Acute lymphoblastic leukemia (ALL), Philadelphia chromosome-positive (Ph+), newly diagnosed: Note: Use in combination with chemotherapy; dose escalation is not recommended; initiate dasatinib on or before day 15 of induction chemotherapy. Continue treatment for 2 years. Recalculate the dose every 3 months or as clinically necessary based on changes in body weight.
Children weighing ≥10 kg and Adolescents: Oral:
10 to <20 kg: 40 mg once daily.
20 to <30 kg: 60 mg once daily.
30 to <45 kg: 70 mg once daily.
≥45 kg: 100 mg once daily.
Chronic myelogenous leukemia (CML), Philadelphia chromosome-positive (Ph+), chronic phase: Note: Continue dasatinib until disease progression or unacceptable toxicity. Recalculate the dose every 3 months or as clinically necessary based on changes in body weight.
Children weighing ≥10 kg and Adolescents: Oral:
10 to <20 kg: Initial: 40 mg once daily; may escalate to 50 mg once daily if hematologic or cytogenetic response is not achieved.
20 to <30 kg: Initial: 60 mg once daily; may escalate to 70 mg once daily if hematologic or cytogenetic response is not achieved.
30 to <45 kg: Initial: 70 mg once daily; may escalate to 90 mg once daily if hematologic or cytogenetic response is not achieved.
≥45 kg: Initial: 100 mg once daily; may escalate to 120 mg once daily if hematologic or cytogenetic response is not achieved.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity:
Hematologic toxicity: Children and Adolescents: Adjustments are specific for indications. Note: Growth factor support may be considered in patients with resistant myelosuppression.
Acute lymphoblastic leukemia, Philadelphia chromosome-positive (Ph+ ALL): If neutropenia and/or thrombocytopenia result in a delay of the next block of treatment by >14 days, interrupt dasatinib treatment and resume at the same level once the next block of treatment is started. If neutropenia and/or thrombocytopenia persist and the next block of treatment is delayed another 7 days, perform a bone marrow assessment to assess cellularity and blast percentage. If marrow cellularity is <10%, interrupt dasatinib treatment until ANC >500/mm3 and then resume dasatinib at the full dose. If marrow cellularity is >10%, consider resuming dasatinib.
Chronic myelogenous leukemia, Philadelphia chromosome-positive (Ph+ CML):
If cytopenia (eg, neutropenia, thrombocytopenia) persists for >3 weeks, determine if cytopenia is due to leukemia by performing a marrow aspirate or biopsy.
If cytopenia is unrelated to leukemia, withhold dasatinib until ANC ≥1,000/mm3 and platelets ≥75,000/mm3 and resume dasatinib at the original starting dose or at a reduced dose.
If cytopenia recurs, repeat marrow aspirate/biopsy and resume dasatinib at a reduced dose.
Note: If ≥ grade 3 neutropenia or thrombocytopenia recurs during complete hematologic response, interrupt dasatinib therapy and resume at a reduced dose. Temporary dose reductions for intermediate degrees of cytopenia and disease response may be used as needed.
Recommended dose reductions for neutropenia and thrombocytopenia in Ph+ CML:
If the original starting dose is 40 mg daily, may reduce dose to 20 mg once daily (one-level dose reduction); further dose reductions cannot be made due to available tablet sizes.
If the original starting dose is 60 mg once daily, may reduce dose to 40 mg once daily (one-level dose reduction), and then to 20 mg once daily (two-level dose reduction).
If the original starting dose is 70 mg once daily, may reduce dose to 60 mg once daily (one-level dose reduction), and then to 50 mg once daily (two-level dose reduction).
If the original starting dose is 100 mg once daily, may reduce dose to 80 mg once daily (one-level dose reduction), and then to 70 mg once daily (two-level dose reduction).
Nonhematologic toxicity: Recommendations exclude altered liver enzymes (see Dosing: Hepatic Impairment: Pediatric).
Ph+ ALL:
Grade 2 toxicity: If no recovery despite symptomatic management, consider interrupting dasatinib therapy; once recovered to ≤ grade 1, resume at the original starting dose. For recurrent events, resume dasatinib at a reduced dose (see the following dose reductions).
Grade ≥3 toxicity: Withhold dasatinib until recovered to grade 1 or lower, and then resume at a reduced dose (see the following dose reductions).
Recommended dose reductions for non-hematologic toxicities Ph+ ALL:
If the original starting dose is 40 mg daily, may reduce dose to 20 mg once daily (one-level dose reduction); further dose reductions cannot be made due to available tablet sizes.
If the original starting dose is 60 mg once daily, may reduce dose to 40 mg once daily (one-level dose reduction), and then to 20 mg once daily (two-level dose reduction).
If the original starting dose is 70 mg once daily, may reduce dose to 60 mg once daily (one-level dose reduction), and then to 50 mg once daily (two-level dose reduction).
If the original starting dose is 100 mg once daily, may reduce dose to 80 mg once daily (one-level dose reduction), and then to 70 mg once daily (two-level dose reduction).
Ph+ CML: Severe nonhematologic toxicity: Withhold treatment until toxicity improvement or resolution; if appropriate, resume treatment at a reduced dose based on the event severity and recurrence.
All indications: Management of other nonhematologic toxicities:
Dermatologic toxicities: Manage rash with antihistamines or topical or systemic steroids (Khoury 2009), or treatment interruption, dose reduction, or discontinuation. Discontinue if dasatinib-related severe mucocutaneous reaction occurs.
Fluid retention: Manage with diuretics, short courses of corticosteroids, and/or supportive care. Severe pleural effusions may require thoracentesis and oxygen therapy; consider dose reduction or treatment interruption.
Pleural effusion: For first episode of grade 3 pleural effusion, withhold treatment until resolves to grade 1 or lower and consider corticosteroids (eg, prednisone for 3 to 4 days), diuretics, thoracentesis, and/or pleurodesis; may resume dasatinib at a decreased dose (one-level dose reduction) when effusion resolves; if pleural effusion recurs, initiate supportive therapy, withhold therapy, and resume at next lower dose level (two-level dose reduction) or discontinue therapy (Khoury 2009).
Pulmonary arterial hypertension: Discontinue with confirmed pulmonary arterial hypertension.
There are no dosage adjustments provided in the manufacturer's labeling; however, <4% of dasatinib and metabolites are renally excreted.
Children and Adolescents: Oral:
Baseline (prior to therapy initiation): No initial dosage adjustment is necessary; use with caution.
Hepatic impairment during therapy:
Ph+ ALL:
If direct bilirubin >5 times ULN or ALT/AST >15 times ULN, first episode: Hold dasatinib; once recovered to ≤ grade 1, resume therapy at the original starting dose.
If direct bilirubin >5 times ULN or ALT/AST >15 times ULN recur, reduce dasatinib dose based on the following:
If the original starting dose is 40 mg daily, may reduce dose to 20 mg once daily (one-level dose reduction); further dose reductions cannot be made due to available tablet sizes.
If the original starting dose is 60 mg once daily, may reduce dose to 40 mg once daily (one-level dose reduction), and then to 20 mg once daily (two-level dose reduction).
If the original starting dose is 70 mg once daily, may reduce dose to 60 mg once daily (one-level dose reduction), and then to 50 mg once daily (two-level dose reduction).
If the original starting dose is 100 mg once daily, may reduce dose to 80 mg once daily (one-level dose reduction), and then to 70 mg once daily (two-level dose reduction).
Ph+ CML: Transaminase or bilirubin elevations during treatment may be managed with treatment interruption or dose reduction.
(For additional information see "Dasatinib: Drug information")
Note: The effect of discontinuation on long-term disease outcome after achieving cytogenetic response (including complete cytogenetic response) or major molecular response is not known.
Acute lymphoblastic leukemia (ALL), Philadelphia chromosome-positive (Ph+): Oral: 140 mg once daily until disease progression or unacceptable toxicity occurs. Consider a dose escalation to 180 mg once daily in patients not achieving hematologic or cytogenetic response at recommended initial dosage.
Chronic myelogenous leukemia (CML), Ph+, newly diagnosed in chronic phase: Oral: 100 mg once daily until disease progression or unacceptable toxicity occurs. Consider a dose escalation to 140 mg once daily in patients not achieving hematologic or cytogenetic response at recommended initial dosage.
CML, Ph+, resistant or intolerant: Oral:
Chronic phase: 100 mg once daily until disease progression or unacceptable toxicity occurs. Consider a dose escalation to 140 mg once daily in patients not achieving hematologic or cytogenetic response at recommended initial dosage.
Accelerated or blast phase: 140 mg once daily until disease progression or unacceptable toxicity occurs. Consider a dose escalation to 180 mg once daily in patients not achieving hematologic or cytogenetic response at recommended initial dosage.
Gastrointestinal stromal tumors (GIST; off-label use): Oral: 70 mg twice daily (Montemurro 2012; Trent 2011).
Missed doses: If a dose is missed, take the next regularly scheduled dose; 2 doses should not be taken at the same time.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling. However, <4% of dasatinib and metabolites are renally excreted.
No initial dosage adjustment is necessary; use with caution. Transaminase or bilirubin elevations during treatment may be managed with treatment interruption or dose reduction.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sprycel: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Sprycel: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg
Generic: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg
Oral: Administer once daily (morning or evening). May be taken without regard to food. Swallow whole; do not break, crush, or chew tablets. Take with a meal if GI upset occurs (Khoury 2009). Do not administer proton pump inhibitors and H2 blockers concomitantly with dasatinib. If needed, may consider antacid administration, separated by at least 2 hours before or 2 hours after the dasatinib dose. Note: Crushing and dispersing a tablet in juice showed decreased exposure to dasatinib (36% lower) in pediatric patients (n=5, age range: 2 to 10 years); safety and efficacy of this administration method are undetermined; an extemporaneous suspension can be prepared (see Extemporaneous Preparations).
Oral: Administer once daily (morning or evening). May be taken without regard to food. Swallow whole; do not break, cut, crush, or chew tablets. Take with a meal if GI upset occurs (Khoury 2009). Do not administer proton pump inhibitors and H2 blockers concomitantly with dasatinib. If needed, may consider antacid administration, separated by at least 2 hours before or 2 hours after the dasatinib dose.
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy (FDA approved in pediatric patients ≥1 year); treatment of chronic phase Ph+ chronic myeloid leukemia (Ph+ CML) (FDA approved in pediatric patients ≥1 year); treatment of Ph+ ALL with resistance or intolerance to prior therapy (FDA approved in adults); treatment of newly diagnosed Ph+ CML in chronic phase (FDA approved in adults); treatment of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib (FDA approved in adults)
Dasatinib may be confused with bosutinib, cabozantinib, dabrafenib, dacomitinib, duvelisib, enasidenib, encorafenib, imatinib, lapatinib, neratinib, nilotinib, PONATinib, regorafenib, SUNItinib, tucatinib, vandetanib
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions occurred in adults unless otherwise indicated.
≥10%:
Cardiovascular: Facial edema, peripheral edema
Central nervous system: Headache (adults and children: 12% to 33%), fatigue (adults: 8% to 26%; children: 10%), pain (11%)
Dermatologic: Skin rash (adults and children: 11% to 21%), pruritus (12%)
Endocrine & metabolic: Fluid retention (adults: 19% to 48%; children: 10%; cardiac-related: 9%)
Gastrointestinal: Diarrhea (adults: 17% to 31%; children: 21%), nausea (adults and children: 8% to 24%), vomiting (adults and children: 5% to 16%), abdominal pain (adults and children: 7% to 16%)
Hematologic & oncologic: Thrombocytopenia (grades 3/4: 22% to 85%), neutropenia (grades 3/4: 29% to 79%), anemia (grades 3/4: 13% to 74%), hemorrhage (8% to 26%; grades 3/4: 1% to 9%), febrile neutropenia (4% to 12%; grades 3/4: 4% to 12%)
Infection: Infection (9% to 14%)
Local: Localized edema (3% to 22%; superficial)
Neuromuscular & skeletal: Musculoskeletal pain (<22%), limb pain (children: 19%), myalgia (7% to 13%), arthralgia (adults and children: ≤13%)
Respiratory: Pleural effusion (5% to 28%), dyspnea (3% to 24%)
Miscellaneous: Fever (6% to 18%)
1% to <10%:
Cardiovascular: Cardiac conduction disturbance (7%), ischemic heart disease (4%), cardiac disorder (≤4%), edema (≤4%), pericardial effusion (≤4%), prolonged QT interval on ECG (≤1%), cardiac arrhythmia, chest pain, flushing, hypertension, palpitations, tachycardia
Central nervous system: Intracranial hemorrhage (≤3%), chills, depression, dizziness, drowsiness, insomnia, myasthenia, neuropathy, peripheral neuropathy
Dermatologic: Acne vulgaris, alopecia, dermatitis, eczema, hyperhidrosis, urticaria, xeroderma
Endocrine & metabolic: Growth suppression, hyperuricemia, weight gain, weight loss
Gastrointestinal: Constipation (10%), gastrointestinal hemorrhage (2% to 9%), abdominal distention, change in appetite, colitis (including neutropenic colitis), dysgeusia, dyspepsia, enterocolitis, gastritis, mucositis, stomatitis
Hematologic & oncologic: Bruise
Hepatic: Increased serum bilirubin (grades 3/4: ≤6%), increased serum alanine aminotransferase (grades 3/4: ≤5%), increased serum aspartate aminotransferase (grades 3/4: ≤4%), ascites (≤1%)
Infection: Herpes virus infection, sepsis
Neuromuscular & skeletal: Muscle spasm (5%), abnormal bone growth (children; epiphyses delayed fusion), asthenia, stiffness
Ophthalmic: Blurred vision, decreased visual acuity, dry eye syndrome, visual disturbance
Otic: Tinnitus
Renal: Increased serum creatinine (grades 3/4: ≤8%)
Respiratory: Pulmonary hypertension (≤5%), pulmonary edema (≤4%), cough, pneumonia, pneumonitis, pulmonary infiltrates, upper respiratory tract infection
Miscellaneous: Soft tissue injury (oral)
<1%, postmarketing, and/or case reports: Abnormal gait, abnormal platelet aggregation, abnormal T waves on ECG, acute coronary syndrome, acute pancreatitis, acute respiratory distress, amnesia, anal fissure, angina pectoris, anxiety, arthritis, asthma, ataxia, atrial fibrillation, atrial flutter, bronchospasm, bullous skin disease, cardiomegaly, cerebrovascular accident, cholecystitis, cholestasis, confusion, conjunctivitis, coronary artery disease, cor pulmonale, cranial nerve palsy (facial), decreased libido, deep vein thrombosis, dehydration, dementia, dermal ulcer, diabetes mellitus, dyschromia, dysphagia, embolism, emotional lability, epistaxis, equilibrium disturbance, erythema nodosum, esophagitis, fibrosis (dermal), fistula (anal), gastroesophageal reflux disease, gastrointestinal disease (protein wasting), gingival hemorrhage, gynecomastia (adults and children), hearing loss, hematoma, hematuria, hemoptysis, hemorrhage (ocular), hepatitis, hypercholesterolemia, hypersensitivity reaction, hypersensitivity angiitis, hyperthyroidism, hypoalbuminemia, hypotension, hypothyroidism, increased creatine phosphokinase, increased gamma-glutamyl transferase, increased lacrimation, increased pulmonary artery pressure, increased troponin, inflammation (panniculitis), interstitial pulmonary disease, intestinal obstruction, livedo reticularis, lymphadenopathy, lymphocytopenia, malaise, menstrual disease, myocarditis, nail disease, nephrotic syndrome, optic neuritis, osteonecrosis, osteopenia (children), ototoxicity (hemorrhage), palmar-plantar erythrodysesthesia, pancreatitis, pericarditis, petechia, photophobia, pleuropericarditis, prolongation P-R interval on ECG, proteinuria, pulmonary embolism, pure red cell aplasia, reactivation of HBV, renal failure syndrome, renal insufficiency, rhabdomyolysis, seizure, skin photosensitivity, Stevens-Johnson syndrome, Sweet's syndrome, syncope, tendinopathy, thrombophlebitis, thrombosis, thrombotic microangiopathy, thyroiditis, transient ischemic attacks, tremor, tumor lysis syndrome, upper gastrointestinal tract ulcer, urinary frequency, uterine hemorrhage, vaginal hemorrhage, ventricular arrhythmia, ventricular tachycardia, vertigo, voice disorder
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to dasatinib or any other component of the formulation; breast-feeding
Concerns related to adverse effects:
• Bone marrow suppression: Severe dose-related bone marrow suppression (thrombocytopenia, neutropenia, anemia) is associated with dasatinib treatment. Hematologic toxicity is usually reversible with dosage adjustment and/or temporary treatment interruption. The incidence of myelosuppression is higher in patients with advanced chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL). Monitor blood counts every 2 weeks for 12 weeks and then every 3 months thereafter or as clinically indicated (for chronic phase CML) or weekly for the first 2 months, then monthly thereafter or as clinically necessary (for accelerated or blast phase CML or for ALL). In pediatric patients with Ph+ ALL, monitor blood counts prior to initiation of each block of chemotherapy and then as clinically indicated; monitor blood counts every 2 days until recovery during the consolidation blocks of chemotherapy.
• Cardiovascular adverse events: Dasatinib may cause cardiac dysfunction; cardiac ischemic events, cardiac fluid retention-related events, and conduction abnormalities (arrhythmia and palpitations) have been reported. Monitor for signs and symptoms of cardiac dysfunction. Monitor blood pressure routinely during dasatinib treatment; if indicated, initiate appropriate antihypertensive treatment to reduce the risk for cardiotoxicity (Armenian 2017).
• Dermatologic toxicity: Cases of severe mucocutaneous dermatologic reactions (including Stevens-Johnson syndrome and erythema multiforme) have been reported with dasatinib. Discontinue dasatinib if severe mucocutaneous reaction occurs and other etiologies have been ruled out.
• Fluid retention: Dasatinib may cause fluid retention, including pleural and pericardial effusions, pulmonary hypertension, and generalized or superficial edema. A prompt chest x-ray (or other appropriate diagnostic imaging) is recommended for symptoms suggestive of effusion (new or worsening dyspnea on exertion or at rest, pleuritic chest pain, or dry cough). Fluid retention may be managed with supportive care (diuretics or corticosteroids); thoracentesis and oxygen therapy may be necessary for severe fluid retention; consider dose reduction or treatment interruption. Utilizing once-daily dosing is associated with a decreased frequency of fluid retention. The risk for pleural effusion is increased in patients with hypertension, prior cardiac history and a twice a day administration schedule; interrupt treatment for grade ≥2 effusion; may consider reinitiating at a reduced dose after resolution (Quintás-Cardama 2007). Grade 3 or 4 fluid retention/pleural effusion was observed in adults and grade 1 or 2 fluid retention was observed in pediatric patients. Use with caution in patients where fluid accumulation may be poorly tolerated, such as in cardiovascular disease (HF or hypertension) and pulmonary disease.
• Hemorrhage: Dasatinib may cause serious and fatal bleeding, including grades 3 and higher CNS hemorrhage. The most frequent hemorrhage site was gastrointestinal. Grades 3 or 4 hemorrhage usually required treatment interruptions and transfusions. Most bleeding events in clinical studies were associated with severe thrombocytopenia, although dasatinib may also cause platelet dysfunction. Concomitant medications that inhibit platelet function or anticoagulants may increase the risk of bleeding.
• Pulmonary arterial hypertension: Dasatinib may increase the risk for pulmonary arterial hypertension (PAH) in both adult and pediatric patients. PAH may occur at any time after starting treatment, including after >12 months of therapy. Evaluate for underlying cardiopulmonary disease prior to therapy initiation and during therapy; evaluate and rule out alternative etiologies in patients with symptoms suggestive of PAH (eg, dyspnea, fatigue, hypoxia, fluid retention) and interrupt therapy if symptoms are severe. Discontinue permanently with confirmed PAH diagnosis (may be reversible upon discontinuation).
• QT prolongation: Dasatinib may increase the risk for QT interval prolongation; there are reports of patients with QTcF >500 msec. Use caution in patients at risk for QT prolongation, including patients with long QT syndrome, patients taking antiarrhythmic medications or other medications that lead to QT prolongation or potassium-wasting diuretics, patients with cumulative high-dose anthracycline therapy, and conditions which cause hypokalemia or hypomagnesemia. Correct hypokalemia and hypomagnesemia prior to and during dasatinib therapy.
• Tumor lysis syndrome: Tumor lysis syndrome (TLS) has been reported in patients with resistance to imatinib therapy, usually in patients with advanced phase disease. Risk for TLS is higher in patients with advanced stage disease and/or a high tumor burden; monitor patients at risk more frequently. Maintain adequate hydration and correct uric acid levels prior to treatment; monitor electrolyte levels.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment due to extensive hepatic metabolism.
Concurrent drug therapy issues:
• Drugs that affect gastric pH: Elevated gastric pH may reduce dasatinib bioavailability; do not administer proton pump inhibitors and H2 blockers concomitantly with dasatinib. If needed, may consider antacid administration separated by at least 2 hours before or 2 hours after the dasatinib dose.
Special populations:
• Elderly: Patients 65 years of age and older are more likely to experience toxicity (compared with younger patients).
• Pediatric: Adverse reactions associated with bone growth and development have been reported in pediatric studies of chronic phase CML (including a report of severe [grade 3] growth retardation). Cases have included epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia; some cases resolved during treatment. Monitor bone growth/development in pediatric patients.
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Acetaminophen: May enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen. Management: Avoid coadministration of acetaminophen and dasatinib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider therapy modification
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Dasatinib may enhance the anticoagulant effect of Agents with Antiplatelet Properties. Risk C: Monitor therapy
Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy
Antacids: May decrease the serum concentration of Dasatinib. Management: Simultaneous administration of dasatinib and antacids should be avoided. Administer antacids 2 hours before or 2 hours after dasatinib. Risk D: Consider therapy modification
Anticoagulants: Dasatinib may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: In the US, after receipt of the single dose COVID-19 adenovirus vector vaccine (Janssen), administer an additional 2nd dose using an mRNA COVID-19 vaccine, at least 28 days after the primary vaccine dose, in patients taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Consider administration of a 3rd dose of COVID-19 vaccine, at least 28 days after completion of the primary 2-dose series, in patients 5 years of age and older taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Dasatinib. Management: Avoid concurrent use of dasatinib with strong CYP3A4 inducers when possible. If such a combination cannot be avoided, consider increasing dasatinib dose and monitor clinical response and toxicity closely. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Dasatinib. Management: This combination should be avoided if possible. If combined, decrease dasatinib dose from 140 mg to 40 mg, 100 mg to 20 mg, or 70 mg to 20 mg. For patients taking 60 mg or 40 mg daily, stop dasatinib until the CYP3A4 inhibitor is discontinued. Risk D: Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification
Echinacea: May diminish the therapeutic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider avoiding echinacea in patients receiving therapeutic immunosuppressants, such as the oncology agents listed in this monograph. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Risk D: Consider therapy modification
Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy
Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Grapefruit Juice: May increase the serum concentration of Dasatinib. Risk X: Avoid combination
Haloperidol: QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Histamine H2 Receptor Antagonists: May decrease the absorption of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of H2-antagonists if some acid-reducing therapy is needed. Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Inhibitors of the Proton Pump (PPIs and PCABs): May decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of PPIs or PCABs if some acid-reducing therapy is needed. Risk X: Avoid combination
Lefamulin: May enhance the QTc-prolonging effect of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid combination
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Levoketoconazole: QT-prolonging CYP3A4 Substrates may enhance the QTc-prolonging effect of Levoketoconazole. Levoketoconazole may increase the serum concentration of QT-prolonging CYP3A4 Substrates. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
OLANZapine: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Ondansetron: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Pentamidine (Systemic): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Posaconazole: May increase the serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Risk X: Avoid combination
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Propacetamol: Dasatinib may enhance the hepatotoxic effect of Propacetamol. Dasatinib may increase serum concentrations of the active metabolite(s) of Propacetamol. Specifically, acetaminophen concentrations may increase. Management: Consider less frequent or lower daily doses of propacetamol in patients taking dasatinib. Patients receiving dasatinib and propacetamol concomitantly, particularly those with greater propacetamol exposure, should be monitored for hepatotoxicity. Risk D: Consider therapy modification
QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Dasatinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider therapy modification
QT-prolonging Antidepressants (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Antipsychotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of other QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Miscellaneous Agents (Moderate Risk): QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of QT-prolonging Kinase Inhibitors (Moderate Risk). Risk C: Monitor therapy
QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): Dasatinib may enhance the QTc-prolonging effect of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Dasatinib. Management: Avoid this combination if possible. If combined, decrease dasatinib dose from 140 mg to 40 mg, 100 mg to 20 mg, or 70 mg to 20 mg. If taking 60 mg or 40 mg daily, stop dasatinib until the CYP3A4 inhibitor is discontinued. Monitor for prolonged QT interval Risk D: Consider therapy modification
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Saquinavir: Dasatinib may enhance the QTc-prolonging effect of Saquinavir. Saquinavir may increase the serum concentration of Dasatinib. Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
St John's Wort: May decrease the serum concentration of Dasatinib. Risk X: Avoid combination
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Dasatinib serum concentrations may be increased when taken with grapefruit or grapefruit juice. Management: Avoid concurrent use.
Avoid grapefruit juice.
Sexually active patients who may become pregnant or who can father a child should use effective contraception during treatment and for 30 days after the final dasatinib dose.
Dasatinib crosses the placenta, with fetal plasma and amniotic concentrations comparable to maternal concentrations. Adverse effects, including hydrops fetalis and fetal leukopenia and thrombocytopenia have been reported following maternal exposure to dasatinib. Persons who are pregnant are advised to avoid exposure to crushed or broken tablets.
CBC with differential:
ALL, newly diagnosed: Baseline, prior to initiation of each block of chemotherapy, and then as clinically indicated and every 2 days until recovery during consolidation blocks of chemotherapy
CML chronic phase: Every 2 weeks for 12 weeks and then every 3 months thereafter or as clinically indicated
ALL accelerated or blast phase CML: Weekly for 2 months, then monthly or as clinically necessary
Bone marrow biopsy; liver function tests, electrolytes including calcium, phosphorus, magnesium; monitor for fluid retention; monitor for signs/symptoms of cardiac dysfunction; ECG monitoring if at risk for QTc prolongation; chest x-ray is recommended for symptoms suggestive of pleural effusion (eg, cough, dyspnea); signs/symptoms of tumor lysis syndrome and dermatologic reactions. Monitor bone growth/development in pediatric patients. Monitor blood pressure routinely (Armenian 2017). Monitor adherence.
Thyroid function testing recommendations (Hamnvik 2011):
Preexisting levothyroxine therapy: Obtain baseline TSH levels, then monitor every 4 weeks until levels and levothyroxine dose are stable, then monitor every 2 months
Without preexisting thyroid hormone replacement: TSH at baseline, then monthly for 4 months, then every 2 to 3 months
Dasatinib is a BCR-ABL tyrosine kinase inhibitor that targets most imatinib-resistant BCR-ABL mutations (except the T315I and F317V mutants) by distinctly binding to active and inactive ABL-kinase. Kinase inhibition halts proliferation of leukemia cells. It also inhibits SRC family (including SRC, LKC, YES, FYN); c-KIT, EPHA2 and platelet derived growth factor receptor (PDGFRβ).
Distribution: 2,505 L
Protein binding: Dasatinib: ~96%; metabolite (active): 93%
Bioavailability: The adjusted geometric mean ratio was 0.84 for AUC in healthy adults who received tablets dispersed in juice (compared with intact tablets).
Metabolism: Hepatic (extensive); metabolized by CYP3A4 (primarily), flavin-containing mono-oxygenase-3 (FOM-3) and uridine diphosphate-glucuronosyltransferase (UGT) to an active metabolite and other inactive metabolites (the active metabolite plays only a minor role in the pharmacology of dasatinib)
Half-life elimination: Terminal: 3 to 5 hours (adults); 2 to 5 hours (pediatrics)
Time to peak, plasma: 0.5 to 6 hours
Excretion: Feces (~85%, 19% as unchanged drug); urine (~4%, 0.1% as unchanged drug)
Hepatic function impairment: Patients with moderate hepatic impairment (Child-Pugh class B) had decreases in dose-normalized Cmax and AUC by 47% and 8%, respectively, compared to subjects with normal hepatic function. Patients with severe hepatic impairment (Child-Pugh class C) had decreases in dose-normalized Cmax and AUC of 43% and 28%, respectively, compared with healthy controls.
An oral suspension may be prepared by dissolving dasatinib tablet(s) for one dose in 30 mL chilled orange or apple juice (without preservatives). After 5 minutes, swirl the contents for 3 seconds and repeat the process every 5 minutes for a total of 20 minutes following addition of tablet(s). Minimize time between end of 20 minutes and administration since suspension will taste more bitter if allowed to stand longer. Swirl contents of container one last time, then administer immediately. To ensure the full dose is administered, rinse container with 15 mL juice and administer residue. May be administered orally (or by nasogastric tube). Discard any unused portion after 60 minutes.
Tablets (Sprycel Oral)
20 mg (per each): $175.81
50 mg (per each): $351.61
70 mg (per each): $351.61
80 mg (per each): $633.72
100 mg (per each): $633.72
140 mg (per each): $633.72
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