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Dasatinib (Monograph)

Brand names: Phyrago, Sprycel
Drug class: Antineoplastic Agents

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Antineoplastic agent; a kinase inhibitor.

Uses for Dasatinib

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 the chronic, accelerated, or myeloid or lymphoid blast 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 (Sprycel only).

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 (Sprycel only).

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

Dasatinib Dosage and Administration

General

Pretreatment Screening

Patient Monitoring

Dispensing and Administration Precautions

Other General Considerations

Administration

Oral Administration

Administer orally once daily 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

Pediatric patients ≥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.

In clinical studies, treatment was continued until evidence of disease progression or until no longer tolerated by the patient.

Effect of discontinuance of treatment after achievement of a complete cytogenetic response not established.

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

ALL
Oral

Pediatric patients ≥1 year of age: 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. In clinical studies, treatment was continued 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 for Toxicity
Nonhematologic Adverse Effects
Oral

In pediatric patients with Ph+ CML, 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 severity and recurrence.

In pediatric patients with Ph+ ALL, temporarily interrupt therapy if grade 2 nonhematologic toxicity occurs if no recovery despite symptomatic therapy; when the toxicity improves to grade 1 or less, resume therapy at original dosage or reduced 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.

In pediatric patients with Ph+ ALL who experience elevated direct bilirubin concentrations >5 times the ULN or AST/ALT concentration >15 times the ULN occurs, temporarily interrupt therapy; when hepatotoxicity resolves to grade 1 or less, resume therapy at the original dosage or reduced dosage (following a subsequent episode) as described in Table 4.

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

Original Starting Dose

One-level Dose Reduction

Two-level Dose 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

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

In pediatric patients with Ph+ CML experiencing persistent (>3 weeks) neutropenia or thrombocytopenia unrelated to leukemia (as determined by bone marrow aspirate or biopsy), withhold treatment. 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).

Table 5. Dasatinib Dosage Adjustment for Neutropenia or Thrombocytopenia in Pediatric Patients with Ph+ CML1

Original Starting Dose

One-level Dose

Two-level Dose

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

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

Pediatric patients with Ph+ ALL: 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 marrow cellularity is less than 10%, interrupt treatment untilANC >500/mm3, at which time treatment may be resumed at full dosage. If bone marrow cellularity is greater than 10%, consider resuming therapy.

Dosage Modification for Concomitant Therapy with CYP3A4 Inducers or Inhibitors

Dosage modifications are necessary when dasatinib is used concomitantly with strong inducers or inhibitors of CYP3A4 (see Drugs Affecting Hepatic Microsomal Enzymes under Drug Interactions).

Adults

CML
Chronic Phase
Oral

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

In clinical studies, treatment was continued until evidence of disease progression or until no longer tolerated by the patient.

Optimal duration of therapy has not been established.

Effect of discontinuance of treatment after achievement of a complete cytogenetic response not established.

Accelerated or Myeloid or Lymphoid Blast Phase
Oral

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

In clinical studies, treatment was continued until evidence of disease progression or until no longer tolerated by the patient.

Optimal duration of therapy has not been established.

Effect of discontinuance of treatment after achievement of a complete cytogenetic response not established.

ALL
Oral

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

Optimal duration of therapy has not been established.

Effect of discontinuance of treatment after achievement of a complete cytogenetic response not 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 severity and recurrence.

Hematologic Adverse Effects
Oral

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

Adults with Chronic Phase CML: Dasatinib therapy should be withheld if ANC decreases to less than 500/mm3 or platelet counts decrease to less than 50,000/mm3. Treatment may be resumed at the original starting dosage of 100 mg once daily if ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 50,000/mm3 in 7 days or less.

Following a second episode of neutropenia or thrombocytopenia, in which ANC decreases to less than 500/mm3 for longer than 7 days or platelet counts decrease to less than 25,000/mm3, treatment should again be withheld. Treatment may be resumed at a reduced dosage of 80 mg once daily when ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 50,000/mm3.

Following a third episode of neutropenia or thrombocytopenia, in which ANC decreases to less than 500/mm3for longer than 7 days or platelet counts decrease to less than 25,000/mm3, treatment should again be withheld in patients receiving dasatinib for newly diagnosed disease; treatment in these patients may be resumed at a reduced dosage of 50 mg once daily when ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 50,000/mm3. However, dasatinib should be discontinued following a third such episode in patients receiving the drug following failure of prior therapy including imatinib.

Adults with Accelerated Phase or Blast Phase CML: Dasatinib therapy should be withheld if ANC decreases to less than 500/mm3 or platelet counts decrease to less than 10,000/mm3 and the cytopenia is unrelated to leukemia (as determined by bone marrow aspirate or biopsy). Treatment may be resumed at the original starting dosage of 140 mg once daily when ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 20,000/mm3. Treatment should again be withheld if the ANC decreases to less than 500/mm3 or platelet counts decrease to less than 10,000/mm3. Treatment may be resumed at a reduced dosage of 100 mg once daily (following a second episode) or 80 mg once daily (following a third episode) when ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 20,000/mm3.

If patients in the accelerated phase or blast phase of CML have reductions in ANC to less than 500/mm3 or reductions in platelet counts to less than 10,000/mm3 and the cytopenia is related to leukemia (as determined by bone marrow aspirate or biopsy), consider dosage escalation to 180 mg once daily.

Adults with Ph+ALL: Withhold therapy if ANC decreases to less than 500/mm3 or platelet counts decrease to less than 10,000/mm3 and the cytopenia is unrelated to leukemia (as determined by marrow aspirate or biopsy). Treatment may be resumed at the original starting dosage of 140 mg once daily when ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 20,000/mm3. Treatment should again be withheld if ANC decreases to less than 500/mm3 or platelet counts decrease to less than 10,000/mm3. Treatment may be resumed at a reduced dosage of 100 mg once daily (following a second episode) or 80 mg once daily (following a third episode) when ANC reaches or exceeds 1000/mm3 and platelet counts reach or exceed 20,000/mm3.

If patients with Ph+ ALL have reductions in ANC to less than 500/mm3 or reductions in platelet counts to less than 10,000/mm3 and the cytopenia is related to leukemia (as determined by marrow aspirate or biopsy), consider dosage escalation to 180 mg once daily.

Dosage Modification for Concomitant Therapy with CYP3A4 Inducers or Inhibitors

Dosage modifications are necessary when dasatinib is used concomitantly with strong inducers or inhibitors of CYP3A4 (see Drugs Affecting Hepatic Microsomal Enzymes under Drug Interactions).

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Patients

No specific dosage recommendations at this time.

Cautions for Dasatinib

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, or discontinuation of treatment.

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 advanced 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 of dasatinib (Sprycel) contains 189 mg of lactose monohydrate; 100-mg daily dosage of dasatinib (Sprycel) contains 135 mg of lactose monohydrate. Dasatinib (Phyrago) tablets do not contain lactose.

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.

Pediatric labeled indications are approved for Sprycel tablets. However, due to marketing exclusivity rights, the Phyrago preparation is not labeled for pediatric indications.

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 (Sprycel) monotherapy evaluated in pediatric patients ≥1 year of age with newly diagnosed chronic phase CML. Safety and efficacy of dasatinib (Sprycel) also 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

Reduced peak plasma concentration and AUC of dasatinib in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) as compared to patients with normal hepatic function.

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 adult patients receiving dasatinib as monotherapy include myelosuppression, fluid retention, diarrhea, headache, rash, hemorrhage, dyspnea, fatigue, nausea, 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, altered state of consciousness.

Drug Interactions

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 strong 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). In patients taking a current dasatinib dosage of 40 or 60 mg, consider interrupting dasatinib therapy until the inhibitor is discontinued. 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 strong 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

Dasatinib Pharmacokinetics

Absorption

Bioavailability

Bioavailability of dispersed tablets is estimated to be 36% lower in pediatric patients.

Onset

Following oral administration, peak plasma concentrations are attained within 0.5–6 hours in adult and pediatric patients.

Special Populations

In patients with moderate or severe hepatic impairment (Child-Pugh class B or C), peak plasma concentrations and AUC (normalized for differences in administered doses) are lower than in healthy individuals; differences not considered clinically important.

No clinically relevant effects of age and gender on pharmacokinetics.

Food

AUC of dasatinib (Sprycel; single 100-mg dose) increased by 14% following administration with a high-fat meal. No clinically significant differences observed after dasatinib (Phyrago) administration with a high-fat meal.

Distribution

Extent

Extensively distributed into the extravascular space.

Volume of distribution changes with body weight in pediatric patients.

Plasma Protein Binding

Approximately 96 and 93% for dasatinib and active metabolite, respectively.

Elimination

Metabolism

Metabolized in the liver, principally by CYP3A4, to an active metabolite and several inactive metabolites.

Elimination Route

Eliminated principally in feces (85%) mainly as metabolites and to a lesser extent in urine (4%).

Half-life

Adults: 3–5 hours for dasatinib film-coated tablets (Sprycel); 5 hours for dasatinib tablets (Phyrago).

Pediatric patients: 2–5 hours.

Stability

Storage

Oral

Tablets

20–25°C (excursions permitted between 15–30°C).

Tablets, film-coated

20–25°C (excursions permitted between 15–30°C).

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care. For further information on the handling of antineoplastic agents, see the ASHP Guidelines on Handling Hazardous Drugs at [Web].

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Dasatinib

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

20 mg

Phyrago

Nanocopoeia

50 mg

Phyrago

Nanocopoeia

70 mg

Phyrago

Nanocopoeia

80 mg

Phyrago

Nanocopoeia

100 mg

Phyrago

Nanocopoeia

140 mg

Phyrago

Nanocopoeia

Tablets, film-coated

20 mg

Sprycel

Bristol Myers-Squibb

50 mg

Sprycel

Bristol Myers-Squibb

70 mg

Sprycel

Bristol Myers-Squibb

80 mg

Sprycel

Bristol Myers-Squibb

100 mg

Sprycel

Bristol Myers-Squibb

140 mg

Sprycel

Bristol Myers Squibb

AHFS DI Essentials™. © Copyright 2024, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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