Dasatinib
Tablet, Film Coated · Oral
Uses
Dasatinib tablets are 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. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)
Dosage and administration
Chronic phase CML in adults: 100 mg once daily. (2) Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults: 140 mg once daily. (2) Chronic phase CML and ALL in pediatrics: starting dose based on body weight. (2) Administer orally, with or without a meal. Do not crush, cut, or chew tablets. (2) 2.1 Dosage of Dasatinib Tablets in Adult Patients The recommended starting dosage of Dasatinib tablets for chronic phase CML in adults is 100 mg administered orally once daily. The recommended starting dosage of Dasatinib tablets for accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL in adults is 140 mg administered orally once daily. Tablets should not be crushed, cut, or chewed; they should be swallowed whole. Dasatinib tablets can be taken with or without a meal, either in the morning or in the evening. 2.2 Dosage of Dasatinib Tablets in Pediatric Patients with CML or Ph+ ALL The recommended starting dosage for pediatrics is based on body weight as shown in Table 1. The recommended dose should be administered orally once daily with or without food. Recalculate the dose every 3 months based on changes in body weight, or more often if necessary. Do not crush, cut or chew tablets. Swallow tablets whole. There are additional administration considerations for pediatric patients who have difficulty swallowing tablets whole [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3) ] . Table 1: Dosage of Dasatinib tablets for Pediatric Patients a Body Weight (kg) b Daily Dose (mg) a For pediatric patients with Ph+ ALL, begin Dasatinib tablet therapy on or before day 15 of induction chemotherapy, when diagnosis is confirmed and continue for 2 years. b Tablet dosing is not recommended for patients weighing less than 10 kg. 10 to less than 20 40 mg 20 to less than 30 60 mg 30 to less than 45 70 mg at least 45 100 mg Refer to Section 2.4 for recommendations on dose escalation in adults with CML and Ph+ ALL, and pediatric patients with CML. 2.3 Dose Modification Strong CYP3A4 Inducers Avoid the use of concomitant strong CYP3A4 inducers and St. John’s wort. If patients must be coadministered a strong CYP3A4 inducer, consider a Dasatinib tablets dose increase. If the dose of Dasatinib tablets is increased, monitor the patient carefully for toxicity [see Drug Interactions (7.1) ] . Strong CYP3A4 Inhibitors Avoid the use of concomitant strong CYP3A4 inhibitors and grapefruit juice. Recommend selecting an alternate concomitant medication with no or minimal enzyme inhibition potential, if possible. If Dasatinib tablets must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
• 40 mg daily for patients taking Dasatinib tablets 140 mg daily.
• 20 mg daily for patients taking Dasatinib tablets 100 mg daily.
• 20 mg daily for patients taking Dasatinib tablets 70 mg daily. For patients taking Dasatinib tablets 60 mg or 40 mg daily, consider interrupting Dasatinib tablets until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating Dasatinib tablets. These reduced doses of Dasatinib tablets are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors. If Dasatinib tablets are not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or interrupt Dasatinib tablets until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before the Dasatinib tablet dose is increased [see Drug Interactions (7.1) ] . 2.4 Dose Escalation in Adults with CML and Ph+ ALL, and Pediatric Patients with CML For adult patients with CML and Ph+ ALL, consider dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML and Ph+ ALL) in patients who do not achieve a hematologic or cytogenetic response at the recommended starting dosage. For pediatric patients with CML, consider dose escalation to 120 mg once daily (see Table 2 below). Dose escalation is not recommended for pediatric patients with Ph+ ALL, where Dasatinib tablets are administered in combination with chemotherapy. Escalate the Dasatinib tablet dose as shown in Table 2 in pediatric patients with chronic phase CML who do not achieve a hematologic or cytogenetic response at the recommended starting dosage. Table 2: Dose Escalation for Pediatric CML Formulation Dose (maximum dose per day) Starting Dose Escalation Tablets 40 mg 50 mg 60 mg 70 mg 70 mg 90 mg 100 mg 120 mg 2.5 Dose Adjustment for Adverse Reactions Myelosuppression In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression. Guidelines for dose modifications for adult and pediatric patients are summarized in Tables 3 and 4, respectively. Table 3: Dose Adjustments for Neutropenia and Thrombocytopenia in Adults * ANC: absolute neutrophil count Chronic Phase CML (starting dose 100 mg once daily) ANC* <0.5 × 10 9 /L or Platelets <50 × 10 9 /L Stop Dasatinib tablets until ANC ≥1.0 × 10 9 /L and platelets ≥50 × 10 9 /L. Resume treatment with Dasatinib tablets at the original starting dose if recovery occurs in ≤7 days. If platelets <25 × 10 9 /L or recurrence of ANC <0.5 × 10 9 /L for >7 days, repeat Step 1 and resume Dasatinib tablets at a reduced dose of 80 mg once daily for second episode. For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue Dasatinib tablets (for patients resistant or intolerant to prior therapy including imatinib).
Dosage forms and strengths
Dasatinib tablets are available as 20-mg, 50-mg, 70-mg, 80-mg, 100-mg, and 140-mg white to off-white, biconvex, film-coated tablets. Tablets: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. (3)
Contraindications
None. None. (4)
Warnings and precautions
Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia, and anemia may occur. Use caution if used concomitantly with medications that inhibit platelet function or anticoagulants. Monitor complete blood counts regularly. Transfuse and interrupt Dasatinib tablets when indicated. (2.5 , 5.1 , 5.2) Fluid Retention: Fluid retention, sometimes severe, including pleural effusions. Manage with supportive care measures and/or dose modification. (2.5 , 5.3) Cardiovascular Toxicity: Monitor patients for signs or symptoms and treat appropriately. (5.4) Pulmonary Arterial Hypertension (PAH): Dasatinib tablets may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop Dasatinib tablets if PAH is confirmed. (5.5) QT Prolongation: Use Dasatinib tablets with caution in patients who have or may develop prolongation of the QT interval. (5.6) Severe Dermatologic Reactions: Individual cases of severe mucocutaneous dermatologic reactions have been reported. (5.7) Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with Dasatinib tablets. (5.8) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of potential risk to fetus and to use effective contraception. (5.9 , 8.1 , 8.3) Effects on Growth and Development in Pediatric Patients: epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development in pediatric patients. (5.10) Hepatotoxicity: Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction. (5.11) 5.1 Myelosuppression Treatment with Dasatinib tablets is associated with severe (NCI CTCAE Grade 3 or 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 [see Adverse Reactions (6.1) ] . 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 Dasatinib tablets 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 Dasatinib tablets temporarily and/or dose reduction [see Dosage and Administration (2.5) ] . 5.2 Bleeding-Related Events Dasatinib tablets 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 dasatinib. The incidence of Grade 3/4 hemorrhage occurred in 5.8% of adult 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 [see Adverse Reactions (6.1) ] . 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. 5.3 Fluid Retention Dasatinib tablets may cause fluid retention [see Adverse Reactions (6.1) ] . After 5 years of follow-up in the adult randomized newly diagnosed chronic phase CML study (n=258), Grade 3 or 4 fluid retention was reported in 5% of patients, including 3% of patients with Grade 3 or 4 pleural effusion. In adult patients with newly diagnosed or imatinib-resistant or -intolerant chronic phase CML, Grade 3 or 4 fluid retention occurred in 6% of patients treated with Dasatinib tablets at the recommended dose (n=548). In adult patients with advanced phase CML or Ph+ ALL treated with Dasatinib tablets at the recommended dose (n=304), Grade 3 or 4 fluid retention was reported in 8% of patients, including Grade 3 or 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. Evaluate patients who develop symptoms of pleural effusion or other fluid retention, such as new or worsened dyspnea on exertion or at rest, pleuritic chest pain, or dry cough, promptly with a chest x-ray or additional diagnostic imaging as appropriate. Fluid retention events were typically managed by supportive care measures that may include diuretics or short courses of steroids. Severe pleural effusion may require thoracentesis and oxygen therapy. Consider dose reduction or treatment interruption [see Dosage and Administration (2.5) ] . 5.4 Cardiovascular Toxicity Dasatinib tablets can cause cardiac dysfunction [see Adverse Reactions (6.1) ] . After 5 years of follow-up in the randomized newly diagnosed chronic phase CML trial in adults (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.
Side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Myelosuppression [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] . Bleeding-related events [see Warnings and Precautions (5.2) ] . Fluid retention [see Warnings and Precautions (5.3) ] . Cardiovascular toxicity [see Warnings and Precautions (5.4) ] . Pulmonary arterial hypertension [see Warnings and Precautions (5.5) ] . QT prolongation [see Warnings and Precautions (5.6) ] . Severe dermatologic reactions [see Warnings and Precautions (5.7) ] . Tumor lysis syndrome [see Warnings and Precautions (5.8) ] . Effects on growth and development in pediatric patients [see Warnings and Precautions (5.10) ] . Hepatotoxicity [see Warnings and Precautions (5.11) ] . Most common adverse reactions (≥15%) in patients receiving Dasatinib tablets as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. (6) Most common adverse reactions (≥30%) in pediatric patients receiving Dasatinib tablets 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. (6) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to dasatinib tablets administered as single-agent therapy at all doses tested in clinical studies (n=2809), including 324 adult patients with newly diagnosed chronic phase CML, 2388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 97 pediatric patients with chronic phase CML. The median duration of therapy in a total of 2712 adult patients was 19.2 months (range 0 to 93.2 months). In a randomized trial in patients with newly diagnosed chronic phase CML, the median duration of therapy was approximately 60 months. The median duration of therapy in 1618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months). The median duration of therapy in 1094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months). 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). In the overall population of 2712 adult patients, 88% of patients experienced adverse reactions at some time and 19% experienced adverse reactions leading to treatment discontinuation. In the randomized trial in adult patients with newly diagnosed chronic phase CML, drug was discontinued for adverse reactions in 16% of 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 1618 patients with chronic phase CML, drug-related adverse reactions leading to discontinuation were reported in 329 (20.3%) patients; among the 1094 patients with advanced phase CML or Ph+ ALL, drug-related adverse reactions leading to discontinuation were reported in 191 (17.5%) patients. Among the 97 pediatric subjects, drug-related adverse reactions leading to discontinuation were reported in 1 patient (1%). Adverse reactions reported in ≥10% of adult patients, and other adverse reactions of interest, in a randomized trial in patients with newly diagnosed chronic phase CML at a median follow-up of approximately 60 months are presented in Table 6. Adverse reactions reported in ≥10% of adult patients treated at the recommended dose of 100 mg once daily (n=165), and other adverse reactions of interest, in a randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy at a median follow-up of approximately 84 months are presented in Table 8. Adverse reactions reported in ≥10% of pediatric patients at a median follow-up of approximately 51.1 months are presented in Table 11. Drug-related serious adverse reactions (SARs) were reported for 16.7% of adult patients in the randomized trial of patients with newly diagnosed chronic phase CML. Serious adverse reactions reported in ≥5% of patients included pleural effusion (5%). Drug-related SARs were reported for 26.1% of patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of adult patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥5% of patients included pleural effusion (10%). Drug-related SARs were reported for 14.4% of pediatric patients. Chronic Myeloid Leukemia (CML) Adverse reactions (excluding laboratory abnormalities) that were reported in at least 10% of adult patients are shown in Table 6 for newly diagnosed patients with chronic phase CML and Tables 8 and 10 for CML patients with resistance or intolerance to prior imatinib therapy.
Drug interactions
Strong CYP3A4 Inhibitors: Dose reduction may be necessary. (2.3 , 7.1) Strong CYP3A4 Inducers: Dose increase may be necessary. (2.3 , 7.1) Antacids: Avoid simultaneous administration. (7.1) H 2 Antagonists and Proton Pump Inhibitors: Avoid coadministration. (7.1) 7.1 Effect of Other Drugs on Dasatinib Strong CYP3A4 Inhibitors The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations [see Clinical Pharmacology (12.3) ] . 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 Dasatinib tablet dose reduction [see Dosage and Administration (2.5) ] . Strong CYP3A4 Inducers The coadministration of Dasatinib tablets with strong CYP3A inducers may decrease dasatinib concentrations [see Clinical Pharmacology (12.3) ] . 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 Dasatinib tablet dose increase. Gastric Acid Reducing Agents The coadministration of Dasatinib tablets with a gastric acid reducing agent may decrease the concentrations of dasatinib. Decreased dasatinib concentrations may reduce efficacy. Do not administer H 2 antagonists or proton pump inhibitors with Dasatinib tablets. Consider the use of antacids in place of H 2 antagonists or proton pump inhibitors. Administer the antacid at least 2 hours prior to or 2 hours after the dose of Dasatinib tablets. Avoid simultaneous administration of Dasatinib tablets with antacids. 7.1 Effect of Other Drugs on Dasatinib Strong CYP3A4 Inhibitors The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations [see Clinical Pharmacology (12.3) ] . 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 Dasatinib tablet dose reduction [see Dosage and Administration (2.5) ] . Strong CYP3A4 Inducers The coadministration of Dasatinib tablets with strong CYP3A inducers may decrease dasatinib concentrations [see Clinical Pharmacology (12.3) ] . 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 Dasatinib tablet dose increase. Gastric Acid Reducing Agents The coadministration of Dasatinib tablets with a gastric acid reducing agent may decrease the concentrations of dasatinib. Decreased dasatinib concentrations may reduce efficacy. Do not administer H 2 antagonists or proton pump inhibitors with Dasatinib tablets. Consider the use of antacids in place of H 2 antagonists or proton pump inhibitors. Administer the antacid at least 2 hours prior to or 2 hours after the dose of Dasatinib tablets. Avoid simultaneous administration of Dasatinib tablets with antacids.
Use in specific populations
Lactation: Advise women not to breastfeed. (8.2) 8.1 Pregnancy Risk Summary Based on limited human data, Dasatinib tablets can cause fetal harm when administered to a pregnant woman. Adverse pharmacologic effects including hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to Dasatinib tablets. Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates. Skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses. These findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib [see Data] . Advise a pregnant woman of the potential risk to a fetus. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Fetal/Neonatal Adverse Reactions Transplacental transfer of dasatinib has been reported. Dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma. Hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. These adverse pharmacologic effects on the fetus are similar to adverse reactions observed in adult patients and may result in fetal harm or neonatal death [see Warnings and Precautions (5.1 , 5.3) ] . Data Human Data Based on human experience, dasatinib is suspected to cause congenital malformations, including neural tube defects, and harmful pharmacological effects on the fetus when administered during pregnancy. Animal Data In nonclinical studies at plasma concentrations below those observed in humans receiving therapeutic doses of dasatinib, embryo-fetal toxicities were observed in rats and rabbits. Fetal death was observed in rats. In both rats and rabbits, the lowest doses of dasatinib tested (rat: 2.5 mg/kg/day [15 mg/m 2 /day] and rabbit: 0.5 mg/kg/day [6 mg/m 2 /day]) resulted in embryo-fetal toxicities. These doses produced maternal AUCs of 105 ng
• h/mL and 44 ng
• h/mL (0.1-fold the human AUC) in rats and rabbits, respectively. Embryo-fetal toxicities included skeletal malformations at multiple sites (scapula, humerus, femur, radius, ribs, and clavicle), reduced ossification (sternum; thoracic, lumbar, and sacral vertebrae; forepaw phalanges; pelvis; and hyoid body), edema, and microhepatia. In a pre- and postnatal development study in rats, administration of dasatinib from gestation day (GD) 16 through lactation day (LD) 20, GD 21 through LD 20, or LD 4 through LD 20 resulted in extensive pup mortality at maternal exposures that were below the exposures in patients treated with dasatinib at the recommended labeling dose. 8.2 Lactation Risk Summary 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 Dasatinib tablets, breastfeeding is not recommended during treatment with Dasatinib tablets and for 2 weeks after the last dose. 8.3 Females and Males of Reproductive Potential Dasatinib tablets can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Contraception Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Dasatinib tablets and for 30 days after the last dose. Infertility Based on animal data, dasatinib may result in damage to female and male reproductive tissues [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use Ph+ CML in Chronic Phase The safety and effectiveness of Dasatinib tablet monotherapy have been demonstrated in pediatric patients with newly diagnosed chronic phase CML [see Clinical Studies (14.3) ] . There are no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of patients [see Warnings and Precautions (5.10) ] . Ph+ ALL The safety and effectiveness of Dasatinib tablets in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. Use of Dasatinib tablets in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year of age. One case of grade 1 osteopenia was reported. The safety profile of Dasatinib tablets in pediatric subjects was comparable to that reported in studies in adult subjects [see Adverse Reactions (6.1) and Clinical Studies (14.3 , 14.4) ] . Monitor bone growth and development in pediatric patients [see Warnings and Precautions (5.10) ] . Pediatric Patients with Difficulty Swallowing Tablets Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of Dasatinib tablet dispersed in juice on Study CA180372. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients [see Clinical Pharmacology (12.3) ] . Due to the limited available clinical data, it is unclear whether dispersing Dasatinib tablets significantly alters the safety and/or efficacy of Dasatinib. 8.5 Geriatric Use Of the 2712 patients in clinical studies of dasatinib, 617 (23%) were 65 years of age and older, and 123 (5%) were 75 years of age and older. No differences in confirmed Complete Cytogenetic Response (cCCyR) and MMR were observed between older and younger patients.
Pregnancy
8.1 Pregnancy Risk Summary Based on limited human data, Dasatinib tablets can cause fetal harm when administered to a pregnant woman. Adverse pharmacologic effects including hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to Dasatinib tablets. Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates. Skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses. These findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib [see Data] . Advise a pregnant woman of the potential risk to a fetus. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Fetal/Neonatal Adverse Reactions Transplacental transfer of dasatinib has been reported. Dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma. Hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia have been reported with maternal exposure to dasatinib. These adverse pharmacologic effects on the fetus are similar to adverse reactions observed in adult patients and may result in fetal harm or neonatal death [see Warnings and Precautions (5.1 , 5.3) ] . Data Human Data Based on human experience, dasatinib is suspected to cause congenital malformations, including neural tube defects, and harmful pharmacological effects on the fetus when administered during pregnancy. Animal Data In nonclinical studies at plasma concentrations below those observed in humans receiving therapeutic doses of dasatinib, embryo-fetal toxicities were observed in rats and rabbits. Fetal death was observed in rats. In both rats and rabbits, the lowest doses of dasatinib tested (rat: 2.5 mg/kg/day [15 mg/m 2 /day] and rabbit: 0.5 mg/kg/day [6 mg/m 2 /day]) resulted in embryo-fetal toxicities. These doses produced maternal AUCs of 105 ng
• h/mL and 44 ng
• h/mL (0.1-fold the human AUC) in rats and rabbits, respectively. Embryo-fetal toxicities included skeletal malformations at multiple sites (scapula, humerus, femur, radius, ribs, and clavicle), reduced ossification (sternum; thoracic, lumbar, and sacral vertebrae; forepaw phalanges; pelvis; and hyoid body), edema, and microhepatia. In a pre- and postnatal development study in rats, administration of dasatinib from gestation day (GD) 16 through lactation day (LD) 20, GD 21 through LD 20, or LD 4 through LD 20 resulted in extensive pup mortality at maternal exposures that were below the exposures in patients treated with dasatinib at the recommended labeling dose.
Pediatric use
8.4 Pediatric Use Ph+ CML in Chronic Phase The safety and effectiveness of Dasatinib tablet monotherapy have been demonstrated in pediatric patients with newly diagnosed chronic phase CML [see Clinical Studies (14.3) ] . There are no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of patients [see Warnings and Precautions (5.10) ] . Ph+ ALL The safety and effectiveness of Dasatinib tablets in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. Use of Dasatinib tablets in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year of age. One case of grade 1 osteopenia was reported. The safety profile of Dasatinib tablets in pediatric subjects was comparable to that reported in studies in adult subjects [see Adverse Reactions (6.1) and Clinical Studies (14.3 , 14.4) ] . Monitor bone growth and development in pediatric patients [see Warnings and Precautions (5.10) ] . Pediatric Patients with Difficulty Swallowing Tablets Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of Dasatinib tablet dispersed in juice on Study CA180372. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients [see Clinical Pharmacology (12.3) ] . Due to the limited available clinical data, it is unclear whether dispersing Dasatinib tablets significantly alters the safety and/or efficacy of Dasatinib.
Geriatric use
8.5 Geriatric Use Of the 2712 patients in clinical studies of dasatinib, 617 (23%) were 65 years of age and older, and 123 (5%) were 75 years of age and older. No differences in confirmed Complete Cytogenetic Response (cCCyR) and MMR were observed between older and younger patients. While the safety profile of dasatinib in the geriatric population was similar to that in the younger population, patients aged 65 years and older 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.
Overdosage
Experience with overdose of dasatinib in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for 1 week was reported in two patients and both developed severe myelosuppression and bleeding. Since Dasatinib tablets are associated with severe myelosuppression [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] , monitor patients who ingest more than the recommended dosage closely for myelosuppression and give appropriate supportive treatment. Acute overdose in animals was associated with cardiotoxicity. Evidence of cardiotoxicity included ventricular necrosis and valvular/ventricular/atrial hemorrhage at single doses ≥100 mg/kg (600 mg/m 2 ) in rodents. There was a tendency for increased systolic and diastolic blood pressure in monkeys at single doses ≥10 mg/kg (120 mg/m 2 ).
Description
Dasatinib tablets are a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22 H 26 ClN 7 O 2 S
• H 2 O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure: Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol. CHem
Mechanism of action
12.1 Mechanism of Action Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro , dasatinib was active in leukemic cell lines representing variants of imatinib mesylate-sensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib could overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression.
How supplied
How Supplied Dasatinib tablets are available as described in Table 21. Table 21: Dasatinib Tablets Trade Presentations NDC Number Strength Description Tablets per Bottle 66993-233-60 20 mg white to off-white, biconvex, round, film-coated tablet with “BMS” debossed on one side and “527” on the other side 60 66993-234-60 50 mg white to off-white, biconvex, oval, film-coated tablet with “BMS” debossed on one side and “528” on the other side 60 66993-235-60 70 mg white to off-white, biconvex, round, film-coated tablet with “BMS” debossed on one side and “524” on the other side 60 66993-236-30 80 mg white to off-white, biconvex, triangle, film-coated tablet with “BMS” and “80” (BMS over 80) debossed on one side and “855” on the other side 30 66993-237-30 100 mg white to off-white, biconvex, oval, film-coated tablet with “BMS 100” debossed on one side and “852” on the other side 30 66993-238-30 140 mg white to off-white, biconvex, round, film-coated tablet with “BMS” and “140” (BMS over 140) debossed on one side and “857” on the other side 30 Storage Dasatinib tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Handling and Disposal Dasatinib tablets are an antineoplastic product. Follow special handling and disposal procedures. 1 Personnel who are pregnant should avoid exposure to crushed or broken tablets. Dasatinib tablets consist of a core tablet, surrounded by a film coating to prevent exposure of healthcare professionals to the active substance. The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimize the risk of dermal exposure.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Myelosuppression Inform patients of the possibility of developing low blood cell counts. Advise patients to immediately report fever particularly in association with any suggestion of infection [see Warnings and Precautions (5.1) ] . Bleeding Inform patients of the possibility of serious bleeding and to report immediately any signs or symptoms suggestive of hemorrhage (unusual bleeding or easy bruising) [see Warnings and Precautions (5.2) ] . Fluid Retention Patients should be informed of the possibility of developing fluid retention (swelling, weight gain, dry cough, chest pain on respiration, or shortness of breath) and advised to seek medical attention promptly if those symptoms arise [see Warnings and Precautions (5.3) ] . Cardiovascular Toxicity Inform patients of the possibility of developing cardiovascular toxicity, including cardiac ischemic events, cardiac-related fluid retention, conduction abnormalities, and TIAs. Advise patients to seek immediate medical attention if symptoms suggestive of cardiovascular toxicity occur, such as chest pain, shortness of breath, palpitations, transient vision problems, or slurred speech [see Warnings and Precautions (5.4) ] . Pulmonary Arterial Hypertension Inform patients of the possibility of developing pulmonary arterial hypertension (dyspnea, fatigue, hypoxia, and fluid retention) and advise them to seek medical attention promptly if those symptoms arise [see Warnings and Precautions (5.5) ] . Tumor Lysis Syndrome Inform patients to immediately report and seek medical attention for any symptoms such as nausea, vomiting, weakness, edema, shortness of breath, muscle cramps, and seizures, which may indicate tumor lysis syndrome [see Warnings and Precautions (5.8) ] . Growth and Development in Pediatric Patients Inform pediatric patients and their caregivers of the possibility of developing bone growth abnormalities, bone pain, or gynecomastia and advise them to seek medical attention promptly if those symptoms arise [see Warnings and Precautions (5.10) ] . Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Dasatinib tablets and for 30 days after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking Dasatinib tablets [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise women that breastfeeding is not recommended during treatment with Dasatinib tablets and for 2 weeks after the final dose [see Use in Specific Populations (8.2) ] . Gastrointestinal Complaints Inform patients that they may experience nausea, vomiting, or diarrhea with Dasatinib tablets. Advise patients to seek medical attention if these symptoms are bothersome or persistent. Advise patients using antacids to avoid taking Dasatinib tablets and antacids less than 2 hours apart [see Drug Interactions (7.1) ] . Pain Inform patients that they may experience headache or musculoskeletal pain with Dasatinib tablets. Advise patients to seek medical attention if these symptoms are bothersome or persistent. Fatigue Inform patients that they may experience fatigue with Dasatinib tablets. Advise patients to seek medical attention if this symptom is bothersome or persistent. Rash Inform patients that they may experience skin rash with Dasatinib tablets. Advise patients to seek medical attention if this symptom is bothersome or persistent. Lactose Inform patients that Dasatinib tablets contains 135 mg of lactose monohydrate in a 100-mg daily dose and 189 mg of lactose monohydrate in a 140-mg daily dose. Hepatotoxicity Advise patients that Dasatinib tablets can cause hepatotoxicity and that patients with previous history of liver diseases may be at risk. Advise patients to seek immediate medical attention if any symptoms suggestive of hepatotoxicity occur, such as abdominal pain, jaundice and scleral icterus, anorexia, bleeding, bruising, and dark-colored urine [see Warnings and Precautions (5.11) ]. Instructions for Taking Dasatinib Tablets Missed Dose Advise patients that if they miss a dose of Dasatinib tablets, they should take the next scheduled dose at its regular time. The patient should not take two doses at the same time. Grapefruit Juice Advise patients not to drink grapefruit juice as it may increase the amount of Dasatinib tablets in their blood and therefore increase their risk of adverse reactions. Distributed by: Prasco Laboratories Mason, OH 45040 USA Rev. 07/2024
Label text from the FDA structured product label by Prasco Laboratories (revised Jul 9, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dasatinib in 90 products
Dasatinib NDC products (90)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 62332-689 | Dasatinib 140 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-688 | Dasatinib 100 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-687 | Dasatinib 80 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-686 | Dasatinib 70 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-685 | Dasatinib 50 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-684 | Dasatinib 20 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-684 | Dasatinib 20 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-689 | Dasatinib 140 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-688 | Dasatinib 100 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-687 | Dasatinib 80 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-686 | Dasatinib 70 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-685 | Dasatinib 50 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 60505-3629 | Dasatinib 50 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-3630 | Dasatinib 70 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-3631 | Dasatinib 100 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-3816 | Dasatinib 80 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-3817 | Dasatinib 140 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 60505-3628 | Dasatinib 20 mg/1 Tablet, Film Coated | Apotex Corp. | ANDA |
| 59651-542 | Dasatinib 20 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-543 | Dasatinib 50 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-544 | Dasatinib 70 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-545 | Dasatinib 80 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-546 | Dasatinib 100 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-547 | Dasatinib 140 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 73190-051 | Dasatinib 140 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 73190-050 | Dasatinib 100 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 73190-049 | Dasatinib 80 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 73190-048 | Dasatinib 70 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 73190-046 | Dasatinib 20 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 73190-047 | Dasatinib 50 mg/1 Tablet, Film Coated | AvKARE | ANDA |
| 70377-085 | Dasatinib 70 mg/1 Tablet, Film Coated | Biocon Pharma Inc. | ANDA |
| 70377-083 | Dasatinib 20 mg/1 Tablet, Film Coated | Biocon Pharma Inc. | ANDA |
| 70377-088 | Dasatinib 140 mg/1 Tablet, Film Coated | Biocon Pharma Inc. | ANDA |
| 70377-087 | Dasatinib 100 mg/1 Tablet, Film Coated | Biocon Pharma Inc. | ANDA |
| 70377-086 | Dasatinib 80 mg/1 Tablet, Film Coated | Biocon Pharma Inc. | ANDA |
| 70377-084 | Dasatinib 50 mg/1 Tablet, Film Coated | Biocon Pharma Inc. | ANDA |
| 68001-663 | Dasatinib 80 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-665 | Dasatinib 140 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-664 | Dasatinib 100 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-662 | Dasatinib 70 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-661 | Dasatinib 50 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-660 | Dasatinib 20 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 43598-599 | Dasatinib 20 mg/1 Tablet, Film Coated | Dr.Reddys Laboratories Inc | ANDA |
| 43598-604 | Dasatinib 140 mg/1 Tablet, Film Coated | Dr.Reddys Laboratories Inc | ANDA |
| 43598-603 | Dasatinib 100 mg/1 Tablet, Film Coated | Dr.Reddys Laboratories Inc | ANDA |
| 43598-602 | Dasatinib 80 mg/1 Tablet, Film Coated | Dr.Reddys Laboratories Inc | ANDA |
| 43598-601 | Dasatinib 70 mg/1 Tablet, Film Coated | Dr.Reddys Laboratories Inc | ANDA |
| 43598-600 | Dasatinib 50 mg/1 Tablet, Film Coated | Dr.Reddys Laboratories Inc | ANDA |
| 70748-213 | Dasatinib 140 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-212 | Dasatinib 100 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-211 | Dasatinib 80 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-210 | Dasatinib 70 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-209 | Dasatinib 50 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 70748-208 | Dasatinib 20 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 72603-922 | Dasatinib 20 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-927 | Dasatinib 140 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-926 | Dasatinib 100 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-925 | Dasatinib 80 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-924 | Dasatinib 70 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-923 | Dasatinib 50 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72205-324 | Dasatinib 140 mg/1 Tablet | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-323 | Dasatinib 100 mg/1 Tablet | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-322 | Dasatinib 80 mg/1 Tablet | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-321 | Dasatinib 70 mg/1 Tablet | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-320 | Dasatinib 50 mg/1 Tablet | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-319 | Dasatinib 20 mg/1 Tablet | Novadoz Pharmaceuticals LLC | ANDA |
| 0480-5104 | Dasatinib 100 mg/1 Tablet, Film Coated | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-5103 | Dasatinib 70 mg/1 Tablet, Film Coated | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-5102 | Dasatinib 50 mg/1 Tablet, Film Coated | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-3523 | Dasatinib 80 mg/1 Tablet, Film Coated | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-5101 | Dasatinib 20 mg/1 Tablet, Film Coated | Teva Pharmaceuticals, Inc. | ANDA |
| 0480-3524 | Dasatinib 140 mg/1 Tablet, Film Coated | Teva Pharmaceuticals, Inc. | ANDA |
| 70771-1901 | Dasatinib 20 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1905 | Dasatinib 100 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1904 | Dasatinib 80 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1903 | Dasatinib 70 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1902 | Dasatinib 50 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70771-1906 | Dasatinib 140 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 70710-1744 | Dasatinib 80 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1741 | Dasatinib 20 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1742 | Dasatinib 50 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1743 | Dasatinib 70 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1745 | Dasatinib 100 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1746 | Dasatinib 140 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 66993-238 | Dasatinib 140 mg/1 Tablet | Prasco Laboratories | NDA AUTHORIZED GENERIC |
| 66993-233 | Dasatinib 20 mg/1 Tablet | Prasco Laboratories | NDA AUTHORIZED GENERIC |
| 66993-234 | Dasatinib 50 mg/1 Tablet | Prasco Laboratories | NDA AUTHORIZED GENERIC |
| 66993-235 | Dasatinib 70 mg/1 Tablet | Prasco Laboratories | NDA AUTHORIZED GENERIC |
| 66993-236 | Dasatinib 80 mg/1 Tablet | Prasco Laboratories | NDA AUTHORIZED GENERIC |
| 66993-237 | Dasatinib 100 mg/1 Tablet | Prasco Laboratories | NDA AUTHORIZED GENERIC |
Frequently asked questions
What is Dasatinib used for?
Dasatinib tablets are 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…
What are the side effects of Dasatinib?
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Myelosuppression [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] . Bleeding-related events [see Warnings and Precautions (5.2) ] . Fluid retention [see Warnings and Precautions (5.3) ] . Cardiovascular toxicity [see Warnings and Precautions (5.4) ] .… See the full label for the complete list.
Who makes Dasatinib?
Dasatinib is listed by 15 labelers in the FDA NDC directory, including Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Apotex Corp., Aurobindo Pharma Limited.