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  • Indications

    INDICATIONS

    SPRYCEL® (dasatinib) is indicated for the treatment of adult patients with:

    • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
    • Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
    • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

    SPRYCEL® is indicated for the treatment of pediatric patients 1 year of age and older with:

    • Newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy
    • Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
Efficacy: Adults with newly diagnosed Ph+ CML in CP

SPRYCEL patients achieved key milestones with higher & faster cCCyR* and MMR† rates at Years 1 and 5 vs imatinib1‡

DASISION Trial design
  • Results based on a Phase III, open-label, randomized study of SPRYCEL® (dasatinib) 100 mg (n=259) once daily vs imatinib 400 mg once daily (n=260) in adults with newly diagnosed CP Ph+ CML (N=519)1,2
  • Primary endpoint was the rate of cCCyR by 12 months1,2
  • Select secondary endpoints included: MMR at any time, time to MMR, and time to cCCyR1,2
View Full Study Design +

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  • cCCyR* RatesYear 1 & 5 Data
  • MMR† RatesYear 1 & 5 Data
  • Transformation Rates
More patients achieved cCCyR at Year 1 and Year 5 vs imatinib1
Chart shows the primary endpoint results for cCCyR rate where SPRYCEL measured 77% of patients with cCCyR ( 95% Cl, 71%-82%) over Imatinib 66% (95% Cl, 60% - 72%). Chart shows the primary endpoint results for cCCyR rate where SPRYCEL measured 77% of patients with cCCyR ( 95% Cl, 71%-82%) over Imatinib 66% (95% Cl, 60% - 72%).
The image shows that 83% of SPRYCEL patients achieved the cCCyR year 5 treatment milestone vs Imatinib at 79%. The image shows that 83% of SPRYCEL patients achieved the cCCyR year 5 treatment milestone vs Imatinib at 79%.

77% of SPRYCEL patients achieved the cCCyR 12-month treatment milestone. 83% achieved the Year 5 treatment milestone.1

IMPORTANT SAFETY INFORMATION ABOUT ADVERSE REACTIONS

In newly diagnosed chronic phase CML patients:

  • Drug-related serious adverse reactions (SARs) were reported for 16.7% of SPRYCEL-treated patients. Serious adverse reactions reported in ≥5% of patients included pleural effusion (5%)
  • The most common adverse reactions (≥15%) include myelosuppression, fluid retention, and diarrhea
SPRYCEL helped patients achieve cCCyR faster at a median time to response of 3.1 months after 5-year follow-up1,2
Chart shows that SPRYCEL (after 5 years of follow-up) among responders showed median time to cCCyR rates was 3.1 months compared with Imatinib which was 5.8 months. The National Comprehensive Cancer Network® (NCCN ®) recommends achieving PCyR at 3 months. Chart shows that SPRYCEL (after 5 years of follow-up) among responders showed median time to cCCyR rates was 3.1 months compared with Imatinib which was 5.8 months. The National Comprehensive Cancer Network® (NCCN ®) recommends achieving PCyR at 3 months.
More patients achieved higher and faster MMR rates Year 1 through Year 5 on SPRYCEL vs imatinib1,4

Achieving MMR is an important milestone on a patient’s treatment path.5,6

Chart shows MMR rates at 1 year of SPRYCEL vs Imatinib. SPRYCEL achieved 52% MMR rates compared with Imatinib at 34%. Chart shows MMR rates at 1 year of SPRYCEL vs Imatinib. SPRYCEL achieved 52% MMR rates compared with Imatinib at 34%.
Image shows more patients achieved MMR faster vs imatinib at Year 1 Image shows more patients achieved MMR faster vs imatinib at Year 1
Cumulative rates of MMR and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib vs imatinib.8

IMPORTANT SAFETY INFORMATION ABOUT ADVERSE REACTIONS

  • With a minimum of 60 months follow-up, adverse reactions that were reported in ≥10% of patients with newly diagnosed chronic phase CML for patients taking SPRYCEL (n=258) included:
    • All grades: fluid retention (38%) [including pleural effusion (28%), superficial localized edema (14%), pulmonary hypertension (5%), generalized edema (4%), pericardial effusion (4%), congestive heart failure/cardiac dysfunction|| (2%), pulmonary edema (1%)], diarrhea (22%), musculoskeletal pain (14%), rash (14%), headache (14%), abdominal pain (11%), fatigue (11%), nausea (10%), myalgia (7%), arthralgia (7%), hemorrhage# (8%) [including gastrointestinal bleeding (2%), other bleeding** (6%)], vomiting (5%), muscle spasms (5%)
    • Grade 3/4: fluid retention (5%) [including pleural effusion (3%), pulmonary hypertension (1%), pericardial effusion (1%)], diarrhea (1%), hemorrhage (1%) [including gastrointestinal bleeding (1%)]
On SPRYCEL, more patients achieved MMR Year 1 through Year 5 vs imatinib1,9
Chart shows SPRYCEL having higher MMR rates vs Imatinib at Year 5. After 5 years of follow-up, median time to MMR among responders was 9.3 months in the SPRYCEL arm (n=198) and 15 months in the imatinib arm (n=167). Chart shows SPRYCEL having higher MMR rates vs Imatinib at Year 5. After 5 years of follow-up, median time to MMR among responders was 9.3 months in the SPRYCEL arm (n=198) and 15 months in the imatinib arm (n=167).

After 5 years of follow-up, median time to MMR among responders was 9.3 months in the SPRYCEL arm (n=198) and 15 months in the imatinib arm (n=167)1

5-year MMR rates across all Hasford risk scores with SPRYCEL1
Chart shows SPRYCEL having MMR rates at any time across all Hasford risk groups. MMR (at any time) defined as BCR-ABL ratios of ≤0.1% by RQ-PCR in peripheral blood samples standardized on the International Scale. These are cumulative rates representing minimum follow-up for the time frame specified. Chart shows SPRYCEL having MMR rates at any time across all Hasford risk groups. MMR (at any time) defined as BCR-ABL ratios of ≤0.1% by RQ-PCR in peripheral blood samples standardized on the International Scale. These are cumulative rates representing minimum follow-up for the time frame specified.

Baseline Hasford risk scores1,2

  • SPRYCEL: low: 33% (n=86);
    intermediate: 48% (n=124);
    high: 19% (n=49)
  • imatinib: low: 34% (n=87);
    intermediate: 47% (n=123); high: 19% (n=50)
97% of patients on SPRYCEL remained in the chronic phase over a minimum of 5 years’ follow-up1

Patient transformations by year while on study10

Chart shows patients who transformed to accelerated phase (AP) or Blast Crisis (BC) while on the study by year 5. SPRYCEL had 3% transformed by 5 years while Imatinib had 6% transformed by 5 years. In the DASISION Trial, patients who transformed to AP/BC on Study included all patients in the intent-to-treat population regardless of response. Included at least 30-day follow-up for patients who discontinued therapy. Excluded clonal evolution in the definition of accelerated phase. Chart shows patients who transformed to accelerated phase (AP) or Blast Crisis (BC) while on the study by year 5. SPRYCEL had 3% transformed by 5 years while Imatinib had 6% transformed by 5 years. In the DASISION Trial, patients who transformed to AP/BC on Study included all patients in the intent-to-treat population regardless of response. Included at least 30-day follow-up for patients who discontinued therapy. Excluded clonal evolution in the definition of accelerated phase.

SPRYCEL patients experienced no new transformations after Year 3 and continuing through Year 510

Chart shows patients who transformed to accelerated phase (AP) or Blast Crisis (BC) while on the study by year 5. SPRYCEL had 3% transformed by 5 years while Imatinib had 6% transformed by 5 years. In the DASISION Trial, patients who transformed to AP/BC on Study included all patients in the intent-to-treat population regardless of response. Included at least 30-day follow-up for patients who discontinued therapy. Excluded clonal evolution in the definition of accelerated phase. Chart shows patients who transformed to accelerated phase (AP) or Blast Crisis (BC) while on the study by year 5. SPRYCEL had 3% transformed by 5 years while Imatinib had 6% transformed by 5 years. In the DASISION Trial, patients who transformed to AP/BC on Study included all patients in the intent-to-treat population regardless of response. Included at least 30-day follow-up for patients who discontinued therapy. Excluded clonal evolution in the definition of accelerated phase.

Imatinib patients experienced 2 new transformations after Year 3 and continuing through Year 510

94% of imatinib-treated patients on study did not transform to accelerated phase or blast crisis (245/260)1,10

All randomized patients who transformed while on study progressed to either accelerated phase or blast crisis.1

  • Lack of transformation to accelerated or blast phase is a key indicator of lack of disease progression11

IMPORTANT SAFETY INFORMATION ABOUT MYELOSUPPRESSION

Treatment with SPRYCEL is associated with severe (NCI CTCAE Grade 3/4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.

  • In patients with chronic phase CML, perform complete blood counts (CBCs) every 2 weeks for 12 weeks, then every 3 months thereafter, or as clinically indicated
  • Myelosuppression is generally reversible and usually managed by withholding SPRYCEL temporarily and/or dose reduction
    • In clinical studies, myelosuppression may have also been managed by discontinuation of study therapy
    • Hematopoietic growth factor has been used in patients with resistant myelosuppression

Dasatinib does not appear to be active against the T315I mutation, based on in vitro data.1

BCR-ABL=breakpoint cluster region-Abelson kinase; cCCyR=confirmed complete cytogenetic response; CI=confidence interval; CP=chronic phase; MMR=major molecular response; Ph+ CML=Philadelphia chromosome-positive chronic myeloid leukemia; RQ-PCR=real-time quantitative polymerase chain reaction.

*cCCyR was defined as CCyR (0% Ph+ metaphases) on 2 consecutive occasions at least 28 days apart.1,2

†MMR (at any time) defined as BCR-ABL ratios of ≤0.1% by RQ-PCR in peripheral blood samples standardized on the International Scale. These are cumulative rates representing minimum follow-up for the time frame specified.1,2

‡Inclusive of cCCyR in newly diagnosed adult patients with CP Ph+ CML by 1 and 5 years.1

§Adjusted for Hasford score and indicated statistical significance at a predefined nominal level of significance.1

||Includes cardiac failure acute, cardiac failure congestive, cardiomyopathy, diastolic dysfunction, ejection fraction decreased, and left ventricular dysfunction.1

Includes erythema, erythema multiforme, rash, rash generalized, rash macular, rash papular, rash pustular, skin exfoliation, and rash vesicular.1

#Adverse reaction of special interest with <10% frequency.1

**Includes conjunctival hemorrhage, ear hemorrhage, ecchymosis, epistaxis, eye hemorrhage, gingival bleeding, hematoma, hematuria, hemoptysis, intra-abdominal hematoma, petechiae, scleral hemorrhage, uterine hemorrhage, and vaginal hemorrhage.1

See efficacy results for adults with Ph+ CML in CP
resistant or intolerant to imatinib
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References:

  1. SPRYCEL full Prescribing Information. Bristol-Myers Squibb Company.
  2. Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260-2270.
  3. Baccarani M, Saglio G, Goldman J, et al. Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet. Blood. 2006;108:1809-1820.
  4. Kantarjian H, Shah NP, Cortes JE, et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012;119(5):1123-1129.
  5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia. V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed November 9, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  6. Cortes J, Quintas-Cardama A, Kantarjian HM. Monitoring molecular response in chronic myeloid leukemia. Cancer. 2011;117(6):1113-1122.
  7. Jabbour E, Kantarjian H, Saglio G, et al. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014;123(4):494-500.
  8. Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333-2340.
  9. Data on file. SPRY 064. Bristol-Myers Squibb Company; 2016.
  10. Data on file. SPRY 061. Bristol-Myers Squibb Company; 2016.
  11. Bavaro L, Martelli M, Cavo M, Soverini S. Mechanism of disease progression and resistance to tyrosine kinase inhibitor therapy in chronic myeloid leukemia: an update. Int J Mol Sci. 2019;20(24):6141.
INDICATIONS

SPRYCEL® (dasatinib) is indicated for the treatment of adult patients with:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
  • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

SPRYCEL® is indicated for the treatment of pediatric patients 1 year of age and older with:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy
  • Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
SUMMARY OF WARNINGS AND PRECAUTIONS

SPRYCEL is associated with the following warnings and precautions: myelosuppression, bleeding-related events, fluid retention, cardiovascular toxicity, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, embryo-fetal toxicity, and hepatotoxicity.

IMPORTANT SAFETY INFORMATION
Myelosuppression:

Treatment with SPRYCEL is associated with severe (NCI CTCAE Grade 3/4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.

  • In patients with chronic phase CML, perform complete blood counts (CBCs) every 2 weeks for 12 weeks, then every 3 months thereafter, or as clinically indicated
  • In patients with advanced phase CML or Ph+ ALL, perform CBCs weekly for the first 2 months and then monthly thereafter, or as clinically indicated
  • In pediatric patients with Ph+ ALL treated with SPRYCEL in combination with chemotherapy, perform CBCs prior to the start of each block of chemotherapy and as clinically indicated. During the consolidation blocks of chemotherapy, perform CBCs every 2 days until recovery
  • Myelosuppression is generally reversible and usually managed by withholding SPRYCEL temporarily and/or dose reduction
    • In clinical studies, myelosuppression may have also been managed by discontinuation of study therapy
    • Hematopoietic growth factor has been used in patients with resistant myelosuppression
Bleeding-Related Events:

SPRYCEL can cause serious and fatal bleeding. In all CML or Ph+ ALL clinical studies, Grade ≥3 central nervous system (CNS) hemorrhages, including fatalities, occurred in <1% of patients receiving SPRYCEL. The incidence of Grade 3/4 hemorrhage occurred in 5.8% of patients and generally required treatment interruptions and transfusions. The incidence of Grade 5 hemorrhage occurred in 0.4% of adult patients. The most frequent site of hemorrhage was gastrointestinal.

  • Most bleeding events in clinical studies were associated with severe thrombocytopenia
  • In addition to causing thrombocytopenia in human subjects, dasatinib caused platelet dysfunction in vitro
  • Concomitant medications that inhibit platelet function or anticoagulants may increase the risk of hemorrhage
Fluid Retention:

SPRYCEL may cause fluid retention. After 5 years of follow-up in the randomized newly diagnosed chronic phase CML study (n=258), grade 3/4 fluid retention was reported in 5% of patients, including 3% of patients with grade 3/4 pleural effusion. In adult patients with newly diagnosed or imatinib-resistant or -intolerant chronic phase CML, grade 3/4 fluid retention occurred in 6% of patients treated with SPRYCEL at the recommended dose (n=548).

In patients with advanced phase CML or Ph+ ALL treated with SPRYCEL at the recommended dose (n=304), grade 3/4 fluid retention was reported in 8% of patients, including grade 3/4 pleural effusion reported in 7% of patients.

In pediatric patients with chronic phase CML, cases of Grade 1 or 2 fluid retention were reported in 10.3% of patients.

  • Patients who develop symptoms of pleural effusion or other fluid retention, such as new or worsened dyspnea on exertion or at rest, pleuritic chest pain, or dry cough should be evaluated promptly with a chest x-ray or additional diagnostic imaging as appropriate
  • Fluid retention events were typically managed by supportive care measures that may include diuretics or short courses of steroids
  • Severe pleural effusion may require thoracentesis and oxygen therapy
  • Consider dose reduction or treatment interruption
Cardiovascular Toxicity:

SPRYCEL can cause cardiac dysfunction. After 5 years of follow-up in the randomized, newly diagnosed chronic phase CML trial (n=258), the following cardiac adverse reactions occurred:

  • Cardiac ischemic events (3.9% dasatinib vs 1.6% imatinib), cardiac-related fluid retention (8.5% dasatinib vs 3.9% imatinib), and conduction system abnormalities, most commonly arrhythmia and palpitations (7.0% dasatinib vs 5.0% imatinib). Two cases (0.8%) of peripheral arterial occlusive disease occurred with imatinib and 2 (0.8%) transient ischemic attacks occurred with dasatinib

Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

Pulmonary Arterial Hypertension (PAH):

SPRYCEL may increase the risk of developing PAH, which may occur any time after initiation, including after more than 1 year of treatment. Manifestations include dyspnea, fatigue, hypoxia, and fluid retention. PAH may be reversible on discontinuation of SPRYCEL.

  • Evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to initiating SPRYCEL and during treatment. If PAH is confirmed, SPRYCEL should be permanently discontinued
QT Prolongation:

SPRYCEL may increase the risk of prolongation of QTc in patients including those with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking antiarrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy.

  • Correct hypokalemia or hypomagnesemia prior to and during SPRYCEL administration
Severe Dermatologic Reactions:

Cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported in patients treated with SPRYCEL.

  • Discontinue permanently in patients who experience a severe mucocutaneous reaction during treatment if no other etiology can be identified
Tumor Lysis Syndrome (TLS):

TLS has been reported in patients with resistance to prior imatinib therapy, primarily in advanced phase disease.

  • Due to potential for TLS, maintain adequate hydration, correct uric acid levels prior to initiating therapy with SPRYCEL, and monitor electrolyte levels
  • Patients with advanced stage disease and/or high tumor burden may be at increased risk and should be monitored more frequently
Embryo-Fetal Toxicity:

Based on limited human data, SPRYCEL can cause fetal harm when administered to a pregnant woman. Hydrops fetalis, fetal leukopenia and fetal thrombocytopenia have been reported with maternal exposure to SPRYCEL. Transplacental transfer of dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma.

  • Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with SPRYCEL and for 30 days after the last dose
Effects on Growth and Development in Pediatric Patients:

In pediatric trials of SPRYCEL in chronic phase CML after at least 2 years of treatment, adverse reactions associated with bone growth and development were reported in 5 (5.2%) patients, one of which was severe in intensity (Growth Retardation Grade 3). These 5 cases included cases of epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia. Of these 5 cases, 1 case of osteopenia and 1 case of gynecomastia resolved during treatment.

Monitor bone growth and development in pediatric patients.

Hepatotoxicity:

SPRYCEL may result in hepatotoxicity as measured by elevation in bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase. Monitor transaminases at baseline and monthly or as clinically indicated during treatment. Reduce dose, withhold, or permanently discontinue SPRYCEL based on severity. When combined with chemotherapy, liver toxicity in the form of transaminase elevation and hyperbilirubinemia has been observed. Monitoring of hepatic function is recommended.

Lactation:

No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. However, dasatinib is present in the milk of lactating rats.

  • Because of the potential for serious adverse reactions in nursing children from SPRYCEL, breastfeeding is not recommended during treatment with SPRYCEL and for 2 weeks after the last dose
Drug Interactions:
Effect of Other Drugs on Dasatinib
  • Strong CYP3A4 inhibitors: The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations. Increased dasatinib concentrations may increase the risk of toxicity. Avoid concomitant use of strong CYP3A4 inhibitors. If concomitant administration of a strong CYP3A4 inhibitor cannot be avoided, consider a SPRYCEL dose reduction
    • Grapefruit juice may increase plasma concentrations of SPRYCEL and should be avoided
  • Strong CYP3A4 inducers: The coadministration of SPRYCEL with strong CYP3A inducers may decrease dasatinib concentrations. Decreased dasatinib concentrations may reduce efficacy. Consider alternative drugs with less enzyme induction potential. If concomitant administration of a strong CYP3A4 inducer cannot be avoided, consider a SPRYCEL dose increase
    • St. John’s wort may decrease plasma concentrations of SPRYCEL and should be avoided
  • Gastric Acid Reducing Agents: The coadministration of SPRYCEL with a gastric acid reducing agent may decrease the concentrations of dasatinib. Decreased dasatinib concentrations may reduce efficacy
    Do not administer H2 antagonists or proton pump inhibitors with SPRYCEL. Consider the use of antacids in place of H2 antagonists or proton pump inhibitors. Administer the antacid at least 2 hours prior to or 2 hours after the dose of SPRYCEL. Avoid simultaneous administration of SPRYCEL with antacids.
Adverse Reactions:

The safety data reflects exposure to SPRYCEL at doses tested in clinical studies (n=2712), including 324 adult patients with newly diagnosed chronic phase CML and 2388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase Ph+ CML or Ph+ ALL.

The median duration of therapy in a total of 2712 SPRYCEL-treated adult patients was 19.2 months (range 0–93.2 months). Median duration of therapy in:

  • 1618 adult patients with chronic phase CML was 29 months (range 0–92.9 months)
  • 324 patients in the newly diagnosed chronic phase CML trial was approximately 60 months
  • 1094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0–93.2 months)

In the overall population of 2712 SPRYCEL-treated adult patients, 88% of patients experienced adverse reactions at some time and 19% experienced adverse reactions leading to treatment discontinuation.

Among the 1618 SPRYCEL-treated patients with chronic phase CML, drug-related adverse reactions leading to discontinuation were reported in 329 (20.3%) patients.

In the newly diagnosed chronic phase CML trial, drug was discontinued for adverse reactions in 16% of the adult patients with a minimum of 60 months of follow-up. After a minimum of 60 months of follow-up, the cumulative discontinuation rate was 39%.

Among the 1094 SPRYCEL-treated patients with advanced phase CML or Ph+ ALL, drug-related adverse reactions leading to discontinuation were reported in 191 (17.5%) patients.

Patients ≥65 years are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema and weight decrease, and should be monitored closely.

  • In newly diagnosed chronic phase CML patients:
    • Drug-related serious adverse reactions (SARs) were reported for 16.7% of SPRYCEL-treated patients. Serious adverse reactions reported in ≥5% of patients included pleural effusion (5%)
    • The most common adverse reactions (≥15%) included myelosuppression, fluid retention, and diarrhea
    • Grade 3/4 laboratory abnormalities included neutropenia (29%), thrombocytopenia (22%), anemia (13%), hypophosphatemia (7%), hypocalcemia (4%), elevated bilirubin (1%), and elevated creatinine (1%)
  • In adult patients resistant or intolerant to prior imatinib therapy:
    • Drug-related SARs were reported for 26.1% of SPRYCEL-treated patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥5% of patients included pleural effusion (10%)
    • The most common adverse reactions (≥15%) included myelosuppression, fluid retention events, headache, diarrhea, fatigue, dyspnea, musculoskeletal pain, nausea, hemorrhage and skin rash
    • Grade 3/4 hematologic laboratory abnormalities in chronic phase CML patients resistant or intolerant to prior imatinib therapy who received SPRYCEL 100 mg once daily with a minimum follow up of 60 months included neutropenia (36%), thrombocytopenia (24%), and anemia (13%). Other grade 3/4 laboratory abnormalities included: hypophosphatemia (10%), and hypokalemia (2%)
  • Grade 3/4 elevations of transaminases or bilirubin and Grade 3/4 hypocalcemia, hypokalemia, and hypophosphatemia were reported in patients with all phases of CML
    • Elevations in transaminases or bilirubin were usually managed with dose reduction or interruption
    • Patients developing Grade 3/4 hypocalcemia during the course of SPRYCEL therapy often had recovery with oral calcium supplementation

In a multicohort study of SPRYCEL administered continuously in combination with multiagent chemotherapy in 81 pediatric patients with newly diagnosed Ph+ ALL, the median duration of therapy was 24 months (range 2 to 27 months).

  • In pediatric subjects with Ph+ ALL who were administered SPRYCEL in combination with multiagent chemotherapy:
    • Fatal adverse reactions occurred in 3 patients (4%), all of which were due to infections
    • Eight patients (10%) experienced adverse reactions leading to treatment discontinuation
    • The most common serious adverse reactions (incidence ≥10%) were pyrexia, febrile neutropenia, mucositis, diarrhea, sepsis, hypotension, infections (bacterial, viral and fungal), hypersensitivity, vomiting, renal insufficiency, abdominal pain, and musculoskeletal pain
    • The most common adverse reactions (≥30%) in pediatric patients receiving SPRYCEL in combination with chemotherapy included mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness
    • Grade 3/4 laboratory abnormalities (≥10%) included neutropenia (96%), thrombocytopenia (88%), anemia (82%), elevated SGPT (ALT) (47%), hypokalemia (40%), elevated SGOT (AST) (26%), hypocalcemia (19%), hyponatremia (19%), elevated bilirubin (11%), and hypophosphatemia (11%)

In two non-randomized trials in 97 pediatric patients with chronic phase CML (51 patients newly diagnosed and 46 patients resistant or intolerant to previous treatment with imatinib), the median duration of therapy was 51.1 months (range 1.9 to 99.6 months).

  • Among the 97 CML pediatric subjects, drug-related adverse reactions leading to discontinuation were reported in 1 patient (1%)
  • Drug-related serious adverse reactions were reported for 14.4% of pediatric patients
  • Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of pediatric patients with chronic phase CML
  • The most common adverse reactions (≥15%) in pediatric patients included myelosuppression, headache, nausea, diarrhea, skin rash, pain in extremity, and abdominal pain.

Please see full Prescribing Information.

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