Possible increased plasma dasatinib concentrations and increased exposure to dasatinib Ketoconazole: Increased dasatinib AUC by fivefold and peak concentration by fourfold

    Avoid concomitant use if possible; if concomitant therapy necessary, closely monitor for toxicity and consider reducing dasatinib dosage

    Grapefruit juice

    Possible increased plasma dasatinib concentrations

    Avoid concomitant use

    Histamine H2-receptor antagonists (e.g., cimetidine, famotidine, ranitidine)

    Possible decreased plasma dasatinib concentrations, secondary to apparent pH-dependence of dasatinib solubility Famotidine: Decreased dasatinib AUC and peak concentration by 61–63% when given 10 hours before dasatinib

    Concomitant use not recommended

    Proton-pump inhibitors (e.g., esOmeprazole, lansoprazole, omeprazole, Pantoprazole, rabeprazole)

    Possible decreased plasma dasatinib concentrations, secondary to apparent pH-dependence of dasatinib solubility Omeprazole: Decreased dasatinib AUC and peak concentration by 42–43% when given 22 hours before dasatinib

    Concomitant use not recommended

    Rifamycins (rifabutin, rifampin)

    Possible decreased plasma dasatinib concentrations and AUC of dasatinib Rifampin: Decreased dasatinib AUC and peak concentration by 81–82%

    Avoid concomitant use if possible; if concomitant therapy necessary, consider increasing dasatinib dosage and closely monitor for toxicity

    St. John’s wort (Hypericum perforatum)

    Potential for unpredictable decreases in plasma dasatinib concentrations

    Concomitant use not recommended

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